Covance Pharmacometrics Template CDISC

CONFIDENTIAL CDISC - Dataset Definitions Covance Pharmacometrics Template

SDTM Version: 3.1.2 Version Date: 39764

Covance Template Version: 1.0 Version Date: 39933

STUDY SPECIFIC Client: Swedish Match AB Protocol Number: SM 08-01 Covance Study Number: 7694-105 Prepared by: Yuan Tian Date: 3/4/2010 Version: 1

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CODTC Date/Time of Comment Char 50 ISO 8601 CRF Timing Date/time of comment on dedicated comment form. Should be null if this is a Perm Yes child record of another domain or if comment date was not collected. EPOCH Epoch Char 50 * Derived Timing Trial Epoch of the related comment record defined by the trail design domains (if Perm Yes created). Examples: SCREENING, TREATMENT PHASE, FOLLOW-UP. VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Perm Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Perm Yes VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

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Covance Page 1 of 1 Confidential CDISC CM DATASET DEFINITIONS

CMSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier defined in the operational database. Example: line number on a concomitant medication page. CMTRT Reported Name of Drug, Med, or Char 200 CRF Topic Verbatim medication name that is either pre-printed or collected on a CRF. Req Yes Therapy CMMODIFY Modified Reported Name Char 200 Assigned Synonym Qualifier Revised Drug Name if collected. Perm Yes CMDECOD Standardized Medication Name Char 100 * Assigned Synonym Qualifier Preferred Term from WhoDrug. Perm Yes CMCAT Category for Medication Char 50 * CRF Grouping Qualifier “PREVIOUS MEDICATION” or “CONCOMITANT MEDICATION” from Perm Yes CRF. CMSCAT Subcategory for Medication Char 50 * CRF Grouping Qualifier A further categorization of medication/treatment. Examples: Perm Yes CHEMOTHERAPY, HORMONAL THERAPY, ALTERNATIVE THERAPY. CMPRESP CM Pre-Specified Char 2 (NY) Assigned Record Qualifier Used to indicate whether (Y/null) information about the use of a specific Perm Yes medication was solicited on the CRF. CMOCCUR CM Occurrence Char 2 (NY) CRF Record Qualifier When the use of specific medications is solicited, CMOCCUR is used to indicate Perm Yes whether or not (Y/N) use of the medication occurred. Values are null for medications not specifically solicited. CMSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate that a question about a pre-specified medication was not Perm Yes answered. Should be null or have a value of NOT DONE. CMREASND Reason Medication Not Collected Char 200 CRF Record Qualifier Describes the reason concomitant medication was not collected. Used in Perm Yes conjunction with CMSTAT when value is NOT DONE. CMINDC Indication Char 200 CRF Record Qualifier Indication from CRF. Perm Yes CMCLAS Medication Class Char 50 * Assigned Variable Qualifier Dictionary-derived drug class. When coding to a single class, populate with class Perm Yes value. If using a dictionary and coding to multiple classes, then omit CMCLAS and add values to SUPPCM. CMCLASCD Medication Class Code Char 20 * Assigned Variable Qualifier Dictionary-derived code corresponding to CMCLAS. When coding to a single Perm Yes class, populate with class code. If using a dictionary and coding to multiple classes, then omit CMCLAS and add values to SUPPCM. CMDOSE Dose per Administration Num 8 CRF Record Qualifier Numerical Dose from CRF. Perm Yes CMDOSTXT Dose Description Char 50 Derived/CRF Record Qualifier Dosing amounts or a range of dosing information collected in text form. If Perm Yes CMDOSE is non-numeric then populated. CMDOSU Dose Units Char 40 *(UNIT) CRF Variable Qualifier Units from CRF. Perm Yes CMDOSFRM Dose Form Char 50 *(FRM) CRF Record Qualifier Dose form for CMTRT. Perm Yes CMDOSFRQ Dosing Frequency Per Interval Char 50 *(FREQ) CRF Variable Qualifier Usually expressed at the number of repeated administrations of CMDOSE within Perm Yes a specified time period. Examples: BID (twice daily), Q12H (every 12 hours).

CMDOSTOT Total Daily Dose Num 8 Derived/CRF Record Qualifier Total daily dose of CMTRT using the units in CMDOSU. Total dose over a Perm Yes period other than day could be recorded in a separate Supplemental Qualifier variable. CMDOSTOT should be used in addition to CMDOSE, and not in place of it. CMDOSRGM Intended Dose Regimen Char 100 CRF/Protocol Variable Qualifier Regimen from CRF, if collected or derived from protocol. Perm Yes CMROUTE Route of Administration Char 50 *(ROUTE) CRF Variable Qualifier Route from CRF. Perm Yes CMSTDTC Start Date/Time of Medication Char 50 ISO 8601 CRF Timing Start Date/Time from CRF. Perm Yes CMENDTC End Date/Time of Medication Char 50 ISO 8601 CRF Timing Stop Date/Time from CRF. Perm Yes CMSTDY Study Day of Start of Medication Num 8 Derived Timing CMSTDTC-RFSTDTC. If >= 0 then add one. Perm Yes CMENDY Study Day of End of Medication Num 8 Derived Timing CMENDTC-RFSTDTC. If >= 0 then add one. Perm Yes CMDUR Duration of Medication Char 50 ISO 8601 CRF Timing Collected duration of medication in ISO 8601 format. Used only if collected on Perm Yes the CRF and not derived from start and end date/times.

Covance Page 1 of 2 Confidential CDISC CM DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? CMSTRF Start Relative to Reference Period Char 40 (STENRF) Derived Timing CMSTRF = “BEFORE” when CMSTDTC < RFSTDTC Perm Yes CMSTRF = “AFTER” when CMSTDTC > RFENDTC CMSTRF = “DURING” when RFSTDTC <= CMSTDTC <= RFENDTC if CMSTDTC is null then CESTRF is null. CMENRF End Relative to Reference Period Char 40 (STENRF) Derived Timing CMENRF = “BEFORE” when CMENDTC < RFSTDTC Perm Yes CMENRF = “AFTER” when CMENDTC > RFENDTC CMENRF = “DURING” when RFSTDTC <= CMENDTC <= RFENDTC if CMENDTC is null then CMENRF is null. CMSTRTPT Start Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the start of the medication as being before or after the reference time Perm Yes AFTER, U point defined by variable CMSTTPT. If information such as "PRIOR" was collected on CRF, this information should be translated into CMSTRTPT. CMSTTPT Start Reference Time Point Char 40 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by CMSTRTPT. Examples: "2003-12-15" or "VISIT 1". CMENRTPT End Relative to Reference Time Point Char 50 BEFORE, COINCIDENT, Derived Timing Identifies the end of the medication as being before or after the reference time Perm Yes AFTER, ONGOING, U point defined by variable CMENTPT. If information such as "ONGOING", or "CONTINUING" was collected on CRF, this information should be translated into CMENRTPT. CMENTPT End Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by CMENRTPT. Examples: "2003-12-25" or "VISIT 2". * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC EX DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol. Req Yes DOMAIN Domain Abbreviation Char 2 EX Assigned Identifier Domain name. Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes EXSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. EXGRPID Group ID Char 40 Derived/CRF Identifier Populated with value to identify or group together related records as appropriate. Perm Yes Example: If multiple doses are given on a same day, a unique value could be assigned for that day. EXSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier defined in the operational database. EXTRT Name of Actual Treatment Char 200 CRF/Protocol Topic Treatment from CRF or Protocol. Req Yes EXCAT Category for Treatment Char 50 * CRF Grouping Qualifier Category if multiple categories exist in CRF. Perm Yes EXSCAT Subcategory for Treatment Char 50 * CRF/Protocol Grouping Qualifier A further categorization of treatment. Perm Yes EXDOSE Dose per Administration Num 8 CRF/Protocol Record Qualifier Numeric amount of Dose level from protocol or CRF or study randomization. Exp Yes Example: If dose is 100 mg, then EXDOSE would be "100". EXDOSTXT Dose Description Char 50 CRF Record Qualifier Text form of Dose from protocol or CRF. Populated if EXDOSE and EXDOSU Perm Yes are null. EXDOSU Dose Units Char 40 *(UNIT) CRF Variable Qualifier Units for EXDOSE and EXDOSTOT from CRF or protocol. Exp Yes EXDOSFRM Dose Form Char 50 *(FRM) CRF Variable Qualifier Dose Form of EXTRT from protocol or CRF. Exp Yes EXDOSFRQ Dosing Frequency Per Interval Char 50 *(FREQ) CRF/Protocol Variable Qualifier Usually expressed as the number of repeated administrations of EXDOSE within Perm Yes a specific time period. Examples: BID (twice daily), Q4S (once every four weeks), BIS (twice a week). EXDOSTOT Total Daily Dose Num 8 CRF/Protocol Record Qualifier Total daily dose of EXTRT using the units in EXDOSU derived from protocol or Perm Yes CRF. Total dose over a period other than one day could be recorded in a separate Supplemental Qualifier variable. EXDOSRGM Intended Dose Regimen Char 100 CRF/Protocol Variable Qualifier Text description of the (intended) schedule regimen derived from protocol or Perm Yes CRF. EXROUTE Route of Administration Char 50 *(ROUTE) CRF/Protocol Variable Qualifier Route of administration from protocol or CRF. Perm Yes EXLOT Lot Number Char 50 CRF Record Qualifier Lot Number of the EXTRT product from CRF or pharmacy record. Perm Yes EXLOC Location of Dose Administration Char 100 *(LOC) CRF/Protocol Record Qualifier Location of administration from CRF or protocol. Example: LEFT ARM for a Perm Yes topical application. EXTRTV Treatment Vehicle Char 100 * CRF/Protocol Record Qualifier Describes vehicle used for treatment. Example: SALINE. Perm Yes EXVAMT Treatment Vehicle Amount Num 8 CRF/Protocol Variable Qualifier Amount administered of the treatment vehicle indicated by EXTRTV. Perm Yes EXVAMTU Treatment Vehicle Amount Units Char 50 *(UNIT) CRF/Protocol Variable Qualifier Units of the treatment vehicle amount indicated by EXVAMT. Perm Yes EXADJ Reason for Dose Adjustment Char 200 * CRF Record Qualifier Describes reason or explanation of why a dose is adjusted – used only when an Perm Yes adjustment is represented in EX. May be used for variations from protocol- specified doses, or changes from expected doses. TAETORD Planned Order of Elements with Arm Num 8 CRF/Protocol Timing Number that gives the planned order of the Element within the subject's assigned Perm Yes ARM as represented in TA domain. EPOCH Epoch Char 50 * Derived Timing Trial Epoch of the related comment record defined by the trail design domains (if Perm Yes created). Examples: SCREENING, TREATMENT PHASE, FOLLOW-UP. EXSTDTC Start Date/Time of Treatment Char 50 ISO 8601 CRF Timing The date/time when administration of the treatment indicated by EXTRT and Exp Yes EXDOSE began. EXENDTC End Date/Time of Treatment Char 50 ISO 8601 CRF Timing The date/time when administration of the treatment indicated by EXTRT and Perm Yes EXDOSE ended. EXSTDY Study Day of Start of Treatment Num 8 Derived Timing EXSTDTC-RFSTDTC. If >= 0 then add one. Perm Yes EXENDY Study Day of End of Treatment Num 8 Derived Timing EXENDTC-RFSTDTC. If >= 0 then add one. Perm Yes EXDUR Duration of Treatment Char 50 ISO 8601 CRF Timing Collected duration and unit of a treatment. Used only if collected on the CRF Perm Yes and derived from start and end date/times. EXTPT Planned Time Point Name Char 100 CRF Timing Scheduled Timepoint in CRF (not the header) if applicable. Perm Yes EXTPTNUM Planned Time Point Number Num 8 Derived Timing Numeric form of EXTPT for sorting. Perm Yes EXELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned elapsed time (in ISO 8601) format relative to the planned fixed reference Perm Yes Ref (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time. Represented as an ISO duration.

Covance Page 1 of 2 Confidential CDISC EX DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? EXTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point referred to by EXELTM, EXTPTNUM, and Perm Yes EXTPT. Examples: PREVIOUS DOES, PREVIOUS MEAL. * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC SU DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specifed in Protocol. Req Yes DOMAIN Domain Abbreviation Char 2 SU Assigned Identifier Domain name. Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes SUSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. SUGRPID Group ID Char 40 Derived/CRF Identifier Populated with value to identify or group together related records as appropriate. Perm Yes Example: If multiple substances are assessed on a same day, a unique value could be assigned for that day. SUSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier defined in the operational database. SUTRT Reported Name of Substance Char 200 CRF Topic Verbatim Substance name from CRF. Examples: Tobacco, Alcohol, Cigarettes, Req Yes Beer SUMODIFY Modified Substance Name Char 200 Assigned Synonym Qualifier If SUTRT is modified, then the modifed text is placed here. Perm Yes SUDECOD Standardized Substance Name Char 100 * Assigned Synonym Qualifier Standardized or dictionary-derived text description of SUTRT or SUMODIFY if Perm Yes the substance use is coded. If an intervention term does not have a decode value in the dictionary then SUDECOD will be null. SUCAT Category for Substance Use Char 50 * CRF Grouping Qualifier Used to define a category of related records. Examples: TOBACCO, Perm Yes ALCOHOL, or CAFFEINE. SUSCAT Subcategory for Substance Use Char 50 * CRF Grouping Qualifier A further categorization of substance use. Examples: CIGARS, CIGARETTES, Perm Yes BEER, WINE. SUPRESP SU Pre-Specified Char 2 (NY) Assigned Record Qualifier Used to indicate whether (Y/null) information about the use of a specific Perm Yes substance was solicited on the CRF. SUOCCUR SU Occurrence Char 2 (NY) CRF Record Qualifier When the use of specific substances is solicited (ex. "Does the subject smoke or Perm Yes use tobacco products?") on CRF, SUOCCUR is used to indicate whether or not (Y/N) a particular pre-specified substance was used. If subject is an ex-smoker, SUOCCUR = Y and a SUSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier When the use of pre-specified substances is solicited, the completion status Perm Yes indicates that there was no response to the question about the pre-specified substance. When there is no pre-specified list on the CRF, then the completion status indicates that SUREASND Reason Substance Use Not Collected Char 200 CRF Record Qualifier Describes the reason substance use was not collected. Used in conjunction with Perm Yes SUSTAT when value is NOT DONE. SUCLAS Substance Use Class Char 50 * Assigned Variable Qualifier Dictionary-derived. When coding to a single class, populate with class value. If Perm Yes using a dictionary and coding to multiple classes, then omit SUCLAS and add values to SUPPSU. SUCLASCD Substance Use Class Code Char 20 * Assigned Variable Qualifier Dictionary-derived code corresponding to SUCLAS. When coding to a single Perm Yes class, populate with class code. If using a dictionary and coding to multiple classes, then omit SUCLAS and add values to SUPPSU. SUDOSE Substance Use Consumption Num 8 CRF Record Qualifier Amount of SUTRT consumed as specified on CRF (i.e. Number of cigarettes Perm Yes consumed per day). SUDOSTXT Substance Use Consumption Text Char 50 CRF Record Qualifier Substance use consumption amounts or a range of consumption information Perm Yes collected in text form Example: LESS THAN 5. SUDOSU Consumption Units Char 40 *(UNIT) CRF Variable Qualifier Units for SUDOSE, SUDOSTXT and SUDOSTOT. Examples: OUNCES, Perm Yes CIGARETTE EQUIVALENTS, or GRAMS. SUDOSFRM Dose Form Char 50 *(FRM) CRF Record Qualifier Dose form for SUTRT. Examples: INJECTABLE, LIQUID, or POWDER. Perm Yes SUDOSFRQ Use Frequency Per Interval Char 50 *(FREQ) CRF Variable Qualifier Frequency or number of repeated administrations of SUDOSE within a specifed Perm Yes time period from CRF. Examples: Q24H (every day). SUDOSTOT Total Daily Consumption Num 8 Derived/CRF Record Qualifier Total daily dose of SUTRT using the units in SUDOSU. Total dose over a period Perm Yes other than day could be recorded in a separate Supplemental Qualifier variable. SUDOSTOT should be used in addition to SUDOSE, and not in place of it.

SUROUTE Route of Administration Char 50 *(ROUTE) CRF Variable Qualifier Route from CRF of administrationif specifed for SUTRT. Examples: ORAL, Perm Yes INTRAVENEOUS. SUSTDTC Start Date/Time of Substance Use Char 50 ISO 8601 CRF Timing Start Date/Time from CRF. Perm Yes

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? SUENDTC End Date/Time of Substance Use Char 50 ISO 8601 CRF Timing Stop Date/Time from CRF (i.e. Populated for ex-smokers). Perm Yes SUSTDY Study Day of Start of Substance Use Num 8 Derived Timing SUSTDTC-RFSTDTC. If >= 0 then add one. Perm Yes SUENDY Study Day of End of Substance Use Num 8 Derived Timing SUENDTC-RFSTDTC. If >= 0 then add one. Perm Yes SUDUR Duration of Substance Use Char 50 ISO 8601 CRF Timing Collected duration of substance use in ISO 8601 format. Used only if collected Perm Yes on the CRF and not derived from start and end date/times. SUSTRF Start Relative to Reference Period Char 40 (STENRF) Derived Timing SUSTRF = “BEFORE” when SUSTDTC < RFSTDTC Perm Yes SUSTRF = “AFTER” when SUSTDTC > RFENDTC SUSTRF = “DURING” when RFSTDTC <= SUSTDTC <= RFENDTC if SUSTDTC is null then SUSTRF is null. SUENRF End Relative to Reference Period Char 40 (STENRF) Derived Timing SUENRF = “BEFORE” when SUENDTC < RFSTDTC Perm Yes SUENRF = “AFTER” when SUENDTC > RFENDTC SUENRF = “DURING” when RFSTDTC <= SUENDTC <= RFENDTC if SUENDTC is null then SUENRF is null. SUSTRTPT Start Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the start of the substance use as being before or after the reference time Perm Yes AFTER, U point defined by variable SUSTTPT. If information such as "PRIOR" was collected on CRF, this information should be translated into SUSTRTPT. SUSTTPT Start Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by SUSTRTPT. Examples: "2003-12-15" or "VISIT 1". SUENRTPT End Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the end of the medication as being before or after the reference time Perm Yes AFTER, ONGOING, U point defined by variable SUENTPT. If information such as "ONGOING", or "CONTINUING" was collected on CRF, this information should be translated into SUENRTPT. SUENTPT End Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by SUENRTPT. Examples: "2003-12-25" or "VISIT 2". * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC AE DATASET DEFINITIONS

AEREFID Reference ID Char 40 Derived/CRF Identifier Reference number for SAE from safety database. Null for non-serious adverse Perm Yes events. AESPID Sponsor-Defined Identifier Char 40 CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier defined in the operational database. Example: Adverse event number on the CRF. AETERM Reported Term for the Adverse Event Char 200 CRF Topic Verbatim Adverse Event Term from CRF. Req Yes AEMODIFY Modified Reported Term Char 200 Assigned Synonym Qualifier If AETERM is modified to facilitate coding, then AEMODIFY will contain the Perm Yes modified text. AEDECOD Dictionary-Derived Term Char 150 * Assigned Synonym Qualifier Preferred Term (PT) from MedDRA. Req Yes AECAT Category for Adverse Event Char 50 * Assigned/CRF Grouping Qualifier Used to define category of related records. Perm Yes AESCAT Subcategory for Adverse Event Char 50 * Assigned/CRF Grouping Qualifier Further categorization of adverse events. Perm Yes AEPRESP Pre-Specified Adverse Event Char 2 (NY) Assigned Record Qualifier A value of “Y” indicates that this adverse event was pre-specified on the CRF. Perm Yes Values are null for spontaneously reported events (i.e., those collected as free- text verbatim terms). AEBODSYS Body System or Organ Class Char 70 * Assigned Record Qualifier Body system or organ class used by the sponsor from the coding dictionary (i.e. Exp Yes MedDRA). AELOC Location of Event Char 100 *(LOC) CRF Record Qualifier Describes anatomical location relevant for the event as specified on the CRF Perm Yes Example: LEFT ARM for skin rash. AESEV Severity/Intensity Char 10 (AESEV) CRF Record Qualifier The severity or intensity of the event. Examples: MILD, MODERATE, Perm Yes SEVERE. AESER Serious Event Char 2 (NY) Derived/CRF Record Qualifier A value of "Y" indicates a serious adverse event, otherwise coded to "N". Exp Yes AEACN Action Taken with Study Treatment Char 20 (ACN) CRF Record Qualifier Describes changes to the study treatment as a result of the event. AEACN is Exp Yes specifically for the relationship to study treatment. AEACNOTH is for actions unrelated to dose adjustments of study treatment. Examples: DRUG WITHDRAWN, DOSE REDUCED, DOSE INCREA AEACNOTH Other Action Taken Char 200 CRF Record Qualifier Describes other actions taken as a result of the event that are unrelated to dose Perm Yes adjustments of study treatment. Usually reported as free text. Example: “TREATMENT UNBLINDED. PRIMARY CARE PHYSICIAN NOTIFIED.” AEREL Causality Char 50 * CRF Record Qualifier Records the investigator’s opinion as to the causality of the event to the treatment Exp Yes as specified on CRF. Examples: NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED. AERELNST Relationship to Non-Study Treatment Char 200 CRF Record Qualifier Records the investigator's opinion as to whether the event may have been due to a Perm Yes treatment other than study drug. May be reported as free text. Example: "MORE LIKELY RELATED TO ASPIRIN USE.”. AEPATT Pattern of Adverse Event Char 50 * CRF Record Qualifier Used to indicate the pattern of the event over time as indicated on CRF. Perm Yes Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT. AEOUT Outcome of Adverse Event Char 35 (OUT) CRF Record Qualifier Description of the outcome of an event. Examples: RECOVERED/ RESOLVED, Perm Yes RECOVERING/ RESOLVING, NOT RECOVERED/ NOT RESOLVED, RECOVERED/ RESOLVED WITH SEQUELAE, FATAL or UNKNOWN.

AESCAN Involves Cancer Char 2 (NY) CRF Record Qualifier Was the serious event associated with the development of cancer? Perm Yes AESCONG Congenital Anomaly or Birth Defect Char 2 (NY) CRF Record Qualifier Was the serious event associated with congenital anomaly or birth defect? Perm Yes AESDISAB Persist or Signif Disability/Incapacity Char 2 (NY) CRF Record Qualifier Did the serious event result in persistent or significant disability/incapacity? Perm Yes AESDTH Results in Death Char 2 (NY) Derived/CRF Record Qualifier Did the serious event result in death? Perm Yes AESHOSP Requires or Prolongs Hospitalization Char 2 (NY) Derived/CRF Record Qualifier Did the serious event require or prolong hospitalization? Perm Yes AESLIFE Is Life Threatening Char 2 (NY) Derived/CRF Record Qualifier Was the serious event life threatening? Perm Yes AESOD Occurred with Overdose Char 2 (NY) Derived/CRF Record Qualifier Did the serious event occur with an overdose? Perm Yes

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? AESMIE Other Medically Important Serious Char 2 (NY) Derived/CRF Record Qualifier Do additional categories for seriousness apply? Perm Yes Event AECONTRT Concomitant or Additional Trtmnt Char 2 (NY) Derived/CRF Record Qualifier Was another treatment give because of the occurrence of the event? Perm Yes Given AETOXGR Standard Toxicity Grade Char 8 (TOXGR) Derived/CRF Record Qualifier Toxicity grade according to a standard toxicity scale such as Common Perm Yes Terminology Criteria for Adverse Events v3.0 (CTCAE). If value is from a numeric scale, represent only the number. Example: "2" and not "Grade 2". AESTDTC Start Date/Time of Adverse Event Char 50 ISO 8601 Derived/CRF Timing Start Date/Time from CRF Exp Yes AEENDTC End Date/Time of Adverse Event Char 50 ISO 8601 Derived/CRF Timing Stop Date/Time from CRF Exp Yes AESTDY Study Day of Start of Adverse Event Num 8 Derived Timing AESTDTC-RFSTDTC. If >= 0 then add one. Perm Yes AEENDY Study Day of End of Adverse Event Num 8 Derived Timing AEENDTC-RFSTDTC. If >= 0 then add one. Perm Yes AEDUR Duration of Adverse Event Char 50 ISO 8601 CRF Timing Collected duration and unit of an adverse event. Used only if collected on the Perm Yes CRF and not derived from start and end date/times. Example: P1DT2H (for 1 day, 2 hours). AEENRF End Relative to Reference Period Char 40 (STENRF) Derived Timing AEENRF = “BEFORE” when AEENDTC < RFSTDTC Perm Yes AEENRF = “AFTER” when AEENDTC > RFENDTC AEENRF = “DURING” when RFSTDTC <= AEENDTC <= RFENDTC if AEENDTC is null then AEENRF is null. AEENRTPT End Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the end of the event as being before or after the reference time point Perm Yes AFTER, ONGOING, U defined by variable AEENTPT. AEENTPT End Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by AEENRTPT. Examples: "2003-12-25" or "VISIT 2". * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC DS DATASET DEFINITIONS

DSREFID Reference ID Char 40 Derived/CRF Identifier Internal or external identifier. Perm Yes DSSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier defined in the operational database, the adverse event number if the subject discontinued due to an AE, and/or the informed co DSTERM Reported Term for the Disposition Char 200 CRF Topic Verbatim name of the event or protocol milestone. Some terms in DSTERM will Req Yes Event match DSDECOD, but others, such as 'Subject moved, ' will map to controlled terminology in DSDECOD, such as 'LOST TO FOLLOW-UP.' Also captures the additonal specified text suppor DSDECOD Standardized Disposition Term Char 50 *(NCOMPLT) Derived/CRF Synonym Qualifier Controlled terminology for the name of disposition event or protocol milestone. Req Yes Examples: COMPLETED, ADVERSE EVENT, DEATH, LACK OF EFFICACY, LOST TO FOLLOW-UP, NON-COMPLIANCE WITH STUDY DRUG, PHYSICIAN DECISION, PREGNANCY, PROGRESSIVE DISEASE, PROTOCOL VI DSCAT Category for Disposition Event Char 50 *(DSCAT) Assigned/Derived Grouping Qualifier Used to define a category of related records. DSCAT may be null if there are Exp Yes only “disposition events”; however, it is recommended that DSCAT always be populated. DSSCAT Subcategory for Disposition Event Char 50 * Assigned/Derived Grouping Qualifier A further categorization of disposition event. Perm Yes EPOCH Epoch Char 50 * Derived Timing Trial Epoch of the related comment record defined by the trail design domains (if Perm Yes created). Examples: SCREENING, TREATMENT PHASE, FOLLOW-UP. DSDTC Date/Time of Collection Char 50 ISO 8601 CRF Timing Date of collection of the event from the CRF. Perm Yes DSSTDTC Start Date/Time of Disposition Event Char 50 ISO 8601 CRF Timing Start Date/Time of disposition event from CRF Exp Yes DSSTDY Study Day of Start of Disposition Event Num 8 Derived Timing DSSTDTC-RFSTDTC. If >= 0 then add one. Perm Yes

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC MH DATASET DEFINITIONS

MHREFID Reference ID Char 40 Derived/CRF Identifier Internal or external medical history identifier. Perm Yes MHSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes as an explicit line identifier or record identifier, or code for medical history category defined in the operational database or on the CRF. MHTERM Reported Term for the Medical History Char 200 CRF Topic Diagnosis or Procedure from CRF. Req Yes

MHMODIFY Modified Reported Term Char 200 Assigned Synonym Qualifier If MHTERM is modified to facilitate coding, then MHMODIFY will contain the Perm Yes modified text. MHDECOD Dictionary-Derived Term Char 150 * Derived Synonym Qualifier Preferred Term (PT) from MedDRA (if used). Perm Yes MHCAT Category for Medical History Char 50 * Assigned Grouping Qualifier Used to define category of related records or type of medical history. Examples: Perm Yes GENERAL, CARDIAC, SURGICAL. MHSCAT Subcategory for Medical History Char 50 * CRF Grouping Qualifier Further categorization of condition or event. If CRF specifies medical history Perm Yes categories, MHSCAT will contain the text. Examples: DERMATOLOGICAL, HEENT. MHPRESP Medical History Event Pre-Specified Char 2 (NY) Assigned Record Qualifier A value of “Y” indicates that this medical history event was pre-specified on the Perm Yes CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms). MHOCCUR Medical History Occurrence Char 2 (NY) CRF Record Qualifier Used when the occurrence of specific medical history conditions is solicited to Perm Yes indicate whether or not (Y/N) a medical condition (MHTERM) had ever occurred. Values are null for spontaneously reported events. MHSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Use to indicate if an entire exam, group of tests, or individual test is not done. Perm Yes MHREASND Reason Medical History Not Collected Char 200 CRF Record Qualifier Describes the reason medical history was not collected. Used in conjunction with Perm Yes MHSTAT when value is NOT DONE. MHBODSYS Body System or Organ Class Char 70 * Assigned Record Qualifier SOC term from MedDRA if used. Perm Yes MHDTC Date/Time of History Collection Char 50 ISO 8601 CRF Timing Collection Date/Time from CRF header Perm Yes MHSTDTC Start Date/Time of Medical History Char 50 ISO 8601 CRF Timing Onset Date from CRF. Perm Yes Event MHENDTC End Date/Time of Medical History Char 50 ISO 8601 CRF Timing Stop Date from CRF. Perm Yes Event MHDY Study Day of History Collection Num 8 Derived Timing MHSTDTC-RFSTDTC. If >= 0 then add one. Perm Yes MHENRF End Relative to Reference Period Char 40 (STENRF) Derived Timing MHENRF = “BEFORE” when MHENDTC < RFSTDTC Perm Yes MHENRF = “AFTER” when MHENDTC > RFENDTC MHENRF = “DURING” when RFSTDTC <= MHENDTC <= RFENDTC if MHENDTC is null then MHENRF is null. MHENRTPT End Relative to Reference Time Point Char 40 BEFORE, AFTER, Derived Timing Identifies the end of the event as being before or after the reference time point Perm Yes COINCIDENT, defined by variable MHENTPT. If information such as "ONGOING", or ONGOING, U "CONTINUING" was collected on CRF, this information should be translated into MHENRTPT. MHENTPT End Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by MHENRTPT. Examples: "2003-12-25" or "VISIT 2". * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC Table of Contents DATASET DEFINITIONS

Section

Changes

Comments

Examples

Metadata

CDISC SDTM Controlled Terminolgy

CVD Controlled Terminolgy

SUPP-- Terminolgy

SPECIAL-PURPOSE DOMAINS Domain Used DM Demographics Yes CO Comments Yes SE Subject Elements No SV Subject Visits Yes

GENERAL OBSERVATION CLASSES - INTERVENTIONS CM Concomitant Medications Yes EX Exposure Yes SU Substance Use No

GENERAL OBSERVATION CLASSES - EVENTS AE Adverse Events Yes DS Disposition Yes MH Medical History Yes DV Protocol Deviations No CE Clinical Events No

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Section

GENERAL OBSERVATION CLASSES - FINDINGS EG ECG Test Results Yes IE Inclusion/Exclusion Criteria Not Met Yes LB Laboratory Test Results Yes PE Physical Examination Yes QS Questionnaire Yes SC Subject Characteristics Yes VS Vital Signs Yes DA Drug Accountability Yes MB Microbiology specimen No MS Microbiology Susceptibility No PC Pharmacokinetics Concentrations Yes PP Pharmacokinetics Parameters Yes FA Findings About Yes

TRIAL DESIGN DATASETS TA Trial Arms No TE Trial Elements No TV Trial Visits No TI Trial Inclusion/Exclusion Criteria No TS Trial Summary No

SPECIAL PURPOSE DATASETS RELREC Related Records No SUPP-- Supplemental Qualifiers for [domain name] Yes

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CEREFID Reference ID Char 40 Derived/CRF Identifier Internal or external identifier. Perm Yes CESPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. Example: Line number on a CRF page. CETERM Reported Term for the Clinical Event Char 200 CRF Topic Term for the medical condition or event. Most likely pre-printed on the CRF. Req Yes CEDECOD Dictionary-Derived Term Char 50 * Derived Synonym Qualifier Controlled terminology for the name of the clinical event. Perm Yes CECAT Category for Clinical Event Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Perm Yes CESCAT Subcategory for Clinical Event Char 50 * Derived/CRF Grouping Qualifier A further categorization of the condition or event. Perm Yes CEPRESP Clinical Event Pre-specified Char 2 (NY) Derived Record Qualifier Used to indicate whether the event in CETERM was pre-specified. Value is Y Perm Yes for pre-specified events, null for spontaneously reported events. CEOCCUR Clinical Event Occurrence Char 2 (NY) CRF Record Qualifier Used when the occurrence of specific events is solicited to indicate whether or Perm Yes not a clinical event occurred. Values are null for spontaneously reported events.

CESTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier The status indicates that a question from a pre-specified list was not answered. Perm Yes CEREASND Reason Clinical Event Not Collected Char 200 CRF Record Qualifier Describes the reason clinical event was not collected. Used in conjunction with Perm Yes CESTAT when value is NOT DONE. CEBODSYS Body System or Organ Class Char 70 * Assigned Record Qualifier SOC term from MedDRA if used. Perm Yes CESEV Severity/Intensity Char 10 * CRF Record Qualifier The severity or intensity of the event. Examples: MILD, MODERATE, Perm Yes SEVERE. CEDTC Date/Time of Event Collection Char 50 ISO 8601 CRF Timing Collection Date/Time from CRF header Perm Yes CESTDTC Start Date/Time of Clinical Event Char 50 ISO 8601 CRF Timing Onset Date from CRF. Perm Yes CEENDTC End Date/Time of Clinical Event Char 50 ISO 8601 CRF Timing Stop Date from CRF if collected. Perm Yes CEDY Study Day of Event Collection Num 8 Derived Timing CESTDTC-RFSTDTC. If >= 0 then add one. Perm Yes CESTRF Start Relative to Reference Period Char 40 (STENRF) Derived Timing CESTRF = “BEFORE” when CESTDTC < RFSTDTC Perm Yes CESTRF = “AFTER” when CESTDTC > RFENDTC CESTRF = “DURING” when RFSTDTC <= CESTDTC <= RFENDTC if CESTDTC is null then CESTRF is null. CEENRF End Relative to Reference Period Char 40 (STENRF) Derived Timing CEENRF = “BEFORE” when CEENDTC < RFSTDTC Perm Yes CEENRF = “AFTER” when CEENDTC > RFENDTC CEENRF = “DURING” when RFSTDTC <= CEENDTC <= RFENDTC if CEENDTC is null then CEENRF is null. CESTRTPT Start Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the start of the medication as being before or after the reference time Perm Yes AFTER, U point defined by variable CESTTPT. If information such as "PRIOR" was collected on CRF, this information should be translated into CESTRTPT. CESTTPT Start Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by CESTRTPT. Examples: "2003-12-15" or "VISIT 1". CEENRTPT End Relative to Reference Time Point Char 40 BEFORE, COINCIDENT, Derived Timing Identifies the end of the medication as being before or after the reference time Perm Yes AFTER, ONGOING, U point defined by variable CEENTPT. If information such as "ONGOING", or "CONTINUING" was collected on CRF, this information should be translated into CEENRTPT. CEENTPT End Reference Time Point Char 50 Derived Timing Description or date/time in ISO 8601 character format of the reference point Perm Yes referred to by CEENRTPT. Examples: "2003-12-25" or "VISIT 2". * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

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EGREFID ECG Reference ID Char 40 Derived/CRF Identifier Internal or external identifier. Example: Accession number from external file or Perm Yes reference number from CRF. EGSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. Example: Line number on a CRF page or order reference if multiple ECGs are collected within the same timepoint. EGTESTCD ECG Test or Examination Short Name Char 8 *(EGTESTCD) Assigned Topic Abbreviation of the measurement, test or examination described in EGTEST. Req Yes Examples: HR, PR, QRS, QT, INTP, etc. EGTEST ECG Test or Examination Name Char 40 *(EGTEST) Assigned Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding from the CRF. Examples: PR Interval, QT Interval, Interpretation, etc. EGCAT Category for ECG Char 50 * Derived Grouping Qualifier Used to categorize ECG observation across subjects. Examples: Perm Yes MEASUREMENT for ECG parameters or FINDING for interpretation. EGSCAT Subcategory for ECG Char 50 * Derived Grouping Qualifier A further categorization of the ECG. Perm Yes EGPOS ECG Position of Subject Char 50 *(POSITION) CRF Record Qualifier Position from CRF or protocol Examples: SUPINE, STANDING, SITTING. Perm Yes EGORRES Result or Finding in Original Units Char 200 CRF Result Qualifier Result of the ECG measurement or finding as originally received or collected on Exp Yes the CRF. If Abnormal is specified on CRF, EGORRES & EGSTRESC are set to 'ABNORMAL' and specify text should be added as an additional record as EGTESTCD = 'ABNTXT', EGTEST = EGORRESU Original Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Original units in which the data were collected or as indicated on the CRF. Perm Yes Examples: sec, or msec. EGSTRESC Character Result/Finding in Std Format Char 200 *(EGSTRESC) Derived Result Qualifier Contains the result value for all findings, copied or derived from EGORRES in a Exp Yes standard format or standard units. EGSTRESC should store all results or findings in character format if results are numeric, they should also be stored in numeric format in E EGSTRESN Numeric Result/Finding in Standard Num 8 Derived Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Perm Yes Units numeric format from EGSTRESC. EGSTRESN should store all numeric test results or findings. EGSTRESU Standard Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Standardized unit used form EGSTRESC or EGSTRESN. Perm Yes EGSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate an ECG was not done or an ECG measurement was not taken. Perm Yes Should be null if a result exists in EGORRES. EGREASND Reason ECG Not Performed Char 200 CRF Record Qualifier Describes why a measurement or test was not performed. Used in conjunction Perm Yes with EGSTAT when value is NOT DONE. EGXFN ECG External File Name Char 100 Assigned Record Qualifier File name for the external ECG file. Perm Yes EGNAM Vendor Name Char 50 Assigned Record Qualifier Name or identifier of the laboratory or vendor who provided the test results. Perm Yes EGLOC Lead Location Used for Measurement Char 20 *(LOC) CRF Variable Qualifier The lead used for the measurement. Examples: V1, V6, aVR, I, II, III. Perm Yes EGMETHOD Method of ECG Test Char 50 *(EGMETHOD) CRF Record Qualifier Method of the ECG test. Examples: HOLTER MONITOR, SERIAL, 12-LEAD. Perm Yes

EGBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator to identify baseline value. Usually sponsor defined in protocol or last Exp Yes reading prior to first dose. “Y” to indicate a baseline flag, otherwise.

EGDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be "Y" or null. Records Perm Yes which represent the average of other records, or that do not come from the CRF, or are not as originally collected or received are examples of records that would be derived for EGEVAL Evaluator Char 50 *(EVAL) CRF Record Qualifier Role of the person who provided the evaluation. Used only for results that are Perm Yes subjective (i.e. assigned by a person or group). Should be null for records that contain collected or derived data. Examples: INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR.

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes EGDTC Date/Time of ECG Char 50 ISO 8601 CRF Timing Actual Date/ Time from CRF. Exp Yes EGDY Study Day of ECG Num 8 Derived Timing EGDTC-RFSTDTC. If >= 0 then add one. Perm Yes EGTPT Planned Time Point Name Char 100 CRF Timing Scheduled Timepoint in CRF (not the header) if applicable. Perm Yes EGTPTNUM Planned Time Point Number Num 8 Derived Timing Numeric form of EGTPT for sorting Perm Yes EGELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned elapsed time (in ISO 8601) relative to a fixed time point reference Perm Yes Ref (EGTPTREF). Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: '-PT15M' to represent the period of 15 minutes prior to the reference point in EGTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point referred to by EGELTM, EGTPTNUM, and Perm Yes EGTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. EGRFTDTC Date/Time of Reference Timepoint Char 50 ISO 8601 CRF Timing Date/time of the reference timepoint, EGTPTREF. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

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Covance Page 1 of 1 Confidential CDISC LB DATASET DEFINITIONS

LBREFID Specimen ID Char 40 Derived/CRF Identifier Requisition/Accession number from local laboratory site Perm Yes LBSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. Example: sort order for lab test parameters to facilitate order or grouping on the listing or table.

LBTESTCD Lab Test or Examination Short Name Char 8 *(LBTESTCD) Derived Topic Short name of the measurement, test, or examination described in LBTEST. It Req Yes can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a nu LBTEST Lab Test or Examination Name Char 40 *(LBTEST) CRF Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding. Note any test normally performed by a clinical laboratory is considered a lab test. The value in LBTEST cannot be longer than 40 characters. Examples: Alanine Aminotransf LBCAT Category for Lab Test Char 50 * eDT/Derived Grouping Qualifier Used to define a category of related records across subjects. Examples: Exp Yes HEMATOLOGY, URINALYSIS, CHEMISTRY. LBSCAT Subcategory for Lab Test Char 50 * eDT/Derived Grouping Qualifier A further categorization of a test category such as DIFFERENTIAL, Perm Yes COAGULATION, LIVER FUNCTION, ELECTROLYTES. LBORRES Result or Finding in Original Units Char 200 eDT Result Qualifier Result of the measurement or finding as originally received or collected. Exp Yes LBORRESU Original Units Char 50 *(UNIT) eDT Variable Qualifier Original units in which the data were collected. The unit for LBORRES. Exp Yes Example: g/L. LBORNRLO Reference Range Lower Limit in Orig Char 20 eDT Variable Qualifier Lower end of the reference range for continuous measurements in original units. Exp Yes Unit Should be populated only for continuous results. LBORNRHI Reference Range Upper Limit in Orig Char 20 eDT Variable Qualifier Upper end of the reference range for continuous measurements in original units. Exp Yes Unit Should be populated only for continuous results. LBSTRESC Character Result/Finding in Std Format Char 200 eDT/Derived Result Qualifier Contains the result value of all findings, copied or derived from LBORRES in a Exp Yes standard format or standard units. LBSTRESC should store all results for findings in a character format; if results are numeric, they should also be stored in numeric format i LBSTRESN Numeric Result/Finding in Standard Num 8 eDT/Derived Result Qualifier Used for continuous or numeric results in standard format: copied in numeric Exp Yes Units format from LBSTRESC. LBSTRESN should store all numeric test results for findings. LBSTRESU Standard Units Char 50 *(UNIT) eDT/Derived Variable Qualifier Standardized unit used for LBSTRESC or LBSTRESN. Exp Yes LBSTNRLO Reference Range Lower Limit-Std Num 8 eDT/Derived Variable Qualifier Lower end of the reference range for continuous measurements in standardized Exp Yes Units units. Should be populated only for continuous results. LBSTNRHI Reference Range Upper Limit-Std Units Num 8 eDT/Derived Variable Qualifier Upper end of the reference range for continuous measurements in standardized Exp Yes units. Should be populated only for continuous results. LBSTNRC Reference Range for Char Rslt-Std Char 200 eDT/Derived Variable Qualifier For normal range values that are character in ordinal scale or if categorical ranges Perm Yes Units were supplied. Examples: "-1 to +1", "NEGATIVE TO TRACE". LBNRIND Reference Range Indicator Char 8 * eDT/Derived Variable Qualifier Indicates where the value falls with respect to reference range defined by Exp Yes LBSTNRLO and LBSTNRHI, or by LBSTNRC. Examples: NORMAL, ABNORMAL, HIGH, LOW. LBSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Use to indicate if an entire exam, group of tests, or individual test is not done. Perm Yes Should be null if a result exists in LBORRES. LBREASND Reason Test Not Done Char 200 CRF Record Qualifier Describes why a measurement or test was not performed such as BROKEN Perm Yes EQUIPMENT, SUBJECT REFUSED, or SPECIMEN LOST. Used in conjunction with LBSTAT when value is NOT DONE. LBNAM Vendor Name Char 50 Assigned Record Qualifier The name or identifier of the laboratory that performed the test. Perm Yes

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? LBLOINC LOINC Code Char 200 * eDT Synonym Qualifier Dictionary-derived LOINC Code for LBTEST if provided by laboratory. Perm Yes

LBSPEC Specimen Type Char 50 *(SPECTYPE) CRF/Protocol Record Qualifier Defines the type of specimen used for a measurement. Examples: SERUM, Perm Yes PLASMA, URINE. LBSPCCND Specimen Condition Char 50 *(SPECCOND) eDT Record Qualifier Free or standardized text describing the condition of the specimen. Examples: Perm Yes HEMOLYZED, ICTERIC, LIPEMIC, etc. LBMETHOD Method of Test or Examination Char 100 * eDT/Protocol Record Qualifier Method of the test or examination. Examples: EIA (Enzyme Immunoassay), Perm Yes ELECTROPHORESIS, DIPSTICK LBBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator to identify baseline value. Usually sponsor defined in protocol or last Exp Yes reading prior to first dose. “Y” to indicate a baseline flag, otherwise.

LBFAST Fasting Status Char 2 (NY) CRF/eDT Record Qualifier Indicator used to identify fasting status such as Y, N, U, or null if not relevant. Perm Yes LBDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be Y or null. Records that Perm Yes represent the average of other records, or do not come from the CRF, or are not as originally received or collected are examples of records that might be derived for the subm LBTOX Toxicity Char 20 * Derived Variable Qualifier Description of toxicity quantified by LBTOXGR.. Perm Yes LBTOXGR Standard Toxicity Grade Char 3 * Derived Variable Qualifier Records toxicity grade value using a standard toxicity scale (such as the NCI Perm Yes CTCAE). If the value is from a numeric scale, represent only the number (e.g. "2" and not "Grade 2"). VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes LBDTC Date/Time of Specimen Collection Char 50 ISO 8601 CRF Timing Actual Date/ Time from CRF. Exp Yes LBENDTC End Date/Time of Specimen Collection Char 50 ISO 8601 CRF Timing End Date/ Time from CRF if provided. Perm Yes

LBDY Study Day of Specimen Collection Num 8 Derived Timing LBDTC-RFSTDTC. If >= 0 then add one. Perm Yes LBTPT Planned Time Point Name Char 100 CRF Timing Scheduled Timepoint in CRF (not the header) if applicable. Perm Yes LBTPTNUM Planned Time Point Number Num 8 Derived Timing Numeric form of LBTPT for sorting. Perm Yes LBELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned Elapsed time (in ISO 8601) relative to a planned fixed reference Perm Yes Ref (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: '-PT15M' to represen LBTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point referred to by LBELTM, if used for Perm Yes LBTPTNUM, and LBTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. LBRFTDTC Date/Time of Reference Point Char 50 ISO 8601 CRF Timing Date/time of the reference time point, LBTPTREF. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

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PESPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. Examples: Numerical code of the examination category. PETESTCD Body System Examined Short Name Char 8 *(petestcd) Assigned Topic Short name of the measurement, test, or examination described in PETEST. It Req Yes can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PETESTCD cannot be longer than 8 characters, nor can it start with a nu PETEST Body System Examined Char 40 *(petest) Assigned Synonym Qualifier Verbatim term part of the body examined. The value in PETEST cannot be Req Yes longer than 40 characters. Examples: CARDIOVASCULAR and RESPIRATORY. For subject-level exam, value should be 'PHYSICAL EXAMINATION'. PEMODIFY Modified Reported Term Char 200 Assigned Synonym Qualifier If PEORRES is modified as part of a defined procedure, then PEMODIFY will Perm Yes contain the modified text. PECAT Category for Examination Char 50 * Derived/CRF Grouping Qualifier “GENERAL” if collected during Physical Exam, “NEUROLOGICAL” if Perm Yes collected during Neurological Exam, etc. PESCAT Subcategory for Examination Char 50 * Derived/CRF Grouping Qualifier A further categorization of the examination. Used if needed to add further detail Perm Yes to PECAT. PEBODSYS Body System or Organ Class Char 70 * Assigned Result Qualifier Body system or organ class (MedDRA SOC) that is involved in a measurement Perm Yes from the standard hierarchy (e.g. MedDRA).

PEORRES Verbatim Examination Finding Char 200 CRF Result Qualifier Text description of any abnormal findings. If the examination was completed Exp Yes and there were no abnormal findings, the value should be NORMAL. If the examination was not performed on a particular body system, or at the subject level, then the value should PEORRESU Original Units Char 50 *(UNIT) CRF Variable Qualifier Original units in which the data were collected. The unit for PEORRES. Perm Yes

PESTRESC Character Result/Finding in Std Format Char 200 Derived Result Qualifier If there are findings for a body system, then either the dictionary preferred term Exp Yes (if findings are coded using a dictionary) or PEORRES (if findings are not coded) should appear here. If PEORRES is null, PESTRESC should be null PESTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Use to indicate if an entire exam, group of tests, or individual test is not done. Perm Yes Should be null if a result exists in PEORRES. PEREASND Reason Not Examined Char 200 CRF or Derived Record Qualifier Describes why an examination was not performed or why a body system was not Perm Yes examined. Example: SUBJECT REFUSED. Used in conjunction with STAT when value is NOT DONE. PELOC Location of Physical Exam Finding Char 50 *(LOC) CRF or Sponsor Record Qualifier Can be used to specify where a physical exam finding occurred. Example: LEFT Perm Yes Defined ARM for skin rash. PEMETHOD Method of Test or Examination Char 50 * CRF or Sponsor Record Qualifier Method of the test or examination. Examples: XRAY, MRI. Perm Yes Defined PEEVAL Evaluator Char 50 *(EVAL) CRF or Derived Record Qualifier Role of the person who provided the evaluation. Used only for results that are Yes subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR. VISITNUM Visit Number Num 8 CRF or Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 CRF or Derived Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 CRF or Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? PEDTC Date/Time of Examination Char 50 ISO 8601 CRF or Derived Timing Collection Date/Time of Physical Exam from CRF. Exp Yes PEDY Study Day of Examination Num 8 Derived Timing PEDTC-RFSTDTC. If >= 0 then add one. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC QS DATASET DEFINITIONS

QSSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. QSGRPID Group ID Char 40 Derived/CRF Identifier Populated with value to identify or group together related records as appropriate. Perm Yes

QSSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. QSTESTCD Question Short Name Char 8 *(qstestcd) Assigned Topic Topic variable for QS. Short name for the value in QSTEST, which can be used Req Yes as a column name when converting the dataset from a vertical format to a horizontal format. The value in QSTESTCD cannot be longer than 8 characters, nor can it start with a numb QSTEST Question Name Char 200 *(qstest) Assigned Synonym Qualifier Verbatim name of the question or group of questions used to obtain the Req Yes measurement or finding. The value in QSTEST cannot be longer than 40 characters. Example: In General, Would You Say Your Health Is? QSCAT Category of Question Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records that will be meaningful to the Req Yes Reviewer. Examples: HAMILTON DEPRESSION SCALE, SF36, ADAS. QSSCAT Subcategory for Question Char 50 * Derived/CRF Grouping Qualifier A further categorization of the questions within the category. Examples: Perm Yes MENTAL HEALTH DOMAIN, DEPRESSION DOMAIN, WORD RECALL. QSORRES Finding in Original Units Char 200 CRF Result Qualifier Finding as originally received or collected (e.g. RARELY, SOMETIMES). When Exp Yes sponsors apply codelist to indicate the code values are statistically meaningful standardized scores, which are defined by sponsors or by valid methodologies such as SF36 questionn QSORRESU Original Units Char 50 *(UNIT) CRF Variable Qualifier Original units in which the data were collected. The unit for QSORRES, such as Perm Yes minutes or seconds or the units associated with a visual analog scale. QSSTRESC Character Result/Finding in Std Format Char 200 Derived/CRF Result Qualifier Contains the finding for all questions or sub-scores, copied or derived from Exp Yes QSORRES in a standard format or standard units. QSSTRESC should store all findings in character format; if findings are numeric, they should also be stored in numeric format in Q QSSTRESN Numeric Finding in Standard Units Num 8 Derived/CRF Result Qualifier Used for continuous or numeric findings in standard format; copied in numeric Perm Yes format from QSSTRESC. QSSTRESN should store all numeric results or findings. QSSTRESU Standard Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Standardized unit used for QSSTRESC or QSSTRESN. Perm Yes QSSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate a questionnaire or response to a questionnaire was not done. Perm Yes Should be null if a result exists in QSORRES. QSREASND Reason Not Performed Char 200 CRF Record Qualifier Describes why a question was not answered. Example: subject refused. Used in Perm Yes conjunction with QSSTAT when value is NOT DONE. QSBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Exp Yes QSDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be Y or null. Records that Perm Yes represent the average of other records or questionnaire sub-scores that do not come from the CRF are examples of records that would be derived for the submission datasets. If Q VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes QSDTC Date/Time of Finding Char 50 ISO 8601 CRF Timing Collection Date/Time from CRF. Exp Yes QSDY Study Day of Finding Num 8 Derived Timing QSDTC-RFSTDTC. If >= 0 then add one. Perm Yes QSTPT Planned Time Point Name Char 100 CRF Timing Scheduled Timepoint in CRF (not the header) if applicable. Perm Yes QSTPTNUM Planned Time Point Number Num 8 Derived Timing Numeric form of QSTPT for sorting. Perm Yes

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Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? QSELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned Elapsed time (in ISO 8601) relative to a planned fixed reference Perm Yes Ref (QSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: '-PT15M' to represen QSTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point referred to by QSELTM, QSTPTNUM, and Perm Yes QSTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. QSRFTDTC Date/Time of Reference Timepoint Char 50 ISO 8601 CRF Timing Date/time of the reference timepoint, QSTPTREF. Perm Yes QSEVLINT Evaluation Interval Char 50 ISO 8601 Derived Timing Evaluation Interval associated with a QSTEST question represented in ISO 8601 Perm Yes character format. Example: "-P2Y" to represent an interval of 2 years in the question "Have you experienced any episodes in the past 2 years?" * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC SC DATASET DEFINITIONS

SCSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. SCTESTCD Subject Characteristic Short Name Char 8 *(SCCD) Assigned Topic Short name of the measurement, test, or examination described in SCTEST. Req Yes Examples: SUBJINIT, EYECD, etc. Randomization number should go to SUPPDM. SCTEST Subject Characteristic Char 40 *(sctest) Assigned Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding. Examples: Subject Initials, Eye Color, etc. SCCAT Category for Subject Characteristic Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Perm Yes SCSCAT Subcategory for Question Char 50 * Derived/CRF Grouping Qualifier A further categorization of the subject characteristic. Perm Yes SCORRES Result or Finding in Original Units Char 200 CRF Result Qualifier Result of subject characteristic as originally received or collected on the CRF. Exp Yes SCORRESU Original Units Char 50 *(UNIT) CRF Variable Qualifier Original unit in which the data were collected. The unit for SCORRES. Perm Yes SCSTRESC Character Result/Finding in Std Format Char 200 Derived/CRF Result Qualifier Contains the result value for all findings, copied or derived from SCORRES in a Exp Yes standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN Numeric Result/Finding in Standard Num 8 Derived/CRF Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Perm Yes Units numeric format from SCSTRESC. SCSTRESN should store all numeric test results or findings. SCSTRESU Standard Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Standardized unit used for SCSTRESC or SCSTRESN. Perm Yes SCSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Use to indicate that the measurement was not done. Should be null if a result Perm Yes exists in SCORRES. SCREASND Reason Test Not Done Char 200 CRF Record Qualifier Describes why the observation has no result. Used in conjunction with SCSTAT Perm Yes when value is NOT DONE. SCDTC Date/Time of Collection Char 50 ISO 8601 CRF Timing Collection Date/Time from CRF. Perm Yes SCDY Study Day of Examination Num 8 Derived Timing SCDTC-RFSTDTC. If >= 0 then add one. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC VS DATASET DEFINITIONS

VSSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the operational database. VSTESTCD Vital Signs Test Short Name Char 8 *(VSTESTCD) Assigned Topic Short name of the measurement, test, or examination described in VSTEST. Req Yes Examples: SYSBP, DIABP, BMI. VSTEST Vital Signs Test Name Char 40 *(VSTEST) Assigned Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding. The value in VSTEST cannot be longer than 40 characters. Examples: Systolic Blood Pressure, Diastolic Blood Pressure, Body Mass Index. VSCAT Category for Vital Signs Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Perm Yes VSSCAT Subcategory for Vital Signs Char 50 * Derived/CRF Grouping Qualifier A further categorization of a measurement or examination. Perm Yes VSPOS Vital Signs Position of Subject Char 50 *(POSITION) CRF Record Qualifier Position of the subject during the measurement or examination. Examples: Perm Yes SUPINE, STANDING, SITTING. VSORRES Result or Finding in Original Units Char 200 CRF Result Qualifier Result of the vital sign measurements as originally received or collected. Exp Yes VSORRESU Original Units Char 50 *(VSRESU) CRF Variable Qualifier Original units in which the data were collected. The unit for VSORRES. Exp Yes Examples: IN, LB, BEATS/MIN. VSSTRESC Character Result/Finding in Std Format Char 200 Derived/CRF Result Qualifier Contains the result value for all findings, copied or derived from VSORRES in a Exp Yes standard format or standard units. VSSTRESC should store all results or finings in character format; if results are numeric, they should also be stored in numeric format in V VSSTRESN Numeric Result/Finding in Standard Num 8 Derived/CRF Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Exp Yes Units numeric format from VSSTRESC. VSSTRESN should store all numeric test results or findings. VSSTRESU Standard Units Char 50 *(VSRESU) Derived/CRF Variable Qualifier Standardized unit used for VSSTRESC and VSSTRESN. Exp Yes VSSTAT Vitals Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate if an entire exam, group of tests, or individual test is not done. Perm Yes Should be null if a result exists in VSORRES. VSREASND Reason Not Performed Char 200 CRF Record Qualifier Describes why a measurement or test was not performed. Used in conjunction Perm Yes with VSSTAT when value is NOT DONE. VSLOC Location of Vital Signs Measurement Char 20 *(LOC) Derived/CRF Record Qualifier Location relevant to the collection of vital signs measurement from CRF or Perm Yes protocol. Example: RIGHT ARM. VSBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Usually sponsor defined in protocol or last reading prior to first dose. “Y” to Exp Yes indicate a baseline flag. VSDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier “Y” if variable was calculated. Perm Yes VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes VSDTC Date/Time of Measurements Char 50 ISO 8601 CRF Timing Actual Date/ Time from CRF. Exp Yes VSDY Study Day of Vital Signs Num 8 Derived Timing VSDTC-RFSTDTC. If >= 0 then add one. Perm Yes VSTPT Planned Time Point Name Char 100 CRF Timing Scheduled Timepoint in CRF (not the header) if applicable. (i.e. – 1 HOUR, 8 Perm Yes HOURS, etc.) VSTPTNUM Planned Time Point Number Num 8 Derived Timing Numeric form of VSTPT for sorting Perm Yes VSELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned Elapsed time (in ISO 8601) relative to a planned fixed reference Perm Yes Ref (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: '-PT15M' to represen VSTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point referred to by VSELTM, if used for Perm Yes VSTPTNUM, and VSTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL. VSRFTDTC Date/Time of Reference Point Char 50 ISO 8601 CRF Timing Date/time of the reference time point, VSTPTREF. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value)

Covance Page 1 of 2 Confidential CDISC VS DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC DA DATASET DEFINITIONS

DAREFID Reference ID Char 40 Derived/CRF Identifier Internal or external identifier such as label number. Perm Yes DASPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the sponsor’s operational database. Examples: Line number on the Drug Accountability page, drug label code. DATESTCD Short Name of Accountability Char 8 * Assigned Topic Short character value for DATEST used as a column name. Examples: Req Yes Assessment DISPAMT, RETAMT. DATEST Name of Accountability Assessment Char 40 * Assigned Synonym Qualifier Verbatim name, corresponding to the topic variable, of the test or examination Req Yes used to obtain the drug accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: Amount Dispensed, Amount Returned.

DACAT Category of Assessment Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Examples: STUDY MEDICATION, Perm Yes RESCUE MEDICATION. DASCAT Subcategory of Assessment Char 50 * Derived/CRF Grouping Qualifier Used to define a further categorization level for a group of related records. Perm Yes DAORRES Assessment Result in Original Units Char 200 CRF Result Qualifier Result of the Drug Accountability assessment as originally received or collected. Exp Yes

DAORRESU Original Units Char 50 *(UNIT) CRF Variable Qualifier Unit for DAORRES. Perm Yes DASTRESC Assessment Result in Std Format Char 200 Derived/CRF Result Qualifier Contains the result value for all Drug Accountability assessments, copied or Exp Yes derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be sto DASTRESN Numeric Result/Finding in Standard Num 8 Derived/CRF Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Perm Yes Units numeric format from DASTRESC. DASTRESN should store all numeric test results or findings. DASTRESU Assessment Standard Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Standardized units used for DASTRESC or DASTRESN. Perm Yes DASTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate that a drug accountability assessment was not done. Should be Perm Yes null or have a value of NOT DONE. DAREASND Reason Not Performed Char 200 CRF Record Qualifier Reason not done. Used in conjunction with DASTAT when value is NOT Perm Yes DONE. VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes DADTC Date/Time of Accountability Char 50 ISO 8601 CRF Timing Actual Date/Time of accountability from CRF. Exp Yes Assessment DADY Study Day of Accountability Num 8 Derived Timing DADTC-RFSTDTC. If >= 0 then add one. Perm Yes Assessment * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC Changes DATASET DEFINITIONS

Version Changes By Date 1 Created Final 3.1.2 version Eric Larson/ 30-Apr-2009 John Swithenbank

Covance Page 1 of 1 Confidential CDISC MB DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol. Req Yes DOMAIN Domain Abbreviation Char 2 MB Assigned Identifier Domain name. Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes MBSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. MBGRPID Group ID Char 40 Derived/CRF Identifier Used to tie together a block of related records in a single domain to support Exp Yes relationships within the domain and between domains. In MB, used to link to findings about organisms which are stored in MS. MBREFID MB Reference ID Char 200 Derived/CRF Identifier Internal or external specimen identifier. Example: Specimen ID. Perm Yes MBSPID Sponsor-Defined Identifier Char 200 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the sponsor's operational database. Example: Organism identifier. For organism identification, MBSPID would remain the same each time the same or MBTESTCD Microbiology Test or Finding Short Char 8 * Assigned Topic Short name of the measurement, test, or finding described in MBTEST. It can be Req Yes Name used as a column name when converting a dataset from a vertical to a horizontal format. The value in MBTESTCD cannot be longer than 8 characters, nor can it start with a number MBTEST Microbiology Test or Finding Name Char 40 * Assigned Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding. The value in MBTEST cannot be longer than 40 characters. Examples: GRAM NEGATIVE RODS, GRAM NEGATIVE COCCI, SQUAMOUS EPITHELIAL CELLS, PMN PER FLOW LOW, ORGANISM PRESENT. MBCAT Category for Microbiology Finding Char 200 * Derived/CRF Grouping Qualifier Used to define a category of related records. Perm Yes MBSCAT Subcategory for Microbiology Finding Char 200 * Derived/CRF Grouping Qualifier Used to define a further categorization of MBCAT. Perm Yes MBORRES Result or Finding in Original Units Char 200 CRF Result Qualifier Result of the Microbiology measurement or finding as originally received or Exp Yes collected. Examples for GRAM STAIN findings: +3 MODERATE, +2 FEW, <10. Examples for CULTURE PLATE (ORGANISM) findings: KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PNEUMONIAE PENICILLIN R MBORRESU Original Units Char 200 *(UNIT) CRF Grouping Qualifier Original unit for MBORRES. Example: mcg/mL. Perm Yes MBSTRESC Character Result/Finding in Std Format Char 200 Derived/CRF Result Qualifier Contains the result value for all findings, copied or derived from MBORRES in a Exp Yes standard format or standard units. MBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in M MBSTRESN Numeric Result/Finding in Standard Num 8 Derived/CRF Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Perm Yes Units numeric format from MBSTRESC. MBSTRESN should store all numeric test results or findings. MBSTRESU Standard Units Char 200 *(UNIT) Derived/CRF Variable Qualifier Standardized unit used for MBSTRESC or MBSTRESN. Perm Yes MBRESCAT Result Category Char 200 * Derived/CRF Variable Qualifier Used to categorize the result of a finding in a standard format. Example for Exp Yes ORGANISM finding: Example: INFECTING, COLONIZER, CONTAMINANT, or NORMAL FLORA. MBSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate Microbiology was not done, or a test was not done. Should be Perm Yes null or have a value of NOT DONE. MBREASND Reason Microbiology Not Performed Char 200 CRF Record Qualifier Reason not done. Used in conjunction with MBSTAT when value is NOT Perm Yes DONE. Examples: BROKEN EQUIPMENT or SUBJECT REFUSED. MBNAM Vendor Name Char 200 Assigned Record Qualifier Name or identifier of the laboratory or vendor who provides the test results. Perm Yes MBLOINC LOINC Code Char 200 * Derived Synonym Qualifier 1. Dictionary-derived LOINC Code for MBTEST. Perm Yes 2. The LOINC version should be provided in the comments column in the data definition file. MBSPEC Specimen Type Char 200 * Derived/CRF Record Qualifier Defines the type of specimen used for a measurement. Examples: SPUTUM, Perm Yes BLOOD, PUS. MBSPCCND Specimen Condition Char 200 Derived/CRF Record Qualifier Free or standardized text describing the condition of the specimen. Example: Perm Yes CONTAMINATED. MBLOC Specimen Collection Location Char 200 *(LOC) Derived/CRF Record Qualifier Location relevant to the collection of the measurement. Examples: LUNG, VEIN, Perm Yes LEFT KNEE WOUND, ARM ULCER 1, RIGHT THIGH LATERAL MBMETHOD Method of Test or Examination Char 200 * Derived/CRF Record Qualifier Method of the test or examination. Examples: GRAM STAIN, CULTURE Exp Yes PLATE, BROTH.

Covance Page 1 of 2 Confidential CDISC MB DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? MBBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Perm Yes MBDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be Y or null. Records that Perm Yes represent the average of other records or some other derivation, and those that do not come from the CRF, are examples of records that would be derived for the submission datas VISITNUM Visit Number Num 8 Derived Timing 1. Clinical encounter number. Exp Yes 2. Numeric version of VISIT, used for sorting. VISIT Visit Name Char 200 Protocol Timing 1. Protocol-defined description of clinical encounter. Perm Yes 2. May be used in addition to VISITNUM and/or VISITDY. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based on RFSTDTC in Demographics. Perm Yes MBDTC Date/Time of MB Specimen Collection Char 50 ISO 8601 CRF Timing Exp Yes

MBDY Study Day of MB Specimen Collection Num 8 Derived Timing MBDTC-RFSTDTC. If >= 0 then add one. Perm Yes MBTPT Planned Time Point Name Char 200 CRF Timing 1. Text Description of time when specimen should be taken. Perm Yes 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MBTPTNUM and MBTPTREF. Examples: Start, 5 min post. MBTPTNUM Planned Time Point Number Num 8 Derived Timing Numerical version of MBTPT to aid in sorting. Perm Yes MBELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned elapsed time (in ISO 8601) relative to a planned fixed reference Perm Yes Ref (MBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: '-P15M' to represent MBTPTREF Time Point Reference Char 200 Derived Timing Name of the fixed reference point referred to by MBELTM, MBTPTNUM, and Perm Yes MBTPT. Example: PREVIOUS DOSE. MBRFTDTC Date/Time of Reference Time Point Char 50 ISO 8601 CRF Timing Date/time of the reference time point, MBTPTREF. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC MS DATASET DEFINITIONS

MSREASND Reason Test Not Done Char 200 CRF Record Qualifier Reason not done. Describes why a measurement or test was not performed. Used Perm Yes in conjunction with MSSTAT when value is NOT DONE. Example: SAMPLE LOST. MSNAM Vendor Name Char 200 Assigned Record Qualifier Name or identifier of the laboratory or vendor that provided the test results. Perm Yes MSLOINC LOINC Code Char 200 *(LOC) Derived Synonym Qualifier 1. Dictionary-derived LOINC Code for MSTEST. Perm Yes 2. The LOINC version should be provided in the comments column in the data definition file. MSMETHOD Method of Test or Examination Char 200 * CRF Record Qualifier Method of the test or examination. Example for SUSCEPTIBILITY: ETEST, Exp Yes BROTH DILUTION. MSBLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Perm Yes MSDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be Y or null. Records that Perm Yes represent the average of other records or some other derivation, and those that do not come from the CRF, are examples of records that would be derived for the submission datas

Covance Page 1 of 2 Confidential CDISC MS DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? VISITNUM Visit Number Num 8 Derived Timing 1. Clinical encounter number. Exp Yes 2. Numeric version of VISIT, used for sorting. VISIT Visit Name Char 200 Protocol Timing 1. Protocol-defined description of clinical encounter. Perm Yes 2. May be used in addition to VISITNUM and/or VISITDY. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes MSDTC Date/Time of Test Char 50 ISO 8601 CRF Timing Perm Yes MSDY Study Day of Test Num 8 Derived Timing MSDTC-RFSTDTC. If >= 0 then add one. Perm Yes MSTPT Planned Time Point Name Char 200 CRF Timing 1. Text Description of time when specimen should be taken. Perm Yes 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See MSTPTNUM and MSTPTREF. Examples: Start, 5 min post. MSTPTNUM Planned Time Point Number Num 8 Derived Timing Numerical version of MSTPT to aid in sorting. Perm Yes MSELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Elapsed time (in ISO 8601) relative to a planned fixed reference (MSTPTREF). Perm Yes Ref This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Examples: '-PT15M' to represent the period of 15 minutes prior to the refer MSTPTREF Time Point Reference Char 200 Derived Timing Name of the fixed reference point referred to by MSELTM, MSTPTNUM, and Perm Yes MSTPT. Example: PREVIOUS DOSE. * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC PC DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol. Req Yes DOMAIN Domain Abbreviation Char 2 PC Assigned Identifier Domain name. Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes PCSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. PCGRPID Group ID Char 40 Derived/CRF Identifier Used to tie relatable records together between PC and PP via the RELREC Perm Yes dataset. PCGRPID will primarily be used to link full PK concentrations profiles to a single set of output PK parameters in PP in a MANY to ONE relationship. Examples of acceptable PCG PCREFID Reference ID Char 40 Derived/CRF Identifier Sample ID or accession number. Perm Yes PCSPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. To be optionally populated with batch ID Perm Yes information. PCTESTCD Pharmacokinetic Test Short Name Char 8 Assigned Topic Short name of the analyte or specimen characteristic. It can be used as a column Req Yes name when converting a dataset from a vertical to a horizontal format. The value in PCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g.'1TEST'). PCTEST Pharmacokinetic Test Name Char 40 Assigned Synonym Qualifier Name of the analyte or specimen characteristic. Note any test normally Req Yes performed by a clinical laboratory is considered a lab test. The value in PCTEST cannot be longer than 40 characters. Examples: Acetylsalicylc Acid, Volume, Specific Gravity. PCCAT Test Category Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Examples: ANALYTE, Perm Yes METABOLITE, SPECIMEN PROPERTY. PCSCAT Test Subcategory Char 50 * Derived/CRF Grouping Qualifier A further categorization of a test category. Perm Yes PCORRES Result or Finding in Original Units Char 200 CRF/eDT Result Qualifier Result of the measurement or finding as originally received or collected. Exp Yes PCORRESU Original Units Char 50 *(UNIT) CRF/eDT Variable Qualifier Original units in which the data were collected. The unit for PCORRES. Exp Yes Example: mg/L. PCSTRESC Character Result/Finding in Std Format Char 200 Derived/eDT Result Qualifier Contains the result value for all findings, copied or derived from PCORRES in a Exp Yes standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in P PCSTRESN Numeric Result/Finding in Standard Num 8 Derived/eDT Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Exp Yes Units numeric format from PCSTRESC. PCSTRESN should store all numeric test results or findings. PCSTRESU Standard Units Char 50 *(UNIT) Derived/eDT Variable Qualifier Standardized unit used for PCSTRESC or PCSTRESN. Exp Yes PCSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate a result was not obtained. Should be null if a result exists in Perm Yes PCORRES. PCREASND Reason Test Not Done Char 200 CRF Record Qualifier Describes why a result was not obtained such as SPECIMEN LOST. Used in Perm Yes conjunction with PCSTAT when value is NOT DONE. PCNAM Vendor Name Char 200 Assigned Record Qualifier Name or identifier of the laboratory or vendor who provides the test results. Exp Yes PCSPEC Specimen Material Type Char 50 *(SPECTYPE) Derived/CRF Record Qualifier Defines the type of specimen used for a measurement. Examples: SERUM, Req Yes PLASMA, URINE. PCSPCCND Specimen Condition Char 50 *(SPECCOND) Derived/CRF Record Qualifier Free or standardized text describing the condition of the specimen e.g. Perm Yes HAEMOLYSED, ICTERIC, LIPEMIC etc. PCMETHOD Method of Test or Examination Char 100 * Derived/CRF Record Qualifier Method of the test or examination. Examples include HPLC/MS, ELISA. This Perm Yes should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study. PCFAST Fasting Status Char 2 (NY) Derived/CRF Record Qualifier Indicator used to identify fasting status. Values can be "Y" , "N" or null. Perm Yes PCDRVFL Derived Flag Char 2 (NY) Derived Record Qualifier Used to indicate a derived record. The value should be Y or null. Records that Perm Yes represent the average of other records or questionnaire subscores, which do not come from the CRF, are examples of records that would be derived for the submission datasets. If PCLLOQ Lower Limit of Quantitation Num 8 Assigned Variable Qualifier Indicates the lower limit of quantitation for an assay. Wnits should be those used Exp Yes in PCORRESU. VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes

Covance Page 1 of 2 Confidential CDISC PC DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes PCDTC Date/Time of Specimen Collection Char 50 ISO 8601 CRF Timing Date/time of specimen collection represented in IS0 8601 character format. If Exp Yes there is no end time, then this will be the collection time. PCENDTC End Date/Time of Specimen Collection Char 50 ISO 8601 CRF Timing End date/time of specimen collection represented in IS0 8601 character format. If Perm Yes there is no end time, the collection time should be stored in PCDTC, and PCENDTC should be null. PCDY Actual Study Day of Specimen Num 8 Derived Timing PCDTC-RFSTDTC. If >= 0 then add one. Perm Yes Collection PCTPT Planned Time Point Name Char 100 CRF Timing 1. Text Description of time when specimen should be taken. Perm Yes 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PCTPTNUM and PCTPTREF. Examples: Start, 5 min post. PCTPTNUM Planned Time Point Number Num 8 Derived Timing Numerical version of PCTPT to aid in sorting. Perm Yes PCELTM Planned Elapsed Time from Time Point Char 50 ISO 8601 Derived Timing Planned elapsed time (in ISO 8601) relative to a planned fixed reference Perm Yes Ref (PCTPTREF) such as 'Previous Dose' or 'Previous Meal'. This variable is useful where there are repetitive measures. Not a clock time or a date time variable. PCTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point used as a basis for PCTPT, PCTPTNUM, and Perm Yes PCELTM. Example: Most Recent Dose. PCRFTDTC Date/Time of Reference Point Char 50 ISO 8601 CRF Timing Date/time of the reference time point described by PCTPTREF. Perm Yes PCEVLINT Evaluation Interval Char 50 ISO 8601 Derived Timing Evaluation Interval associated with a PCTEST record represented in ISO 8601 Perm Yes character format. Example: "-P2H" to represent an interval of 2 hours prior to aPCTPT. * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 2 of 2 Confidential CDISC PP DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specifed in Protocol. Req Yes DOMAIN Domain Abbreviation Char 2 PP Assigned Identifier Domain name. Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes PPSEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. PPGRPID Group ID Char 40 Derived/CRF Identifier Used to tie relatable recoreds together between PC and PP via the RELREC Perm Yes dataset. PCGRPID will primarily be used to link PK parameters to the respective PK concentration profiles in PC. Examples of acceptable PPGRPIDs are singular Alpha Numerical values e PPTESTCD Parameter Short Name Char 8 *(pptestcd) Assigned Topic Short name of the analyte or specimen characteristic. It can be used as a column Req Yes name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g.'1TEST'). PPTEST Parameter Name Char 40 *(pptest) Assigned Synonym Qualifier Name of the pharmacokinetric parameter. The value in PPTEST cannot be longer Req Yes than 40 characters. Examples: AUC, Tmax, Cmax. PPCAT Parameter Category Char 50 Derived/CRF Grouping Qualifier Used to define a category of related records. For PP, this should be the name of Exp Yes the analyte in PCTEST whose profile the parameter is associated with. PPSCAT Parameter Subcategory Char 50 Derived/CRF Grouping Qualifier Categorization of the model type used to calculate the PK parameters. Examples: Perm Yes COMPARTMENTAL, NON-COMPARTMENTAL. PPORRES Result or Finding in Original Units Char 200 eDT Result Qualifier Result of the measurement or finding as originally received or collected. Exp Yes PPORRESU Original Units Char 50 *(UNIT) eDT Variable Qualifier Original units in which the data were collected. The unit for PPORRES. Exp Yes Example: ng/L. PPSTRESC Character Result/Finding in Std Units Char 200 eDT Result Qualifier Contains the result value for all findings, copied or derived from PPORRES in a Exp Yes standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in P PPSTRESN Numeric Result/Finding in Standard Num 8 eDT Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Exp Yes Units numeric format from PPSTRESC. PPSTRESN should store all numeric test results or findings. PPSTRESU Standard Units Char 50 *(UNIT) eDT Variable Qualifier Standardized unit used for PPSTRESC or PPSTRESN. Exp Yes PPSTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate that a parameter was not calculated. Should be null if a result Perm Yes exists in PCORRES. PPREASND Reason Parameter Not Calculated Char 200 CRF Record Qualifier Describes why a parameter was not performed, such INSUFFICIENT DATA. Perm Yes Used in conjunction with PCSTAT when value is NOT DONE. PPSPEC Specimen Material Type Char 50 *(SPECTYPE) CRF Record Qualifier Defines the type of specimen used for a measurement. If multiple specimen types Exp Yes are used for a calculation (e.g., serum and urine for creatinine clearance), then this field should be left blank. Examples: SERUM, PLASMA, URINE. PPDTC Date/Time of Parameter Calculations Char 50 ISO 8601 CRF Timing Nominal date/time of parameter calculations. Perm Yes PPRFTDTC Date/Time of Reference Point Char 50 ISO 8601 CRF Timing Date/time of the reference time point from the PC records used to calculate a Exp Yes parameter record. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. PPTPTREF Time Point Reference Char 100 Derived Timing Name of the fixed reference point used as a basis for PPRFTDTC. Should Perm Yes correspond with PCTPTREF from the PC domain. Example: Most Recent Dose.

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC FA DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol Req Yes DOMAIN Domain Abbreviation Char 2 FA Assigned Identifier Domain name Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID Req Yes FASEQ Sequence Number Num 8 Derived Identifier Sequence Number given to ensure uniqueness of subject records within a Req Yes domain. May be any valid number. FAGRPID Group ID Char 40 Derived/CRF Identifier Used to tie together a block of related records in a single domain for a subject. Perm Yes FASPID Sponsor-Defined Identifier Char 40 Derived/CRF Identifier Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit Perm Yes line identifier or defined in the sponsor’s operational database. Example: Line number on a CRF. FATESTCD Findings About Test Short Name Char 8 * Assigned Topic Short name of the measurement, test, or examination described in FATEST. It Req Yes can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FATESTCD cannot be longer than 8 characters, nor can it start with a nu FATEST Findings About Test Name Char 40 * Assigned Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or Req Yes finding. The value in FATEST cannot be longer than 40 characters. Examples: Severity/Intensity, Occurrence. FAOBJ Object of the Observation Char 200 Derived Record Qualifier Used to describe the object or focal point of the findings about observation that is Req Yes represented by --TEST. Examples: the term (such as ACNE) describing a clinical sign or symptom that is being measured by a SEVERITY test or, an event such as VOMIT where FACAT Category for Findings About Char 50 * Derived/CRF Grouping Qualifier Used to define a category of related records. Examples: GERD, PRE- Perm Yes SPECIFIED AE. FASCAT Subcategory for Findings About Char 50 * Derived/CRF Grouping Qualifier A further categorization of FACAT. Perm Yes FAORRES Result or Finding in Original Units Char 200 CRF Result Qualifier Result of the test as originally received or collected. Exp Yes FAORRESU Original Units Char 50 *(UNIT) CRF Variable Qualifier Original Unit in which the data were collected. The unit for FAORRES. Perm Yes FASTRESC Character Result/Finding in Std Format Char 200 Derived/CRF Result Qualifier Contains the result value for all findings, copied or derived from FAORRES in a Exp Yes standard format or standard units. FASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in F FASTRESN Numeric Result/Finding in Standard Num 8 Derived/CRF Result Qualifier Used for continuous or numeric results or findings in standard format; copied in Exp Yes Units numeric format from FASTRESC. FASTRESN should store all numeric test results or findings. FASTRESU Standard Units Char 50 *(UNIT) Derived/CRF Variable Qualifier Standardized unit used for FASTRESC or FASTRESN. Exp Yes FASTAT Completion Status Char 8 (ND) Derived/CRF Record Qualifier Used to indicate that the measurement was not done. Should be null if a result Perm Yes exists in FAORRES. FAREASND Reason Not Performed Char 200 CRF Record Qualifier Describes why a question was not answered. Example: subject refused. Used in Perm Yes conjunction with FASTAT when value is NOT DONE. FALOC Location of the Finding About Char 200 *(LOC) CRF Variable Qualifier Used to specify the location of the finding about evaluated. Example: LEFT Perm Yes ARM. FABLFL Baseline Flag Char 2 (NY) Derived Record Qualifier Indicator used to identify a baseline value. Perm Yes FAEVAL Evaluator Char 50 *(EVAL) Derived Record Qualifier Role of the person who provided the evaluation. Used only for results that are Perm Yes subjective (i.e. assigned by a person or group). Should be null for records that contain collected or derived data. Examples: INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR. VISITNUM Visit Number Num 8 Derived Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp Yes VISIT Visit Name Char 100 Protocol Timing Protocol-defined description of clinical encounter. Note: Unscheduled Perm Yes assessments should be mapped to the appropriate visit. VISITDY Planned Study Day of Visit Num 8 Derived Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm Yes FADTC Date/Time of Collection Char 50 ISO 8601 CRF Timing Collection Date/ Time of finding about taken from CRF or taken from alternate Exp Yes source data. FADY Study Day of Collection Num 8 Derived Timing FADTC-RFSTDTC. If >= 0 then add one. Perm Yes * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC TA DATASET DEFINITIONS

Covance Page 1 of 1 Confidential CDISC TE DATASET DEFINITIONS

Covance Page 1 of 1 Confidential CDISC TV DATASET DEFINITIONS

TVENRL Visit End Rule Char 200 Assigned Rule Rule for describing when the Visit ends, in relation to the sequence of Elements. Perm Yes See SDTMIG 3.1.2 for examples. * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC TI DATASET DEFINITIONS

IECAT Inclusion//Exclusion Category Char 10 (IECAT) Derived Grouping Qualifier Used for categorization of the inclusion or exclusion criteria. Req Yes IESCAT Inclusion//Exclusion Subcategory Char 10 * Derived Grouping Qualifier A further categorization of the exception criterion. Can be used to distinguish Perm Yes criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: MAJOR, MINOR. TIRL Inclusion/Exclusion Criterion Rule Char 200 Derived Rule Rule that expresses the criterion in computer-executable form. Not populated if Perm Yes inclusion/exclusion responses are provided on CRF. TIVERS Protocol Criteria Versions Char 200 Derived/CRF The number of this version of the Inclusion/Exclusion criteria. May be omitted if Perm Yes there is only one version. * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC TS DATASET DEFINITIONS

TSPARM Trial Summary Parameter Char 40 *(TSPARM) Protocol Synonym Qualifier Term for the Trial Summary Parameter. The value in TSPARM cannot be longer Req Yes than 40 characters. Examples: Planned Minimum Age of Subjects, Planned Maximum Age of Subjects. TSVAL Parameter Value Char 200 * Protocol Result Qualifier Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Req Yes Indications". If multiple values for TSVAL exist for a single TSPARMCD, a new record is created for each value. TSVAL cannot be null – a value is required for the record to be valid. The TSVA * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC Comments DATASET DEFINITIONS

Covance uses the FDA preferred CDISC specifications when creating datasets for any sponsor, using CDISC SDTMIG version 3.1.2.

We follow CDISC conventions for all datasets and create all domain models on the general classes and special purposes discussed in the CDISC SDTM documentation. We include all required and expected variables and permissible variables as needed in each dat

Any additional variables not in the SDTM Model are captured in the supplemental qualifier (SUPP--) dataset.

If required by the sponsor, Times or Dates which are Character, .e.g. UNK or ND, we will populate these values in the SUPP-- dataset for the purposes of displaying the values in the listing.

Text values are formatted as uppercase with the exception of units, controlled terms, or free text variables.

Screen Failure Subjects are not included in SDTM datasets unless contracted by Sponsor.

If a permissible field is not collected on CRF it will be null in the dataset, or dropped per sponsor request. *** Covance Internal Comments This document is a template. It is intended as a starting point and will be modified depending on the study and sponsor’s needs.

The Origin field in each domain should be updated to reflect the origin of the variable for that study. Values to specify the origin are controlled terms and can be: CRF, eDT, Derived, Assigned, Protocol. See SDTM IG 4.1.1.8.1 for further definition of

The mapping notes/comments relate to Covance’s CRF template and will be modified depending on the study and sponsor’s needs.

The key variables in the Metadata tab are recommended sort order variables that should be used to assign the --SEQ order. If a different order is used or requested by the sponsor, the sort variables should be updated in the Metadata tab.

Standard controlled terminology can be found in either the "SDTM Terminology" tab or the "CVD Terminology" tab. Controlled terms are indicated with the domains in the "Controlled Terms or Format" column. When standard controlled terms exist, the codelis

Covance Page 1 of 2 Confidential CDISC Comments DATASET DEFINITIONS

A new domain may be created if a published standard domain does not exist for the data that is being modeled. Reserved domain names in controlled terminology (DOMAIN) and SDTM documentation (SDTM IG 2.6 and 8.6.2) should be referenced prior to the creati

Covance Page 2 of 2 Confidential CDISC RELREC DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol. Req Yes RDOMAIN Related Domain Abbreviation Char 2 (DOMAIN) Assigned Two-character abbreviation for the domain of the parent record(s). Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID Exp Yes IDVAR Identifying Variable Char 8 * Assigned Name of the identifying variable in the general-observation-class dataset that Req Yes identifies the related record(s). Examples include --SEQ and --GRPID. IDVARVAL Identifying Variable Value Char 200 Derived Value of identifying variable described in IDVAR. If --GRPID is the variable Exp Yes being used to describe this record, then the value of --GRPID would be entered here. RELTYPE Relationship Type Char 4 (RELTYPE) Assigned Identifies the hierarchical level of the records in the relationship. Values should Exp Yes be either ONE or MANY. RELID Relationship Identifier Char 200 Derived Unique value within USUBJID that identifies the relationship. All records for the Req Yes same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to id * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential CDISC SUPP-- DATASET DEFINITIONS

Variable Name Variable Label Type Length Controlled Terms or Origin Role Mapping Notes/Comments Core In Data- Format set? STUDYID Study Identifier Char 20 CRF Identifier Protocol Number as specified in Protocol. Req Yes RDOMAIN Related Domain Abbreviation Char 2 (DOMAIN) Assigned Domain Abbreviation of the Parent record(s). Req Yes USUBJID Unique Subject Identifier Char 50 CRF Identifier Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Req Yes IDVAR Identifying Variable Char 8 * Assigned Identifying variable in the dataset that identifies the related record(s). Examples: - Exp Yes -SEQ, --GRPID. IDVARVAL Identifying Variable Value Char 40 Derived Value of identifying variable of the parent record(s). Exp Yes QNAM Qualifier Variable Name Char 8 * Assigned The short name of the Qualifier variable, which is used as a column name in a Req Yes domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., '1TEST'). QNAM cannot contain character QLABEL Qualifier Variable Label Char 40 Assigned This is the long name or label associated with QNAM. The value in QLABEL Req Yes cannot be longer than 40 characters. This will often be the column label in the sponsor’s original dataset. QVAL Data Value Char 200 CRF Result of, response to, or value associated with QNAM. A value for this column Req Yes is required; no records can be in SUPP-- with a null value for QVAL. QORIG Origin Char 200 Assigned Since QVAL can represent a mixture of collected (on a CRF), derived, or Req Yes assigned items, QORIG is used to indicate the origin of this data. Examples include CRF, ASSIGNED, or DERIVED. QEVAL Evaluator Char 200 *(EVAL) Assigned/CRF Used only for results that are subjective (e.g., assigned by a person or a group). Exp Yes Should be null for records that contain objectively collected or derived data. Some examples include ADJUDICATION COMMITTEE, STATISTICIAN, DATABASE ADMINISTRATOR, CLINICAL * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Covance Page 1 of 1 Confidential How to handle unscheduled visits (VISIT, VISITNUM, --TPT, --TPTNUM, ELEMENT, EPOCH, --UPDES, TAETORD)

Unscheduled Visit Example:

Below is an example of a subject Returning for Unscheduled Lab Safety after Post Study and then a further unscheduled Lab Safety and vitals signs:

SV Domain for above Hypothetical example:

DOMAIN USUBJID VISITNUM VISIT VISITDY SVSTDTC SVENDTC SVUPDES

SV 12345-001-001 1 SCREENING -28 2009-01-01T10:12 2009-01-10T09:12 SV 12345-001-001 2 TREATMENT PERIOD 1 -1 2009-01-10T09:12 2009-01-21T10:14 SV 12345-001-001 3 TREATMENT PERIOD 2 10 2009-01-21T10:14 2009-01-31T12:14 SV 12345-001-001 4 FOLLOW UP 20 2009-02-31T12:14 2009-01-31T22:00 SV 12345-001-001 4.01 UNSCHEDULED . 2009-03-21T10:12 2009-03-21T10:12 REPEAT LAB EVALUATION REPEAT LAB EVALUATION SV 12345-001-001 4.02 UNSCHEDULED 2009-03-27T09:12 2009-03-27T09:12 + VITAL SIGNS

LB Domain for above Hypothetical Example:

DOMAIN USUBJID VISITNUM VISIT VISITDY LBTPT LBTPTNUM LBDTC

LB 12345-001-001 1 SCREENING -28 SCREENING -999 2009-01-01 LB 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 -24 2009-01-10 LB 12345-001-001 3 TREATMENT PERIOD 2 10 DAY -1 -24 2009-01-21 LB 12345-001-001 4 FOLLOW UP 20 FOLLOW UP 999 2009-02-31 LB 12345-001-001 4.01 UNSCHEDULED . 2009-03-21 LB 12345-001-001 4.02 UNSCHEDULED . 2009-03-27

VS Domain for above Hypothetical Example:

DOMAIN USUBJID VISITNUM VISIT VISITDY VSTPT VSTPTNUM VSDTC

VS 12345-001-001 1 SCREENING -28 SCREENING -999 2009-01-01 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 -24 2009-01-10 VS 12345-001-001 3 TREATMENT PERIOD 2 10 DAY -1 -24 2009-01-21 VS 12345-001-001 4 FOLLOW UP 20 FOLLOW UP 999 2009-02-31 VS 12345-001-001 4.02 UNSCHEDULED . 2009-03-27 Below is an example of a subject Returning for Unscheduled Lab Safety after period 1 assuming a none end to end visit structure:

SV Domain for above Hypothetical example:

DOMAIN USUBJID VISITNUM VISIT VISITDY SVSTDTC SVENDTC SVUPDES

SV 12345-001-001 1 SCREENING -28 2009-01-01T10:12 2009-01-10T09:12 SV 12345-001-001 2 TREATMENT PERIOD 1 -1 2009-01-10T09:12 2009-01-21T10:14 SV 12345-001-001 2.01 UNSCHEDULED . 2009-01-12T12:00 2009-01-12T14:00 REPEAT LAB VISIT SV 12345-001-001 3 TREATMENT PERIOD 2 10 2009-01-21T10:14 2009-01-31T12:14 SV 12345-001-001 4 FOLLOW UP 20 2009-02-31T12:14 2009-01-31T22:00

LB Domain for above Hypothetical Example:

DOMAIN USUBJID VISITNUM VISIT VISITDY LBTPT LBTPTNUM LBDTC

LB 12345-001-001 1 SCREENING -28 SCREENING -999 2009-01-01 LB 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 -24 2009-01-10 LB 12345-001-001 2.01 UNSCHEDULED . 2009-01-12 LB 12345-001-001 3 TREATMENT PERIOD 2 10 DAY -1 -24 2009-01-21 LB 12345-001-001 4 FOLLOW UP 20 FOLLOW UP 999 2009-02-31 . 2009-03-21 Below is an example of a subject with a series of 3 succesant unscheduled vital signs within a scheduled period:

VS Domain for above Hypothetical Example utilising a derived nominal time for xxTPTNUM:

DOMAIN USUBJID VISITNUM VISIT VISITDY VSTPT VSTPTNUM VSDTC

VS 12345-001-001 1 SCREENING -28 SCREENING -999 2009-01-01T12:00 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 -24 2009-01-10T09:00 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED -23.99 2009-01-12T09:05 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED -23.98 2009-01-12T09:07 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED -23.97 2009-01-12T09:09 VS 12345-001-001 3 TREATMENT PERIOD 2 10 DAY -1 -24 2009-01-21T09:00 VS 12345-001-001 4 FOLLOW UP 20 FOLLOW UP 999 2009-02-31T10:00

VS Domain for above Hypothetical Example assuming an incrementation sort number aligned to Visit:

DOMAIN USUBJID VISITNUM VISIT VISITDY VSTPT VSTPTNUM VSDTC

VS 12345-001-001 1 SCREENING -28 SCREENING 1 2009-01-01T12:00 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 2 2009-01-10T09:00 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED 2.01 2009-01-12T09:05 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED 2.02 2009-01-12T09:07 VS 12345-001-001 2 TREATMENT PERIOD 1 -1 DAY -1 - UNSCHEDULED 2.03 2009-01-12T09:09 VS 12345-001-001 3 TREATMENT PERIOD 2 10 DAY -1 3 2009-01-21T09:00 VS 12345-001-001 4 FOLLOW UP 20 FOLLOW UP 4 2009-02-31T10:00 Below is an example of the links bewteen PC and PP using RELREC as a way of defining relationships

Below Represnts a typical set of standard PK concentration for two metabolites of a study drug

DOMAIN USUBJID PCSEQ PCGRPID PCTEST PCORRES PCORRESU PCTPT

PC 12345-001-001 1 1 DRUGA 0.812 ng/mL DAY 1, 1 H PC 12345-001-001 2 1 DRUGA 5.2 ng/mL DAY 1, 2 H PC 12345-001-001 3 1 DRUGA 6.06 ng/mL DAY 1, 3 H PC 12345-001-001 4 1 DRUGA 8.9 ng/mL DAY 1, 4 H PC 12345-001-001 5 1 DRUGA 14.8 ng/mL DAY 1, 5 H PC 12345-001-001 6 1 DRUGA 18.8 ng/mL DAY 1, 6 H PC 12345-001-001 7 1 DRUGA 21.7 ng/mL DAY 1, 7 H PC 12345-001-001 8 1 DRUGA 19.3 ng/mL DAY 1, 8 H PC 12345-001-001 9 1 DRUGA 17.5 ng/mL DAY 1, 10 H PC 12345-001-001 10 1 DRUGA 9.62 ng/mL 24 H (DAY 2) PC 12345-001-001 11 1 DRUGA 7.55 ng/mL 48 H (DAY 3) PC 12345-001-001 12 1 DRUGA 3.7 ng/mL 72 H (DAY 4) PC 12345-001-001 13 1 DRUGA 2.23 ng/mL 96 H (DAY 5) PC 12345-001-001 14 1 DRUGA 0.688 ng/mL 144 H (DAY 7) PC 12345-001-001 15 1 DRUGA <0.400 ng/mL 192 H (DAY 9) PC 12345-001-001 16 1 DRUGA <0.400 ng/mL 240 H (DAY 11) PC 12345-001-001 17 1 DRUGA <0.400 ng/mL 312 H (DAY 14) PC 12345-001-001 18 2 DRUGB 0.812 pg/mL DAY 1, 1 H PC 12345-001-001 19 2 DRUGB 5.2 pg/mL DAY 1, 2 H PC 12345-001-001 20 2 DRUGB 6.06 pg/mL DAY 1, 3 H PC 12345-001-001 21 2 DRUGB 8.9 pg/mL DAY 1, 4 H PC 12345-001-001 22 2 DRUGB 14.8 pg/mL DAY 1, 5 H PC 12345-001-001 23 2 DRUGB 18.8 pg/mL DAY 1, 6 H PC 12345-001-001 24 2 DRUGB 21.7 pg/mL DAY 1, 7 H PC 12345-001-001 25 2 DRUGB 19.3 pg/mL DAY 1, 8 H PC 12345-001-001 26 2 DRUGB 17.5 pg/mL DAY 1, 10 H PC 12345-001-001 27 2 DRUGB 9.62 pg/mL 24 H (DAY 2) PC 12345-001-001 28 2 DRUGB 7.55 pg/mL 48 H (DAY 3) PC 12345-001-001 29 2 DRUGB 3.7 pg/mL 72 H (DAY 4) PC 12345-001-001 30 2 DRUGB 2.23 pg/mL 96 H (DAY 5) PC 12345-001-001 31 2 DRUGB 0.688 pg/mL 144 H (DAY 7) PC 12345-001-001 32 2 DRUGB <0.400 pg/mL 192 H (DAY 9) PC 12345-001-001 33 2 DRUGB <0.400 pg/mL 240 H (DAY 11) PC 12345-001-001 34 2 DRUGB <0.400 pg/mL 312 H (DAY 14)

Below shows a typical set of PK Parameters

DOMAIN USUBJID PPSEQ PPGRPID PPTEST PPCAT PPORRES PPORRESU

PP 12345-001-001 1 1 AUC 0-inf DRUGA 803.4104939 h*ng/mL PP 12345-001-001 2 1 AUC Extrapolated DRUGA 3.598636819 % PP 12345-001-001 3 1 AUC 0-t DRUGA 774.4986681 h*ng/mL PP 12345-001-001 4 1 Cmax DRUGA 21.7 ng/mL PP 12345-001-001 5 1 R-Squared DRUGA 0.995732448 PP 12345-001-001 6 1 t1/2 DRUGA 29.12812583 h PP 12345-001-001 7 1 Lambda Z DRUGA 0.023796491 1/h PP 12345-001-001 8 1 Mean Residence Time DRUGA 41.92448374 h PP 12345-001-001 9 2 AUC Extrapolated DRUGB 35.63667923 % PP 12345-001-001 10 2 AUC 0-t DRUGB 1051.898401 h*pg/mL PP 12345-001-001 11 2 Clearance DRUGB 61.18777319 L/h PP 12345-001-001 12 2 Cmax DRUGB 102 pg/mL PP 12345-001-001 13 2 R-Squared DRUGB 0.998808946 PP 12345-001-001 14 2 t1/2 DRUGB 30.81674361 h PP 12345-001-001 15 2 Lambda Z DRUGB 0.022492551 1/h PP 12345-001-001 16 2 Mean Residence Time DRUGB 41.92448374 h

Below shows the direct relationship joins when relating the calcultated PK Parameters (PP) to the source PK Concentrations (PC) using --GRPID within RELREC

As per SDTM conventions the IDVAR references the source variables that should be used in merging the data and the IDVARVAL the value contained within the merge variable. The RELID as indicated is used to show the correlation between the related data by incrementation of a consistent value e.g. all records under a specific RELID are as per definition related to each other

STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID 12345 PC 12345-001-001 PCGRPID 1 ONE 1 12345 PP 12345-001-001 PPGRPID 1 ONE 1 12345 PC 12345-001-001 PCGRPID 2 ONE 2 12345 PP 12345-001-001 PPGRPID 2 ONE 2 The examples of PC, PP & RELREC below show that --GRPID can be any textual or variation of an identifier that may be required to make the study data logical

DOMAIN USUBJID PCSEQ PCGRPID PCTEST PCORRES PCORRESU PCTPT

PC 12345-001-001 1 DRUGAP1 DRUGA 0.812 ng/mL DAY 1, 1 H PC 12345-001-001 2 DRUGAP1 DRUGA 5.2 ng/mL DAY 1, 2 H PC 12345-001-001 3 DRUGAP1 DRUGA 6.06 ng/mL DAY 1, 3 H PC 12345-001-001 4 DRUGAP1 DRUGA 8.9 ng/mL DAY 1, 4 H PC 12345-001-001 5 DRUGBP1 DRUGB 0.812 pg/mL DAY 1, 1 H PC 12345-001-001 6 DRUGBP1 DRUGB 5.2 pg/mL DAY 1, 2 H PC 12345-001-001 7 DRUGBP1 DRUGB 6.06 pg/mL DAY 1, 3 H PC 12345-001-001 8 DRUGBP1 DRUGB 8.9 pg/mL DAY 1, 4 H

DOMAIN USUBJID PPSEQ PPGRPID PPTEST PPCAT PPORRES PPORRESU

PP 12345-001-001 1 DRUGAP1 AUC 0-inf DRUGA 803.4104939 h*ng/mL PP 12345-001-001 2 DRUGAP1 AUC Extrapolated DRUGA 3.598636819 % PP 12345-001-001 3 DRUGAP1 AUC 0-t DRUGA 774.4986681 h*ng/mL PP 12345-001-001 4 DRUGAP1 Cmax DRUGA 21.7 ng/mL PP 12345-001-001 5 DRUGAP1 R-Squared DRUGA 0.995732448 PP 12345-001-001 6 DRUGAP1 t1/2 DRUGA 29.12812583 h PP 12345-001-001 7 DRUGAP1 Lambda Z DRUGA 0.023796491 1/h PP 12345-001-001 8 DRUGAP1 Mean Residence Time DRUGA 41.92448374 h PP 12345-001-001 9 DRUGBP1 AUC Extrapolated DRUGB 35.63667923 % PP 12345-001-001 10 DRUGBP1 AUC 0-t DRUGB 1051.898401 h*pg/mL PP 12345-001-001 11 DRUGBP1 Clearance DRUGB 61.18777319 L/h PP 12345-001-001 12 DRUGBP1 Cmax DRUGB 102 pg/mL PP 12345-001-001 13 DRUGBP1 R-Squared DRUGB 0.998808946 PP 12345-001-001 14 DRUGBP1 t1/2 DRUGB 30.81674361 h PP 12345-001-001 15 DRUGBP1 Lambda Z DRUGB 0.022492551 1/h PP 12345-001-001 16 DRUGBP1 Mean Residence Time DRUGB 41.92448374 h

STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID

12345 PC 12345-001-001 PCGRPID DRUGAP1 ONE 1 12345 PP 12345-001-001 PPGRPID DRUGAP1 ONE 1 12345 PC 12345-001-001 PCGRPID DRUGBP1 ONE 2 12345 PP 12345-001-001 PPGRPID DRUGBP1 ONE 2 CDISC Metadata DATASET DEFINITIONS

Dataset Description Location Structure Class Purpose Key Variables DM Demographics dm.xpt One record per subject Special Purpose Domains Tabulation STUDYID, USUBJID CO Comments co.xpt One record per comment per subject Special Purpose Domains Tabulation STUDYID, USUBJID, COSEQ SE Subject Elements se.xpt One record per actual Element per subject Special Purpose Domains Tabulation STUDYID, USUBJID, ETCD, SESTDTC SV Subject Visits sv.xpt One record per actual visit per subject Special Purpose Domains Tabulation STUDYID, USUBJID, VISITNUM CM Concomitant Medications cm.xpt One record per recorded medication occurrence per Interventions Tabulation STUDYID, USUBJID, CMTRT, subject CMSTDTC EX Exposure ex.xpt One record per constant dosing interval per subject Interventions Tabulation STUDYID, USUBJID, EXTRT, EXSTDTC SU Substance Use su.xpt One record per substance type per reported occurrence Interventions Tabulation STUDYID, USUBJID, SUTRT, per subject SUSTDTC AE Adverse Events ae.xpt One record per adverse event per subject Events Tabulation STUDYID, USUBJID, AEDECOD, AESTDTC DS Disposition ds.xpt One record per disposition status or protocol milestone Events Tabulation STUDYID, USUBJID, DSSTDTC, per subject DSDECOD MH Medical History mh.xpt One record per medical history event per subject Events Tabulation STUDYID, USUBJID, MHDECOD DV Protocol Deviations dv.xpt One record per protocol deviation per subject Events Tabulation STUDYID, USUBJID, DVTERM, DVSTDTC CE Clinical Events ce.xpt One record per event per subject Events Tabulation STUDYID, USUBJID, CETERM, CESTDTC EG ECG Test Results eg.xpt One record per ECG observation per time point per visit Findings Tabulation STUDYID, USUBJID, EGTESTCD, per subject VISITNUM, EGTPTNUM IE Inclusion/ Exclusion Criteria Not ie.xpt One record per inclusion/exclusion criterion not met per Findings Tabulation STUDYID, USUBJID, IETESTCD Met subject LB Laboratory Tests Results lb.xpt One record per lab test per specimen per time point per Findings Tabulation STUDYID, USUBJID, LBTESTCD, visit per subject LBSPEC, VISITNUM, LBTPTNUM PE Physical Examination pe.xpt One record per body system or abnormality per visit per Findings Tabulation STUDYID, USUBJID, PETESTCD, subject VISITNUM QS Questionnaires qs.xpt One record per question per questionnaire per time point Findings Tabulation STUDYID, USUBJID, QSCAT, per visit per subject QSTESTCD, VISITNUM, QSTPTNUM SC Subject Characteristics sc.xpt One record per characteristic per subject Findings Tabulation STUDYID, USUBJID, SCTESTCD VS Vital Signs vs.xpt One record per vital sign measurement per time point per Findings Tabulation STUDYID, USUBJID, VSTESTCD, visit per subject VISITNUM, VSTPTNUM DA Drug Accountability da.xpt One record per drug accountability finding per subject Findings Tabulation STUDYID, USUBJID, DATESTCD, DADTC MB Microbiology Specimen mb.xpt One record per microbiology specimen finding per time Findings Tabulation STUDYID, USUBJID, MBTESTCD, point per visit per subject VISITNUM, MBTPTNUM MS Microbiology Susceptibility Test ms.xpt One record per microbiology susceptibility test (or other Findings Tabulation STUDYID, USUBJID, MSTESTCD, organism-related finding) per organism found in MB VISITNUM, MSTPTNUM

Covance Page 1 of 2 Confidential CDISC Metadata DATASET DEFINITIONS

Dataset Description Location Structure Class Purpose Key Variables PC Pharmacokinetic Concentrations pc.xpt One record per time-point concentration or sample Findings Tabulation STUDYID, USUBJID, PCTESTCD, characteristic per analyte per subject VISITNUM, PCTPTNUM, PCTPTREF PP Pharmacokinetic Parameters pp.xpt One record per PK parameter per time-concentration Findings Tabulation STUDYID, USUBJID, PPTESTCD, profile per modeling method per subject PPCAT, VISITNUM, PPTPTREF FA Findings About fa.xpt One record per finding per subject per visit per time point Findings Tabulation STUDYID, USUBJID, FATESTC, VISITNUM, TPTNUM TA Trial Arms ta.xpt One record per planned Element per Arm Trial Design Tabulation STUDYID, ARMCD, TAETORD TE Trial Elements te.xpt One record per planned Element Trial Design Tabulation STUDYID, ETCD TV Trial Visits tv.xpt One record per planned Visit per Arm Trial Design Tabulation STUDYID, VISITNUM, ARMCD TI Trial Inclusion/ Exclusion Criteria ti.xpt One record per I/E criterion Trial Design Tabulation STUDYID, IETESTCD TS Trial Summary ts.xpt One record per Trial Summary parameter per occurrence Trial Design Tabulation STUDYID, TSPARMCD, TSSEQ RELREC Related Records relrec.xpt One record per related record, group of records or Special Purpose Datasets Tabulation STUDYID, RDOMAIN, USUBJID, datasets IDVAR, IDVARVAL, RELID SUPP-- Supplemental Qualifiers for [domain supp--.xpt One record per IDVAR, IDVARVAL, and QNAM per Special-Purpose Datasets Tabulation STUDYID, RDOMAIN, USUBJID, name] subject IDVAR, IDVARVAL, QNAM

Covance Page 2 of 2 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C66767 No Action Taken with Study Treatment ACN ACN Action Taken with Study The reason that changes were made to the therapy under CDISC SDTM Action Taken with Production Treatment study. (NCI) Study Treatment Terminology

C49503 C66767 Action Taken with Study Treatment DOSE INCREASED DOSE INCREASED An indication that a medication schedule was modified by Dose Increased Production E2B Code addition; either by changing the frequency, strength or Organization Name: EMEA amount. (NCI) Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k.

C49504 C66767 Action Taken with Study Treatment DOSE NOT CHANGED DOSE NOT CHANGED An indication that a medication schedule was maintained. Dose Not Changed Production E2B Code (NCI) Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k. C49505 C66767 Action Taken with Study Treatment DOSE REDUCED DOSE REDUCED An indication that a medication schedule was modified by Dose Reduced Production E2B Code subtraction, either by changing the frequency, strength or Organization Name: EMEA amount. (NCI) Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k.

C49501 C66767 Action Taken with Study Treatment DRUG INTERRUPTED DRUG INTERRUPTED An indication that a medication schedule was modified by Drug Interrupted Production Not an E2B code temporarily terminating a prescribed regimen of medication. (NCI) C49502 C66767 Action Taken with Study Treatment DRUG WITHDRAWN DRUG WITHDRAWN An indication that a medication schedule was modified Drug Withdrawn Production E2B Code through termination of a prescribed regimen of medication. Organization Name: EMEA (NCI) Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k.

C48660 C66767 Action Taken with Study Treatment NOT APPLICABLE NOT APPLICABLE NA Determination of a value is not relevant in the current context. Not Applicable Production E2B Code (NCI) Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k. C17998 C66767 Action Taken with Study Treatment UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production E2B Code Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2. Guideline Content of the Data Elements Codelist_Name: B.4.k. C66768 No Outcome of Event OUT OUT Outcome of Event A condition or event that is attributed to the adverse event and CDISC SDTM Adverse Event Production is the result or conclusion of the adverse event. (NCI) Outcome Terminology

C48275 C66768 Outcome of Event FATAL FATAL Grade 5; 5 The termination of life as a result of an adverse event. (NCI) Death Related to Adverse Event Production E2B code Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the

C49494 C66768 Outcome of Event NOT RECOVERED/NOT NOT RECOVERED/NOT One of the possible results of an adverse event outcome that Not Recovered or Not Resolved Production E2B code RESOLVED RESOLVED indicates that the event has not improved or recuperated. Organization Name: EMEA (NCI) Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the C49498 C66768 Outcome of Event RECOVERED/RESOLVED RECOVERED/RESOLVED One of the possible results of an adverse event outcome that Recovered or Resolved Production E2B code indicates that the event has improved or recuperated. (NCI) Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the C49495 C66768 Outcome of Event RECOVERED/RESOLVED WITH RECOVERED/RESOLVED WITH One of the possible results of an adverse event outcome Recovered or Resolved with Production E2B code SEQUELAE SEQUELAE where the subject recuperated but retained pathological Sequelae Organization Name: EMEA conditions resulting from the prior disease or injury. (NCI) Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the C49496 C66768 Outcome of Event RECOVERING/RESOLVING RECOVERING/RESOLVING One of the possible results of an adverse event outcome that Recovering or Resolving Production E2B code indicates that the event is improving. (NCI) Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the

Covance Page 1 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17998 C66768 Outcome of Event UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production E2B code Organization Name: EMEA Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Document Version: Not Applicable Date: November 16, 2000 Chapter: 2. Guideline Content of the C66780 Yes Age Span AGESPAN AGESPAN Age Span Subgroups of populations based on age. (NCI) CDISC SDTM Age Group Production Terminology C27954 C66780 Age Span ADOLESCENT (12-17 YEARS) ADOLESCENT (12-17 YEARS) A juvenile between the onset of puberty and maturity; in the Adolescent Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, state of development between puberty and maturity. (NCI) page 18

C49685 C66780 Age Span ADULT (18-65) ADULT (18-65) A person from 18 years to 65 years of age. (NCI) Adult 18-65 Years Old Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, page 18

C49683 C66780 Age Span CHILDREN (2-11 YEARS) CHILDREN (2-11 YEARS) A person from 2 years to 11 years of age. (NCI) Children 2-11 Years Old Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, page 18

C16268 C66780 Age Span ELDERLY (> 65) ELDERLY (> 65) An age group comprised by people 65 years of age and older. Elderly Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, (NCI) page 18

C49641 C66780 Age Span IN UTERO IN UTERO The period of time during which the embryo or foetus is In Utero Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, present in the uterus of the female. Also describes the location page 18 of the embryo or foetus as being in the uterus in contrast to outside the uterus (ex utero). (NCI)

C49643 C66780 Age Span INFANT AND TODDLER (28 DAYS - INFANT AND TODDLER (28 DAYS - A person from 28 days to 23 months of age. (NCI) Infant And Toddler Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, 23 MONTHS) 23 MONTHS) page 18

C16731 C66780 Age Span NEWBORN (0-27 DAYS) NEWBORN (0-27 DAYS) An infant during the first month after birth. (NCI) Newborn Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, page 18

C49642 C66780 Age Span PRETERM NEWBORN INFANTS PRETERM NEWBORN INFANTS An infant born prior to completion of the normal gestation Preterm Newborn Infant Production Detailed guidance on the European clinical trials database (EUDRACT Database), April, 2003, period. (NCI) page 18

C66781 No Age Unit AGEU AGEU Age Unit Those units of time that are routinely used to express the age CDISC SDTM Age Unit Production of a person. (NCI) Terminology C25301 C66781 Age Unit DAYS DAYS The time for Earth to make a complete rotation on its axis; Day Production Organization Name: CDISC ordinarily divided into twenty-four hours. This also refers to a Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials specific day. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 5.1.1 Page: 36 Field Name: Controlled Terms or Format C25529 C66781 Age Unit HOURS HOURS A unit measure of time equal to 3,600 seconds or 60 minutes. Hour Production Organization Name: CDISC It is approximately 1/24 of a median day. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter: 5.1.1 Page: 36 Field Name: Controlled Terms or Format C29846 C66781 Age Unit MONTHS MONTHS One of the 12 divisions of a year as determined by a calendar Month Production Organization Name: CDISC It corresponds to the unit of time of approximately to one cycle Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials of the moon's phases, about 30 days or 4 weeks. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 5.1.1 Page: 36 Field Name: Controlled Terms or Format C29844 C66781 Age Unit WEEKS WEEKS Any period of seven consecutive days. (NCI) Week Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter: 5.1.1 Page: 36 Field Name: Controlled Terms or Format C29848 C66781 Age Unit YEARS YEARS The period of time that it takes for Earth to make a complete Year Production Organization Name: CDISC revolution around the sun, approximately 365 days; a specific Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials one year period. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 5.1.1 Page: 36 Field Name: Controlled Terms or Format C66797 No Category for Inclusion/Exclusion IECAT IECAT Category for A collection of criteria on which subjects are evaluated and CDISC SDTM Category of Production Inclusion/Exclusion that must be met by all study subjects. (NCI) Inclusion And Or Exclusion Terminology

C25370 C66797 Category for Inclusion/Exclusion EXCLUSION EXCLUSION List of characteristics in a protocol, any one of which may Exclusion Production Organization Name: CDISC exclude a potential subject from participation in a study. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials (CDISC glossary) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 6.3.2 Page: 70 Field Name: Controlled Terms or Format

Covance Page 2 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C25532 C66797 Category for Inclusion/Exclusion INCLUSION INCLUSION The criteria in a protocol that prospective subjects must meet Inclusion Production Organization Name: CDISC to be eligible for participation in a study. NOTE: Exclusion Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials and inclusion criteria define the study population. See also Document Version: 3.1.1 exclusion criteria. (CDISC glossary) Date: 2005-08-26 Chapter: 6.3.2 Page: 70 Field Name: Controlled Terms or Format

C66783 No CDISC System Organ Class SOC SOC CDISC System Organ Class Terms at the highest level of the CDISC system organ class CDISC SDTM System Organ Production terminology. Class Terminology C35814 C66783 CDISC System Organ Class BLOOD AND LYMPHATIC BLOOD AND LYMPHATIC Any deviation from the normal structure or function of the Hematopoietic and Lymphoid Production SYSTEM DISORDERS SYSTEM DISORDERS blood or lymphatic system that is manifested by a System Disorder characteristic set of symptoms and signs. (NCI) C3079 C66783 CDISC System Organ Class CARDIAC DISORDERS CARDIAC DISORDERS Any deviation from the normal structure or function of the Heart Disorder Production cardiac system that is manifested by a characteristic set of symptoms and signs. (NCI) C49399 C66783 CDISC System Organ Class CONGENITAL, FAMILIAL AND CONGENITAL, FAMILIAL AND A class of disorders that encompasses conditions resulting Congenital, Familial and Genetic Production GENETIC DISORDERS GENETIC DISORDERS from a congenital, familial hereditary trait or genetic Disorder Class abnormality as is manifested by a characterstic set of symptoms and signs. (NCI) C49400 C66783 CDISC System Organ Class EAR AND LABYRINTH EAR AND LABYRINTH Any deviation from the normal structure or function of the ear Ear and Labyrinth Disorder Class Production DISORDERS DISORDERS or labyrinth that is manifested by a characteristic set of symptoms and signs. (NCI) C3009 C66783 CDISC System Organ Class ENDOCRINE DISORDERS ENDOCRINE DISORDERS Any deviation from the normal structure or function of the Endocrine Disorder Production endocrine system that is manifested by a characteristic set of symptoms and signs. (NCI) C26767 C66783 CDISC System Organ Class EYE DISORDERS EYE DISORDERS Any deviation from the normal structure or function of the eye Eye Disorder Production that is manifested by a characteristic set of symptoms and signs. (NCI) C2990 C66783 CDISC System Organ Class GASTROINTESTINAL GASTROINTESTINAL Diseases of the digestive tract (oral cavity to anus) and Gastrointestinal Disorder Production DISORDERS DISORDERS associated organs (salivary glands, liver, pancreas). (NCI)

C49401 C66783 CDISC System Organ Class GENERAL DISORDERS AND GENERAL DISORDERS AND A class of disorders that encompasses conditions of a general General Disorders and Production ADMINISTRATION SITE ADMINISTRATION SITE kind that result from a disease, the treatment of disease or Administration Site Conditions CONDITIONS CONDITIONS administration of treatment at a particular site and are Class manifested by a characteristic set of symptoms and signs. (NCI) C3959 C66783 CDISC System Organ Class HEPATOBILIARY DISORDERS HEPATOBILIARY DISORDERS Any deviation from the normal structure or function of the liver Liver and Biliary Tract Disorder Production or biliary tract that is manifested by a characteristic set of symptoms and signs. (NCI) C3507 C66783 CDISC System Organ Class IMMUNE SYSTEM DISORDERS IMMUNE SYSTEM DISORDERS A disorder resulting from an abnormality in the immune Immune System Disorder Production system. -- 2003 (NCI) C26726 C66783 CDISC System Organ Class INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS A disorder resulting from the presence and activity of a Infectious Disorder Production microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. -- 2003 (NCI)

C49402 C66783 CDISC System Organ Class INJURY, POISONING AND INJURY, POISONING AND A class of disorders that encompasses conditions resulting Injury, Poisoning and Procedural Production PROCEDURAL COMPLICATIONS PROCEDURAL COMPLICATIONS from an injury, poisoning or procedure. (NCI) Complication Class

C41198 C66783 CDISC System Organ Class INVESTIGATIONS INVESTIGATIONS The act or process of a systematic and thorough examination; Investigation Production research, study; the process of inquiring into or following up, intended to develop facts. (NCI)

C49403 C66783 CDISC System Organ Class METABOLISM AND NUTRITION METABOLISM AND NUTRITION A class of disorders that encompasses conditions occurring asMetabolism and Nutrition Production DISORDERS DISORDERS a result of metabolic dysfunction or deviation from the normal Disorder Class nutritional requirements. (NCI) C27574 C66783 CDISC System Organ Class MUSCULOSKELETAL AND MUSCULOSKELETAL AND Any deviation from the normal structure or function of the Connective and Soft Tissue Production CONNECTIVE TISSUE CONNECTIVE TISSUE musculoskeletal or connective tissue that is manifested by a Disorder DISORDERS DISORDERS characteristic set of symptoms and signs. (NCI)

C3262 C66783 CDISC System Organ Class NEOPLASMS BENIGN, NEOPLASMS BENIGN, An abnormal tissue growth resulted from uncontrolled cell Neoplasm Production MALIGNANT AND UNSPECIFIED MALIGNANT AND UNSPECIFIED proliferation. Benign neoplastic cells resemble normal cells (INCL CYSTS AND POLYPS) (INCL CYSTS AND POLYPS) without exhibiting significant cytologic atypia, while malignant ones exhibit overt signs such as dysplastic features, atypical mitotic

C26835 C66783 CDISC System Organ Class NERVOUS SYSTEM DISORDERS NERVOUS SYSTEM DISORDERS Any deviation from the normal structure or function of the Nervous System Disorder Production nervous system that is manifested by a characteristic set of symptoms and signs. (NCI) C49404 C66783 CDISC System Organ Class PREGNANCY, PUERPERIUM AND PREGNANCY, PUERPERIUM AND A class of conditions associated with pregnancy, puerperium Pregnancy, Puerperium and Production PERINATAL CONDITIONS PERINATAL CONDITIONS and perinatal status. (NCI) Perinatal Condition Class

C2893 C66783 CDISC System Organ Class PSYCHIATRIC DISORDERS PSYCHIATRIC DISORDERS Any deviation from the normal structure or function of the Psychiatric Disorder Production brain and a psychiatric condition, that results in an impairment of an individual's normal cognitive, emotional, or behavioral functioning, and is caused by physiological or psychosocial factors. C3430 C66783 CDISC System Organ Class RENAL AND URINARY RENAL AND URINARY Disorders of any part of the urologic system. (NCI) Urinary System Disorder Production DISORDERS DISORDERS C49405 C66783 CDISC System Organ Class REPRODUCTIVE SYSTEM AND REPRODUCTIVE SYSTEM AND Any deviation from the normal structure or function of the Reproductive System and Breast Production BREAST DISORDERS BREAST DISORDERS reproductive system or breast that is manifested by a Disorder Class characteristic set of symptoms and signs. (NCI)

Covance Page 3 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C27669 C66783 CDISC System Organ Class RESPIRATORY, THORACIC AND RESPIRATORY, THORACIC AND Any deviation from the normal structure or function of the Respiratory and Thoracic Production MEDIASTINAL DISORDERS MEDIASTINAL DISORDERS respiratory system including the thorax and mediastinum that Disorder is manifested by a characteristic set of symptoms and signs. (NCI) C3371 C66783 CDISC System Organ Class SKIN AND SUBCUTANEOUS SKIN AND SUBCUTANEOUS Any deviation from the normal structure or function of the skin Skin Disorder Production TISSUE DISORDERS TISSUE DISORDERS or subcutaneous tissue that is manifested by a characteristic set of symptoms and signs.(NCI) C20188 C66783 CDISC System Organ Class SOCIAL CIRCUMSTANCES SOCIAL CIRCUMSTANCES A set of concepts that results from or is influenced by criteria Social Circumstances Production or activities associated with the social environment of a person. (NCI) C25218 C66783 CDISC System Organ Class SURGICAL AND MEDICAL SURGICAL AND MEDICAL A particular course of action intended to achieve a result. Procedure Production PROCEDURES PROCEDURES (NCI) C35117 C66783 CDISC System Organ Class VASCULAR DISORDERS VASCULAR DISORDERS Any deviation from the normal structure or function of the Vascular Disorder Production vascular system that is manifested by a characteristic set of symptoms and signs. (NCI) C66784 No Common Terminology Criteria for Adverse Events TOXGR TOXGR Common Terminology Criteria A standard terminology developed to report adverse events CDISC SDTM Common Production for Adverse Events occurring in cancer clinical trials. Common terminology Terminology Criteria for Adverse criteria for adverse events (CTCAE) are used in study adverse Event Grade Terminology event summaries and Investigational New Drug reports to the Food and Drug Admi

C41338 C66784 Common Terminology Criteria for Adverse Events 1 MILD Grade 1; 1 A type of adverse event that is usually transient and may Mild Adverse Event Production Organization Name: CDISC require only minimal treatment or therapeutic intervention. The Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials event does not generally interfere with usual activities of daily Document Version: 3.1.1 living. Date: 2005-08-26 Chapter: 6.2.1 Page: 55 Field Name: CDISC Notes for AETOXGR - "Value should contain valid numbers

C41339 C66784 Common Terminology Criteria for Adverse Events 2 MODERATE Grade 2; 2 A type of adverse event that is usually alleviated with Moderate Adverse Event Production Organization Name: CDISC additional specific therapeutic intervention. The event Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials interferes with usual activities of daily living, causing Document Version: 3.1.1 discomfort but poses no significant or permanent risk of harm Date: 2005-08-26 to the research partici Chapter: 6.2.1 Page: 55 Field Name: CDISC Notes for AETOXGR - "Value should contain valid numbers C41340 C66784 Common Terminology Criteria for Adverse Events 3 SEVERE Grade 3; 3 A type of adverse event that requires intensive therapeutic Severe Adverse Event Production Organization Name: CDISC intervention. The event interrupts usual activities of daily living Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials or significantly affects clinical status. The event possesses a Document Version: 3.1.1 significant risk of harm to the research participant and hospi Date: 2005-08-26 Chapter: 6.2.1 Page: 55 Field Name: CDISC Notes for AETOXGR - "Value should contain valid numbers C41337 C66784 Common Terminology Criteria for Adverse Events 4 LIFE THREATENING Grade 4; 4 An adverse event, and/or its immediate sequelae, which is Life Threatening or Disabling Production Organization Name: CDISC associated with an imminent risk of death or which is Adverse Event Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials associated with physical or mental disabilities that affect or Document Version: 3.1.1 limit the ability of a person to perform activities of daily living Date: 2005-08-26 (eating, amb Chapter: 6.2.1 Page: 55 Field Name: CDISC Notes for AETOXGR - "Value should contain valid numbers C48275 C66784 Common Terminology Criteria for Adverse Events 5 FATAL Grade 5; 5 The termination of life as a result of an adverse event. (NCI) Death Related to Adverse Event Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter: 6.2.1 Page: 55 Field Name: CDISC Notes for AETOXGR - "Value should contain valid numbers C66785 Yes Control Type TCNTRL TCNTRL Control Type; Type of Control Comparator against which the study treatment is evaluated CDISC SDTM Control Type Production (e.g., concurrent (placebo, no treatment, dose-response, Terminology active), external (historical, published literature).

C49649 C66785 Control Type ACTIVE ACTIVE A type of control, which has a demonstrated effect, Active Control Production administered as a comparator, to subjects in a clinical trial. [From ICH E10].

C41132 C66785 Control Type NONE NONE No person or thing, nobody, not any. (NCI) None Production

C49648 C66785 Control Type PLACEBO PLACEBO Use of an inactive compound identical in appearance to drug Placebo Control Production or treatment being tested in experimental research, which may or may not be known to the physician and/or subject, administered to distinguish between drug action and suggestive effect of the dru

C66786 No Country COUNTRY COUNTRY Country A collective generic term that refers here to a wide variety of CDISC SDTM Country Production dependencies, areas of special sovereignty, uninhabited Terminology islands, and other entities in addition to the traditional countries or independent states. (NCI)

Covance Page 4 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17884 C66786 Country ABW ABW ARUBA Island in the Caribbean Sea, north of Venezuela. Aruba Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

C16267 C66786 Country AFG AFG AFGHANISTAN A country in Southern Asia, north and west of Pakistan, east Afghanistan Production Organization Name: HL7 of Iran. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16292 C66786 Country AGO AGO ANGOLA A country in Southern Africa, bordering the South Atlantic Angola Production Organization Name: HL7 Ocean, between Namibia and Democratic Republic of the Document Title: HL7 Vocabulary Domain Congo. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20133 C66786 Country AIA AIA ANGUILLA An island in the Caribbean Sea, east of Puerto Rico. Anguilla Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C44481 C66786 Country ALA ALA ALAND ISLANDS An archipelago in the Baltic Sea at the entrance to the Gulf of Aland Islands Production Organization Name: HL7 Bothnia between Sweden and Finland. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16271 C66786 Country ALB ALB ALBANIA A country in Southeastern Europe, bordering the Adriatic Sea Albania Production Organization Name: HL7 and Ionian Sea, between Greece and Serbia and Montenegro. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16289 C66786 Country AND AND ANDORRA A country in Southwestern Europe, between France and Andorra Production Organization Name: HL7 Spain. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16904 C66786 Country ANT ANT NETHERLANDS ANTILLES A country in the Caribbean, comprising two island groups in Netherlands Antilles Production Organization Name: HL7 the Caribbean Sea - one includes Curacao and Bonaire north Document Title: HL7 Vocabulary Domain of Venezuela; the other is east of the Virgin Islands. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17232 C66786 Country ARE ARE UNITED ARAB EMIRATES A country in the Middle East, bordering the Gulf of Oman and United Arab Emirates Production Organization Name: HL7 the Persian Gulf, between Oman and Saudi Arabia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16305 C66786 Country ARG ARG ARGENTINA A country in Southern South America, bordering the South Argentina Production Organization Name: HL7 Atlantic Ocean, between Chile and Uruguay. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16306 C66786 Country ARM ARM ARMENIA A country in Southwestern Asia, east of Turkey. Armenia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17739 C66786 Country ASM ASM AMERICAN SAMOA A group of islands in the South Pacific Ocean, about half way American Samoa Production Organization Name: HL7 between Hawaii and New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C18007 C66786 Country ATA ATA ANTARCTICA The continent lying mostly south of the Antarctic Circle. Antarctica Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20105 C66786 Country ATF ATF FRENCH SOUTHERN Islands in the southern Indian Ocean, south of Africa, about French Southern Territories Production Organization Name: HL7 TERRITORIES equidistant between Africa, Antarctica, and Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16303 C66786 Country ATG ATG ANTIGUA AND BARBUDA Islands between the Caribbean Sea and the North Atlantic Antigua and Barbuda Production Organization Name: HL7 Ocean, east-southeast of Puerto Rico. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

Covance Page 5 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16311 C66786 Country AUS AUS AUSTRALIA The continent between the Indian Ocean and the South Australia Production Organization Name: HL7 Pacific Ocean. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16312 C66786 Country AUT AUT AUSTRIA A country in Central Europe, north of Italy and Slovenia. Austria Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16316 C66786 Country AZE AZE AZERBAIJAN A country in Southwestern Asia, bordering the Caspian Sea, Azerbaijan Production Organization Name: HL7 between Iran and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16371 C66786 Country BDI BDI BURUNDI A country in Central Africa, east of Democratic Republic of theBurundi Production Organization Name: HL7 Congo. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16329 C66786 Country BEL BEL BELGIUM A country in Western Europe, bordering the North Sea, Belgium Production Organization Name: HL7 between France and the Netherlands. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16333 C66786 Country BEN BEN BENIN REPUBLIC A country in Western Africa, bordering the North Atlantic Benin Republic Production Organization Name: HL7 Ocean, between Nigeria and Togo. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16369 C66786 Country BFA BFA BURKINA FASO A country in Western Africa, north of Ghana. Burkina Faso Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16323 C66786 Country BGD BGD BANGLADESH A country in Southern Asia, bordering the Bay of Bengal, Bangladesh Production Organization Name: HL7 between Burma and India. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16368 C66786 Country BGR BGR BULGARIA A country in Southeastern Europe, bordering the Black Sea, Bulgaria Production Organization Name: HL7 between Romania and Turkey. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16322 C66786 Country BHR BHR BAHRAIN An archipelago in the Persian Gulf, east of Saudi Arabia. Bahrain Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16321 C66786 Country BHS BHS BAHAMAS A chain of islands in the North Atlantic Ocean, southeast of Bahamas Production Organization Name: HL7 Florida. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16361 C66786 Country BIH BIH BOSNIA-HERZEGOVINA A country in Southeastern Europe, bordering the Adriatic Sea Bosnia-Herzegovina Production Organization Name: HL7 and Croatia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16372 C66786 Country BLR BLR BELARUS A country in Eastern Europe, east of Poland. Belarus Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16331 C66786 Country BLZ BLZ BELIZE A country in Central America, bordering the Caribbean Sea, Belize Production Organization Name: HL7 between Guatemala and Mexico. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16334 C66786 Country BMU BMU BERMUDA No Definition Bermuda Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16359 C66786 Country BOL BOL BOLIVIA A country in Central South America, southwest of Brazil. Bolivia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

Covance Page 6 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16364 C66786 Country BRA BRA BRAZIL A country in Eastern South America, bordering the Atlantic Brazil Production Organization Name: HL7 Ocean. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16324 C66786 Country BRB BRB BARBADOS An island between the Caribbean Sea and the North Atlantic Barbados Production Organization Name: HL7 Ocean, northeast of Venezuela. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16367 C66786 Country BRN BRN BRUNEI A country in Southeastern Asia, bordering the South China Brunei Darussalam Production Organization Name: HL7 Sea and Malaysia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16336 C66786 Country BTN BTN BHUTAN A country in Southern Asia, between China and India. Bhutan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20104 C66786 Country BVT BVT BOUVET ISLAND An island in the South Atlantic Ocean, south-southwest of the Bouvet Island Production Organization Name: HL7 Cape of Good Hope (South Africa). Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16363 C66786 Country BWA BWA BOTSWANA A country in Southern Africa, north of South Africa. Botswana Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16409 C66786 Country CAF CAF CENTRAL AFRICAN A country in Central Africa, north of Democratic Republic of Central African Republic Production Organization Name: HL7 REPUBLIC the Congo. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16380 C66786 Country CAN CAN CANADA A country in Northern North America, bordering the North Canada Production Organization Name: HL7 Atlantic Ocean on the east, North Pacific Ocean on the west, Document Title: HL7 Vocabulary Domain and the Arctic Ocean on the north, north of the conterminous Document Version: HL7 RIM 3 US. Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16445 C66786 Country CCK CCK COCOS (KEELING) A group of islands in the Indian Ocean, south of Indonesia, Cocos (Keeling) Islands Production Organization Name: HL7 ISLANDS about halfway from Australia to Sri Lanka. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17181 C66786 Country CHE CHE SWITZERLAND A country in Central Europe, east of France, north of Italy. Switzerland Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16427 C66786 Country CHL CHL CHILE A country in Southern South America, bordering the South Chile Production Organization Name: HL7 Atlantic Ocean and South Pacific Ocean, between Argentina Document Title: HL7 Vocabulary Domain and Peru. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16428 C66786 Country CHN CHN CHINA A country in Eastern Asia, bordering the East China Sea, China Production Organization Name: HL7 Korea Bay, Yellow Sea, and South China Sea, between North Document Title: HL7 Vocabulary Domain Korea and Vietnam. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16762 C66786 Country CIV CIV COTE D'IVOIRE A country in Western Africa, bordering the North Atlantic Cote d'Ivoire Production Organization Name: HL7 Ocean, between Ghana and Liberia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16379 C66786 Country CMR CMR CAMEROON A country in Western Africa, bordering the Bight of Biafra, Cameroon Production Organization Name: HL7 between Equatorial Guinea and Nigeria. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17266 C66786 Country COD COD DEMOCRATIC REPUBLIC A country in Central Africa, northeast of Angola. Democratic Republic of the Production Organization Name: HL7 OF THE CONGO Congo Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16467 C66786 Country COG COG CONGO A country in Western Africa, bordering the South Atlantic Congo Production Organization Name: HL7 Ocean, between Angola and Gabon. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

Covance Page 7 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16469 C66786 Country COK COK COOK ISLANDS A group of islands in the South Pacific Ocean, about one-half Cook Islands Production Organization Name: HL7 of the way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16449 C66786 Country COL COL COLOMBIA A country in Northern South America, bordering the CaribbeanColombia Production Organization Name: HL7 Sea, between Panama and Venezuela, and bordering the Document Title: HL7 Vocabulary Domain North Pacific Ocean, between Ecuador and Panama. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16458 C66786 Country COM COM COMOROS A group of islands in the Mozambique Channel, about two- Comoros Production Organization Name: HL7 thirds of the way between northern Madagascar and northern Document Title: HL7 Vocabulary Domain Mozambique. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16382 C66786 Country CPV CPV CAPE VERDE A group of islands in the North Atlantic Ocean, west of Cape Verde Production Organization Name: HL7 Senegal. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16470 C66786 Country CRI CRI COSTA RICA A country in Central America, bordering both the Caribbean Costa Rica Production Organization Name: HL7 Sea and the North Pacific Ocean, between Nicaragua and Document Title: HL7 Vocabulary Domain Panama. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16477 C66786 Country CUB CUB CUBA An island between the Caribbean Sea and the North Atlantic Cuba Production Organization Name: HL7 Ocean, 150 km south of Key West, Florida. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C44482 C66786 Country CXR CXR CHRISTMAS ISLAND An Australian-administered island in the eastern Indian Ocean Christmas Island Production Organization Name: HL7 south of Java, Indonesia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16391 C66786 Country CYM CYM CAYMAN ISLANDS An island group in the Caribbean Sea, nearly one-half of the Cayman Islands Production Organization Name: HL7 way from Cuba to Honduras. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16480 C66786 Country CYP CYP CYPRUS An island in the Mediterranean Sea, south of Turkey. Cyprus Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17668 C66786 Country CZE CZE CZECH REPUBLIC A country in Central Europe, southeast of Germany. Czech Republic Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16636 C66786 Country DEU DEU GERMANY A country in Central Europe, bordering the Baltic Sea and the Germany Production Organization Name: HL7 North Sea, between the Netherlands and Poland, south of Document Title: HL7 Vocabulary Domain Denmark. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16506 C66786 Country DJI DJI DJIBOUTI A country in Eastern Africa, bordering the Gulf of Aden and Djibouti Production Organization Name: HL7 the Red Sea, between Eritrea and Somalia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16519 C66786 Country DMA DMA DOMINICA An island between the Caribbean Sea and the North Atlantic Dominica Production Organization Name: HL7 Ocean, about one-half of the way from Puerto Rico to Trinidad Document Title: HL7 Vocabulary Domain and Tobago. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16496 C66786 Country DNK DNK DENMARK A country in Northern Europe, bordering the Baltic Sea and Denmark Production Organization Name: HL7 the North Sea, on a peninsula north of Germany (Jutland); Document Title: HL7 Vocabulary Domain also includes two major islands (Sjaelland and Fyn). Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16520 C66786 Country DOM DOM DOMINICAN REPUBLIC A country comprising the eastern two-thirds of the island of Dominican Republic Production Organization Name: HL7 Hispaniola, between the Caribbean Sea and the North Atlantic Document Title: HL7 Vocabulary Domain Ocean, east of Haiti. Document Version: HL7 RIM 3 C16274 C66786 Country DZA DZA ALGERIA A country in Northern Africa, bordering the Mediterranean Algeria Production OrganizationCh t 2 1 HL7Name: V HL7 b l D i V l Sea, between Morocco and Tunisia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

Covance Page 8 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16528 C66786 Country ECU ECU ECUADOR A country in Western South America, bordering the Pacific Ecuador Production Organization Name: HL7 Ocean at the Equator, between Colombia and Peru. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16530 C66786 Country EGY EGY EGYPT A country in Northern Africa, bordering the Mediterranean Egypt Production Organization Name: HL7 Sea, between Libya and the Gaza Strip. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16558 C66786 Country ERI ERI ERITREA A country in Eastern Africa, bordering the Red Sea, between Eritrea Production Organization Name: HL7 Djibouti and Sudan. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20113 C66786 Country ESH ESH WESTERN SAHARA A country in Northern Africa, bordering the North Atlantic Western Sahara Production Organization Name: HL7 Ocean, between Mauritania and Morocco. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17152 C66786 Country ESP ESP SPAIN A country in Southwestern Europe, bordering the Bay of Spain Production Organization Name: HL7 Biscay, Mediterranean Sea, North Atlantic Ocean, and Document Title: HL7 Vocabulary Domain Pyrenees Mountains, southwest of France. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16562 C66786 Country EST EST ESTONIA A country in Eastern Europe, bordering the Baltic Sea and Estonia Production Organization Name: HL7 Gulf of Finland, between Latvia and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16563 C66786 Country ETH ETH ETHIOPIA A country in Eastern Africa, west of Somalia. Ethiopia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16584 C66786 Country FIN FIN FINLAND A country in Northern Europe, bordering the Baltic Sea, Gulf Finland Production Organization Name: HL7 of Bothnia, and Gulf of Finland, between Sweden and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16582 C66786 Country FJI FJI FIJI An island group in the South Pacific Ocean, about two-thirds Fiji Production Organization Name: HL7 of the way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17954 C66786 Country FLK FLK FALKLAND ISLANDS Islands in the South Atlantic Ocean, east of southern Falkland Islands Production Organization Name: HL7 Argentina. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16592 C66786 Country FRA FRA FRANCE A country in Western Europe, bordering the Bay of Biscay andFrance Production Organization Name: HL7 English Channel, between Belgium and Spain, southeast of Document Title: HL7 Vocabulary Domain the UK; bordering the Mediterranean Sea, between Italy and Document Version: HL7 RIM 3 Spain. Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16573 C66786 Country FRO FRO FAROE ISLANDS An island group between the Norwegian Sea and the North Faroe Islands Production Organization Name: HL7 Atlantic Ocean, about one-half of the way from Iceland to Document Title: HL7 Vocabulary Domain Norway. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17881 C66786 Country FSM FSM MICRONESIA, FEDERATED An island group in the North Pacific Ocean, about three- Federated States of Micronesia Production Organization Name: HL7 STATES OF quarters of the way from Hawaii to Indonesia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16596 C66786 Country GAB GAB GABON A country in Western Africa, bordering the Atlantic Ocean at Gabon Production Organization Name: HL7 the Equator, between Republic of the Congo and Equatorial Document Title: HL7 Vocabulary Domain Guinea. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17233 C66786 Country GBR GBR UNITED KINGDOM A country in Western Europe, comprising islands, including United Kingdom Production Organization Name: HL7 the northern one-sixth of the island of Ireland, between the Document Title: HL7 Vocabulary Domain North Atlantic Ocean and the North Sea, northwest of France. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16634 C66786 Country GEO GEO GEORGIA A country in Southwestern Asia, bordering the Black Sea, Georgia Production Organization Name: HL7 between Turkey and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64375 C66786 Country GGY GGY GUERNSEY The island of Guernsey and the other Channel Islands Guernsey Production Organization Name: HL7 represent the last remnants of the medieval Dukedom of Document Title: HL7 Vocabulary Domain Normandy, which held sway in both France and England. Document Version: HL7 RIM 3 Guernsey is a British crown dependency, but is not part of the Chapter: 2.1 HL7 Vocabulary Domain Values UK. Codelist_Name: Country Field Name: MNEMONIC C26330 C66786 Country GHA GHA GHANA A country in Western Africa, bordering the Gulf of Guinea, Ghana Production Organization Name: HL7 between Cote d'Ivoire and Togo. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16638 C66786 Country GIB GIB GIBRALTAR A dependency in Southwestern Europe, bordering the Strait of Gibraltar Production Organization Name: HL7 Gibraltar, on the southern coast of Spain. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16655 C66786 Country GIN GIN GUINEA A country in Western Africa, bordering the North Atlantic Guinea Production Organization Name: HL7 Ocean, between Guinea-Bissau and Sierra Leone. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16651 C66786 Country GLP GLP GUADELOUPE Islands in the eastern Caribbean Sea, southeast of Puerto Guadeloupe Production Organization Name: HL7 Rico. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16598 C66786 Country GMB GMB GAMBIA A country in Western Africa, bordering the North Atlantic Gambia Production Organization Name: HL7 Ocean and Senegal. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16656 C66786 Country GNB GNB GUINEA-BISSAU A country in Western Africa, bordering the North Atlantic Guinea-Bissau Production Organization Name: HL7 Ocean, between Guinea and Senegal. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16557 C66786 Country GNQ GNQ EQUATORIAL GUINEA A country in Western Africa, bordering the Bight of Biafra, Equatorial Guinea Production Organization Name: HL7 between Cameroon and Gabon; composed of a mainland Document Title: HL7 Vocabulary Domain portion and five inhabited islands. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16645 C66786 Country GRC GRC GREECE A country in Southern Europe, bordering the Aegean Sea, Greece Production Organization Name: HL7 Ionian Sea, and the Mediterranean Sea, between Albania and Document Title: HL7 Vocabulary Domain Turkey. Document Version: HL7 RIM 3 C16647 C66786 Country GRD GRD GRENADA An island between the Caribbean Sea and Atlantic Ocean, Grenada Production Organization Name: HL7 north of Trinidad and Tobago. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16646 C66786 Country GRL GRL GREENLAND An island between the Arctic Ocean and the North Atlantic Greenland Production Organization Name: HL7 Ocean, northeast of Canada. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16654 C66786 Country GTM GTM GUATEMALA A country in Central America, bordering the Caribbean Sea, Guatemala Production Organization Name: HL7 between Honduras and Belize and bordering the North Pacific Document Title: HL7 Vocabulary Domain Ocean, between El Salvador and Mexico. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16593 C66786 Country GUF GUF FRENCH GUIANA A country in Northern South America, bordering the North French Guiana Production Organization Name: HL7 Atlantic Ocean, between Brazil and Suriname. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16652 C66786 Country GUM GUM GUAM Island in the North Pacific Ocean, about three-quarters of the Guam Production Organization Name: HL7 way from Hawaii to the Philippines. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16657 C66786 Country GUY GUY GUYANA A country in Northern South America, bordering the North Guyana Production Organization Name: HL7 Atlantic Ocean, between Suriname and Venezuela. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16695 C66786 Country HKG HKG HKG; HONG KONG A special administrative region of China, bordering the South Hong Kong Production Organization Name: HL7 China Sea and China. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20106 C66786 Country HMD HMD HEARD ISLAND AND Islands in the Indian Ocean, about two-thirds of the way from Heard Island and McDonald Production Organization Name: HL7 MCDONALD ISLANDS Madagascar to Antarctica. Islands Document Title: HL7 Vocabulary Domain D t V i HL7 RIM 3

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16694 C66786 Country HND HND HONDURAS A country in Central America, bordering the Caribbean Sea, Honduras Production Organization Name: HL7 between Guatemala and Nicaragua and bordering the North Document Title: HL7 Vocabulary Domain Pacific Ocean, between El Salvador and Nicaragua. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16474 C66786 Country HRV HRV CROATIA A country in Southeastern Europe, bordering the Adriatic Sea, Croatia Production Organization Name: HL7 between Bosnia and Herzegovina and Slovenia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16660 C66786 Country HTI HTI HAITI A country comprising the western one-third of the island of Haiti Production Organization Name: HL7 Hispaniola, between the Caribbean Sea and the North Atlantic Document Title: HL7 Vocabulary Domain Ocean, west of the Dominican Republic. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16699 C66786 Country HUN HUN HUNGARY A country in Central Europe, northwest of Romania. Hungary Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16728 C66786 Country IDN IDN INDONESIA A country in Southeastern Asia, comprising the archipelago Indonesia Production Organization Name: HL7 between the Indian Ocean and the Pacific Ocean. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16727 C66786 Country IND IND INDIA A country in Southern Asia, bordering the Arabian Sea and India Production Organization Name: HL7 the Bay of Bengal, between Burma and Pakistan. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16365 C66786 Country IOT IOT BRITISH INDIAN OCEAN An archipelago in the Indian Ocean, about one-half the way British Indian Ocean Territory Production Organization Name: HL7 TERRITORY from Africa to Indonesia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16757 C66786 Country IRL IRL IRELAND A country in Western Europe, occupying five-sixths of the Ireland Production Organization Name: HL7 island of Ireland in the North Atlantic Ocean, west of Great Document Title: HL7 Vocabulary Domain Britain. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16755 C66786 Country IRN IRN IRAN A country in the Middle East, bordering the Gulf of Oman, the Iran Production Organization Name: HL7 Persian Gulf, and the Caspian Sea, between Iraq and Document Title: HL7 Vocabulary Domain Pakistan. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16756 C66786 Country IRQ IRQ IRAQ A country in the Middle East, bordering the Persian Gulf, Iraq Production Organization Name: HL7 between Iran and Kuwait. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16704 C66786 Country ISL ISL ICELAND A country in Northern Europe, island between the Greenland Iceland Production Organization Name: HL7 Sea and the North Atlantic Ocean, northwest of the UK. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16760 C66786 Country ISR ISR ISRAEL A country in the Middle East, bordering the Mediterranean Israel Production Organization Name: HL7 Sea, between Egypt and Lebanon. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16761 C66786 Country ITA ITA ITALY A country in Southern Europe, occupying a peninsula Italy Production Organization Name: HL7 extending into the central Mediterranean Sea, northeast of Document Title: HL7 Vocabulary Domain Tunisia. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16763 C66786 Country JAM JAM JAMAICA An island in the Caribbean Sea, south of Cuba. Jamaica Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16765 C66786 Country JOR JOR JORDAN A country in the Middle East, northwest of Saudi Arabia. Jordan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16764 C66786 Country JPN JPN JAPAN A country in Eastern Asia, occupying an island chain between Japan Production Organization Name: HL7 the North Pacific Ocean and the Sea of Japan, east of the Document Title: HL7 Vocabulary Domain Korean Peninsula. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64374 C66786 Country JRE JRE JERSEY Jersey and the other Channel Islands represent the last Jersey Production Organization Name: HL7 remnants of the medieval Dukedom of Normandy that held Document Title: HL7 Vocabulary Domain sway in both France and England. Jersey is a British crown Document Version: HL7 RIM 3 dependency, but is not part of the UK. Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20107 C66786 Country KAZ KAZ KAZAKHSTAN A country in Central Asia, northwest of China. Kazakhstan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16769 C66786 Country KEN KEN KENYA A country in Eastern Africa, bordering the Indian Ocean, Kenya Production Organization Name: HL7 between Somalia and Tanzania. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16771 C66786 Country KGZ KGZ KYRGYZSTAN A country in Central Asia, west of China. Kyrgyzstan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16378 C66786 Country KHM KHM CAMBODIA A country in Southeastern Asia, bordering the Gulf of Cambodia Production Organization Name: HL7 Thailand, between Thailand, Vietnam, and Laos. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16639 C66786 Country KIR KIR KIRIBATI A group of 33 coral atolls in the Pacific Ocean, straddling the Kiribati Production Organization Name: HL7 equator; the capital Tarawa is about one-half of the way from Document Title: HL7 Vocabulary Domain Hawaii to Australia. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17885 C66786 Country KNA KNA SAINT KITTS AND NEVIS Islands in the Caribbean Sea, about one-third of the way from Saint Kitts and Nevis Production Organization Name: HL7 Puerto Rico to Trinidad and Tobago. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16774 C66786 Country KOR KOR SOUTH KOREA A country in Eastern Asia, occupying the southern half of the South Korea Production Organization Name: HL7 Korean Peninsula, bordering the Sea of Japan and the Yellow Document Title: HL7 Vocabulary Domain Sea. Document Version: HL7 RIM 3 C16775 C66786 Country KWT KWT KUWAIT A country in the Middle East, bordering the Persian Gulf, Kuwait Production Organization Name: HL7 between Iraq and Saudi Arabia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16780 C66786 Country LAO LAO LAO PEOPLE'S A country in Southeastern Asia, northeast of Thailand, west of Lao People's Democratic Production Organization Name: HL7 DEMOCRATIC REPUBLIC Vietnam. Republic Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16784 C66786 Country LBN LBN LEBANON A country in the Middle East, bordering the Mediterranean Lebanon Production Organization Name: HL7 Sea, between Israel and Syria. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16791 C66786 Country LBR LBR LIBERIA A country in Western Africa, bordering the North Atlantic Liberia Production Organization Name: HL7 Ocean, between Cote d'Ivoire and Sierra Leone. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16793 C66786 Country LBY LBY LIBYAN ARAB JAMAHIRIYA A country in Northern Africa, bordering the Mediterranean Libyan Arab Jamahiriya Production Organization Name: HL7 Sea, between Egypt and Tunisia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 C17113 C66786 Country LCA LCA SAINT LUCIA A country in the Caribbean, occupying an island between the Saint Lucia Production Organization Name: HL7 Caribbean Sea and North Atlantic Ocean, north of Trinidad Document Title: HL7 Vocabulary Domain and Tobago. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16794 C66786 Country LIE LIE LIECHTENSTEIN A country in Central Europe, between Austria and Liechtenstein Production Organization Name: HL7 Switzerland. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17163 C66786 Country LKA LKA SRI LANKA A country in Southern Asia, occupying an island in the Indian Sri Lanka Production Organization Name: HL7 Ocean, south of India. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16787 C66786 Country LSO LSO LESOTHO A country in Southern Africa, an enclave of South Africa. Lesotho Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16799 C66786 Country LTU LTU LITHUANIA A country in Eastern Europe, bordering the Baltic Sea, Lithuania Production Organization Name: HL7 between Latvia and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16803 C66786 Country LUX LUX LUXEMBOURG A country in Western Europe, between France, Belgium, and Luxembourg Production Organization Name: HL7 Germany. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16783 C66786 Country LVA LVA LATVIA A country in Eastern Europe, bordering the Baltic Sea, Latvia Production Organization Name: HL7 between Estonia and Lithuania. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16807 C66786 Country MAC MAC MACAO A country in Eastern Asia, bordering the South China Sea and Macao Production Organization Name: HL7 China. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16878 C66786 Country MAR MAR MOROCCO A country in Northern Africa, bordering the North Atlantic Morocco Production Organization Name: HL7 Ocean and the Mediterranean Sea, between Algeria and Document Title: HL7 Vocabulary Domain Western Sahara. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16874 C66786 Country MCO MCO MONACO A country in Western Europe, bordering the Mediterranean Monaco Production Organization Name: HL7 Sea on the southern coast of France, near the border with Document Title: HL7 Vocabulary Domain Italy. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16871 C66786 Country MDA MDA MOLDOVA, REPUBLIC OF A country in Eastern Europe, northeast of Romania. Moldova Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16808 C66786 Country MDG MDG MADAGASCAR A country in Southern Africa, occupying an island in the Madagascar Production Organization Name: HL7 Indian Ocean, east of Mozambique. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16815 C66786 Country MDV MDV MALDIVES A country in Southern Asia, occupying a group of atolls in the Maldives Production Organization Name: HL7 Indian Ocean, south-southwest of India. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16850 C66786 Country MEX MEX MEXICO A country in Central America, bordering the Caribbean Sea Mexico Production Organization Name: HL7 and the Gulf of Mexico, between Belize and the US and Document Title: HL7 Vocabulary Domain bordering the North Pacific Ocean, between Guatemala and Document Version: HL7 RIM 3 the US. Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16822 C66786 Country MHL MHL MARSHALL ISLANDS A group of atolls and reefs in the North Pacific Ocean, about Marshall Islands Production Organization Name: HL7 one-half of the way from Hawaii to Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17654 C66786 Country MKD MKD REPUBLIC OF MACEDONIA A country in Southeastern Europe, north of Greece. Republic of Macedonia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16816 C66786 Country MLI MLI MALI A country in Western Africa, southwest of Algeria. Mali Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16817 C66786 Country MLT MLT MALTA A country in Southern Europe, occupying islands in the Malta Production Organization Name: HL7 Mediterranean Sea, south of Sicily (Italy). Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16370 C66786 Country MMR MMR MYANMAR A country in Southeastern Asia, bordering the Andaman Sea Myanmar Production Organization Name: HL7 and the Bay of Bengal, between Bangladesh and Thailand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C64378 C66786 Country MNE MNE MONTENEGRO A republic in Southeastern Europe, bordering the Adriatic Sea Montenegro Production Organization Name: HL7 between Albania and Bosnia and Herzegovina. Formerly part Document Title: HL7 Vocabulary Domain of Serbia and Montenegro (Federation Republic of Document Version: HL7 RIM 3 Yugoslavia). Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16875 C66786 Country MNG MNG MONGOLIA A country in Northern Asia, between China and Russia. Mongolia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17882 C66786 Country MNP MNP NORTHERN MARIANA A country in the Pacific, comprising islands in the North Northern Mariana Islands Production Organization Name: HL7 ISLANDS Pacific Ocean, about three-quarters of the way from Hawaii to Document Title: HL7 Vocabulary Domain the Philippines. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16882 C66786 Country MOZ MOZ MOZAMBIQUE A country in Southern Africa, bordering the Mozambique Mozambique Production Organization Name: HL7 Channel, between South Africa and Tanzania. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16826 C66786 Country MRT MRT MAURITANIA A country in Northern Africa, bordering the North Atlantic Mauritania Production Organization Name: HL7 Ocean, between Senegal and Western Sahara. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16876 C66786 Country MSR MSR MONTSERRAT A country in the Caribbean, occupying an island in the Montserrat Production Organization Name: HL7 Caribbean Sea, southeast of Puerto Rico. Document Title: HL7 Vocabulary Domain C16823 C66786 Country MTQ MTQ MARTINIQUE An island in the Caribbean Sea, north of Trinidad and Tobago.Martinique Production OrganizatioD t Vn Name: i HL7HL7 RIM 3 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16827 C66786 Country MUS MUS MAURITIUS A country in Southern Africa, occupying an island in the Mauritius Production Organization Name: HL7 Indian Ocean, east of Madagascar. Document Title: HL7 Vocabulary Domain C16813 C66786 Country MWI MWI MALAWI A country in Southern Africa, east of Zambia. Malawi Production OrganizationD t V Name: i HL7HL7 RIM 3 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16814 C66786 Country MYS MYS MALAYSIA A country in Southeastern Asia, occupying a peninsula and Malaysia Production Organization Name: HL7 the northern one-third of the island of Borneo, bordering Document Title: HL7 Vocabulary Domain Indonesia and the South China Sea, south of Vietnam. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16828 C66786 Country MYT MYT MAYOTTE A country in Southern Africa, occupying an island in the Mayotte Production Organization Name: HL7 Mozambique Channel, about one-half of the way from northern Document Title: HL7 Vocabulary Domain Madagascar to northern Mozambique. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16891 C66786 Country NAM NAM NAMIBIA A country in Southern Africa, bordering the South Atlantic Namibia Production Organization Name: HL7 Ocean, between Angola and South Africa. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16913 C66786 Country NCL NCL NEW CALEDONIA A country in the Pacific, comprised of islands in the South New Caledonia Production Organization Name: HL7 Pacific Ocean, east of Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16916 C66786 Country NER NER NIGER A country in Western Africa, southeast of Algeria. Niger Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16919 C66786 Country NFK NFK NORFOLK ISLAND A country in the Pacific, occupying an island in the South Norfolk Island Production Organization Name: HL7 Pacific Ocean, east of Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16917 C66786 Country NGA NGA NIGERIA A country in Western Africa, bordering the Gulf of Guinea, Nigeria Production Organization Name: HL7 between Benin and Cameroon. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16915 C66786 Country NIC NIC NICARAGUA A country in Central America, bordering both the Caribbean Nicaragua Production Organization Name: HL7 Sea and the North Pacific Ocean, between Costa Rica and Document Title: HL7 Vocabulary Domain Honduras. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16918 C66786 Country NIU NIU NIUE A country in the Pacific, occupying an island in the South Niue Production Organization Name: HL7 Pacific Ocean, east of Tonga. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16903 C66786 Country NLD NLD NETHERLANDS A country in Western Europe, bordering the North Sea, Netherlands Production Organization Name: HL7 between Belgium and Germany. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16920 C66786 Country NOR NOR NORWAY A country in Northern Europe, bordering the North Sea and Norway Production Organization Name: HL7 the North Atlantic Ocean, west of Sweden. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16901 C66786 Country NPL NPL NEPAL A country in Southern Asia, between China and India. Nepal Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16896 C66786 Country NRU NRU NAURU A country in Oceania, occupying an island in the South PacificNauru Production Organization Name: HL7 Ocean, south of the Marshall Islands. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16914 C66786 Country NZL NZL NEW ZEALAND A country in the Pacific, comprised of islands in the South New Zealand Production Organization Name: HL7 Pacific Ocean, southeast of Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16933 C66786 Country OMN OMN OMAN A country in the Middle East, bordering the Arabian Sea, Gulf Oman Production Organization Name: HL7 of Oman, and Persian Gulf, between Yemen and the United Document Title: HL7 Vocabulary Domain Arab Emirates. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16949 C66786 Country PAK PAK PAKISTAN A country in Southern Asia, bordering the Arabian Sea, Pakistan Production Organization Name: HL7 between India on the east and Iran and Afghanistan on the Document Title: HL7 Vocabulary Domain west and China in the north. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16951 C66786 Country PAN PAN PANAMA A country in Central America, bordering both the Caribbean Panama Production Organization Name: HL7 Sea and the North Pacific Ocean, between Colombia and Document Title: HL7 Vocabulary Domain Costa Rica. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16993 C66786 Country PCN PCN PITCAIRN A country in the Pacific, comprised of islands in the South Pitcairn Island Production Organization Name: HL7 Pacific Ocean, about midway between Peru and New Document Title: HL7 Vocabulary Domain Zealand. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16972 C66786 Country PER PER PERU A country in Western South America, bordering the South Peru Production Organization Name: HL7 Pacific Ocean, between Chile and Ecuador. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16978 C66786 Country PHL PHL PHILIPPINES A country in Southeastern Asia, comprised of an archipelago Philippines Production Organization Name: HL7 between the Philippine Sea and the South China Sea, east of Document Title: HL7 Vocabulary Domain Vietnam. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17733 C66786 Country PLW PLW PALAU A country in the Pacific, comprising a group of islands in the Palau Production Organization Name: HL7 North Pacific Ocean, southeast of the Philippines. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16952 C66786 Country PNG PNG PAPUA NEW GUINEA A country in Southeastern Asia, comprising a group of islands Papua New Guinea Production Organization Name: HL7 and including the eastern half of the island of New Guinea, Document Title: HL7 Vocabulary Domain between the Coral Sea and the South Pacific Ocean, east of Document Version: HL7 RIM 3 Indonesia. Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17002 C66786 Country POL POL POLAND A country in Central Europe, east of Germany. Poland Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17043 C66786 Country PRI PRI PUERTO RICO An island between the Caribbean Sea and the North Atlantic Puerto Rico Production Organization Name: HL7 Ocean, east of the Dominican Republic. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16773 C66786 Country PRK PRK NORTH KOREA A country in Eastern Asia, occupying the northern half of the North Korea Production Organization Name: HL7 Korean Peninsula, bordering the Korea Bay and the Sea of Document Title: HL7 Vocabulary Domain Japan, between China and South Korea. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17006 C66786 Country PRT PRT PORTUGAL A country in Southwestern Europe, bordering the North Portugal Production Organization Name: HL7 Atlantic Ocean, west of Spain. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16953 C66786 Country PRY PRY PARAGUAY A country in Central South America, northeast of Argentina. Paraguay Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20110 C66786 Country PSE PSE PALESTINIAN TERRITORY, A collective name for the West Bank and the Gaza Strip, two Palestinian Territory, Occupied Production Organization Name: HL7 OCCUPIED territories in Palestine. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16594 C66786 Country PYF PYF FRENCH POLYNESIA An archipelago in the South Pacific Ocean, about one-half of French Polynesia Production Organization Name: HL7 the way from South America to Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17045 C66786 Country QAT QAT QATAR A country in the Middle East, occupying a peninsula bordering Qatar Production Organization Name: HL7 the Persian Gulf and Saudi Arabia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17095 C66786 Country REU REU REUNION An Southern Africa, occupying an island in the Indian Ocean, Reunion Production Organization Name: HL7 east of Madagascar. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17108 C66786 Country ROU ROU ROMANIA A country in Southeastern Europe, bordering the Black Sea, Romania Production Organization Name: HL7 between Bulgaria and Ukraine. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17111 C66786 Country RUS RUS RUSSIAN FEDERATION A country in Northern Asia (that part west of the Urals is Russia Production Organization Name: HL7 sometimes included with Europe), bordering the Arctic Ocean, Document Title: HL7 Vocabulary Domain between Europe and the North Pacific Ocean. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17112 C66786 Country RWA RWA RWANDA A country in Central Africa, east of Democratic Republic of theRwanda Production Organization Name: HL7 Congo. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17117 C66786 Country SAU SAU SAUDI ARABIA A country in the Middle East, bordering the Persian Gulf and Saudi Arabia Production Organization Name: HL7 the Red Sea, north of Yemen. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C64377 C66786 Country SCG SCG SERBIA A republic in Southeastern Europe, bordering the Adriatic Sea Serbia Production Organization Name: HL7 between Albania and Bosnia and Herzegovina. Formerly part Document Title: HL7 Vocabulary Domain of Serbia and Montenegro (Federation Republic of Document Version: HL7 RIM 3 Yugoslavia). Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17170 C66786 Country SDN SDN SUDAN A country in Northern Africa, bordering the Red Sea, between Sudan Production Organization Name: HL7 Egypt and Eritrea. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17121 C66786 Country SEN SEN SENEGAL A country in Western Africa, bordering the North Atlantic Senegal Production Organization Name: HL7 Ocean, between Guinea-Bissau and Mauritania. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17134 C66786 Country SGP SGP SINGAPORE A country in Southeastern Asia, comprised of islands between Singapore Production Organization Name: HL7 Malaysia and Indonesia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20111 C66786 Country SGS SGS SOUTH GEORGIA AND THE A group of islands in the South Atlantic Ocean, east of the tip South Georgia and the South Production Organization Name: HL7 SOUTH SANDWICH of South America. Sandwich Islands Document Title: HL7 Vocabulary Domain ISLANDS Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17164 C66786 Country SHN SHN SAINT HELENA Islands in the South Atlantic Ocean, about midway between Saint Helena Production Organization Name: HL7 South America and Africa. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17178 C66786 Country SJM SJM SVALBARD AND JAN Islands between the Arctic Ocean, Barents Sea, Greenland Svalbard and Jan Mayen Production Organization Name: HL7 MAYEN Sea, and Norwegian Sea, northeast of Iceland and north of Document Title: HL7 Vocabulary Domain Norway. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17148 C66786 Country SLB SLB SOLOMON ISLANDS A group of islands in the South Pacific Ocean, east of Papua Solomon Islands Production Organization Name: HL7 New Guinea. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17130 C66786 Country SLE SLE SIERRA LEONE A country in Western Africa, bordering the North Atlantic Sierra Leone Production Organization Name: HL7 Ocean, between Guinea and Liberia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C16532 C66786 Country SLV SLV EL SALVADOR A country in Central America, bordering the North Pacific El Salvador Production Organization Name: HL7 Ocean, between Guatemala and Honduras. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17115 C66786 Country SMR SMR SAN MARINO A country in Southern Europe, an enclave in central Italy. San Marino Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17149 C66786 Country SOM SOM SOMALIA A country in Eastern Africa, bordering the Gulf of Aden and Somalia Production Organization Name: HL7 the Indian Ocean, east of Ethiopia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17165 C66786 Country SPM SPM SAINT PIERRE AND A country in Northern North America, comprised of islands in Saint Pierre and Miquelon Production Organization Name: HL7 MIQUELON the North Atlantic Ocean, south of Newfoundland (Canada). Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17116 C66786 Country STP STP SAO TOME AND PRINCIPE A country in Western Africa, comprised of islands in the Gulf Sao Tome and Principe Production Organization Name: HL7 of Guinea, straddling the Equator, west of Gabon. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17175 C66786 Country SUR SUR SURINAME A country in Northern South America, bordering the North Suriname Production Organization Name: HL7 Atlantic Ocean, between French Guiana and Guyana. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17669 C66786 Country SVK SVK SLOVAKIA A country in Central Europe, south of Poland. Slovakia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17138 C66786 Country SVN SVN SLOVENIA A country in Central Europe, bordering the Adriatic Sea, Slovenia Production Organization Name: HL7 between Austria and Croatia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17180 C66786 Country SWE SWE SWEDEN A country in Northern Europe, bordering the Baltic Sea, Gulf Sweden Production Organization Name: HL7 of Bothnia, Kattegat, and Skagerrak, between Finland and Document Title: HL7 Vocabulary Domain Norway. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17179 C66786 Country SWZ SWZ SWAZILAND A country in Southern Africa, between Mozambique and Swaziland Production Organization Name: HL7 South Africa. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17129 C66786 Country SYC SYC SEYCHELLES A country in Eastern Africa, comprised of a group of islands in Seychelles Production Organization Name: HL7 the Indian Ocean, northeast of Madagascar. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17182 C66786 Country SYR SYR SYRIAN ARAB REPUBLIC A country in the Middle East, bordering the Mediterranean Syria Production Organization Name: HL7 Sea, between Lebanon and Turkey. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17224 C66786 Country TCA TCA TURKS AND CAICOS Two island groups in the North Atlantic Ocean, southeast of Turks and Caicos Islands Production Organization Name: HL7 ISLANDS The Bahamas. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C16412 C66786 Country TCD TCD CHAD A country in Central Africa, south of Libya. Chad Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17202 C66786 Country TGO TGO TOGO A country in Western Africa, bordering the Bight of Benin, Togo Production Organization Name: HL7 between Benin and Ghana. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17192 C66786 Country THA THA THAILAND A country in Southeastern Asia, bordering the Andaman Sea Thailand Production Organization Name: HL7 and the Gulf of Thailand, southeast of Burma. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17183 C66786 Country TJK TJK TAJIKISTAN A country in Central Asia, west of China. Tajikistan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17704 C66786 Country TKL TKL TOKELAU A group of three atolls in the South Pacific Ocean, about one- Tokelau Production Organization Name: HL7 half of the way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17223 C66786 Country TKM TKM TURKMENISTAN A country in Central Asia, bordering the Caspian Sea, Turkmenistan Production Organization Name: HL7 between Iran and Kazakhstan. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17200 C66786 Country TLS TLS TIMOR-LESTE A country in Southeastern Asia, northwest of Australia in the Timor-Leste Production Organization Name: HL7 Lesser Sunda Islands at the eastern end of the Indonesian Document Title: HL7 Vocabulary Domain archipelago. East Timor includes the eastern half of the island Document Version: HL7 RIM 3 of Timor, the Oecussi (Ambeno) region on the northwest Chapter: 2.1 HL7 Vocabulary Domain Values portion of the i Codelist_Name: Country Field Name: MNEMONIC

C17205 C66786 Country TON TON TONGA An archipelago in the South Pacific Ocean, about two-thirds ofTonga Production Organization Name: HL7 the way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain C17217 C66786 Country TTO TTO TRINIDAD AND TOBAGO Islands between the Caribbean Sea and the North Atlantic Trinidad and Tobago Production OrganizationD t V Name: i HL7HL7 RIM 3 Ocean, northeast of Venezuela. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17221 C66786 Country TUN TUN TUNISIA A country in Northern Africa, bordering the Mediterranean Tunisia Production Organization Name: HL7 Sea, between Algeria and Libya. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17222 C66786 Country TUR TUR TURKEY A country in southeastern Europe and southwestern Asia (that Turkey Production Organization Name: HL7 portion of Turkey west of the Bosporus is geographically part Document Title: HL7 Vocabulary Domain of Europe), bordering the Black Sea, between Bulgaria and Document Version: HL7 RIM 3 Georgia, and bordering the Aegean Sea and the Chapter: 2.1 HL7 Vocabulary Domain Values Mediterranean Sea, between G Codelist_Name: Country Field Name: MNEMONIC C17225 C66786 Country TUV TUV TUVALU An island group consisting of nine coral atolls in the South Tuvalu Production Organization Name: HL7 Pacific Ocean, about one-half of the way from Hawaii to Document Title: HL7 Vocabulary Domain Australia. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17184 C66786 Country TWN TWN TAIWAN A group of islands bordering the East China Sea, Philippine Taiwan Production Organization Name: HL7 Sea, South China Sea, and Taiwan Strait, north of the Document Title: HL7 Vocabulary Domain Philippines, off the southeastern coast of China. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17185 C66786 Country TZA TZA TANZANIA, UNITED A country in Eastern Africa, bordering the Indian Ocean, Tanzania Production Organization Name: HL7 REPUBLIC OF between Kenya and Mozambique. Document Title: HL7 Vocabulary Domain C17228 C66786 Country UGA UGA UGANDA A country in Eastern Africa, west of Kenya. Uganda Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17229 C66786 Country UKR UKR UKRAINE A country in Eastern Europe, bordering the Black Sea, Ukraine Production Organization Name: HL7 between Poland and Russia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C20112 C66786 Country UMI UMI UNITED STATES MINOR The U.S. Minor Outlying Islands consist of Baker Island, United States Minor Outlying Production Organization Name: HL7 OUTLYING ISLANDS Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Islands Document Title: HL7 Vocabulary Domain Midway Island, Navassa Island, Palmyra Atoll, and Wake Document Version: HL7 RIM 3 Island (Wake Atoll). Chapter: 2.1 HL7 Vocabulary Domain Values Codelist Name: Country

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17244 C66786 Country URY URY URUGUAY A country in Southern South America, bordering the South Uruguay Production Organization Name: HL7 Atlantic Ocean, between Argentina and Brazil. Document Title: HL7 Vocabulary Domain C17234 C66786 Country USA USA UNITED STATES A country in North America, bordering both the North Atlantic United States Production OrganizationD t V Name: i HL7HL7 RIM 3 Ocean and the North Pacific Ocean, between Canada and Document Title: HL7 Vocabulary Domain Mexico. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17246 C66786 Country UZB UZB UZBEKISTAN A country in Central Asia, north of Afghanistan. Uzbekistan Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17249 C66786 Country VAT VAT VATICAN CITY STATE An enclave of Rome (Italy). Holy See Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17114 C66786 Country VCT VCT SAINT VINCENT AND THE A country in the Caribbean, comprised of islands in the Saint Vincent and the Production Organization Name: HL7 GRENADINES Caribbean Sea, north of Trinidad and Tobago. Grenadines Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17250 C66786 Country VEN VEN VENEZUELA A country in Northern South America, bordering the CaribbeanVenezuela Production Organization Name: HL7 Sea and the North Atlantic Ocean, between Colombia and Document Title: HL7 Vocabulary Domain Guyana. Document Version: HL7 RIM 3 C17653 C66786 Country VGB VGB VIRGIN ISLANDS, BRITISH Islands between the Caribbean Sea and the North Atlantic British Virgin Islands Production Organization Name: HL7 Ocean, east of Puerto Rico. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17255 C66786 Country VIR VIR VIRGIN ISLANDS, U.S. Islands between the Caribbean Sea and the North Atlantic United States Virgin Islands Production Organization Name: HL7 Ocean, east of Puerto Rico. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17252 C66786 Country VNM VNM VIETNAM A country in Southeastern Asia, bordering the Gulf of Vietnam Production Organization Name: HL7 Thailand, Gulf of Tonkin, and South China Sea, alongside Document Title: HL7 Vocabulary Domain China, Laos, and Cambodia. Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17247 C66786 Country VUT VUT VANUATU A group of islands in the South Pacific Ocean, about three- Vanuatu Production Organization Name: HL7 quarters of the way from Hawaii to Australia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17259 C66786 Country WLF WLF WALLIS AND FUTUNA Islands in the South Pacific Ocean, about two-thirds of the Wallis and Futuna Islands Production Organization Name: HL7 way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17740 C66786 Country WSM WSM SAMOA A group of islands in the South Pacific Ocean, about one-half Samoa Production Organization Name: HL7 of the way from Hawaii to New Zealand. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17264 C66786 Country YEM YEM YEMEN A country in the Middle East, bordering the Arabian Sea, Gulf Yemen Production Organization Name: HL7 of Aden, and Red Sea, between Oman and Saudi Arabia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17151 C66786 Country ZAF ZAF SOUTH AFRICA A country in Southern Africa, at the southern tip of the South Africa Production Organization Name: HL7 continent of Africa. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17267 C66786 Country ZMB ZMB ZAMBIA A country in Southern Africa, east of Angola. Zambia Production Organization Name: HL7 Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C17268 C66786 Country ZWE ZWE ZIMBABWE A country in Southern Africa, between South Africa and Zimbabwe Production Organization Name: HL7 Zambia. Document Title: HL7 Vocabulary Domain Document Version: HL7 RIM 3 Chapter: 2.1 HL7 Vocabulary Domain Values Codelist_Name: Country Field Name: MNEMONIC C66787 Yes Diagnosis Group TDIGRP TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure oCDISC SDTM Diagnosis Group Production disease, or lack thereof (e.g. healthy volunteers, type 2 Terminology diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a C49651 C66787 Diagnosis Group HEALTHY SUBJECTS HEALTHY SUBJECTS An individual who is or becomes a participant in a research Healthy Subject Production study and has no significant health-related issues. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C66788 Yes Dictionary Name DICTNAM DICTNAM Dictionary Name; Name of A name given to a reference source that lists words and gives CDISC SDTM Dictionary Name Production Dictionary their meaning. (NCI) Terminology

C49471 C66788 Dictionary Name COSTART COSTART Coding Symbols for a A terminology developed and used by the Food and Drug Thesaurus of Adverse Reaction Production Thesaurus of Adverse Administration (FDA) for the coding, filing and retrieving of Term Coding Symbols Reaction Terms post marketing adverse reaction reports. (NCI) C49474 C66788 Dictionary Name ICD ICD International Classification of A system of categories to which morbid entries are assigned International Classification of Production Diseases according to established criteria. Included is the entire range Diseases of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health O C49476 C66788 Dictionary Name LOINC LOINC Logical Observation Identifiers Published by the The Regenstrief Institute, the Logical Logical Observation Identifiers Production Names and Codes Observation Identifiers Names and Codes covers clinical and Names and Codes clinical laboratory terminology. (NCI) C43820 C66788 Dictionary Name MedDRA MedDRA Medical Dictionary for MedDRA is an international medical terminology designed to MedDRA Production Regulatory Activities support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the Intern C53489 C66788 Dictionary Name SNOMED SNOMED Systematized Nomenclature of A multiaxial, hierarchical classification system for diseases in Systematized Nomenclature of Production Medicine man developed by the College of American Pathologists. Medicine (NCI) C49468 C66788 Dictionary Name WHOART WHOART World Health Organization A terminology implemented by the World Health Organization World Health Organization Production Adverse Reaction Terms to describe adverse reactions to a prescribed medication or Adverse Reaction Terminology treatment regimen. (NCI) C49475 C66788 Dictionary Name WHODD WHODD World Health Organization A reference source of drugs and drug associated information World Health Organization Drug Production Drug Dictionary maintained by the World Health Organization. (NCI) Dictionary C66789 No Not Done ND ND Not Done Indicates a task, process or examination that has either not CDISC SDTM Not Done Production been initiated or completed. (NCI) Terminology C49484 C66789 Not Done NOT DONE NOT DONE Indicates a task, process or examination that has either not Not Done Production Organization Name: CDISC been initiated or completed. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter: 4.1.5 Other Assumptions / 4.1.5.1 Page: 31

C66790 Yes Patient Ethnic Group ETHNIC ETHNIC Patient Ethnic Group A social group characterized by a distinctive social and CDISC SDTM Patient Ethnic Production cultural tradition maintained from generation to generation, a Group Terminology common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of C17459 C66790 Patient Ethnic Group HISPANIC OR LATINO HISPANIC OR LATINO A person of Mexican, Puerto Rican, Cuban, Central or South Hispanic or Latino Production Organization Name: FDA American or other Spanish culture or origin, regardless of Document Title: Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials race. (NCI) Date: September, 2005 Chapter: III COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS Codelist_Name: ETHNIC

C41222 C66790 Patient Ethnic Group NOT HISPANIC OR LATINO NOT HISPANIC OR LATINO A person not of Cuban, Mexican, Puerto Rican, South or Not Hispanic or Latino Production Organization Name: FDA Central American, or other Spanish culture or origin, Document Title: Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials regardless of race. An arbitrary ethnic classification. (NCI) Date: September, 2005 Chapter: III COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS Codelist_Name: ETHNIC

C43234 C66790 Patient Ethnic Group NOT REPORTED NOT REPORTED Not reported Not provided or available Not Stated Production

C17998 C66790 Patient Ethnic Group UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production

C66726 Yes Pharmaceutical Dosage Form FRM FRM Pharmaceutical Dosage Form; The form of the completed pharmaceutical product, e.g. CDISC SDTM Pharmaceutical Production Dose Form tablet, capsule, injection, elixir, suppository. Dosage form can Dosage Form Terminology have a significant effect on the onset, duration and intensity of the pharmacological action of a drug. A pharmaceutical dosage form co C42887 C66726 Pharmaceutical Dosage Form AEROSOL AEROSOL A product that is packaged under pressure and contains Aerosol Dosage Form Production Organization Name: FDA therapeutically active ingredients that are released upon Document Title: CDER Data Standards Manual activation of an appropriate valve system; it is intended for Document Version: 002 topical application to the skin as well as local application into Date: Revised November 28, 2006 the nose (nasa Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

C42888 C66726 Pharmaceutical Dosage Form AEROSOL, FOAM AEROSOL, FOAM A dosage form containing one or more active ingredients, Aerosol Foam Dosage Form Production Organization Name: FDA surfactants, aqueous or non-aqueous liquids, and the Document Title: CDER Data Standards Manual propellants; if the propellant is in the internal (discontinuous) Document Version: 002 phase (i.e., of the oil-in-water type), a stable foam is Date: Revised November 28, 2006 discharged, and if the Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42960 C66726 Pharmaceutical Dosage Form AEROSOL, METERED AEROSOL, METERED A pressurized dosage form consisting of metered dose valves Metered Aerosol Dosage Form Production Organization Name: FDA which allow for the delivery of a uniform quantity of spray upon Document Title: CDER Data Standards Manual each activation. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42971 C66726 Pharmaceutical Dosage Form AEROSOL, POWDER AEROSOL, POWDER A product that is packaged under pressure and contains Powder Aerosol Dosage Form Production Organization Name: FDA therapeutically active ingredients, in the form of a powder, that Document Title: CDER Data Standards Manual are released upon activation of an appropriate valve system. Document Version: 002 (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42889 C66726 Pharmaceutical Dosage Form AEROSOL, SPRAY AEROSOL, SPRAY An aerosol product which utilizes a compressed gas as the Aerosol Spray Dosage Form Production Organization Name: FDA propellant to provide the force necessary to expel the product Document Title: CDER Data Standards Manual as a wet spray; it is applicable to solutions of medicinal agents Document Version: 002 in aqueous solvents. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42892 C66726 Pharmaceutical Dosage Form BAR, CHEWABLE BAR, CHEWABLE A solid dosage form usually in the form of a rectangle that is Chewable Bar Dosage Form Production Organization Name: FDA meant to be chewed. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42890 C66726 Pharmaceutical Dosage Form BEAD BEAD A solid dosage form in the shape of a small ball. (NCI) Bead Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C43451 C66726 Pharmaceutical Dosage Form BEAD, IMPLANT, EXTENDED BEAD, IMPLANT, EXTENDED A small sterile solid mass consisting of a highly purified drug Extended Release Bead Implant Production Organization Name: FDA RELEASE RELEASE intended for implantation in the body which would allow at Dosage Form Document Title: CDER Data Standards Manual least a reduction in dosing frequency as compared to that drug Document Version: 002 presented as a conventional dosage form. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42891 C66726 Pharmaceutical Dosage Form BLOCK BLOCK Solid dosage form, usually in the shape of a square or Block Dosage Form Production Organization Name: FDA rectangle. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C25158 C66726 Pharmaceutical Dosage Form CAPSULE CAPSULE A solid pharmaceutical dosage form that contains medicinal Capsule Dosage Form Production Organization Name: FDA agent within either a hard or soft soluble container or shell, Document Title: CDER Data Standards Manual usually used for the oral administration of medicine. The shells Document Version: 002 are made of a suitable form of gelatin or other substance. Date: Revised November 28, 2006 (NCI) Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42895 C66726 Pharmaceutical Dosage Form CAPSULE, COATED CAPSULE, COATED A solid dosage form in which the drug is enclosed within Coated Capsule Dosage Form Production Organization Name: FDA either a hard or soft soluble container or "shell" made from a Document Title: CDER Data Standards Manual suitable form of gelatin; additionally, the capsule is covered in Document Version: 002 a designated coating. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42896 C66726 Pharmaceutical Dosage Form CAPSULE, COATED PELLETS CAPSULE, COATED PELLETS A solid dosage form in which the drug is enclosed within Coated Pellets in Capsule Production Organization Name: FDA either a hard or soft soluble container or "shell" made from a Dosage Form Document Title: CDER Data Standards Manual suitable form of gelatin; the drug itself is in the form of Document Version: 002 granules to which varying amounts of coating have been Date: Revised November 28, 2006 applied. (NCI) Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42917 C66726 Pharmaceutical Dosage Form CAPSULE, COATED, EXTENDED CAPSULE, COATED, EXTENDED A solid dosage form in which the drug is enclosed within Extended Release Coated Production Organization Name: FDA RELEASE RELEASE either a hard or soft soluble container or "shell" made from a Capsule Dosage Form Document Title: CDER Data Standards Manual suitable form of gelatin; additionally, the capsule is covered in Document Version: 002 a designated coating, and which releases a drug (or drugs) in Date: Revised November 28, 2006 such a Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42902 C66726 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE CAPSULE, DELAYED RELEASE A solid dosage form in which the drug is enclosed within Delayed Release Capsule Production Organization Name: FDA either a hard or soft soluble container made from a suitable Dosage Form Document Title: CDER Data Standards Manual form of gelatin, and which releases a drug (or drugs) at a time Document Version: 002 other than promptly after administration. Enteric-coated Date: Revised November 28, 2006 articles are del Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42904 C66726 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE CAPSULE, DELAYED RELEASE A solid dosage form in which the drug is enclosed within Delayed Release Pellets in Production Organization Name: FDA PELLETS PELLETS either a hard or soft soluble container or "shell" made from a Capsule Dosage Form Document Title: CDER Data Standards Manual suitable form of gelatin; the drug itself is in the form of Document Version: 002 granules to which enteric coating has been applied, thus Date: Revised November 28, 2006 delaying release o Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42916 C66726 Pharmaceutical Dosage Form CAPSULE, EXTENDED RELEASE CAPSULE, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within Extended Release Capsule Production Organization Name: FDA either a hard or soft soluble container made from a suitable Dosage Form Document Title: CDER Data Standards Manual form of gelatin, and which releases a drug (or drugs) in such a Document Version: 002 manner to allow a reduction in dosing frequency as compared Date: Revised November 28, 2006 to that drug Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42928 C66726 Pharmaceutical Dosage Form CAPSULE, FILM COATED, CAPSULE, FILM COATED, A solid dosage form in which the drug is enclosed within Extended Release Film Coated Production Organization Name: FDA EXTENDED RELEASE EXTENDED RELEASE either a hard or soft soluble container or "shell" made from a Capsule Dosage Form Document Title: CDER Data Standards Manual suitable form of gelatin; additionally, the capsule is covered in Document Version: 002 a designated film coating, and which releases a drug (or Date: Revised November 28, 2006 drugs) in su Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42936 C66726 Pharmaceutical Dosage Form CAPSULE, GELATIN COATED CAPSULE, GELATIN COATED A solid dosage form in which the drug is enclosed within Gelatin Coated Capsule Dosage Production Organization Name: FDA either a hard or soft soluble container made from a suitable Form Document Title: CDER Data Standards Manual form of gelatin; through a banding process, the capsule is Document Version: 002 coated with additional layers of gelatin so as to form a Date: Revised November 28, 2006 complete seal. (NCI) Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42954 C66726 Pharmaceutical Dosage Form CAPSULE, LIQUID FILLED CAPSULE, LIQUID FILLED A solid dosage form in which the drug is enclosed within a Liquid Filled Capsule Dosage Production Organization Name: FDA soluble, gelatin shell which is plasticized by the addition of a Form Document Title: CDER Data Standards Manual polyol, such as sorbitol or glycerin, and is therefore of a Document Version: 002 somewhat thicker consistency than that of a hard shell Date: Revised November 28, 2006 capsule; typical Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C45414 C66726 Pharmaceutical Dosage Form CEMENT CEMENT A substance that serves to produce solid union between two Cement Dosage Form Production Organization Name: FDA surfaces. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42678 C66726 Pharmaceutical Dosage Form CIGARETTE CIGARETTE A narrow tube filled with material that is capable to burn with Cigarette Dosage Form Production Organization Name: FDA release of therapeutically-active substance(s) during the Document Title: CDER Data Standards Manual process of smoking. Cigarette is a very efficient drug-delivery Document Version: 002 inhaler system for fast-acting substances.(FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60884 C66726 Pharmaceutical Dosage Form CLOTH CLOTH A large piece of relatively flat, absorbent material that contains Cloth Dosage Form Production Organization Name: FDA a drug. It is typically used for applying medication or for Document Title: CDER Data Standards Manual cleansing. (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60891 C66726 Pharmaceutical Dosage Form CONCENTRATE CONCENTRATE A liquid preparation of increased strength and reduced volume Concentrate Dosage Form Production Organization Name: FDA which is usually diluted prior to administration. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42900 C66726 Pharmaceutical Dosage Form CONE CONE A solid dosage form bounded by a circular base and the Cone Dosage Form Production Organization Name: FDA surface formed by line segments joining every point of the Document Title: CDER Data Standards Manual boundary of the base to a common vertex. A cone (usually Document Version: 002 containing antibiotics) is normally placed below the gingiva Date: Revised November 28, 2006 after a dental extracti Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42919 C66726 Pharmaceutical Dosage Form CORE, EXTENDED RELEASE CORE, EXTENDED RELEASE An ocular system placed in the eye from which the drug Extended Release Core Dosage Production Organization Name: FDA diffuses through a membrane at a constant rate over a Form Document Title: CDER Data Standards Manual specified period. (NCI) Document Version: 002 Date: Revised November 28 2006 C28944 C66726 Pharmaceutical Dosage Form CREAM CREAM A semisolid emulsion of either the oil-in-water or the water-in- Cream Dosage Form Production Organization Name: FDA oil type, ordinarily intended for topical use. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60897 C66726 Pharmaceutical Dosage Form CREAM, AUGMENTED CREAM, AUGMENTED A cream dosage form that enhances drug delivery. Augmented Cream Dosage Form Production Organization Name: FDA Augmentation does not refer to the strength of the drug in the Document Title: CDER Data Standards Manual dosage form. NOTE: CDER has decided to refrain from Document Version: 002 expanding the use of this dosage form due to difficulties in Date: Revised November 28, 2006 setting specific criteria that Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42901 C66726 Pharmaceutical Dosage Form CRYSTAL CRYSTAL A naturally produced angular solid of definite form in which theCrystal Dosage Form Production Organization Name: FDA ultimate units from which it is built up are systematically Document Title: CDER Data Standards Manual arranged; they are usually evenly spaced on a regular space Document Version: 002 lattice. Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C45415 C66726 Pharmaceutical Dosage Form CULTURE CULTURE The propagation of microorganisms or of living tissue cells in Culture Dosage Form Production Organization Name: FDA special media conducive to their growth. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47890 C66726 Pharmaceutical Dosage Form DIAPHRAGM DIAPHRAGM A device usually dome-shaped, worn during copulation over Diaphragm Dosage Form Production Organization Name: FDA the cervical mouth for prevention of conception or infection. Document Title: CDER Data Standards Manual (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C43525 C66726 Pharmaceutical Dosage Form DISC DISC A circular plate-like organ or structure. (FDA) Disc Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42679 C66726 Pharmaceutical Dosage Form DOUCHE DOUCHE A liquid preparation, intended for the irrigative cleansing of the Douche Dosage Form Production Organization Name: FDA vagina, that is prepared from powders, liquid solutions, or Document Title: CDER Data Standards Manual liquid concentrates and contains one or more chemical Document Version: 002 substances dissolved in a suitable solvent or mutually miscible Date: Revised November 28, 2006 solvents. Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42763 C66726 Pharmaceutical Dosage Form DRESSING DRESSING The application of various materials for protecting a Dressing Dosage Form Production Organization Name: FDA wound.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C17423 C66726 Pharmaceutical Dosage Form DRUG DELIVERY SYSTEM DRUG DELIVERY SYSTEM Modern technology, distributed with or as a part of a drug Drug Delivery System Production Organization Name: FDA product that allows for the uniform release or targeting of Document Title: CDER Data Standards Manual drugs to the body. (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42912 C66726 Pharmaceutical Dosage Form ELIXIR ELIXIR A clear, pleasantly flavored, sweetened hydroalcoholic liquid Elixir Dosage Form Production Organization Name: FDA containing dissolved medicinal agents; it is intended for oral Document Title: CDER Data Standards Manual use. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42913 C66726 Pharmaceutical Dosage Form EMULSION EMULSION A dosage form consisting of a two-phase system comprised of Emulsion Dosage Form Production Organization Name: FDA at least two immiscible liquids (1), one of which is dispersed Document Title: CDER Data Standards Manual as droplets (internal or dispersed phase) within the other liquid Document Version: 002 (external or continuous phase), generally stabilized with one or Date: Revised November 28, 2006 m Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42915 C66726 Pharmaceutical Dosage Form ENEMA ENEMA A rectal preparation for therapeutic, diagnostic, or nutritive Enema Dosage Form Production Organization Name: FDA purposes. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42929 C66726 Pharmaceutical Dosage Form EXTRACT EXTRACT A concentrated preparation of vegetable or animal drugs Extract Dosage Form Production Organization Name: FDA obtained by removal of the active constituents of the Document Title: CDER Data Standards Manual respective drugs with a suitable menstrua, evaporation of all o Document Version: 002 nearly all of the solvent, and adjustment of the residual Date: Revised November 28, 2006 masses or powders to t Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60926 C66726 Pharmaceutical Dosage Form FIBER, EXTENDED RELEASE FIBER, EXTENDED RELEASE A slender and elongated solid thread-like substance that Extended Release Fiber Dosage Production Organization Name: FDA delivers drug in such a manner to allow a reduction in dosing Form Document Title: CDER Data Standards Manual frequency as compared to that drug (or drugs) presented as a Document Version: 002 conventional dosage form. (FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42932 C66726 Pharmaceutical Dosage Form FILM FILM A thin layer or coating. (NCI) Film Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42920 C66726 Pharmaceutical Dosage Form FILM, EXTENDED RELEASE FILM, EXTENDED RELEASE A drug delivery system in the form of a film that releases the Extended Release Film Dosage Production Organization Name: FDA drug over an extended period in such a way as to maintain Form Document Title: CDER Data Standards Manual constant drug levels in the blood or target tissue. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42984 C66726 Pharmaceutical Dosage Form FILM, SOLUBLE FILM, SOLUBLE A thin layer or coating which is susceptible to being dissolved Soluble Film Dosage Form Production Organization Name: FDA when in contact with a liquid. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60927 C66726 Pharmaceutical Dosage Form FOR SOLUTION FOR SOLUTION A product, usually a solid, intended for solution prior to Dosage Form For Solution Production Organization Name: FDA administration. (FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C60928 C66726 Pharmaceutical Dosage Form FOR SUSPENSION FOR SUSPENSION A product, usually a solid, intended for suspension prior to Dosage Form For Suspension Production Organization Name: FDA administration. (FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60929 C66726 Pharmaceutical Dosage Form FOR SUSPENSION, EXTENDED FOR SUSPENSION, EXTENDED A product, usually a solid, intended for suspension prior to Extended Release Dosage Form Production Organization Name: FDA RELEASE RELEASE administration; once the suspension is administered, the drug For Suspension Document Title: CDER Data Standards Manual will be released at a constant rate over a specified period. Document Version: 002 (FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42933 C66726 Pharmaceutical Dosage Form GAS GAS Any elastic aeriform fluid in which the molecules are separatedGas Dosage Form Production Organization Name: FDA from one another and have free paths. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42934 C66726 Pharmaceutical Dosage Form GEL GEL A semisolid (1) dosage form that contains a gelling agent to Gel Dosage Form Production Organization Name: FDA provide stiffness to a solution or a colloidal dispersion (2). A Document Title: CDER Data Standards Manual gel may contain suspended particles. Note 1: A semisolid is Document Version: 002 not pourable; it does not flow or conform to its container at Date: Revised November 28, 2006 room t Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42906 C66726 Pharmaceutical Dosage Form GEL, DENTIFRICE GEL, DENTIFRICE A combination of a dentifrice (formulation intended to clean Dentifrice Gel Dosage Form Production Organization Name: FDA and/or polish the teeth, and which may contain certain Document Title: CDER Data Standards Manual additional agents), and a gel. It is used with a toothbrush for Document Version: 002 the purpose of cleaning and polishing the teeth. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60930 C66726 Pharmaceutical Dosage Form GEL, METERED GEL, METERED A gel preparation, with metered dose valves, which allow for Metered Gel Dosage Form Production Organization Name: FDA the delivery of a uniform quantity of gel upon each activation. Document Title: CDER Data Standards Manual (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C48193 C66726 Pharmaceutical Dosage Form GENERATOR GENERATOR An apparatus for the formation of vapor or gas from a liquid or Generator Dosage Form Production Organization Name: FDA solid by heat or chemical action. The term GENERATOR also Document Title: CDER Data Standards Manual applies to radioactive columns from which radionuclides are Document Version: 002 provided. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42937 C66726 Pharmaceutical Dosage Form GLOBULE GLOBULE Also called pellets or pilules, are made of pure sucrose, Globule Dosage Form Production Organization Name: FDA lactose, or other polysaccharides. They are formed into small Document Title: CDER Data Standards Manual globular masses of various sizes, and are medicated by Document Version: 002 placing them in a vial and adding the liquid drug attenuation in Date: Revised November 28, 2006 the proportion Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C45416 C66726 Pharmaceutical Dosage Form GRAFT GRAFT A slip of skin or of other tissue for implantation. (NCI) Graft Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42938 C66726 Pharmaceutical Dosage Form GRANULE GRANULE A small particle or grain. (NCI) Granule Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42903 C66726 Pharmaceutical Dosage Form GRANULE, DELAYED RELEASE GRANULE, DELAYED RELEASE A small medicinal particle or grain to which an enteric or other Delayed Release Granule Production Organization Name: FDA coating has been applied, thus delaying release of the drug Dosage Form Document Title: CDER Data Standards Manual until its passage into the intestines. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42909 C66726 Pharmaceutical Dosage Form GRANULE, EFFERVESCENT GRANULE, EFFERVESCENT A small particle or grain containing a medicinal agent in a dry Effervescent Granule Dosage Production Organization Name: FDA mixture usually composed of sodium bicarbonate, citric acid, Form Document Title: CDER Data Standards Manual and tartaric acid which, when in contact with water, has the Document Version: 002 capability to release gas, resulting in effervescence. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42939 C66726 Pharmaceutical Dosage Form GRANULE, FOR SOLUTION GRANULE, FOR SOLUTION A small medicinal particle or grain made available in its more Granule For Solution Dosage Production Organization Name: FDA stable dry form, to be reconstituted with solvent just before Form Document Title: CDER Data Standards Manual dispensing; the granules are so prepared to contain not only Document Version: 002 the medicinal agent, but the colorants, flavorants, and any Date: Revised November 28, 2006 other des Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42940 C66726 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION GRANULE, FOR SUSPENSION A small medicinal particle or grain made available in its more Granule For Suspension Dosage Production Organization Name: FDA stable dry form, to be reconstituted with solvent just before Form Document Title: CDER Data Standards Manual dispensing to form a suspension; the granules are so prepared Document Version: 002 to contain not only the medicinal agent, but the colorants, Date: Revised November 28, 2006 flavoran Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42921 C66726 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION, GRANULE, FOR SUSPENSION, A small medicinal particle or grain made available in its more Extended Release Granule For Production Organization Name: FDA EXTENDED RELEASE EXTENDED RELEASE stable dry form, to be reconstituted with solvent just before Suspension Dosage Form Document Title: CDER Data Standards Manual dispensing to form a suspension; the extended release system Document Version: 002 achieves slow release of the drug over an extended period of Date: Revised November 28, 2006 time and Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42941 C66726 Pharmaceutical Dosage Form GUM GUM A mucilaginous excretion from various plants. (NCI) Gum Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42894 C66726 Pharmaceutical Dosage Form GUM, CHEWING GUM, CHEWING A sweetened and flavored insoluble plastic material of various Chewing Gum Dosage Form Production Organization Name: FDA shapes which when chewed, releases a drug substance into Document Title: CDER Data Standards Manual the oral cavity. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42978 C66726 Pharmaceutical Dosage Form GUM, RESIN GUM, RESIN Natural mixture of gum and resin, usually obtained as Resin Gum Dosage Form Production Organization Name: FDA exudations from plants. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42942 C66726 Pharmaceutical Dosage Form IMPLANT IMPLANT A material containing drug intended to be inserted securely Implant Dosage Form Production Organization Name: FDA and deeply in a living site for growth, slow release, or Document Title: CDER Data Standards Manual formation of an organic union. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42944 C66726 Pharmaceutical Dosage Form INHALANT INHALANT A special class of inhalations consisting of a drug or Inhalant Dosage Form Production Organization Name: FDA combination of drugs, that by virtue of their high vapor Document Title: CDER Data Standards Manual pressure, can be carried by an air current into the nasal Document Version: 002 passage where they exert their effect; the container from Date: Revised November 28, 2006 which the inhalant generall Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60931 C66726 Pharmaceutical Dosage Form INJECTABLE, LIPOSOMAL INJECTABLE, LIPOSOMAL An injection, which either consists of or forms liposomes (a Liposomal Injection Dosage Production Organization Name: FDA lipid bilayer vesicle usually composed of phospholipids which Form Document Title: CDER Data Standards Manual is used to encapsulate an active drug substance). (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42946 C66726 Pharmaceutical Dosage Form INJECTION INJECTION A sterile preparation intended for parenteral use; five distinct Injectable Dosage Form Production Organization Name: FDA classes of injections exist as defined by the USP. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42914 C66726 Pharmaceutical Dosage Form INJECTION, EMULSION INJECTION, EMULSION An emulsion consisting of a sterile, pyrogen-free preparation Emulsion for Injection Dosage Production Organization Name: FDA intended to be administered parenterally.(FDA) Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42950 C66726 Pharmaceutical Dosage Form INJECTION, LIPID COMPLEX INJECTION, LIPID COMPLEX [definition pending](FDA) Injectable Lipid Complex Dosage Production Organization Name: FDA Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42974 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR INJECTION, POWDER, FOR A sterile preparation intended for reconstitution to form a Powder For Injectable Solution Production Organization Name: FDA SOLUTION SOLUTION solution for parenteral use. (NCI) Dosage Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42976 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR INJECTION, POWDER, FOR A sterile preparation intended for reconstitution to form a Powder For Injectable Production Organization Name: FDA SUSPENSION SUSPENSION suspension for parenteral use. (NCI) Suspension Dosage Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42977 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR INJECTION, POWDER, FOR A dried preparation intended for reconstitution to form a Powder For Injectable Extended Production Organization Name: FDA SUSPENSION, EXTENDED SUSPENSION, EXTENDED suspension for parenteral use which has been formulated in a Release Suspension Dosage Document Title: CDER Data Standards Manual RELEASE RELEASE manner to allow at least a reduction in dosing frequency as Form Document Version: 002 compared to that drug presented as a conventional dosage Date: Revised November 28, 2006 form (e.g., as a so Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42959 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, INJECTION, POWDER, A sterile freeze dried preparation intended for reconstitution forLyophilized Powder For Production Organization Name: FDA LYOPHILIZED, FOR LIPOSOMAL LYOPHILIZED, FOR LIPOSOMAL parenteral use which has been formulated in a manner that Injectable Liposomal Suspension Document Title: CDER Data Standards Manual SUSPENSION SUSPENSION would allow liposomes (a lipid bilayer vesicle usually Dosage Form Document Version: 002 composed of phospholipids which is used to encapsulate an Date: Revised November 28, 2006 active drug subst Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42957 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, INJECTION, POWDER, A dosage form intended for the solution prepared by Lyophilized Powder For Production Organization Name: FDA LYOPHILIZED, FOR SOLUTION LYOPHILIZED, FOR SOLUTION lyophilization ('freeze drying'), a process which involves the Injectable Solution Dosage Form Document Title: CDER Data Standards Manual removal of water from products in the frozen state at extremely Document Version: 002 low pressures; this is intended for subsequent addition of Date: Revised November 28, 2006 liquid to create Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42958 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, INJECTION, POWDER, A liquid preparation, intended for parenteral use, that contains Lyophilized Powder For Production Organization Name: FDA LYOPHILIZED, FOR SUSPENSION LYOPHILIZED, FOR SUSPENSION solids suspended in a suitable fluid medium and conforms in Injectable Suspension Dosage Document Title: CDER Data Standards Manual all respects to the requirements for Sterile Suspensions; the Form Document Version: 002 medicinal agents intended for the suspension are prepared by Date: Revised November 28, 2006 lyophil Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42956 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, INJECTION, POWDER, A sterile freeze dried preparation intended for reconstitution forLyophilized Powder For Production Organization Name: FDA LYOPHILIZED, FOR LYOPHILIZED, FOR SUSPENSION parenteral use which has been formulated in a manner to Extended Release Injectable Document Title: CDER Data Standards Manual SUSPENSION, EXTENDED allow at least a reduction in dosing frequency as compared to Suspension Dosage Form Document Version: 002 RELEASE that drug presented as a conventional dosage form (e.g., as a Date: Revised November 28, 2006 solution Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42945 C66726 Pharmaceutical Dosage Form INJECTION, SOLUTION INJECTION, POWDER, A liquid preparation containing one or more drug substances Injectable Solution Dosage Form Production Organization Name: FDA LYOPHILIZED, FOR dissolved in a suitable solvent or mixture of mutually miscible Document Title: CDER Data Standards Manual SUSPENSION, EXTENDED solvents that is suitable for injection. (NCI) Document Version: 002 RELEASE Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42899 C66726 Pharmaceutical Dosage Form INJECTION, SOLUTION, INJECTION, SOLUTION A sterile preparation for parenteral use which, upon the Concentrate for Injectable Production Organization Name: FDA CONCENTRATE addition of suitable solvents, yields a solution conforming in all Solution Dosage Form Document Title: CDER Data Standards Manual respects to the requirements for Injections. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42995 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION INJECTION, SOLUTION, A liquid preparation, suitable for injection, which consists of Injectable Suspension Dosage Production Organization Name: FDA CONCENTRATE solid particles dispersed throughout a liquid phase in which Form Document Title: CDER Data Standards Manual the particles are not soluble. It can also consist of an oil phase Document Version: 002 dispersed throughout an aqueous phase, or vice-versa. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42926 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, INJECTION, SUSPENSION A sterile preparation intended for parenteral use which has Injectable Extended Release Production Organization Name: FDA EXTENDED RELEASE been formulated in a manner to allow at least a reduction in Suspension Dosage Form Document Title: CDER Data Standards Manual dosing frequency as compared to that drug presented as a Document Version: 002 conventional dosage form (e.g., as a solution or a prompt drug- Date: Revised November 28, 2006 releasing, con Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42951 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, INJECTION, SUSPENSION, A liquid parenteral pharmaceutical dosage form structured as Injectable Liposomal Suspension Production Organization Name: FDA LIPOSOMAL EXTENDED RELEASE a multilamellar composition of concentric phospholipid Dosage Form Document Title: CDER Data Standards Manual spheres that encapsulate the drug (drug delivery systems) Document Version: 002 separated by layers of water. Drug release is facilitated and Date: Revised November 28, 2006 controlled by in vi Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42988 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, INJECTION, SUSPENSION, A liquid preparation, suitable for injection, which consists of Injectable Sonicated Suspension Production Organization Name: FDA SONICATED SONICATED solid particles dispersed throughout a liquid phase in which Dosage Form Document Title: CDER Data Standards Manual the particles are not soluble. In addition, the product is Document Version: 002 sonicated while a gas is bubbled through the suspension, and Date: Revised November 28, 2006 this resul Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60933 C66726 Pharmaceutical Dosage Form INSERT INSERT A specially formulated and shaped non-encapsulated solid Insert Dosage Form Production Organization Name: FDA preparation intended to be placed into a non-rectal orifice of Document Title: CDER Data Standards Manual the body, where drug is released, generally for localized Document Version: 002 effects. (FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42922 C66726 Pharmaceutical Dosage Form INSERT, EXTENDED RELEASE INSERT, EXTENDED RELEASE A specially formulated and shaped solid preparation (e.g., ringExtended Release Insert Dosage Production Organization Name: FDA tablet, or stick) intended to be placed in the vagina by special Form Document Title: CDER Data Standards Manual inserters, where the medication is released, generally for Document Version: 002 localized effects; the extended release preparation is designed Date: Revised November 28, 2006 to Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C47915 C66726 Pharmaceutical Dosage Form INTRAUTERINE DEVICE INTRAUTERINE DEVICE A device inserted and left in the uterus to prevent effective Intrauterine Device Dosage Form Production Organization Name: FDA conception. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42947 C66726 Pharmaceutical Dosage Form IRRIGANT IRRIGANT A sterile solution intended to bathe or flush open wounds or Irrigant Dosage Form Production Organization Name: FDA body cavities; they're used topically, never parenterally. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42948 C66726 Pharmaceutical Dosage Form JELLY JELLY A class of gels--semisolid systems which consist of Jelly Dosage Form Production Organization Name: FDA suspensions made up of either small inorganic particles or Document Title: CDER Data Standards Manual large organic molecules interpenetrated by a liquid--in which Document Version: 002 the structural coherent matrix contains a high portion of liquid, Date: Revised November 28, 2006 usually water. ( Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47916 C66726 Pharmaceutical Dosage Form KIT KIT A packaged collection of related material. (NCI) Kit Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C45413 C66726 Pharmaceutical Dosage Form LINER, DENTAL LINER, DENTAL A material applied to the inside of the dental cavity, for Dental Liner Dosage Form Production Organization Name: FDA protection or insulation of the surface.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42949 C66726 Pharmaceutical Dosage Form LINIMENT LINIMENT A solution or mixture of various substances in oil, alcoholic Liniment Dosage Form Production Organization Name: FDA solutions of soap, or emulsions intended for external Document Title: CDER Data Standards Manual application. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42952 C66726 Pharmaceutical Dosage Form LIPSTICK LIPSTICK A waxy solid, usually colored cosmetic, in stick form for the Lipstick Dosage Form Production Organization Name: FDA lips. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42953 C66726 Pharmaceutical Dosage Form LIQUID LIQUID A dosage form consisting of a pure chemical in its liquid state. Liquid Dosage Form Production Organization Name: FDA This dosage form term should not be applied to solutions. Document Title: CDER Data Standards Manual Note: A liquid is pourable; it flows and conforms to its Document Version: 002 container at room temperature. It displays Newtonian or Date: Revised November 28, 2006 pseudoplastic flow Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60934 C66726 Pharmaceutical Dosage Form LIQUID, EXTENDED RELEASE LIQUID, EXTENDED RELEASE A liquid that delivers a drug in such a manner to allow a Extended Release Liquid Dosage Production Organization Name: FDA reduction in dosing frequency as compared to that drug (or Form Document Title: CDER Data Standards Manual drugs) presented as a conventional dosage form. (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C29167 C66726 Pharmaceutical Dosage Form LOTION LOTION An emulsion, liquid (1) dosage form. This dosage form is Lotion Dosage Form Production Organization Name: FDA generally for external application to the skin (2). Note 1: A Document Title: CDER Data Standards Manual liquid is pourable; it flows and conforms to its container at Document Version: 002 room temperature. It displays Newtonian or pseudoplastic Date: Revised November 28, 2006 flow behavior. N Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60957 C66726 Pharmaceutical Dosage Form LOTION. AUGMENTED LOTION. AUGMENTED A lotion dosage form that enhances drug delivery. Augmented Lotion Dosage Form Production Organization Name: FDA Augmentation does not refer to the strength of the drug in the Document Title: CDER Data Standards Manual dosage form. NOTE: CDER has decided to refrain from Document Version: 002 expanding the use of this dosage form due to difficulties in Date: Revised November 28, 2006 setting specific criteria tha Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60958 C66726 Pharmaceutical Dosage Form LOTION/SHAMPOO LOTION/SHAMPOO A lotion dosage form which has a soap or detergent that is Lotion Shampoo Dosage Form Production Organization Name: FDA usually used to clean the hair and scalp; it is often used as a Document Title: CDER Data Standards Manual vehicle for dermatologic agents. (FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42955 C66726 Pharmaceutical Dosage Form LOZENGE LOZENGE A solid preparation containing one or more medicaments, Lozenge Dosage Form Production Organization Name: FDA usually in a flavored, sweetened base which is intended to Document Title: CDER Data Standards Manual dissolve or disintegrate slowly in the mouth. A lollipop is a Document Version: 002 lozenge on a stick.(FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C29269 C66726 Pharmaceutical Dosage Form MOUTHWASH MOUTHWASH An aqueous solution which is most often used for its Mouthwash Dosage Form Production Organization Name: FDA deodorant, refreshing, or antiseptic effect. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C48624 C66726 Pharmaceutical Dosage Form NOT APPLICABLE NOT APPLICABLE The use of a dosage form term is not relevant or appropriate. Dosage Form Not Applicable Production Organization Name: FDA (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42965 C66726 Pharmaceutical Dosage Form OIL OIL An unctuous, combustible substance which is liquid, or easily Oil Dosage Form Production Organization Name: FDA liquefiable, on warming, and is soluble in ether but insoluble in Document Title: CDER Data Standards Manual water. Such substances, depending on their origin, are Document Version: 002 classified as animal, mineral, or vegetable oils. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42966 C66726 Pharmaceutical Dosage Form OINTMENT OINTMENT A suspension or emulsion, semisolid (1) dosage form, usually Ointment Dosage Form Production Organization Name: FDA containing < 20% water and volatiles (2) and > 50% Document Title: CDER Data Standards Manual hydrocarbons, waxes, or polyols as the vehicle. This dosage Document Version: 002 form is generally for external application to the skin or mucous Date: Revised November 28, 2006 membranes. Note 1: Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60984 C66726 Pharmaceutical Dosage Form OINTMENT, AUGMENTED OINTMENT, AUGMENTED An ointment dosage form that enhances drug delivery. Augmented Ointment Dosage Production Organization Name: FDA Augmentation does not refer to the strength of the drug in the Form Document Title: CDER Data Standards Manual dosage form. NOTE: CDER has decided to refrain from Document Version: 002 expanding the use of this dosage form due to difficulties in Date: Revised November 28, 2006 setting specific criteria Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47887 C66726 Pharmaceutical Dosage Form PACKING PACKING A material, usually covered by or impregnated with a drug, Packing Dosage Form Production Organization Name: FDA that is inserted into a body cavity or between the tooth enamel Document Title: CDER Data Standards Manual and the gingival margin.(FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42967 C66726 Pharmaceutical Dosage Form PASTE PASTE A semisolid dosage form, containing a large proportion (20 - Paste Dosage Form Production Organization Name: FDA 50%) of solids finely dispersed in a fatty vehicle. This dosage Document Title: CDER Data Standards Manual form is generally for external application to the skin or mucous Document Version: 002 membranes. Note: A semisolid is not pourable; it does not Date: Revised November 28, 2006 flow or Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42907 C66726 Pharmaceutical Dosage Form PASTE, DENTIFRICE PASTE, DENTIFRICE A paste formulation intended to clean and/or polish the teeth, Dentifrice Paste Dosage Form Production Organization Name: FDA and which may contain certain additional agents. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60985 C66726 Pharmaceutical Dosage Form PASTILLE PASTILLE An aromatic preparation, often with a pleasing flavor, usually Pastille Dosage Form Production Organization Name: FDA intended to dissolve in the mouth. (FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42968 C66726 Pharmaceutical Dosage Form PATCH PATCH A drug delivery system that often contains an adhesive Patch Dosage Form Production Organization Name: FDA backing that is usually applied to an external site on the body. Document Title: CDER Data Standards Manual Its ingredients either passively diffuse from, or are actively Document Version: 002 transported from, some portion of the patch. Depending upon Date: Revised November 28, 2006 the patch, Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42923 C66726 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE PATCH, EXTENDED RELEASE A drug delivery system in the form of a patch that releases the Extended Release Patch Dosage Production Organization Name: FDA drug in such a manner that a reduction in dosing frequency Form Document Title: CDER Data Standards Manual compared to that drug presented as a conventional dosage Document Version: 002 form (e.g., a solution or a prompt drug-releasing, conventional Date: Revised November 28, 2006 solid dosag Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42911 C66726 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE, PATCH, EXTENDED RELEASE, A drug delivery system in the form of a patch which is Electrically Controlled Extended Production Organization Name: FDA ELECTRICALLY CONTROLLED ELECTRICALLY CONTROLLED controlled by an electric current that releases the drug in such Release Patch Dosage Form Document Title: CDER Data Standards Manual a manner that a reduction in dosing frequency compared to Document Version: 002 that drug presented as a conventional dosage form (e.g., a Date: Revised November 28, 2006 solution or a prom Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42969 C66726 Pharmaceutical Dosage Form PELLET PELLET A small sterile solid mass consisting of a highly purified drug Pellet Dosage Form Production Organization Name: FDA (with or without excipients) made by the formation of granules, Document Title: CDER Data Standards Manual or by compression and molding. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42943 C66726 Pharmaceutical Dosage Form PELLET, IMPLANTABLE PELLET, IMPLANTABLE A small sterile solid mass consisting of a highly purified drug Implantable Pellet Dosage Form Production Organization Name: FDA (with or without excipients) made by the formation of granules, Document Title: CDER Data Standards Manual or by compression and molding; they are intended for Document Version: 002 implantation in the body (usually subcutaneously) for the Date: Revised November 28, 2006 purpose of provi Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42918 C66726 Pharmaceutical Dosage Form PELLETS, COATED, EXTENDED PELLETS, COATED, EXTENDED A solid dosage form in which the drug itself is in the form of Extended Release Coated PelletsProduction Organization Name: FDA RELEASE RELEASE granules to which varying amounts of coating have been Dosage Form Document Title: CDER Data Standards Manual applied, and which releases a drug (or drugs) in such a Document Version: 002 manner to allow a reduction in dosing frequency as compared Date: Revised November 28, 2006 to that drug (or drug Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C25394 C66726 Pharmaceutical Dosage Form PILL PILL A dose of medicine in the form of a small pellet. (NCI) Pill Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42970 C66726 Pharmaceutical Dosage Form PLASTER PLASTER Substance intended for external application made of such Plaster Dosage Form Production Organization Name: FDA materials and of such consistency as to adhere to the skin and Document Title: CDER Data Standards Manual attach to a dressing; plasters are intended to afford protection Document Version: 002 and support and/or to furnish an occlusion and macerating Date: Revised November 28, 2006 action and t Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47913 C66726 Pharmaceutical Dosage Form POULTICE POULTICE A soft, moist mass of meal, herbs, seed, etc., usually applied Poultice Dosage Form Production Organization Name: FDA hot in cloth that consists of gruel-like consistency. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42972 C66726 Pharmaceutical Dosage Form POWDER POWDER An intimate mixture of dry, finely divided drugs and/or Powder Dosage Form Production Organization Name: FDA chemicals that may be intended for internal or external use. Document Title: CDER Data Standards Manual (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42908 C66726 Pharmaceutical Dosage Form POWDER, DENTIFRICE POWDER, DENTIFRICE A powder formulation intended to clean and/or polish the Dentifrice Powder Dosage Form Production Organization Name: FDA teeth, and which may contain certain additional agents. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42973 C66726 Pharmaceutical Dosage Form POWDER, FOR SOLUTION POWDER, FOR SOLUTION An intimate mixture of dry, finely divided drugs and/or Powder for Solution Dosage Production Organization Name: FDA chemicals, which, upon the addition of suitable vehicles, Form Document Title: CDER Data Standards Manual yields a solution. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42975 C66726 Pharmaceutical Dosage Form POWDER, FOR SUSPENSION POWDER, FOR SUSPENSION An intimate mixture of dry, finely divided drugs and/or Powder for Suspension Dosage Production Organization Name: FDA chemicals, which, upon the addition of suitable vehicles, Form Document Title: CDER Data Standards Manual yields a suspension (a liquid preparation containing the solid Document Version: 002 particles dispersed in the liquid vehicle). (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42961 C66726 Pharmaceutical Dosage Form POWDER, METERED POWDER, METERED A powder dosage form that is situated inside a container that Metered Powder Dosage Form Production Organization Name: FDA has a mechanism to deliver a specified quantity. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60988 C66726 Pharmaceutical Dosage Form RING RING A small circular object with a vacant circular center that is Ring Dosage Form Production Organization Name: FDA usually intended to be placed in the body by special inserters, Document Title: CDER Data Standards Manual where the medication is released, generally for localized Document Version: 002 effects. (FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42979 C66726 Pharmaceutical Dosage Form RINSE RINSE A liquid used to cleanse by flushing. (NCI) Rinse Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42980 C66726 Pharmaceutical Dosage Form SALVE SALVE A thick ointment or cerate (a fat or wax based preparation with Salve Dosage Form Production Organization Name: FDA a consistency between an ointment and a plaster). (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42981 C66726 Pharmaceutical Dosage Form SHAMPOO SHAMPOO A liquid soap or detergent used to clean the hair and scalp andShampoo Dosage Form Production Organization Name: FDA is often used as a vehicle for dermatologic agents. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42982 C66726 Pharmaceutical Dosage Form SHAMPOO, SUSPENSION SHAMPOO, SUSPENSION A liquid soap or detergent containing one or more solid, Shampoo Suspension Dosage Production Organization Name: FDA insoluble substances dispersed in a liquid vehicle that is used Form Document Title: CDER Data Standards Manual to clean the hair and scalp and is often used as a vehicle for Document Version: 002 dermatologic agents. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42983 C66726 Pharmaceutical Dosage Form SOAP SOAP Any compound of one or more fatty acids, or their equivalents, Soap Dosage Form Production Organization Name: FDA with an alkali; soap is detergent and is much employed in Document Title: CDER Data Standards Manual liniments, enemas, and in making pills. It is also a mild Document Version: 002 aperient, antacid and antiseptic. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42986 C66726 Pharmaceutical Dosage Form SOLUTION SOLUTION A clear, homogeneous liquid dosage form that contains one or Solution Dosage Form Production Organization Name: FDA more chemical substances dissolved in a solvent or mixture of Document Title: CDER Data Standards Manual mutually miscible solvents. Note: A liquid is pourable; it flows Document Version: 002 and conforms to its container at room temperature. It displays Date: Revised November 28, 2006 Newt Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42898 C66726 Pharmaceutical Dosage Form SOLUTION, CONCENTRATE SOLUTION, CONCENTRATE A liquid preparation (i.e., a substance that flows readily in its Concentrate for Solution Dosage Production Organization Name: FDA natural state) that contains a drug dissolved in a suitable Form Document Title: CDER Data Standards Manual solvent or mixture of mutually miscible solvents; the drug has Document Version: 002 been strengthened by the evaporation of its non-active parts. Date: Revised November 28, 2006 (NCI Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42987 C66726 Pharmaceutical Dosage Form SOLUTION, FOR SLUSH SOLUTION, FOR SLUSH A solution for the preparation of an iced saline slush, which is Solution For Slush Dosage Form Production Organization Name: FDA administered by irrigation and used to induce regional Document Title: CDER Data Standards Manual hypothermia (in conditions such as certain open heart and Document Version: 002 kidney surgical procedures) by its direct application. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60994 C66726 Pharmaceutical Dosage Form SOLUTION, GEL FORMING / SOLUTION, GEL FORMING / A solution, which after usually being administered in a drop- Gel Forming Drops Solution Production Organization Name: FDA DROPS DROPS wise fashion, forms a gel. (FDA) Dosage Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42935 C66726 Pharmaceutical Dosage Form SOLUTION, GEL FORMING, SOLUTION, GEL FORMING, A solution that forms a gel when it comes in contact with Extended Release Gel Forming Production Organization Name: FDA EXTENDED RELEASE EXTENDED RELEASE ocular fluid, and which allows at least a reduction in dosing Solution Dosage Form Document Title: CDER Data Standards Manual frequency Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60992 C66726 Pharmaceutical Dosage Form SOLUTION/ DROPS SOLUTION/ DROPS A solution which is usually administered in a drop-wise Drops Solution Dosage Form Production Organization Name: FDA fashion. (FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47912 C66726 Pharmaceutical Dosage Form SPONGE SPONGE A porous, interlacing, absorbent material that contains a drug. Sponge Dosage Form Production Organization Name: FDA It is typically used for applying or introducing medication, or Document Title: CDER Data Standards Manual for cleansing. A sponge usually retains its shape.(FDA) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42989 C66726 Pharmaceutical Dosage Form SPRAY SPRAY A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42962 C66726 Pharmaceutical Dosage Form SPRAY, METERED SPRAY, METERED A non-pressurized dosage form consisting of valves which Metered Spray Dosage Form Production Organization Name: FDA allow the dispensing of a specified quantity of spray upon each Document Title: CDER Data Standards Manual activation. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42990 C66726 Pharmaceutical Dosage Form SPRAY, SUSPENSION SPRAY, SUSPENSION A liquid preparation containing solid particles dispersed in a Spray Suspension Dosage Form Production Organization Name: FDA liquid vehicle and in the form of coarse droplets or as finely Document Title: CDER Data Standards Manual divided solids to be applied locally, most usually to the nasal- Document Version: 002 pharyngeal tract, or topically to the skin. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42991 C66726 Pharmaceutical Dosage Form STICK STICK A dosage form prepared in a relatively long and slender often Stick Dosage Form Production Organization Name: FDA cylindrical form. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47914 C66726 Pharmaceutical Dosage Form STRIP STRIP A long narrow piece of material. Strip Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42993 C66726 Pharmaceutical Dosage Form SUPPOSITORY SUPPOSITORY A solid body of various weights and shapes, adapted for Suppository Dosage Form Production Organization Name: FDA introduction into the rectal, vaginal, or urethral orifice of the Document Title: CDER Data Standards Manual human body; they usually melt, soften, or dissolve at body Document Version: 002 temperature. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42924 C66726 Pharmaceutical Dosage Form SUPPOSITORY, EXTENDED SUPPOSITORY, EXTENDED A drug delivery system in the form of a suppository that allows Extended Release Suppository Production Organization Name: FDA RELEASE RELEASE at least a reduction in dosing frequency. (NCI) Dosage Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42994 C66726 Pharmaceutical Dosage Form SUSPENSION SUSPENSION A liquid dosage form that contains solid particles dispersed in Suspension Dosage Form Production Organization Name: FDA a liquid vehicle. Note: A liquid is pourable; it flows and Document Title: CDER Data Standards Manual conforms to its container at room temperature. It displays Document Version: 002 Newtonian or pseudoplastic flow behavior.(FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42925 C66726 Pharmaceutical Dosage Form SUSPENSION, EXTENDED SUSPENSION, EXTENDED A liquid preparation consisting of solid particles dispersed Extended Release Suspension Production Organization Name: FDA RELEASE RELEASE throughout a liquid phase in which the particles are not Dosage Form Document Title: CDER Data Standards Manual soluble; the suspension has been formulated in a manner to Document Version: 002 allow at least a reduction in dosing frequency as compared to Date: Revised November 28, 2006 that drug presen Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C60995 C66726 Pharmaceutical Dosage Form SUSPENSION/DROPS SUSPENSION/DROPS A suspension which is usually administered in a dropwise Drops Suspension Dosage Form Production Organization Name: FDA fashion. (FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47889 C66726 Pharmaceutical Dosage Form SUTURE SUTURE A strand or fiber used to hold wound edges in apposition Suture Dosage Form Production Organization Name: FDA during healing. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C47898 C66726 Pharmaceutical Dosage Form SWAB SWAB A small piece of relatively flat absorbent material that contains Swab Dosage Form Production Organization Name: FDA a drug. A swab may also be attached to one end of a small Document Title: CDER Data Standards Manual stick. A swab is typically used for applying medication or for Document Version: 002 cleansing. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42996 C66726 Pharmaceutical Dosage Form SYRUP SYRUP An oral solution containing high concentrations of sucrose or Syrup Dosage Form Production Organization Name: FDA other sugars; the term has also been used to include any othe Document Title: CDER Data Standards Manual liquid dosage form prepared in a sweet and viscid vehicle, Document Version: 002 including oral suspensions. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42998 C66726 Pharmaceutical Dosage Form TABLET TABLET A solid dosage form containing medicinal substances with or Tablet Dosage Form Production Organization Name: FDA without suitable diluents. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42893 C66726 Pharmaceutical Dosage Form TABLET, CHEWABLE TABLET, CHEWABLE A solid dosage form containing medicinal substances with or Chewable Tablet Dosage Form Production Organization Name: FDA without suitable diluents that is intended to be chewed, Document Title: CDER Data Standards Manual producing a pleasant tasting residue in the oral cavity that is Document Version: 002 easily swallowed and does not leave a bitter or unpleasant Date: Revised November 28, 2006 after-taste. (N Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42897 C66726 Pharmaceutical Dosage Form TABLET, COATED TABLET, COATED A solid dosage form that contains medicinal substances with Coated Tablet Dosage Form Production Organization Name: FDA or without suitable diluents and is covered with a designated Document Title: CDER Data Standards Manual coating. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C60997 C66726 Pharmaceutical Dosage Form TABLET, COATED PARTICLES TABLET, COATED PARTICLES A solid dosage form containing a conglomerate of medicinal Tablet Coated Particles Dosage Production Organization Name: FDA particles that have each been covered with a coating. (FDA) Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42905 C66726 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE TABLET, DELAYED RELEASE A solid dosage form which releases a drug (or drugs) at a timeDelayed Release Tablet Dosage Production Organization Name: FDA other than promptly after administration. Enteric-coated Form Document Title: CDER Data Standards Manual articles are delayed release dosage forms. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42997 C66726 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE TABLET, DELAYED RELEASE A solid dosage form containing a conglomerate of medicinal Delayed Release Particles Tablet Production Organization Name: FDA PARTICLES PARTICLES particles that have been covered with a coating which releasesDosage Form Document Title: CDER Data Standards Manual a drug (or drugs) at a time other than promptly after Document Version: 002 administration. Enteric-coated articles are delayed release Date: Revised November 28, 2006 dosage forms. (NCI Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42910 C66726 Pharmaceutical Dosage Form TABLET, EFFERVESCENT TABLET, EFFERVESCENT A solid dosage form containing mixtures of acids (e.g., citric Effervescent Tablet Dosage FormProduction Organization Name: FDA acid, tartaric acid) and sodium bicarbonate, which release Document Title: CDER Data Standards Manual carbon dioxide when dissolved in water; it is intended to be Document Version: 002 dissolved or dispersed in water before administration.(FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42927 C66726 Pharmaceutical Dosage Form TABLET, EXTENDED RELEASE TABLET, EXTENDED RELEASE A solid dosage form containing a drug which allows at least a Extended Release Tablet DosageProduction Organization Name: FDA reduction in dosing frequency as compared to that drug Form Document Title: CDER Data Standards Manual presented in conventional dosage form. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42931 C66726 Pharmaceutical Dosage Form TABLET, FILM COATED TABLET, FILM COATED A solid dosage form that contains medicinal substances with Film Coated Tablet Dosage Form Production Organization Name: FDA or without suitable diluents and is coated with a thin layer of a Document Title: CDER Data Standards Manual water-insoluble or water-soluble polymer. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42930 C66726 Pharmaceutical Dosage Form TABLET, FILM COATED, TABLET, FILM COATED, A solid dosage form that contains medicinal substances with Film Coated Extended Release Production Organization Name: FDA EXTENDED RELEASE EXTENDED RELEASE or without suitable diluents and is coated with a thin layer of a Tablet Dosage Form Document Title: CDER Data Standards Manual water-insoluble or water-soluble polymer; the tablet is Document Version: 002 formulated in such manner as to make the contained Date: Revised November 28, 2006 medicament available o Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C61004 C66726 Pharmaceutical Dosage Form TABLET, FOR SOLUTION TABLET, FOR SOLUTION A tablet that forms a solution when placed in a liquid. (FDA) Tablet For Solution Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C61005 C66726 Pharmaceutical Dosage Form TABLET, FOR SUSPENSION TABLET, FOR SUSPENSION; A tablet that forms a suspension when placed in a liquid Tablet For Suspension Dosage Production Organization Name: FDA TABLET, DISPERSIBLE (formerly referred to as a Dispersible Tablet). Form Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28 2006 C42964 C66726 Pharmaceutical Dosage Form TABLET, MULTILAYER TABLET, MULTILAYER A solid dosage form containing medicinal substances that Multilayered Tablet Dosage Form Production Organization Name: FDA have been compressed to form a multiple-layered tablet or a Document Title: CDER Data Standards Manual tablet-within-a-tablet, the inner tablet being the core and the Document Version: 002 outer portion being the shell. (NCI) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 C42963 C66726 Pharmaceutical Dosage Form TABLET, MULTILAYER, TABLET, MULTILAYER, A solid dosage form containing medicinal substances that Multilayered Extended Release Production Organization Name: FDA EXTENDED RELEASE EXTENDED RELEASE have been compressed to form a multiple-layered tablet or a Tablet Dosage Form Document Title: CDER Data Standards Manual tablet-within-a-tablet, the inner tablet being the core and the Document Version: 002 outer portion being the shell, which, additionally, is covered in Date: Revised November 28, 2006 a design Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42999 C66726 Pharmaceutical Dosage Form TABLET, ORALLY TABLET, ORALLY A solid dosage form containing medicinal substances which Orally Disintegrating Tablet Production Organization Name: FDA DISINTEGRATING DISINTEGRATING disintegrates rapidly, usually within a matter of seconds, when Dosage Form Document Title: CDER Data Standards Manual placed upon the tongue. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist Name: Dosage Form C61006 C66726 Pharmaceutical Dosage Form TABLET, ORALLY TABLET, ORALLY A solid dosage form containing medicinal substances which Tablet Orally Disintegrating Production Organization Name: FDA DISINTEGRATING, DELAYED DISINTEGRATING, DELAYED disintegrates rapidly, usually within a matter of seconds, when Delayed Release Dosage Form Document Title: CDER Data Standards Manual RELEASE RELEASE placed upon the tongue, but which releases a drug (or drugs) Document Version: 002 at a time other than promptly after administration. (FDA) Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C42985 C66726 Pharmaceutical Dosage Form TABLET, SOLUBLE TABLET, SOLUBLE A solid dosage form that contains medicinal substances with Soluble Tablet Dosage Form Production Organization Name: FDA or without suitable diluents and possesses the ability to Document Title: CDER Data Standards Manual dissolve in fluids. (NCI) Document Version: 002 Date: Revised November 28, 2006 C42992 C66726 Pharmaceutical Dosage Form TABLET, SUGAR COATED TABLET, SUGAR COATED A solid dosage form that contains medicinal substances with Sugar Coated Tablet Dosage Production OrganizationCdlitN Name: D FDA F or without suitable diluents and is coated with a colored or an Form Document Title: CDER Data Standards Manual uncolored water-soluble sugar. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist Name: Dosage Form

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C47892 C66726 Pharmaceutical Dosage Form TAMPON TAMPON A plug made of cotton, sponge, or oakum variously used in Tampon Dosage Form Production Organization Name: FDA surgery to plug the nose, vagina, etc., for the control of Document Title: CDER Data Standards Manual hemorrhage or the absorption of secretions. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist Name: Dosage Form C47897 C66726 Pharmaceutical Dosage Form TAPE TAPE A narrow woven fabric, or a narrow extruded synthetic (such Tape Dosage Form Production Organization Name: FDA as plastic), usually with an adhesive on one or both sides. Document Title: CDER Data Standards Manual (NCI) Document Version: 002 Date: Revised November 28 2006 C43000 C66726 Pharmaceutical Dosage Form TINCTURE TINCTURE An alcoholic or hydroalcoholic solution prepared from Tincture Dosage Form Production Organization Name: FDA vegetable materials or from chemical substances. (NCI) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28 2006 C43001 C66726 Pharmaceutical Dosage Form TROCHE TROCHE A discoid-shaped solid containing the medicinal agent in a Troche Dosage Form Production Organization Name: FDA suitably flavored base; troches are placed in the mouth where Document Title: CDER Data Standards Manual they slowly dissolve, liberating the active ingredients. (NCI) Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C DRG 00201 C43002 C66726 Pharmaceutical Dosage Form UNASSIGNED UNASSIGNED A dosage form has yet to be assigned. (NCI) Unassigned Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C43003 C66726 Pharmaceutical Dosage Form WAFER WAFER A thin slice of material containing a medicinal agent. (NCI) Wafer Dosage Form Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised November 28, 2006 Codelist_Name: Dosage Form Identifier: C-DRG-00201 Field Name: Name C66727 Yes Completion/Reason for Non-Completion NCOMPLT NCOMPLT Completion/Reason for Non- The reason that a subject was discontinued from a clinical CDISC SDTM Reason for Non- Production Completion trial. Completion Terminology C41331 C66727 Completion/Reason for Non-Completion ADVERSE EVENT ADVERSE EVENT Any untoward medical occurrence in a patient or clinical Adverse Event Production investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign C25250 C66727 Completion/Reason for Non-Completion COMPLETED COMPLETED To possess every necessary or normal part or component or Complete Production step; having come or been brought to a conclusion. (NCI) C28554 C66727 Completion/Reason for Non-Completion DEATH DEATH The absence of life or state of being dead. (NCI) Death Production C48226 C66727 Completion/Reason for Non-Completion LACK OF EFFICACY LACK OF EFFICACY The lack of expected or desired effect related to a therapy. Lack of Efficacy Production (NCI) C48227 C66727 Completion/Reason for Non-Completion LOST TO FOLLOW-UP LOST TO FOLLOW-UP The loss or lack of continuation of follow-up after a study has Lost To Follow-up Production officially closed. See Follow-up. (NCI) C49631 C66727 Completion/Reason for Non-Completion NON-COMPLIANCE WITH STUDY NON-COMPLIANCE WITH STUDY An indication that a subject has not agreed with or followed Non-Compliance With Study Production DRUG DRUG the instructions related to the study medication. (NCI) Drug C17649 C66727 Completion/Reason for Non-Completion OTHER OTHER Other Different than the one(s) previously specified or mentioned. Other Production (NCI) C48250 C66727 Completion/Reason for Non-Completion PHYSICIAN DECISION PHYSICIAN DECISION A position, opinion or judgment reached after consideration by Physician Decision Production a physician with reference to subject. (NCI) C25742 C66727 Completion/Reason for Non-Completion PREGNANCY PREGNANCY Pregnancy is the state or condition of having a developing Pregnancy Production embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. (NCI)

C35571 C66727 Completion/Reason for Non-Completion PROGRESSIVE DISEASE PROGRESSIVE DISEASE A disease process that is increasing in scope or severity. Progressive Disease Production (NCI) C48251 C66727 Completion/Reason for Non-Completion PROTOCOL VIOLATION PROTOCOL VIOLATION An event or decision that stands in contrast to the guidelines Protocol Violation Production set out by the protocol. (NCI)

C25746 C66727 Completion/Reason for Non-Completion RECOVERY RECOVERY A healing process and/or an outcome implying relative health. Recovery Production The term is typically used in the context of direct and indirect effects of sickness or injury. (NCI) C49628 C66727 Completion/Reason for Non-Completion SCREEN FAILURE SCREEN FAILURE The potential subject who does not meet one or more criteria Trial Screen Failure Production required for participation in a trial. C49632 C66727 Completion/Reason for Non-Completion STUDY TERMINATED BY STUDY TERMINATED BY An indication that a clinical study was stopped by its sponsor. Study Terminated By Sponsor Production SPONSOR SPONSOR (NCI) C49633 C66727 Completion/Reason for Non-Completion TECHNICAL PROBLEMS TECHNICAL PROBLEMS A problem with some technical aspect of a clinical study, Technical Problem Production usually related to an instrument. (NCI) C49634 C66727 Completion/Reason for Non-Completion WITHDRAWAL BY SUBJECT WITHDRAWAL BY SUBJECT An indication that a study participant has removed itself from Withdrawal by Subject Production the study. (NCI)

C66728 No Relation to Reference Period STENRF STENRF Relation to Reference Period The name of a code list that contains terms that reference CDISC SDTM Relation to Production timepoints within and without a defined time period. Reference Period Terminology C38008 C66728 Relation to Reference Period AFTER AFTER The time period following a point or another period of time. Status Post Production Organization Name: CDISC (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.4 Actual and Relative Time Assumptions / 4.1.4.7 Page: 29 C25629 C66728 Relation to Reference Period BEFORE BEFORE Earlier in time or order. (NCI) Prior Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.4 Actual and Relative Time Assumptions / 4.1.4.7 Page: 29 C25490 C66728 Relation to Reference Period DURING DURING At some point in a given period of time. (NCI) During Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.4 Actual and Relative Time Assumptions / 4.1.4.7 Page: 29

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C49640 C66728 Relation to Reference Period DURING/AFTER DURING/AFTER Within a certain period of time or after a certain point or period During Or After Production Organization Name: CDISC in time. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.4 Actual and Relative Time Assumptions / 4.1.4.7 Page: 29 C17998 C66728 Relation to Reference Period U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.4 Actual and Relative Time Assumptions / 4.1.4.7 Page: 29 C66729 Yes Route of Administration ROUTE ROUTE Route of Administration The course by which a substance was administered in order CDISC SDTM Route of Production to reach the site of action in the body. Administration Terminology C38192 C66729 Route of Administration AURICULAR (OTIC) AURICULAR (OTIC) Administration to or by way of the ear.(FDA) Auricular Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

C38193 C66729 Route of Administration BUCCAL BUCCAL Administration directed toward the cheek, generally from Buccal Route of Administration Production Organization Name: FDA within the mouth.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38194 C66729 Route of Administration CONJUNCTIVAL CONJUNCTIVAL Administration to the conjunctiva, the delicate membrane that Conjunctival Route of Production Organization Name: FDA lines the eyelids and covers the exposed surface of the Administration Document Title: CDER Data Standards Manual eyeball.(FDA) Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38675 C66729 Route of Administration CUTANEOUS CUTANEOUS Administration to the skin.(FDA) Cutaneous Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38197 C66729 Route of Administration DENTAL DENTAL Administration to a tooth or teeth.(FDA) Dental Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38633 C66729 Route of Administration ELECTRO-OSMOSIS ELECTRO-OSMOSIS Administration of through the diffusion of substance through a Electro-osmosis Route of Production Organization Name: FDA membrane in an electric field.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38205 C66729 Route of Administration ENDOCERVICAL ENDOCERVICAL Administration within the canal of the cervix uteri. Endocervical Route of Production Organization Name: FDA Synonymous with the term intracervical.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38206 C66729 Route of Administration ENDOSINUSIAL ENDOSINUSIAL Administration within the nasal sinuses of the head.(FDA) Endosinusial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38208 C66729 Route of Administration ENDOTRACHEAL ENDOTRACHEAL Administration directly into the trachea. Synonymous with the Endotracheal Route of Production Organization Name: FDA term intratracheal.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38209 C66729 Route of Administration ENTERAL ENTERAL Administration directly into the intestines.(FDA) Enteral Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38210 C66729 Route of Administration EPIDURAL EPIDURAL Administration upon or over the dura mater.(FDA) Epidural Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38211 C66729 Route of Administration EXTRA-AMNIOTIC EXTRA-AMNIOTIC Administration to the outside of the membrane enveloping the Extraamniotic Route of Production Organization Name: FDA fetus.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38212 C66729 Route of Administration EXTRACORPOREAL EXTRACORPOREAL Administration outside of the body.(FDA) Extracorporeal Circulation Route Production Organization Name: FDA of Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38200 C66729 Route of Administration HEMODIALYSIS HEMODIALYSIS Administration through hemodialysate fluid.(FDA) Administration Via Hemodialysis Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38215 C66729 Route of Administration INFILTRATION INFILTRATION Administration that results in substances passing into tissue Infiltration Route of Production Organization Name: FDA spaces or into cells.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38219 C66729 Route of Administration INTERSTITIAL INTERSTITIAL Administration to or in the interstices of a tissue.(FDA) Interstitial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38220 C66729 Route of Administration INTRA-ABDOMINAL INTRA-ABDOMINAL Administration within the abdomen.(FDA) Intraabdominal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38221 C66729 Route of Administration INTRA-AMNIOTIC INTRA-AMNIOTIC Administration within the amnion.(FDA) Intraamniotic Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38222 C66729 Route of Administration INTRA-ARTERIAL INTRA-ARTERIAL Administration within an artery or arteries.(FDA) Intraarterial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38223 C66729 Route of Administration INTRA-ARTICULAR INTRA-ARTICULAR Administration within a joint.(FDA) Intraarticular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38224 C66729 Route of Administration INTRABILIARY INTRABILIARY Administration within the bile, bile ducts or gallbladder.(FDA) Intrabiliary Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38225 C66729 Route of Administration INTRABRONCHIAL INTRABRONCHIAL Administration within a bronchus.(FDA) Intrabronchial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38226 C66729 Route of Administration INTRABURSAL INTRABURSAL Administration within a bursa.(FDA) Intrabursal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38227 C66729 Route of Administration INTRACARDIAC INTRACARDIAC Administration within the heart.(FDA) Intracardiac Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38228 C66729 Route of Administration INTRACARTILAGINOUS INTRACARTILAGINOUS Administration within a cartilage; endochondral.(FDA) Intracartilaginous Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38229 C66729 Route of Administration INTRACAUDAL INTRACAUDAL Administration within the cauda equina.(FDA) Intracaudal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38230 C66729 Route of Administration INTRACAVERNOUS INTRACAVERNOUS Administration within a pathologic cavity, such as occurs in Intracavernous Route of Production Organization Name: FDA the lung in tuberculosis.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38231 C66729 Route of Administration INTRACAVITARY INTRACAVITARY Administration within a non-pathologic cavity, such as that of Intracavitary Route of Production Organization Name: FDA the cervix, uterus, or penis, or such as that is formed as the Administration Document Title: CDER Data Standards Manual result of a wound.(FDA) Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38232 C66729 Route of Administration INTRACEREBRAL INTRACEREBRAL Administration within the cerebrum.(FDA) Intracerebral Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38233 C66729 Route of Administration INTRACISTERNAL INTRACISTERNAL Administration within the cisterna magna Intracisternal Route of Production Organization Name: FDA cerebellomedularis.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38234 C66729 Route of Administration INTRACORNEAL INTRACORNEAL Administration within the cornea (the transparent structure Intracorneal Route of Production Organization Name: FDA forming the anterior part of the fibrous tunic of the eye).(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38217 C66729 Route of Administration INTRACORONAL, DENTAL INTRACORONAL, DENTAL Administration of a drug within a portion of a tooth which is Intracoronal Dental Route of Production Organization Name: FDA covered by enamel and which is separated from the roots by a Administration Document Title: CDER Data Standards Manual slightly constricted region known as the neck.(FDA) Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38218 C66729 Route of Administration INTRACORONARY INTRACORONARY Administration within the coronary arteries.(FDA) Intracoronary Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38235 C66729 Route of Administration INTRACORPORUS CAVERNOSUM INTRACORPORUS CAVERNOSUM Administration within the dilatable spaces of the corporus Intracorporus Cavernosum Route Production Organization Name: FDA cavernosa of the penis.(FDA) of Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38238 C66729 Route of Administration INTRADERMAL INTRADERMAL Administration within the dermis.(FDA) Intradermal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38239 C66729 Route of Administration INTRADISCAL INTRADISCAL Administration within a disc.(FDA) Intradiscal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38240 C66729 Route of Administration INTRADUCTAL INTRADUCTAL Administration within the duct of a gland.(FDA) Intraductal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38241 C66729 Route of Administration INTRADUODENAL INTRADUODENAL Administration within the duodenum.(FDA) Intraduodenal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38242 C66729 Route of Administration INTRADURAL INTRADURAL Administration within or beneath the dura.(FDA) Intradural Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38243 C66729 Route of Administration INTRAEPIDERMAL INTRAEPIDERMAL Administration within the epidermis.(FDA) Intraepidermal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38245 C66729 Route of Administration INTRAESOPHAGEAL INTRAESOPHAGEAL Administration within the esophagus.(FDA) Intraesophageal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38246 C66729 Route of Administration INTRAGASTRIC INTRAGASTRIC Administration within the stomach.(FDA) Intragastric Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38247 C66729 Route of Administration INTRAGINGIVAL INTRAGINGIVAL Administration within the gingivae.(FDA) Intragingival Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38249 C66729 Route of Administration INTRAILEAL INTRAILEAL Administration within the distal portion of the small intestine, Intraileal Route of Administration Production Organization Name: FDA from the jejunum to the cecum.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38250 C66729 Route of Administration INTRALESIONAL INTRALESIONAL Administration within or introduced directly into a localized Intralesional Route of Production Organization Name: FDA lesion.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38251 C66729 Route of Administration INTRALUMINAL INTRALUMINAL Administration within the lumen of a tube.(FDA) Intraluminal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38252 C66729 Route of Administration INTRALYMPHATIC INTRALYMPHATIC Administration within the lymph.(FDA) Intralymphatic Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38253 C66729 Route of Administration INTRAMEDULLARY INTRAMEDULLARY Administration within the marrow cavity of a bone.(FDA) Intramedullary Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38254 C66729 Route of Administration INTRAMENINGEAL INTRAMENINGEAL Administration within the meninges (the three membranes Intrameningeal Route of Production Organization Name: FDA that envelope the brain and spinal cord).(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C28161 C66729 Route of Administration INTRAMUSCULAR INTRAMUSCULAR Administration within a muscle. (FDA) Intramuscular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38255 C66729 Route of Administration INTRAOCULAR INTRAOCULAR Administration within the eye.(FDA) Intraocular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38256 C66729 Route of Administration INTRAOVARIAN INTRAOVARIAN Administration within the ovary.(FDA) Intraovarian Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38257 C66729 Route of Administration INTRAPERICARDIAL INTRAPERICARDIAL Administration within the pericardium.(FDA) Intrapericardial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38258 C66729 Route of Administration INTRAPERITONEAL INTRAPERITONEAL Administration within the peritoneal cavity.(FDA) Intraperitoneal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38259 C66729 Route of Administration INTRAPLEURAL INTRAPLEURAL Administration within the pleura.(FDA) Intrapleural Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38260 C66729 Route of Administration INTRAPROSTATIC INTRAPROSTATIC Administration within the prostate gland.(FDA) Intraprostatic Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38261 C66729 Route of Administration INTRAPULMONARY INTRAPULMONARY Administration within the lungs or its bronchi.(FDA) Intrapulmonary Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38262 C66729 Route of Administration INTRASINAL INTRASINAL Administration within the nasal or periorbital sinuses.(FDA) Intrasinal Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38263 C66729 Route of Administration INTRASPINAL INTRASPINAL Administration within the vertebral column.(FDA) Intraspinal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38264 C66729 Route of Administration INTRASYNOVIAL INTRASYNOVIAL Administration within the synovial cavity of a joint.(FDA) Intrasynovial Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38265 C66729 Route of Administration INTRATENDINOUS INTRATENDINOUS Administration within a tendon.(FDA) Intratendinous Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38266 C66729 Route of Administration INTRATESTICULAR INTRATESTICULAR Administration within the testicle.(FDA) Intratesticular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38267 C66729 Route of Administration INTRATHECAL INTRATHECAL Administration within the cerebrospinal fluid at any level of the Intrathecal Route of Production Organization Name: FDA cerebrospinal axis, including injection into the cerebral Administration Document Title: CDER Data Standards Manual ventricles.(FDA) Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38207 C66729 Route of Administration INTRATHORACIC INTRATHORACIC Administration within the thorax (internal to the ribs); Endothoracic Route of Production Organization Name: FDA synonymous with the term endothoracic.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38268 C66729 Route of Administration INTRATUBULAR INTRATUBULAR Administration within the tubules of an organ.(FDA) Intratubular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38269 C66729 Route of Administration INTRATUMOR INTRATUMOR Intratumor Route of Administration within a tumor.(FDA) Intratumoral Route of Production Organization Name: FDA Administration Administration Document Title: CDER Data Standards Manual Document Version: 002 C38270 C66729 Route of Administration INTRATYMPANIC INTRATYMPANIC Administration within the auris media.(FDA) Intratympanic Route of Production OrganizationD t R i dName: J FDA 11 2006 Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38272 C66729 Route of Administration INTRAUTERINE INTRAUTERINE Administration within the uterus.(FDA) Intrauterine Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38273 C66729 Route of Administration INTRAVASCULAR INTRAVASCULAR Administration within a vessel or vessels.(FDA) Intravascular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38276 C66729 Route of Administration INTRAVENOUS INTRAVENOUS Administration within or into a vein or veins.(FDA) Intravenous Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38274 C66729 Route of Administration INTRAVENOUS BOLUS INTRAVENOUS BOLUS Administration within or into a vein or veins all at once.(FDA) Intravenous Bolus Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38279 C66729 Route of Administration INTRAVENOUS DRIP INTRAVENOUS DRIP Administration within or into a vein or veins over a sustained Intravenous Drip Production Organization Name: FDA period of time.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38277 C66729 Route of Administration INTRAVENTRICULAR INTRAVENTRICULAR Administration within a ventricle.(FDA) Intraventricular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38278 C66729 Route of Administration INTRAVESICAL INTRAVESICAL Administration within the bladder.(FDA) Intravesical Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38280 C66729 Route of Administration INTRAVITREAL INTRAVITREAL Administration within the vitreous body of the eye.(FDA) Intravitreal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38203 C66729 Route of Administration IONTOPHORESIS IONTOPHORESIS Administration by means of an electric current where ions of Iontophoresis Route of Production Organization Name: FDA soluble salts migrate into the tissues of the body.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38281 C66729 Route of Administration IRRIGATION IRRIGATION Administration to bathe or flush open wounds or body Irrigation-Route of Administration Production Organization Name: FDA cavities.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38282 C66729 Route of Administration LARYNGEAL LARYNGEAL Administration directly upon the larynx.(FDA) Laryngeal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38284 C66729 Route of Administration NASAL NASAL Administration to the nose; administered by way of the Nasal Route of Administration Production Organization Name: FDA nose.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38285 C66729 Route of Administration NASOGASTRIC NASOGASTRIC Administration through the nose and into the stomach, usually Nasogastric Route of Production Organization Name: FDA by means of a tube.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C48623 C66729 Route of Administration NOT APPLICABLE NOT APPLICABLE Routes of administration are not applicable.(FDA) Route of Administration Not Production Organization Name: FDA Applicable Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38286 C66729 Route of Administration OCCLUSIVE DRESSING OCCLUSIVE DRESSING Administration by the topical route which is then covered by a Occlusive Dressing Technique Production Organization Name: FDA TECHNIQUE TECHNIQUE dressing which occludes the area.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 C38287 C66729 Route of Administration OPHTHALMIC OPHTHALMIC Administration to the external eye.(FDA) Ophthalmic Route of Production OrganizationD t R i dName: J FDA 11 2006 Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38288 C66729 Route of Administration ORAL ORAL Administration to or by way of the mouth.(FDA) Oral Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38289 C66729 Route of Administration OROPHARYNGEAL OROPHARYNGEAL Administration directly to the mouth and pharynx.(FDA) Oropharyngeal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38290 C66729 Route of Administration OTHER OTHER Administration is different from others on this list.(FDA) Other Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38291 C66729 Route of Administration PARENTERAL PARENTERAL Administration by injection, infusion, or implantation.(FDA) Parenteral Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38676 C66729 Route of Administration PERCUTANEOUS PERCUTANEOUS Administration through the skin.(FDA) Percutaneous Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38292 C66729 Route of Administration PERIARTICULAR PERIARTICULAR Administration around a joint.(FDA) Periarticular Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38677 C66729 Route of Administration PERIDURAL PERIDURAL Administration to the outside of the dura mater of the spinal Peridural Route of Administration Production Organization Name: FDA cord.(FDA) Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38293 C66729 Route of Administration PERINEURAL PERINEURAL Administration surrounding a nerve or nerves.(FDA) Perineural Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38294 C66729 Route of Administration PERIODONTAL PERIODONTAL Administration around a tooth.(FDA) Periodontal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38295 C66729 Route of Administration RECTAL RECTAL Administration to the rectum.(FDA) Rectal Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38216 C66729 Route of Administration RESPIRATORY (INHALATION) RESPIRATORY (INHALATION) Administration within the respiratory tract by inhaling orally or Inhalation Route of Production Organization Name: FDA nasally for local or systemic effect.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38296 C66729 Route of Administration RETROBULBAR RETROBULBAR Administration behind the pons or behind the eyeball.(FDA) Retrobulbar Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38198 C66729 Route of Administration SOFT TISSUE SOFT TISSUE Administration into any soft tissue.(FDA) Soft Tissue Route Of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38297 C66729 Route of Administration SUBARACHNOID SUBARACHNOID Administration beneath the arachnoid.(FDA) Subarachnoid Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38298 C66729 Route of Administration SUBCONJUNCTIVAL SUBCONJUNCTIVAL Administration beneath the conjunctiva.(FDA) Subconjunctival Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38299 C66729 Route of Administration SUBCUTANEOUS SUBCUTANEOUS Administration beneath the skin; hypodermic. Synonymous Subcutaneous Route of Production Organization Name: FDA with the term SUBDERMAL.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38300 C66729 Route of Administration SUBLINGUAL SUBLINGUAL Administration beneath the tongue.(FDA) Sublingual Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38301 C66729 Route of Administration SUBMUCOSAL SUBMUCOSAL Administration beneath the mucous membrane.(FDA) Submucosal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38304 C66729 Route of Administration TOPICAL TOPICAL Administration to a particular spot on the outer surface of the Topical Route of Administration Production Organization Name: FDA body. The E2B term TRANSMAMMARY is a subset of the Document Title: CDER Data Standards Manual term TOPICAL.(FDA) Document Version: 002 Date: Revised January 11, 2006 Codelist Name: Route of Administration C38305 C66729 Route of Administration TRANSDERMAL TRANSDERMAL Administration through the dermal layer of the skin to the Transdermal Route of Production Organization Name: FDA systemic circulation by diffusion.(FDA) Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38283 C66729 Route of Administration TRANSMUCOSAL TRANSMUCOSAL Administration across the mucosa.(FDA) Mucosal Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38307 C66729 Route of Administration TRANSPLACENTAL TRANSPLACENTAL Administration through or across the placenta.(FDA) Transplacental Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C38308 C66729 Route of Administration TRANSTRACHEAL TRANSTRACHEAL Administration through the wall of the trachea.(FDA) Transtracheal Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38309 C66729 Route of Administration TRANSTYMPANIC TRANSTYMPANIC Administration across or through the tympanic cavity.(FDA) Transtympanic Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38310 C66729 Route of Administration UNASSIGNED UNASSIGNED Route of administration has not yet been assigned.(FDA) Unassigned Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38311 C66729 Route of Administration UNKNOWN UNKNOWN Route of administration is unknown.(FDA) Unknown Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38312 C66729 Route of Administration URETERAL URETERAL Administration into the ureter.(FDA) Ureteral Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38271 C66729 Route of Administration URETHRAL URETHRAL Administration into the urethra.(FDA) Intraurethral Route of Production Organization Name: FDA Administration Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C38313 C66729 Route of Administration VAGINAL VAGINAL Administration into the vagina.(FDA) Vaginal Route of Administration Production Organization Name: FDA Document Title: CDER Data Standards Manual Document Version: 002 Date: Revised January 11, 2006 Codelist_Name: Route of Administration Identifier: C-DRG-00301 Field Name: NAME C66769 No Severity/Intensity Scale for Adverse Events AESEV AESEV Severity/Intensity Scale for A scale that defines the degree or state of disease existing in aCDISC SDTM Severity Intensity Production Adverse Events patient as a result of the occurrence of an adverse event. Scale for Adverse Event (NCI) Terminology

C41338 C66769 Severity/Intensity Scale for Adverse Events MILD MILD Grade 1; 1 A type of adverse event that is usually transient and may Mild Adverse Event Production E2A Code require only minimal treatment or therapeutic intervention. The Organization Name: EMEA event does not generally interfere with usual activities of daily Document Title: ICH Topic E2A Clinical Safety Data Management: Definitions and Standards for living. Expedited Reporting Document Version: CPMP/ICH/377/95 Date: November 1994 Chapter: B. Serious Adverse Event or Adverse Drug React C41339 C66769 Severity/Intensity Scale for Adverse Events MODERATE MODERATE Grade 2; 2 A type of adverse event that is usually alleviated with Moderate Adverse Event Production E2A Code additional specific therapeutic intervention. The event Organization Name: EMEA interferes with usual activities of daily living, causing Document Title: ICH Topic E2A Clinical Safety Data Management: Definitions and Standards for discomfort but poses no significant or permanent risk of harm Expedited Reporting to the research partici Document Version: CPMP/ICH/377/95 Date: November 1994 Chapter: B. Serious Adverse Event or Adverse Drug React C41340 C66769 Severity/Intensity Scale for Adverse Events SEVERE SEVERE Grade 3; 3 A type of adverse event that requires intensive therapeutic Severe Adverse Event Production E2A Code intervention. The event interrupts usual activities of daily living Organization Name: EMEA or significantly affects clinical status. The event possesses a Document Title: ICH Topic E2A Clinical Safety Data Management: Definitions and Standards for significant risk of harm to the research participant and hospi Expedited Reporting Document Version: CPMP/ICH/377/95 Date: November 1994 Chapter: B Serious Adverse Event or Adverse Drug Reac C66731 No Sex SEX SEX Sex The assemblage of physical properties or qualities by which CDISC SDTM Sex of Individual Production male is distinguished from female; the physical difference Terminology between male and female; the distinguishing peculiarity of male or female. (NCI) C16576 C66731 Sex F F Female A person who belongs to the sex that normally produces ova. Female Production Organization Name: CDISC The term is used to indicate biological sex distinctions, or Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials cultural gender role distinctions, or both. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter 5.1.1 Page: 36 Field Name: Controlled Terms or Format C20197 C66731 Sex M M Male A person who belongs to the sex that normally produces Male Production Organization Name: CDISC sperm. The term is used to indicate biological sex Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials distinctions, cultural gender role distinctions, or both. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter 5.1.1 Page: 36 Field Name: Controlled Terms or Format

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17998 C66731 Sex U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter 5.1.1 Page: 36 Field Name: Controlled Terms or Format C45908 C66731 Sex UN UN Undifferentiated A person (one of unisexual specimens) who is born with Intersex Production genitalia and/or secondary sexual characteristics of Value is consistent with HL7 (Health Level 7). C66732 No Sex of Participants SEXPOP SEXPOP Sex of Participants Theidt specific i tsex, either hihmale, female, bi for tmixed of fbth the subject CDISC SDTM Sex of Study Production group being studied. (NCI) Group Terminology C49636 C66732 Sex of Participants BOTH BOTH One and the other; relating to or being two in conjunction. Both Production Organization Name: CDISC (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter: 10 Page: 170 C16576 C66732 Sex of Participants F F Female A person who belongs to the sex that normally produces ova. Female Production Organization Name: CDISC The term is used to indicate biological sex distinctions, or Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials cultural gender role distinctions, or both. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 10 Page: 170 C20197 C66732 Sex of Participants M M Male A person who belongs to the sex that normally produces Male Production Organization Name: CDISC sperm. The term is used to indicate biological sex Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials distinctions, cultural gender role distinctions, or both. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter: 10 Page: 170 C66733 Yes Size SIZE SIZE Size The physical magnitude of something. (NCI) CDISC SDTM Size Terminology Production C49508 C66733 Size LARGE LARGE Of considerable or relatively great size, extent, or capacity. Large Production (NCI) C49507 C66733 Size MEDIUM MEDIUM Mid-way between small and large in number, quantity, Medium Production magnitude or extent. (NCI) C25376 C66733 Size SMALL SMALL Limited in number, quantity, magnitude or extent. (NCI) Small Production C66734 Yes Domain Abbreviation DOMAIN DOMAIN Domain Abbreviation A unique, 2-character domain code used in the regulatory CDISC SDTM Submission Production submission process. The domain abbreviation is used Domain Abbreviation consistently throughout the submission, i.e. in the dataset Terminology name, as the value of the domain variable within the dataset, and as a prefix for mos C49563 C66734 Domain Abbreviation AD AD Analysis Dataset Datasets used for statistical analysis and reporting by the Analysis Dataset Domain Production sponsor. These are submitted in addition to the data tabulation datasets.

C49562 C66734 Domain Abbreviation AE AE Adverse Events Adverse events may be captured either as free text or a pre- Adverse Event Domain Production Organization Name: CDISC specified list of terms. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49565 C66734 Domain Abbreviation AU AU Autopsy Additional data about deaths, specific to findings from Autopsy Domain Production Organization Name: CDISC autopsies. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49566 C66734 Domain Abbreviation BM BM Bone Mineral Density (BMD) Findings resulting from evaluations of bone mineral density. Bone Mineral Density Data Production Organization Name: CDISC Data Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49567 C66734 Domain Abbreviation BR BR Biopsy Findings resulting from biopsies. Biopsy Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49568 C66734 Domain Abbreviation CM CM Concomitant Meds Case report form (CRF) data that captures the Concomitant Concomitant Medication Domain Production Organization Name: CDISC and Prior Medications/Therapies used by the subject. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Examples are the Concomitant Medications/Therapies given Document Version: 3.1.1 on an as needed basis and the usual Background Date: 2005-08-26 Medications/Therapies given for a condit Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49569 C66734 Domain Abbreviation CO CO Comments The Comments dataset accommodates two sources of Comment Domain Production Organization Name: CDISC comments: 1) those collected alongside other data on topical Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials case report form (CRF) pages such as Adverse Events and 2) Document Version: 3.1.1 those collected on a separate page specifically dedicated to Date: 2005-08-26 comments. Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C49578 C66734 Domain Abbreviation DA DA Drug Accountability Data regarding the accountability of study drug, such as Drug Accountability Domain Production Organization Name: CDISC information on the receipt, dispensing, return, and packaging. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49570 C66734 Domain Abbreviation DC DC Disease Characteristics Data related to the characteristics of a specific disease state Disease Characteristics Domain Production Organization Name: CDISC under study for a subject. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49572 C66734 Domain Abbreviation DM DM Demographics The Demographics domain includes a set of essential Demographics Domain Production Organization Name: CDISC standard variables that describe each subject in a clinical Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials study. It is the parent domain for all other observations for Document Version: 3.1.1 human clinical subjects Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49576 C66734 Domain Abbreviation DS DS Disposition A subject domain utilized for the submission of information Disposition Domain Production Organization Name: CDISC encompassing and representing data, vocabulary or records Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials related to disposition. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49585 C66734 Domain Abbreviation DV DV Protocol Deviations The intent of the domain is to capture protocol violations and Protocol Deviations Domain Production Organization Name: CDISC deviations during the course of the study and will store only Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials those criteria violation by or deviated from by the subject and Document Version: 3.1.1 not a response to each violation or deviation. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49625 C66734 Domain Abbreviation EE EE Electroencephalogram Findings resulting from electroencephalogram (EEG) tests. Electroencephalogram Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49626 C66734 Domain Abbreviation EG EG Electrocardiogram Findings related to the collection of ECG data, including Electrocardiogram Domain Production Organization Name: CDISC position of the subject, method of evaluation, all cycle Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials measurements and all findings from the ECG including an Document Version: 3.1.1 overall interpretation if collected or derived. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49587 C66734 Domain Abbreviation EX EX Exposure The Exposure domain model records the details of a subject's Exposure Domain Production Organization Name: CDISC exposure to protocol-specified study treatment. Study Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials treatment may be any intervention that is prospectively defined Document Version: 3.1.1 as a test material within a study, and is typically but not Date: 2005-08-26 always supplied Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49588 C66734 Domain Abbreviation FH FH Family History A subject domain utilized for the submission of information Family History Domain Production encompassing and representing data, vocabulary or records related to family history. (NCI) C49589 C66734 Domain Abbreviation HU HU Healthcare Resource Healthcare resource utilization data such as subject visits to Healthcare Resource Utilization Production Organization Name: CDISC Utilization physicians, hospitalizations, and nursing home stays. Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C61536 C66734 Domain Abbreviation IE IE Inclusion/Exclusion The intent of the domain model is to only collect those criteria Inclusion Exclusion Domain Production Organization Name: CDISC that cause the subject to be in violation of the Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials inclusion/exclusion criteria not a response to each criterion. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49592 C66734 Domain Abbreviation LB LB Laboratory Data Laboratory test findings including, but is not limited to Laboratory Data Domain Production Organization Name: CDISC hematology, clinical chemistry and urinalysis data. This Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials domain does not include microbiology or pharmacokinetic Document Version: 3.1.1 data, which are stored in separate domains. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49602 C66734 Domain Abbreviation MB MB Microbiology Microbiology specimen findings, including gram stain results, Microbiology Specimen Domain Production Organization Name: CDISC and organisms found. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49603 C66734 Domain Abbreviation MH MH Medical History The medical history dataset includes the subject's prior history Medical History Domain Production Organization Name: CDISC at the start of the trial. Examples of subject medical history Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials information could include general medical history, Document Version: 3.1.1 gynecological history, and primary diagnosis. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C49604 C66734 Domain Abbreviation ML ML Meal Data Information regarding the subject's meal consumption, such Meal Data Domain Production Organization Name: CDISC as fluid intake, amounts, form (solid or liquid state), frequency, Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials etc., typically used for pharmacokinetic analysis. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C61531 C66734 Domain Abbreviation MS MS Microbiology Susceptibility This includes microbiology susceptibility test results, plus Microbiology Susceptibility Production Organization Name: CDISC results of any other organism-related tests. Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49605 C66734 Domain Abbreviation OM OM Organ Measurements Findings from organ measurement evaluations. Organ Measurement Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49606 C66734 Domain Abbreviation PC PC Pharmacokinetic Concentrations of drugs/metabolites in fluids or tissues as a Pharmacokinetic Concentration Production Organization Name: CDISC Concentration function of time. Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49608 C66734 Domain Abbreviation PE PE Physical Exam Findings collected during a physical examination of the Physical Exam Domain Production Organization Name: CDISC subject. It has findings that are discovered that are related to Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials body systems. Does not include vital signs measurements, Document Version: 3.1.1 which are stored in the vital signs domain. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C61529 C66734 Domain Abbreviation PG PG Pharmacogenomics Pharmacogenomics findings that initially focus on genotype Pharmacogenomics Domain Production Organization Name: CDISC and gene expression data. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49607 C66734 Domain Abbreviation PP PP Pharmacokinetic Parameters Pharmacokinetic parameters derived from pharmacokinetic Pharmacokinetic Parameters Production Organization Name: CDISC concentration-time (PC) data. Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49609 C66734 Domain Abbreviation QS QS Questionnaires Questionnaire data may include, but are not limited to the Questionnaire Domain Production Organization Name: CDISC following: subject reported outcomes, validated or non- Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials validated questionnaires, and validated or non-validated diarie Document Version: 3.1.1 (i.e. data with a common topicality). Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49610 C66734 Domain Abbreviation SC SC Subject Characteristics The subject characteristics domain is for data not collected in Subject Characteristics Domain Production Organization Name: CDISC other domains that is subject-related. Examples: subject Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials initials, other race details, eye color, childbearing status, etc. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49616 C66734 Domain Abbreviation SE SE Subject Element The subject element table describes the actual order of Subject Element Domain Production Organization Name: CDISC elements followed by the subject, together with the start Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials date/time and end date/time for each element. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49611 C66734 Domain Abbreviation SG SG Surgery Surgical information. Surgery Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49612 C66734 Domain Abbreviation SK SK Skin Test Findings from diagnostic skin tests. Skin Test Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49613 C66734 Domain Abbreviation SL SL Sleep Polysomnography Data Findings from diagnostic sleep tests (polysomnography). Sleep Polysomnography Domain Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C49614 C66734 Domain Abbreviation ST ST Stress (Exercise) Test Data Findings from exercise stress tests. Stress Exercise Test Data Production Organization Name: CDISC Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49615 C66734 Domain Abbreviation SU SU Substance Use The intent of the domain is to capture substance use Substance Use Domain Production Organization Name: CDISC information that may be used to assess the efficacy and/or Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials safety of therapies that look to mitigate the effects of chronic Document Version: 3.1.1 substance use. Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49617 C66734 Domain Abbreviation SV SV Subject Visits The subject visits table describes the actual start and end Subject Visits Domain Production Organization Name: CDISC data/time for each visit of each individual subject. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49618 C66734 Domain Abbreviation TA TA Trial Arms The trial arms table describes each planned arm in the trial. Trial Arms Domain Production Organization Name: CDISC An arm is described as an ordered sequence of elements. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49619 C66734 Domain Abbreviation TE TE TE; Trial Elements The trial elements table describes the element code that is Trial Elements Domain Production Organization Name: CDISC unique for each element, the element description, and the Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials rules for starting and ending an element. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49620 C66734 Domain Abbreviation TI TI Trial Inclusion/Exclusion The trial summary information domain is not subject oriented. Trial Inclusion and Exclusion Production Organization Name: CDISC Criteria It contains one record for each of the inclusion and exclusion Criteria Domain Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials criteria for the trial. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C53483 C66734 Domain Abbreviation TS TS Trial Summary The trial summary information domain is not subject oriented. Trial Summary Domain Production Organization Name: CDISC It contains one record for each trial summary characteristic. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49621 C66734 Domain Abbreviation TV TV Trial Visits The trial visits table describes the planned order and number Trial Visits Domain Production Organization Name: CDISC of visits in the study within each arm. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C49622 C66734 Domain Abbreviation VS VS Vital Signs Measurements including but not limited to blood pressure, Vital Signs Domain Production Organization Name: CDISC temperature, respiration, body surface area, BMI, height and Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials weight. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.1 Reserved Domain Codes Page: 165/166 Field Name: CODE & Domain C66735 Yes Trial Blinding Schema TBLIND TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type CDISC SDTM Trial Blinding Production of blinding for the trial. (NCI) Schema Terminology C15228 C66735 Trial Blinding Schema DOUBLE BLIND DOUBLE BLIND A study in which neither the subject nor the investigator nor Double Blind Study Production the research team interacting with the subject or data during the trial knows what treatment a subject is receiving. (CDISC glossary) C49659 C66735 Trial Blinding Schema OPEN LABEL OPEN LABEL A trial in which subjects and investigators know which product Open Label Study Production each subject is receiving; opposite of a blinded or double-blind study. (CDISC glossary) C28233 C66735 Trial Blinding Schema SINGLE BLIND SINGLE BLIND A study in which one party, either the investigator or the Single Blind Study Production subject, does not know which medication or placebo is administered to the subject; also called singlemasked study. (CDISC glossary) C66736 Yes Trial Indication Type TINDTP TINDTP Trial Indication Type The name of a code list that contains terms to define the type CDISC SDTM Trial Indication Production of trial, e.g. cure or prevention. (NCI) Type Terminology C49654 C66736 Trial Indication Type CURE CURE A type of study protocol designed to evaluate intervention(s) Cure Study Production aimed to cure a disease or condition. (NCI) C49653 C66736 Trial Indication Type DIAGNOSIS DIAGNOSIS A type of study protocol designed to evaluate intervention(s) Diagnosis Study Production aimed at identifying a disease or condition. (NCI) C49655 C66736 Trial Indication Type MITIGATION MITIGATION A type of study designed to identify actions necessary to Adverse Effect Mitigation Study Production eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI) C49657 C66736 Trial Indication Type PREVENTION PREVENTION A type of study designed to identify actions necessary to Prevention Study Production permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.

C49656 C66736 Trial Indication Type TREATMENT TREATMENT A type of study protocol designed to evaluate intervention(s) Treatment Study Production for treatment of disease, syndrome or condition. C66737 Yes Trial Phase TPHASE TPHASE Trial Phase Clinical trials are broken into three or four phases: Phase I CDISC SDTM Trial Phase Production tests a new drug or treatment for safety in a small group; Terminology Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure wheth

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C15600 C66737 Trial Phase Phase I Trial Phase I Trial Trial Phase 1; 1 The initial introduction of an investigational new drug into Phase I Trial Production humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacolo

C15693 C66737 Trial Phase Phase I/II Trial Phase I/II Trial Trial Phase 1-2; 1-2 A class of clinical study that combines elements characteristic Phase I/II Trial Production of traditional Phase I and Phase II trials. See also Phase I, Phase II. C15601 C66737 Trial Phase Phase II Trial Phase II Trial Trial Phase 2; 2 Phase 2. Controlled clinical studies conducted to evaluate the Phase II Trial Production effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associa C15694 C66737 Trial Phase Phase II/III Trial Phase II/III Trial Trial Phase 2-3; 2-3 A class of clinical study that combines elements characteristic Phase II/III Trial Production of traditional Phase II and Phase III trials. C49686 C66737 Trial Phase Phase IIa Trial Phase IIa Trial Trial Phase 2A; 2A A clinical research protocol generally refered to as a pilot or Phase IIa Trial Production feasibility trial that aims to prove the concept of the new intervention in question. (NCI) C49688 C66737 Trial Phase Phase IIb Trial Phase IIb Trial Trial Phase 2B; 2B A clinical research protocol generally refered to as a well- Phase IIb Trial Production controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size and w C15602 C66737 Trial Phase Phase III Trial Phase III Trial Trial Phase 3; 3 Phase 3. Studies are expanded controlled and uncontrolled Phase III Trial Production trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety th C49687 C66737 Trial Phase Phase IIIaTrial Phase IIIaTrial Trial Phase 3A; 3A A classification typically assigned retrospectively to a Phase II Phase IIIa Trial Production trial upon determination by regulatory authorities of a need for a Phase III B trial. C49689 C66737 Trial Phase Phase IIIb Trial Phase IIIb Trial Trial Phase 3B; 3B A subcategory of Phase III trials done near the time of Phase IIIb Trial Production approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approva C15603 C66737 Trial Phase Phase IV Trial Phase IV Trial Trial Phase 4; 4 Phase 4. Postmarketing (Phase 4) studies to delineate Phase IV Trial Production additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but w C47865 C66737 Trial Phase Phase V Trial Phase V Trial Trial Phase 5; 5 Postmarketing surveillance is sometimes referred to as Phase Phase V Trial Production V. C48660 C66737 Trial Phase NA NOT APPLICABLE NA Determination of a value is not relevant in the current context. Not Applicable Production (NCI) C66738 Yes Trial Summary Parameter Test Code TSPARMCD TSPARMCD Trial Summary Parameter Individual characteristics of a clinical trial, e.g. description of CDISC SDTM Trial Summary Production Test Code trial design, trial blinding schema, and primary objective of Parameter Terminology by Code trial. (NCI) C49703 C66738 Trial Summary Parameter Test Code ADDON ADDON Added on to Existing The addition of a therapeutic product to the existing regimen inTest Product Added to Existing Production Treatments a clinical trial, where both entities remain as discrete products.Treatment

C49700 C66738 Trial Summary Parameter Test Code AEDICT AEDICT Adverse Event Dictionary A reference source that provides meanings of words related to Adverse Event Dictionary Production adverse events. (NCI) C49694 C66738 Trial Summary Parameter Test Code AGEMAX AGEMAX Planned Maximum Age of The anticipated maximum age of the subjects to be entered in Planned Maximum Age of Production Subjects a clinical trial. (NCI) Subjects C49693 C66738 Trial Summary Parameter Test Code AGEMIN AGEMIN Planned Minimum Age of The anticipated minimum age of the subjects to be entered in Planned Minimum Age of Production Subjects a clinical trial. (NCI) Subjects C20587 C66738 Trial Summary Parameter Test Code AGESPAN AGESPAN Age Span Subgroups of populations based on age. (NCI) Age Group Production

C50400 C66738 Trial Summary Parameter Test Code AGEU AGEU Age Unit Those units of time that are routinely used to express the age Age Unit Production of a person. (NCI) C25488 C66738 Trial Summary Parameter Test Code DOSE DOSE Dose per Administration The amount of drug administered to a patient or test subject atDose Production one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) C49701 C66738 Trial Summary Parameter Test Code DRUGDICT DRUGDICT Drug Dictionary A reference source that provides meanings of words related to Drug Dictionary Production drugs. (NCI) C49697 C66738 Trial Summary Parameter Test Code LENGTH LENGTH Trial Length The anticipated length of a clinical trial measured as a unit of Trial Length Production time. (NCI) C49702 C66738 Trial Summary Parameter Test Code MHDICT MHDICT Medical History Dictionary A reference source that provides meanings of words related to Medical History Dictionary Production medical history. (NCI) C49692 C66738 Trial Summary Parameter Test Code PLANSUB PLANSUB Planned Number of Subjects The number of subjects entered in a clinical trial. (NCI) Planned Subject Number Production

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C25196 C66738 Trial Summary Parameter Test Code RANDOM RANDOM Trial is Randomized The process of assigning trial subjects to treatment or control Randomization Production groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for exampl C38114 C66738 Trial Summary Parameter Test Code ROUTE ROUTE Route of Administration The course by which a substance was administered in order Route of Administration Production to reach the site of action in the body. C49696 C66738 Trial Summary Parameter Test Code SEXPOP SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject Sex of Study Group Production group being studied. (NCI) C49698 C66738 Trial Summary Parameter Test Code STOPRULE STOPRULE Study Stop Rules The rule, regulation and/or condition that determines the point Study Stop Rules Production in time when a clinical trial will be terminated. (NCI) C49658 C66738 Trial Summary Parameter Test Code TBLIND TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type Trial Blinding Schema Production of blinding for the trial. (NCI) C49647 C66738 Trial Summary Parameter Test Code TCNTRL TCNTRL Control Type Comparator against which the study treatment is evaluated Control Type Production (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). C49650 C66738 Trial Summary Parameter Test Code TDIGRP TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure oDiagnosis Group Production disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a C49652 C66738 Trial Summary Parameter Test Code TINDTP TINDTP Trial Indication Type The name of a code list that contains terms to define the type Trial Indication Type Production of trial, e.g. cure or prevention. (NCI) C49802 C66738 Trial Summary Parameter Test Code TITLE TITLE Trial Title The name of a clinical trial. (NCI) Trial Title Production C48281 C66738 Trial Summary Parameter Test Code TPHASE TPHASE Trial Phase Classification Clinical trials are broken into three or four phases: Phase I Trial Phase Production tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure wheth C49660 C66738 Trial Summary Parameter Test Code TTYPE TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Trial Type Production

C67152 Yes Trial Summary Parameter Test Name TSPARM TSPARM Trial Summary Parameter Individual characteristics of a clinical trial, e.g. description of CDISC SDTM Trial Summary Production Test Name trial design, trial blinding schema, and primary objective of Parameter Terminology by Name trial. (NCI) C49703 C67152 Trial Summary Parameter Test Name Added on to Existing Treatments ADDON Added on to Existing The addition of a therapeutic product to the existing regimen inTest Product Added to Existing Production Treatments a clinical trial, where both entities remain as discrete products.Treatment

C49700 C67152 Trial Summary Parameter Test Name Adverse Event Dictionary AEDICT Adverse Event Dictionary A reference source that provides meanings of words related to Adverse Event Dictionary Production adverse events. (NCI) C49694 C67152 Trial Summary Parameter Test Name Planned Maximum Age of Subjects AGEMAX Planned Maximum Age of The anticipated maximum age of the subjects to be entered in Planned Maximum Age of Production Subjects a clinical trial. (NCI) Subjects C49693 C67152 Trial Summary Parameter Test Name Planned Minimum Age of Subjects AGEMIN Planned Minimum Age of The anticipated minimum age of the subjects to be entered in Planned Minimum Age of Production Subjects a clinical trial. (NCI) Subjects C20587 C67152 Trial Summary Parameter Test Name Age Group AGESPAN Age Group Subgroups of populations based on age. (NCI) Age Group Production C50400 C67152 Trial Summary Parameter Test Name Age Unit AGEU Age Unit Those units of time that are routinely used to express the age Age Unit Production of a person. (NCI) C25488 C67152 Trial Summary Parameter Test Name Dose per Administration DOSE Dose per Administration The amount of drug administered to a patient or test subject atDose Production one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) C49701 C67152 Trial Summary Parameter Test Name Drug Dictionary DRUGDICT Drug Dictionary A reference source that provides meanings of words related to Drug Dictionary Production drugs. (NCI) C49697 C67152 Trial Summary Parameter Test Name Trial Length LENGTH Trial Length The anticipated length of a clinical trial measured as a unit of Trial Length Production time. (NCI) C49702 C67152 Trial Summary Parameter Test Name Medical History Dictionary MHDICT Medical History Dictionary A reference source that provides meanings of words related to Medical History Dictionary Production medical history. (NCI)

C49692 C67152 Trial Summary Parameter Test Name Planned Number of Subjects PLANSUB Planned Number of Subjects The number of subjects entered in a clinical trial. (NCI) Planned Subject Number Production

C25196 C67152 Trial Summary Parameter Test Name Trial is Randomized RANDOM Trial is Randomized The process of assigning trial subjects to treatment or control Randomization Production groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for examp C38114 C67152 Trial Summary Parameter Test Name Route of Administration ROUTE Route of Administration The course by which a substance was administered in order Route of Administration Production to reach the site of action in the body.

C49696 C67152 Trial Summary Parameter Test Name Sex of Participants SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject Sex of Study Group Production group being studied. (NCI) C49698 C67152 Trial Summary Parameter Test Name Study Stop Rules STOPRULE Study Stop Rules The rule, regulation and/or condition that determines the point Study Stop Rules Production in time when a clinical trial will be terminated. (NCI) C49658 C67152 Trial Summary Parameter Test Name Trial Blinding Schema TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type Trial Blinding Schema Production of blinding for the trial. (NCI)

C49647 C67152 Trial Summary Parameter Test Name Control Type TCNTRL Control Type Comparator against which the study treatment is evaluated Control Type Production (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). C49650 C67152 Trial Summary Parameter Test Name Diagnosis Group TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure oDiagnosis Group Production disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the C49652 C67152 Trial Summary Parameter Test Name Trial Indication Type TINDTP Trial Indication Type The nameihi of a code hih list that contains terms to define the type Trial Indication Type Production of trial, e.g. cure or prevention. (NCI)

C49802 C67152 Trial Summary Parameter Test Name Trial Title TITLE Trial Title The name of a clinical trial. (NCI) Trial Title Production

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C48281 C67152 Trial Summary Parameter Test Name Trial Phase Classification TPHASE Trial Phase Classification Clinical trials are broken into three or four phases: Phase I Trial Phase Production tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure wheth

C49660 C67152 Trial Summary Parameter Test Name Trial Type TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Trial Type Production

C66739 Yes Trial Type TTYPE TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) CDISC SDTM Trial Type Production Terminology C49664 C66739 Trial Type BIO-AVAILABILITY BIO-AVAILABILITY A study of the degree to which or rate at which a drug or other Bioavailability Study Production substance is absorbed or becomes available at the site of physiological activity after administration. (NCI)

C49665 C66739 Trial Type BIO-EQUIVALENCE BIO-EQUIVALENCE A study most often used to compare the efficacy of different Therapeutic Equivalency Study Production formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI)

C49666 C66739 Trial Type EFFICACY EFFICACY A study of the relative therapeutic efficacy of treatment of a Efficacy Study Production disease. Usually this is a Phase II or III study. (NCI)

C49662 C66739 Trial Type PHARMACODYNAMIC PHARMACODYNAMIC A study of the biochemical and physiological effect of a drug Pharmacodynamic Study Production and the mechanism of drug action and the relationship between drug concentration and effect. (NCI)

C39493 C66739 Trial Type PHARMACOECONOMIC PHARMACOECONOMIC A study that assesses the value associated with a given drug Pharmacoeconomic Study Production in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indi C49661 C66739 Trial Type PHARMACOGENOMIC PHARMACOGENOMIC A study of identification and analysis of genomic variations Pharmacogenomic Study Production that affect the efficacy of a drug. Pharmacogenomic studies can potentially be predictive of an individual's drug-response or adverse reactions or susceptibility to iatrogenic disorders, and may C49663 C66739 Trial Type PHARMACOKINETIC PHARMACOKINETIC A study of the process by which a drug is absorbed, Pharmacokinetic Study Production distributed, metabolized, and eliminated by the body. (NCI) C49667 C66739 Trial Type SAFETY SAFETY A study of the relative safety of treatment of a disease. UsuallySafety Study Production this is a Phase I or II trial. (NCI) C66770 Yes Units for Vital Signs Results VSRESU VSRESU Units for Vital Signs Results The unit used to record and describe the result of a test CDISC SDTM Unit for Vital Sign Production investigating a vital sign. (NCI) Result Terminology

C25613 C66770 Units for Vital Signs Results % % Percentage A fraction or ratio with 100 understood as the denominator. Percentage Production (NCI) C49673 C66770 Units for Vital Signs Results BEATS/MIN BEATS/MIN Beats per Minute The number of heartbeats measured per minute time. (NCI) Beats per Minute Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005

C49674 C66770 Units for Vital Signs Results BREATHS/MIN BREATHS/MIN Breaths per Minute The number of breaths (inhalation and exhalation) taken per Breaths per Minute Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005 minute time. (NCI)

C42559 C66770 Units for Vital Signs Results C C Degree Celsius A unit of temperature of the temperature scale designed so Degree Celsius Production that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple C49668 C66770 Units for Vital Signs Results cm cm Centimeter A basic unit of length in the former CGS version of metric Centimeter Production system, equal to one hundredth of a meter or approximately 0.393 700 787 inch. (NCI) C44277 C66770 Units for Vital Signs Results F F Degree Fahrenheit The Fahrenheit temperature scale is named after the German Degree Fahrenheit Production physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling an

C48155 C66770 Units for Vital Signs Results g g Gram A metric unit of mass equal to one one thousandth of a Gram Production kilogram. (NCI) C48500 C66770 Units for Vital Signs Results IN IN Inch A traditional unit of length equal to 2.54 centimeters. (NCI) Inch Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005

C28252 C66770 Units for Vital Signs Results kg kg Kilogram The basic SI unit of mass. It is defined as the mass of an Kilogram Production international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in terms of a material object, and also the only one with a pr C49671 C66770 Units for Vital Signs Results kg/m2 kg/m2 Kilogram Per Square Meter The SI derived unit of spread rate of a substance by mass, Kilogram Per Square Meter Production used also as a measure of area density. (NCI) C48531 C66770 Units for Vital Signs Results LB LB Pound A traditional unit of mass. By international agreement, one Pound Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005 avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42569 C66770 Units for Vital Signs Results m2 m2 Square Meter The SI unit of area measurement equal to a square whose Square Meter Production sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 ares; 1.196 square yards; 10.76 square feet; 1550 square inches. (NCI) C49670 C66770 Units for Vital Signs Results mmHg mmHg Millimeter of Mercury A unit of pressure equal to 0.001316 atmosphere and equal to Millimeter of Mercury Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005 the pressure indicated by one millimeter rise of mercury in a barometer at the Earth's surface. (NCI) C42554 C66770 Units for Vital Signs Results ohm ohm ohm A unit of electrical resistance equal to the resistance between Ohm Production ICH M5 EWG Units and Measurements Controlled Vocabulary, 10 May 2005 two points on a conductor when a potential difference of one volt between them produces a current of one ampere. Ohm is also used to measure impedance and reactance for complex resistance. A C66741 Yes Vital Signs Test Code VSTESTCD VSTESTCD Vital Signs Test Code The name given to the test that analyzes a particular set of CDISC SDTM Vital Sign Production vital signs including temperature, respiratory rate, heart beat Terminology by Code (pulse), and blood pressure. (NCI) C16358 C66741 Vital Signs Test Code BMI BMI Body Mass Index A general indicator of the body fat an individual is carrying Body Mass Index Production Organization Name: CDISC based upon the ratio of weight to height. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C12472 C66741 Vital Signs Test Code BODYFAT BODYFAT Adipose Tissue A specialized form of connective tissue consisting primarily of Adipose Tissue Production Organization Name: CDISC adipocytes (fat cells), surrounded by a meshwork of collagen Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials fibers. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25157 C66741 Vital Signs Test Code BSA BSA Body Surface Area A measure of the 2-dimensional extent of the body surface Body Surface Area Production Organization Name: CDISC (i.e., the skin). Body surface area (BSA) can be calculated by Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials mathematical formula or from a chart that relates height to Document Version: 3.1.1 weight. BSA is often an important factor in dosing. (NCI) Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25299 C66741 Vital Signs Test Code DIABP DIABP Diastolic Blood Pressure The blood pressure after the contraction of the heart while the Diastolic Blood Pressure Production Organization Name: CDISC chambers of the heart refill with blood. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49680 C66741 Vital Signs Test Code FRMSIZE FRMSIZE Body Frame Size The categorization of a person's body frame into small, Body Frame Size Production Organization Name: CDISC medium and large based on the measurement of wrist Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials circumference or the breadth of the elbow. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25347 C66741 Vital Signs Test Code HEIGHT HEIGHT Height The vertical measurement or distance from the base to the topHeight Production Organization Name: CDISC of an object; the vertical dimension of extension. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49677 C66741 Vital Signs Test Code HR HR Heart Rate The number of heartbeats per unit of time, usually expressed Heart Rate Production Organization Name: CDISC as beats per minute. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49679 C66741 Vital Signs Test Code MAP MAP Mean Arterial Pressure The mean pressure of the blood within the arterial circulation. Mean Arterial Pressure Production Organization Name: CDISC The arterial pressure may be directly measured by insertion of Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials an intra-arterial catheter connected to a transducer. The mean Document Version: 3.1.1 arterial pressure (MAP) can be calculated by subsequent Date: 2005-08-26 analysis Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49676 C66741 Vital Signs Test Code PULSE PULSE Pulse Rate The rate of the pulse as observed in an artery, expressed as Pulse Rate Production Organization Name: CDISC beats per minute. It can be measured at several anatomical Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials sites, including the wrist, neck, temple, groin, behind the Document Version: 3.1.1 knees, or on top of the foot. (NCI) Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49678 C66741 Vital Signs Test Code RESP RESP Respiratory Rate The rate of breathing (inhalation and exhalation) measured Respiratory Rate Production Organization Name: CDISC within in a unit time, usually expressed as breaths per minute. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25298 C66741 Vital Signs Test Code SYSBP SYSBP Systolic Blood The blood pressure during the contraction of the left ventricle Systolic Blood Pressure Production Organization Name: CDISC of the heart. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name:

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C25206 C66741 Vital Signs Test Code TEMP TEMP Temperature The property of a body or region of space that determines Temperature Production Organization Name: CDISC whether or not there will be a net flow of heat into it or out of it Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials from a neighboring body or region and in which direction (if Document Version: 3.1.1 any) the heat will flow, perceptible by living organism as a Date: 2005-08-26 somati Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25208 C66741 Vital Signs Test Code WEIGHT WEIGHT Weight The vertical force exerted by a mass as a result of gravity. Weight Production Organization Name: CDISC (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C67153 Yes Vital Signs Test Name VSTEST VSTEST Vital Signs Test Name The name given to the test that analyzes a particular set of CDISC SDTM Vital Sign Production vital signs including temperature, respiratory rate, heart beat Terminology by Name (pulse), and blood pressure. (NCI) C16358 C67153 Vital Signs Test Name Body Mass Index BMI Body Mass Index A general indicator of the body fat an individual is carrying Body Mass Index Production Organization Name: CDISC based upon the ratio of weight to height. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C12472 C67153 Vital Signs Test Name Adipose Tissue BODYFAT Adipose Tissue A specialized form of connective tissue consisting primarily of Adipose Tissue Production Organization Name: CDISC adipocytes (fat cells), surrounded by a meshwork of collagen Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials fibers. Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25157 C67153 Vital Signs Test Name Body Surface Area BSA Body Surface Area A measure of the 2-dimensional extent of the body surface Body Surface Area Production Organization Name: CDISC (i.e., the skin). Body surface area (BSA) can be calculated by Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials mathematical formula or from a chart that relates height to Document Version: 3.1.1 weight. BSA is often an important factor in dosing. (NCI) Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25299 C67153 Vital Signs Test Name Diastolic Blood Pressure DIABP Diastolic Blood Pressure The blood pressure after the contraction of the heart while the Diastolic Blood Pressure Production Organization Name: CDISC chambers of the heart refill with blood. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49680 C67153 Vital Signs Test Name Body Frame Size FRMSIZE Body Frame Size The categorization of a person's body frame into small, Body Frame Size Production Organization Name: CDISC medium and large based on the measurement of wrist Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials circumference or the breadth of the elbow. (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name:

C25347 C67153 Vital Signs Test Name Height HEIGHT Height The vertical measurement or distance from the base to the topHeight Production Organization Name: CDISC of an object; the vertical dimension of extension. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 C49677 C67153 Vital Signs Test Name Heart Rate HR Heart Rate The number of heartbeats per unit of time, usually expressed Heart Rate Production Organization Name: CDISC as beats per minute. (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49679 C67153 Vital Signs Test Name Mean Arterial Pressure MAP Mean Arterial Pressure The mean pressure of the blood within the arterial circulation. Mean Arterial Pressure Production Organization Name: CDISC The arterial pressure may be directly measured by insertion of Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials an intra-arterial catheter connected to a transducer. The mean Document Version: 3.1.1 arterial pressure (MAP) can be calculated by subsequent Date: 2005-08-26 analysis Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49676 C67153 Vital Signs Test Name Pulse Rate PULSE Pulse Rate The rate of the pulse as observed in an artery, expressed as Pulse Rate Production Organization Name: CDISC beats per minute. It can be measured at several anatomical Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials sites, including the wrist, neck, temple, groin, behind the Document Version: 3.1.1 knees, or on top of the foot. (NCI) Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C49678 C67153 Vital Signs Test Name Respiratory Rate RESP Respiratory Rate The rate of breathing (inhalation and exhalation) measured Respiratory Rate Production Organization Name: CDISC within in a unit time, usually expressed as breaths per minute. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials (NCI) Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25298 C67153 Vital Signs Test Name Systolic Blood Pressure SYSBP Systolic Blood Pressure The blood pressure during the contraction of the left ventricle Systolic Blood Pressure Production Organization Name: CDISC of the heart. Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name:

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C25206 C67153 Vital Signs Test Name Temperature TEMP Temperature The property of a body or region of space that determines Temperature Production Organization Name: CDISC whether or not there will be a net flow of heat into it or out of it Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials from a neighboring body or region and in which direction (if Document Version: 3.1.1 any) the heat will flow, perceptible by living organism as a Date: 2005-08-26 somati Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C25208 C67153 Vital Signs Test Name Weight WEIGHT Weight The vertical force exerted by a mass as a result of gravity. Weight Production Organization Name: CDISC (NCI) Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:10.3.3 Vital Signs Test Codes Page: 167 Field Name: C66742 No No Yes Response NY NY No Yes Response A term that is used to indicate a question with permissible CDISC SDTM Yes No Unknown Production values of yes/no/unknown/not applicable. or Not Applicable Response Terminology

C49487 C66742 No Yes Response N N No The non-affirmative response to a question. (NCI) No Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.3 Coding and Controlled Terminology Assumptions / 4.1.3.7 Page: 25 C48660 C66742 No Yes Response NA NOT APPLICABLE NA Determination of a value is not relevant in the current context. Not Applicable Production (NCI) C17998 C66742 No Yes Response U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.3 Coding and Controlled Terminology Assumptions / 4.1.3.7 Page: 25

C49488 C66742 No Yes Response Y Y Yes The affirmative response to a question. (NCI) Yes Production Organization Name: CDISC Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Document Version: 3.1.1 Date: 2005-08-26 Chapter:4.1.3 Coding and Controlled Terminology Assumptions / 4.1.3.7 Page: 25 C65047 Yes Laboratory Test Code LBTESTCD LBTESTCD Laboratory Test Code Terminology used for Laboratory Tests of the CDISC StandardCDISC SDTM Laboratory Test Production Data Tabulation Model. Terminology by Code

C35266 C65047 Laboratory Test Code ANISO ANISO Anisocytosis A measurement of the inequality in the size of the red blood Anisocytosis Production cells in a whole blood specimen. C35267 C65047 Laboratory Test Code POIKILO POIKILO Poikilocytes A measurement of the odd-shaped erythrocytes in a whole Poikilocytosis Production blood specimen. C38037 C65047 Laboratory Test Code BILI BILI Bilirubin A measurement of the total bilirubin in a biological specimen. Total Bilirubin Production

C38462 C65047 Laboratory Test Code APTT APTT Activated Partial A measurement of the length of time that it takes for clotting toPartial Thromboplastin Time Production Thromboplastin Time occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. C41376 C65047 Laboratory Test Code GLUC GLUC Glucose A measurement of the glucose in a biological specimen. Plasma Glucose Measurement Production C45997 C65047 Laboratory Test Code PH PH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 pH Production to 14. C51946 C65047 Laboratory Test Code RBC RBC Erythrocytes A count of the total erythrocytes per unit of a biological Erythrocyte Count Production specimen. C51947 C65047 Laboratory Test Code RETI RETI Reticulocytes A count of the reticulocytes per unit of a biological specimen. Reticulocyte Count Production C51948 C65047 Laboratory Test Code WBC WBC Leukocytes A count of the leukocytes per unit of a biological specimen. Leukocyte Count Production C51949 C65047 Laboratory Test Code LYM LYM Lymphocytes A count of the lymphocytes per unit of a biological specimen. Lymphocyte Count Production C51951 C65047 Laboratory Test Code PLAT PLAT Platelet A count of the platelets per unit of a biological specimen. Platelet Count Production C61019 C65047 Laboratory Test Code BUN BUN Blood Urea Nitrogen A measurement of the urea nitrogen in a blood specimen. Blood Urea Nitrogen Production Measurement C61032 C65047 Laboratory Test Code CHOL CHOL Cholesterol A measurement of the cholesterol in a biological specimen. Serum Total Cholesterol Production Measurement C61041 C65047 Laboratory Test Code HDL HDL HDL Cholesterol A measurement of the high density lipoprotein cholesterol in a Serum HDL Cholesterol Production biological specimen. Measurement C61042 C65047 Laboratory Test Code LDL LDL LDL Cholesterol A measurement of the low density lipoprotein cholesterol in a Serum LDL Cholesterol Production biological specimen. Measurement C62656 C65047 Laboratory Test Code PT PT Prothrombin Time A blood clotting measurement that evaluates the extrinsic Prothrombin Time Production pathway of coagulation and is expressed in units of time or percent activity. C63321 C65047 Laboratory Test Code NEUT NEUT Neutrophils A count of the neutrophils per unit of a biological specimen. Absolute Neutrophil Count Production C64431 C65047 Laboratory Test Code ALB ALB Albumin A measurement of the albumin protein in a biological Albumin Measurement Production specimen. C64432 C65047 Laboratory Test Code ALP ALP Alkaline Phosphatase A measurement of the alkaline phosphatase in a biological Alkaline Phosphatase Production specimen. Measurement C64433 C65047 Laboratory Test Code ALT ALT Alanine Aminotransferase A measurement of the alanine aminotransferase in a biologicalAlanine Aminotransferase Production specimen. Measurement C64434 C65047 Laboratory Test Code AMYLASE AMYLASE Amylase A measurement of the pancreatic enzyme amylase in a Amylase Measurement Production biological specimen. C64467 C65047 Laboratory Test Code AST AST Aspartate Aminotransferase A measurement of the aspartate aminotransferase in a Aspartate Aminotransferase Production biological specimen. Measurement C64469 C65047 Laboratory Test Code BACT BACT Bacteria A measurement of the bacteria in a biological specimen. Bacterial Count Production C64470 C65047 Laboratory Test Code BASO BASO Basophils A count of the basophils per unit of a biological specimen. Total Basophil Count Production C64471 C65047 Laboratory Test Code BASOLE BASOLE Basophils/Leukocytes A relative measure (ratio or percentage) of the basophils to Basophil To Leukocyte Ratio Production leukocytes in a biological specimen. C64481 C65047 Laboratory Test Code BILDIR BILDIR Direct Bilirubin A measurement of the conjugated or water-soluble bilirubin in Direct Bilirubin Measurement Production a biological specimen. C64483 C65047 Laboratory Test Code BILIND BILIND Indirect Bilirubin A measurement of the unconjugated or non-water-soluble Indirect Bilirubin Measurement Production bilirubin in a biological specimen.

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64487 C65047 Laboratory Test Code BLASTLE BLASTLE Blasts/Leukocytes A relative measure (ratio or percentage) of the blasts to Blast To Leukocyte Ratio Production leukocytes in a biological specimen. C64488 C65047 Laboratory Test Code CA CA Calcium A measurement of the calcium in a biological specimen. Calcium Measurement Production C64489 C65047 Laboratory Test Code CK CK Creatine Kinase A measurement of the total creatine kinase in a biological Creatine Kinase Measurement Production specimen. C64490 C65047 Laboratory Test Code CKBB CKBB Creatine Kinase BB A measurement of the homozygous B-type creatine kinase in Creatine Kinase BB Production a biological specimen. Measurement C64491 C65047 Laboratory Test Code CKMB CKMB Creatine Kinase MB A measurement of the heterozygous MB-type creatine kinase Creatine Kinase MB Production in a biological specimen. Measurement C64494 C65047 Laboratory Test Code CKMM CKMM Creatine Kinase MM A measurement of the homozygous M-type creatine kinase in Creatine Kinase MM Production a biological specimen. Measurement C64495 C65047 Laboratory Test Code CL CL Chloride A measurement of the chloride in a biological specimen. Chloride Measurement Production C64545 C65047 Laboratory Test Code CO2 CO2 Carbon Dioxide A measurement of the carbon dioxide gas in a biological Carbon Dioxide Measurement Production specimen. C64546 C65047 Laboratory Test Code COLOR COLOR Color A measurement of the color of a biological specimen. Color Assessment Production C64547 C65047 Laboratory Test Code CREAT CREAT Creatinine A measurement of the creatinine in a biological specimen. Creatinine Measurement Production C64548 C65047 Laboratory Test Code CRP CRP C Reactive Protein A measurement of the C reactive protein in a biological C-Reactive Protein Measurement Production specimen. C64549 C65047 Laboratory Test Code ELLIPCY ELLIPCY Elliptocytes A count of the elliptocytes per unit of a biological specimen. Elliptocyte Count Production C64550 C65047 Laboratory Test Code EOS EOS Eosinophils A count of the eosinophils per unit of a biological specimen. Eosinophil Count Production C64604 C65047 Laboratory Test Code EOSLE EOSLE Eosinophils/Leukocytes A relative measure (ratio or percentage) of the eosinophils to Eosinophil To Leukocyte Ratio Production leukocytes in a biological specimen. C64605 C65047 Laboratory Test Code EPIC EPIC Epithelial Cells A measurement of the epithelial cells in a biological specimen.Epithelial Cell Count Production

C64606 C65047 Laboratory Test Code FIBRINO FIBRINO Fibrinogen A measurement of the fibrinogen in a biological specimen. Fibrinogen Measurement Production C64796 C65047 Laboratory Test Code HCT HCT Hematocrit The percentage of a whole blood specimen that is composed Hematocrit Production of red blood cells (erythrocytes). C64797 C65047 Laboratory Test Code MCH MCH Ery. Mean Corpuscular A quantitative measurement of the mean amount of Erythrocyte Mean Corpuscular Production Hemoglobin hemoglobin per erythrocyte in a biological specimen. Hemoglobin C64798 C65047 Laboratory Test Code MCHC MCHC Ery. Mean Corpuscular HB A quantitative measurement of the mean amount of Erythrocyte Mean Corpuscular Production Concentration hemoglobin per erythrocytes in a specified volume of a Hemoglobin Concentration biological specimen. C64799 C65047 Laboratory Test Code MCV MCV Ery. Mean Corpuscular A quantitative measurement of the mean volume of Erythrocyte Mean Corpuscular Production Volume erythrocytes in a biological specimen. Volume C64800 C65047 Laboratory Test Code RDW RDW Erythrocytes Distribution A value derived from mean corpuscular volume and the Erythrocyte Distribution Width Production Width standard deviation of the red blood cell volume in a whole Measurement blood specimen. C64801 C65047 Laboratory Test Code TEARDCY TEARDCY Dacryocytes A count of dacryocytes in unit of a biological specimen. Dacryocyte Analysis Production C64802 C65047 Laboratory Test Code HYPO HYPO Hypochromia An observation which indicates that the hemoglobin Hypochromia Production concentration in a red blood cell specimen has fallen below a specified level. C64803 C65047 Laboratory Test Code POLYCHR POLYCHR Polychromasia A measurement of the blue-staining characteristic of newly Polychromasia Production generated erythrocytes. C64805 C65047 Laboratory Test Code INR INR Prothrombin Intl. Normalized A ratio that represents the prothrombin time for a plasma International Normalized Ratio of Production Ratio specimen, divided by the result for a control plasma Prothrombin Time specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test.

C64806 C65047 Laboratory Test Code VLDL VLDL VLDL Cholesterol A measurement of the very low density lipoprotein cholesterol Serum VLDL Cholesterol Production in a biological specimen. Measurement C64807 C65047 Laboratory Test Code LIPASE LIPASE Triacylglycerol Lipase A measurement of the pancreatic lipase in a biological Triacylglycerol Lipase Production specimen. Measurement C64809 C65047 Laboratory Test Code SODIUM SODIUM Sodium A measurement of the sodium in a biological specimen. Sodium Measurement Production C64810 C65047 Laboratory Test Code NITRITE NITRITE Nitrite A measurement of the nitrite in a urine specimen. Nitrite Measurement Production C64812 C65047 Laboratory Test Code TRIG TRIG Triglycerides A measurement of the triglycerides in a biological specimen. Triglyceride Measurement Production C64813 C65047 Laboratory Test Code TSH TSH Thyrotropin A measurement of the thyrotropin in a biological specimen. Thyrotropin Measurement Production C64814 C65047 Laboratory Test Code URATE URATE Urate A measurement of the urate in a biological specimen. Urate Measurement Production C64815 C65047 Laboratory Test Code UREA UREA Urea A measurement of the urea in a biological specimen. Urea Measurement Production C64816 C65047 Laboratory Test Code UROBIL UROBIL Urobilinogen A measurement of the urobilinogen in a biological specimen. Urobilinogen Measurement Production C64817 C65047 Laboratory Test Code VITB12 VITB12 Vitamin B12 A measurement of the Vitamin B12 in a serum specimen. Vitamin B12 Measurement Production C64818 C65047 Laboratory Test Code LYMAT LYMAT Lymphocytes Atypical A count of the atypical lymphocytes per unit of a biological Atypical Lymphocyte Count Production specimen. C64819 C65047 Laboratory Test Code LYMATLE LYMATLE Lymphocytes A relative measure (ratio or percentage) of the atypical Atypical Lymphocyte To Production Atypical/Leukocytes lymphocytes to leukocytes in a biological specimen. Leukocyte Ratio C64820 C65047 Laboratory Test Code LYMLE LYMLE Lymphocytes/Leukocytes A relative measure (ratio or percentage) of the lymphocytes to Lymphocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64821 C65047 Laboratory Test Code MACROCY MACROCY Macrocytes A count of the macrocytes per unit of a biological specimen. Macrocyte Count Production C64822 C65047 Laboratory Test Code MICROCY MICROCY Microcytes A count of the microcytes per unit of a biological specimen. Microcyte Count Production C64823 C65047 Laboratory Test Code MONO MONO Monocytes A count of the monocytes per unit of a biological specimen. Monocyte Count Production C64824 C65047 Laboratory Test Code MONOLE MONOLE Monocytes/Leukocytes A relative measure (ratio or percentage) of the monocytes to Monocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64825 C65047 Laboratory Test Code MYBLALE MYBLALE Myeloblasts/Leukocytes A relative measure (ratio or percentage) of the myeloblasts to Myeloblast To Leukocyte Ratio Production leukocytes in a biological specimen. C64826 C65047 Laboratory Test Code MYCYLE MYCYLE Myelocytes/Leukocytes A relative measure (ratio or percentage) of the myelocytes to Myelocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64827 C65047 Laboratory Test Code NEUTLE NEUTLE Neutrophils/Leukocytes The determination of the ratio of neutrophils compared to Neutrophil To Leukocyte Ratio Production leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. C64828 C65047 Laboratory Test Code RETIRBC RETIRBC Reticulocytes/Erythrocytes A relative measure (ratio or percentage) of reticulocytes to Reticulocyte To Erythrocyte RatioProduction erythrocytes in a biological specimen. C64829 C65047 Laboratory Test Code PRLYMLE PRLYMLE Prolymphocytes/Leukocytes A relative measure (ratio or percentage) of prolymphocytes to Prolymphocyte To Leukocyte Production leukocytes in a biological specimen. Ratio C64830 C65047 Laboratory Test Code NEUTB NEUTB Neutrophils Band Form A count of the banded neutrophils per unit of a biological Neutrophil Band Form Count Production specimen. C64831 C65047 Laboratory Test Code NEUTBLE NEUTBLE Neutrophils Band A relative measure (ratio or percentage) of the banded Neutrophil Band Form To Production Form/Leukocytes neutrophils to leukocytes in a biological specimen. Leukocyte Ratio C64832 C65047 Laboratory Test Code SPGRAV SPGRAV Specific Gravity A ratio of the density of a fluid to the density of water. Specific Gravity Production C64840 C65047 Laboratory Test Code MG MG Magnesium A measurement of the magnesium in a biological specimen. Magnesium Measurement Production C64847 C65047 Laboratory Test Code GGT GGT Gamma Glutamyl Transferase A measurement of the gamma glutamyl transpeptidase in a Gamma Glutamyl Production biological specimen. Transpeptidase Measurement C64848 C65047 Laboratory Test Code HGB HGB Hemoglobin A measurement of the hemoglobin in a biological specimen. Hemoglobin Measurement Production C64849 C65047 Laboratory Test Code HBA1C HBA1C Hemoglobin A1C A measurement of the glycosylated hemoglobin in a biological Glycosylated Hemoglobin Production specimen. Measurement C64850 C65047 Laboratory Test Code HBSAG HBSAG Hepatitis B Virus Surface A measurement of the surface antigen reaction of a biological Hepatitis B Virus Surface Production Antigen specimen to the Hepatitis B virus. Antigen Measurement

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C74605 C65047 Laboratory Test Code BLAST BLAST Blasts A measurement of the blast cells in a biological specimen. Blast Count Production C74606 C65047 Laboratory Test Code CD19 CD19 CD19 A count of the CD19 B cells per unit of a biological specimen. CD19 Expressing B Cell Count Production

C74607 C65047 Laboratory Test Code CD3 CD3 CD3 A count of the CD3 T cells per unit of a biological specimen. CD3 Expressing T Cell Count Production C74608 C65047 Laboratory Test Code CD4 CD4 CD4 A count of the CD4 T cells per unit of a biological specimen. CD4 Expressing T Cell Count Production C74609 C65047 Laboratory Test Code CD8 CD8 CD8 A count of the CD8 T cells per unit of a biological specimen. CD8 Expressing T Cell Count Production C74610 C65047 Laboratory Test Code DOHLE DOHLE Dohle Bodies A measurement of the Dohle bodie (blue-gray, basophilic, Dohle Body Measurement Production leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. C74611 C65047 Laboratory Test Code ESR ESR Erythrocyte Sedimentation The distance (e.g. millimeters) that red blood cells settle in Erythrocyte Sedimentation Rate Production Rate unclotted blood over a specified unit of time (e.g. one hour). Measurement C74612 C65047 Laboratory Test Code HYPSEGCE HYPSEGCE Hypersegmented Cells A measurement of the hypersegmented (more than five lobes) Hypersegmented Neutrophil Production neutrophils in a biological specimen. Measurement C74613 C65047 Laboratory Test Code LYMMCE LYMMCE Lymphoma Cells A measurement of the malignant lymphocytes in a biological Lymphoma Cell Count Production specimen. C74614 C65047 Laboratory Test Code MAYHEG MAYHEG May-Hegglin Anomaly A measurement of the amount of May-Hegglin anomaly May-Hegglin Anomaly Production present in a blood sample. Measurement C74615 C65047 Laboratory Test Code METAMY METAMY Metamyelocytes A measurement of the metamyelocytes (small, myelocytic Metamyelocyte Count Production neutrophils with an indented nucleus) in a biological specimen. C74616 C65047 Laboratory Test Code PAPPEN PAPPEN Pappenheimer Bodies A measurement of the Pappenheimer Bodies (violet or blue Pappenheimer Body Count Production staining, ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. C74617 C65047 Laboratory Test Code PELGERH PELGERH Pelger Huet Anomaly A measurement of the amount of Pelger Huet anomaly Pelger Huet Anomaly Production present in a biological specimen. Measurement C74618 C65047 Laboratory Test Code LYMPL LYMPL Plasmacytoid Lymphocytes; A measurement of the plasmacytoid lymphocytes Plasmacytoid Lymphocyte Count Production Plymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) in a biological specimen. C74619 C65047 Laboratory Test Code PLSPCE PLSPCE Precursor Plasma Cells; A measurement of the precursor (blast stage) plasma cells Precursor Plasma Cell Count Production Plasmablast (antibody secreting cells derived from B cells via antigen stimulation) in a biological specimen. C74620 C65047 Laboratory Test Code PROLYM PROLYM Prolymphocytes A measurement of the prolymphocytes in a biological Prolymphocyte Count Production specimen. C74621 C65047 Laboratory Test Code PROMONO PROMONO Promonocytes A measurement of the promonocytes per unit of a biological Promonocyte Count Production specimen. C74622 C65047 Laboratory Test Code PROMY PROMY Promyelocytes A measurement of the promyelocytes (immature myelocytes) Promyelocyte Count Production in a biological specimen. C74624 C65047 Laboratory Test Code ROULEAUX ROULEAUX Rouleaux Formation A measurement of the number of stacking red blood cells Rouleaux Formation Count Production within a biological specimen. C74625 C65047 Laboratory Test Code SEZCE SEZCE Sezary Cells A measurement of the Sezary cells (atypical lymphocytes with Sezary Cell Count Production cerebriform nuclei) in a biological specimen. C74626 C65047 Laboratory Test Code SCKLCE SCKLCE Sickle Cells A measurement of the sickle cells (sickle shaped red blood Sickle Cell Count Production cells) in a biological specimen. C74627 C65047 Laboratory Test Code SMDGCE SMDGCE Smudge Cells; Basket Cells A measurement of the smudge cells (the nuclear remnant of a Smudge Cell Count Production ruptured white blood cell) in a biological specimen. C74628 C65047 Laboratory Test Code NEUTVAC NEUTVAC Vacuolated Neutrophils A measurement of the neutrophils containing small vacuoles Vacuolated Neutrophil Count Production in a biological specimen. C74630 C65047 Laboratory Test Code BLASTLM BLASTLM Leukemic Blasts; A measurement of the leukemic blasts (lymphoblasts that Leukemic Blast Count Production Lymphocytes; Lymphoblasts; remain in an immature state even when outside the bone Immunoblastic marrow) in a biological specimen. C74631 C65047 Laboratory Test Code MONOBL MONOBL Monoblasts A measurement of the monoblast cells per unit of a biological Monoblast Count Production specimen. C74632 C65047 Laboratory Test Code MYBLA MYBLA Myeloblasts A measurement of the myeloblast cells per unit of a biological Myeloblast Count Production specimen. C74633 C65047 Laboratory Test Code ACANTRBC ACANTRBC Acanthocytes/Erythrocytes A relative measurement (ratio or percentage) of acanthocytes Acanthocyte to Erythrocyte Ratio Production to all erythrocytes in a biological specimen. Measurement C74634 C65047 Laboratory Test Code BTECERBC BTECERBC Bite Cells/Erythrocytes A relative measurement (ratio or percentage) of bite cells Bite Cell to Erythrocyte Ratio Production (erthrocytes with the appearance of a bite having been Measurement removed, due to oxidative hemolysis) to all erythrocytes in a biological specimen . C74635 C65047 Laboratory Test Code CD19LY CD19LY CD19/Lymphocytes A relative measurement (ratio or percentage) of CD19 B cells CD19 B Cell to Lymphocyte Production to all lymphocytes in a biological specimen. Ratio Measurement C74636 C65047 Laboratory Test Code CD3LY CD3LY CD3/Lymphocytes A relative measurement (ratio or percentage) of CD3 T cells to CD3 T Cell to Lymphocyte Ratio Production all lymphocytes in a biological specimen. Measurement C74637 C65047 Laboratory Test Code CD4CD8 CD4CD8 CD4/CD8 A relative measurement (ratio or percentage) of CD4 T cells to CD4 T Cell to CD8 T Cell Ratio Production the CD8 T cells in a biological specimen. Measurement C74638 C65047 Laboratory Test Code CD4LY CD4LY CD4/Lymphocytes A relative measurement (ratio or percentage) of CD4 T cells to CD4 T Cell to Lymphocyte Ratio Production all lymphocytes in a biological specimen. Measurement C74639 C65047 Laboratory Test Code CD8LY CD8LY CD8/Lymphocytes A relative measurement (ratio or percentage) of CD8 T cells to CD8 T Cell to Lymphocyte Ratio Production all lymphocytes in a biological specimen. Measurement C74640 C65047 Laboratory Test Code HRYCELY HRYCELY Hairy Cells/Lymphocytes A relative measurement (ratio or percentage) of the hairy cells Hairy Cell to Lymphocyte Ratio Production (b-cell lymphocytes with hairy projections from the cytoplasm) Measurement to all lymphocytes in a biological specimen .

Covance Page 54 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C74641 C65047 Laboratory Test Code BLSTLMLY BLSTLMLY Leukemic Blasts/Lymphocytes A relative measurement (ratio or percentage) of the leukemic Leukemic Blast to Lymphocyte Production blasts (immature lymphoblasts) to mature lymphocytes in a Ratio Measurement biological specimen. C74643 C65047 Laboratory Test Code MLIGCEBC MLIGCEBC Malignant Cells, NOS/Blood A relative measurement (ratio or percentage) of the malignant Malignant Cell to Blood Cell RatioProduction Cells cells of all types to all blood cells in a biological specimen. Measurement

C74645 C65047 Laboratory Test Code METAMYLE METAMYLE Metamyelocytes/Leukocytes A relative measurement (ratio or percentage) of the Metamyelocyte to Leukocyte Production metamyelocytes (small, myelocytic neutrophils with an Ratio Measurement indented nucleus) to all leukocytes in a biological specimen. C74646 C65047 Laboratory Test Code MONOBLLE MONOBLLE Monoblasts/Leukocytes A relative measurement (ratio or percentage) of monoblast Monoblast to Leukocyte Ratio Production cells to all leukocytes in a biological specimen. Measurement C74647 C65047 Laboratory Test Code RBCNURBC RBCNURBC Nucleated A relative measurement (ratio or percentage) of the nucleated Nucleated Red Blood Cell to Production Erythrocytes/Erythrocytes erythrocytes (large, immature nucleated erythrocytes) to all Erythrocyte Ratio Measurement erythrocytes in a biological specimen. C74648 C65047 Laboratory Test Code LYMPLLY LYMPLLY Plasmacytoid A relative measurement (ratio or percentage) of the Plasmacytoid Lymphocyte to Production Lymphocytes/Lymphocytes plasmacytoid lymphocytes (lymphocytes with peripherally Lymphocyte Ratio Measurement clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) to all lymphocytes in a biological specimen. C74649 C65047 Laboratory Test Code POIKRBC POIKRBC Poikilocytes/Erythrocytes A relative measurement (ratio or percentage) of the Poikilocyte to Erythrocyte Ratio Production poikilocytes irregularly shaped erythrocytes) to all erythrocytes Measurement in a biological specimen. C74650 C65047 Laboratory Test Code PLSPCELY PLSPCELY Precursor Plasma A relative measurement (ratio or percentage) of the precursor Precursor Plasma Cell to Production Cells/Lymphocytes (blast stage) plasma cells (antibody secreting cells derived Lymphocyte Ratio Measurement from B cells via antigen stimulation) to all lymphocytes in a biological specimen. C74651 C65047 Laboratory Test Code PROLYMLY PROLYMLY Prolymphocytes/Lymphocytes A relative measurement (ratio or percentage) of the Prolymphocyte to Lymphocyte Production prolymphocytes to all lymphocytes in a biological specimen. Ratio Measurement C74652 C65047 Laboratory Test Code PROMONLE PROMONLE Promonocytes/Leukocytes A relative measurement (ratio or percentage) of the Promonocyte to Lymphocyte Production promonocytes to all leukocytes in a biological specimen. Ratio Measurement C74653 C65047 Laboratory Test Code PROMYLE PROMYLE Promyelocytes/Leukocytes A relative measurement (ratio or percentage) of the Promyelocyte to Lymphocyte Production promyelocytes (immature myelocytes) to all leukocytes in a Ratio Measurement biological specimen. C74654 C65047 Laboratory Test Code LYMRCTLY LYMRCTLY Reactive A relative measurement (ratio or percentage) of the reactive Reactive Lymphocyte to Production Lymphocytes/Lymphocytes lymphocytes (lymphocytes with peripherally clumped Lymphocyte Ratio Measurement chromatin and often deep blue cytoplasm and that appear similar to plasma cells) to all lymphocytes in a biological specimen. C74655 C65047 Laboratory Test Code SEZCELY SEZCELY Sezary Cells/Lymphocytes A relative measurement (ratio or percentage of the Sezary Sezary Cell to Lymphocyte Ratio Production cells (atypical lymphocytes with cerebriform nuclei) to all Measurement lymphocytes in a biological specimen. C74656 C65047 Laboratory Test Code SCKCERBC SCKCERBC Sickle Cells/Erythrocytes A relative measurement (ratio or percentage) of the sickle cellsSickle Cell to Erythrocyte Ratio Production (sickle shaped red blood cells) to all erythrocytes in a Measurement biological specimen. C74657 C65047 Laboratory Test Code AUERRODS AUERRODS Auer Rods A measurement of the Auer rods (elongated needle structures Auer Rod Measurement Production that are found in the cytoplasm of leukemic blasts and are formed by clumps of azurophilic granular material) in a biological specimen. C74658 C65047 Laboratory Test Code HELMETCE HELMETCE Helmet Cells A measurement of the Helmet cells (specialized Keratocytes Helmet Cell Count Production with two projections on either end that are tapered and hornlike) in a biological specimen. C74659 C65047 Laboratory Test Code LGUNSCE LGUNSCE Large Unstained Cells A measurement of the large, peroxidase-negative cells which Large Unstained Cell Count Production cannot be further characterized (i.e. as large lymphocytes, virocytes, or stem cells) present in a biological specimen. C74660 C65047 Laboratory Test Code MLIGCE MLIGCE Malignant Cells, NOS A measurement of the malignant cells of all types in a Malignant Cell Count Production biological specimen. C74661 C65047 Laboratory Test Code PLSMCE PLSMCE Mature Plasma Cells; A measurement of the mature plasma cells (plasmacytes) in a Mature Plasma Cell Count Production Plasmacytes biological specimen. C74662 C65047 Laboratory Test Code MYCY MYCY Myelocytes A measurement of the myelocytes per unit of a biological Myelocyte Count Production specimen. C74663 C65047 Laboratory Test Code SPERM SPERM Spermatozoa A measurement of the spermatozoa cells present in a Spermatozoa Cell Count Production biological specimen. C74664 C65047 Laboratory Test Code YEAST YEAST Yeast Cells A measurement of the yeast cells present in a biological Yeast Cell Measurement Production specimen. C74665 C65047 Laboratory Test Code CYAMORPH CYAMORPH Amorphous Crystals A measurement of the amorphous (Note: phosphate or urate, Amorphous Crystal MeasurementProduction depending on pH) crystals present in a biological specimen.

C74666 C65047 Laboratory Test Code AMORPHSD AMORPHSD Amorphous Sediment A measurement of the amorphous sediment present in a Amorphous Sediment Production biological specimen. Measurement C74667 C65047 Laboratory Test Code BICARB BICARB Bicarbonate; HCO3 A measurement of the bicarbonate in a biological specimen Bicarbonate Measurement Production C74668 C65047 Laboratory Test Code CYBILI CYBILI Bilirubin Crystals A measurement of the bilirubin crystals present in a biological Bilirubin Crystal Measurement Production specimen. C74669 C65047 Laboratory Test Code CYCACAR CYCACAR Calcium Carbonate Crystals A measurement of the calcium carbonate crystals present in a Calcium Carbonate Crystal Production biological specimen. Measurement C74670 C65047 Laboratory Test Code CYCAOXA CYCAOXA Calcium Oxalate Crystals A measurement of the calcium oxalate crystals present in a Calcium Oxalate Crystal Production biological specimen. Measurement C74671 C65047 Laboratory Test Code CYCAPHOS CYCAPHOS Calcium Phosphate Crystals A measurement of the calcium phosphate crystals present in aCalcium Phosphate Crystal Production biological specimen. Measurement C74672 C65047 Laboratory Test Code CYCHOL CYCHOL Cholesterol Crystals A measurement of the cholesterol crystals present in a Cholesterol Crystal MeasurementProduction biological specimen. C74673 C65047 Laboratory Test Code CRYSTALS CRYSTALS Crystals A statement that indicates crystals were looked for and not Crystal Present Or Absent Production found in a biological specimen. C74674 C65047 Laboratory Test Code CYCYSTIN CYCYSTIN Cystine Crystals A measurement of the cystine crystals present in a biological Cystine Crystal Measurement Production specimen. C74676 C65047 Laboratory Test Code FOLICAC FOLICAC Folic Acid; Vitamin B9 A measurement of the folic acid in a biological specimen. Folic Acid Measurement Production C74677 C65047 Laboratory Test Code CARNITF CARNITF Carnitine, Free A measurement of the free carnitine in a biological specimen. Free Carnitine Measurement Production C74678 C65047 Laboratory Test Code FRUCT FRUCT Fructosamine; Glycated A measurement of the fructosamine in a biological specimen. Fructosamine Measurement Production Serum Protein C74679 C65047 Laboratory Test Code IRON IRON Iron; FE A measurement of the iron in a biological specimen. Iron Measurement Production C74680 C65047 Laboratory Test Code CYLEUC CYLEUC Leucine Crystals A measurement of the leucine crystals present in a biological Leucine Crystal Measurement Production specimen. C74681 C65047 Laboratory Test Code CYMSU CYMSU Monosodium Urate Crystals A measurement of the monosodium urate crystals present in aMonosodium Urate Crystal Production biological specimen. Measurement C74682 C65047 Laboratory Test Code CARNIT CARNIT Carnitine A measurement of the total carnitine in a biological specimen. Total Carnitine Measurement Production

Covance Page 55 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C74683 C65047 Laboratory Test Code CYTYRO CYTYRO Tyrosine Crystals A measurement of the triple phosphate crystals present in a Tyrosine Crystal Measurement Production biological specimen. C74684 C65047 Laboratory Test Code CYURIAC CYURIAC Uric Acid Crystals A measurement of the uric acid crystals present in a biological Uric Acid Crystal Measurement Production specimen. C74685 C65047 Laboratory Test Code ANIONG ANIONG Anion Gap A computed estimate of the unmeasured anions (those other Anion Gap Measurement Production than the chloride and bicarbonate anions) in a biological specimen. C74686 C65047 Laboratory Test Code OCCBLD OCCBLD Occult Blood A measurement of the blood in body products such as a stool Occult Blood Measurement Production sample, not detectable on gross examination. C74687 C65047 Laboratory Test Code AMPHET AMPHET Amphetamine A measurement of any amphetamine class drug present in a Amphetamine Drug Class Production biological specimen. Measurement C74688 C65047 Laboratory Test Code BARB BARB Barbiturate A measurement of any barbiturate class drug present in a Barbiturate Drug Class Production biological specimen. Measurement C74689 C65047 Laboratory Test Code CANNAB CANNAB Cannabinoids A measurement of any cannabinoid class drug present in a Cannabinoid Drug Class Production biological specimen. Measurement C74690 C65047 Laboratory Test Code COCAINE COCAINE Cocaine A measurement of the cocaine present in a biological Cocaine Measurement Production specimen. C74698 C65047 Laboratory Test Code EPIROCE EPIROCE Round Epithelial Cells A measurement of the round epithelial cells present in a urine Round Epithelial Cell Count Production specimen. C74699 C65047 Laboratory Test Code ACANT ACANT Acanthocytes A measurement of the acanthocytes per unit of a biological Acanthocyte Count Production specimen. C74700 C65047 Laboratory Test Code BITECE BITECE Bite Cells A measurement of the bite cells (erthrocytes with the Bite Cell Count Production appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen . C74701 C65047 Laboratory Test Code BURRCE BURRCE Burr Cells; Keratocytes A measurement of the Burr cells (erythrocytes characterized Burr Cell Count Production by the presence of small, blunt projections evenly distributed across the cell surface) in a biological specimen. C74702 C65047 Laboratory Test Code CABOT CABOT Cabot Rings A measurement of the Cabot rings (red-purple staining, Cabot Ring Count Production threadlike, ring or figure 8 shaped filaments in an erythrocyte) in a biological specimen. C74703 C65047 Laboratory Test Code CRENCE CRENCE Crenated Cells; Echinocytes A measurement of the Burr cells (erythrocytes characterized Crenated Cell Measurement Production by the presence of multiple small, sharp projections evenly distributed across the cell surface) in a biological specimen. C74704 C65047 Laboratory Test Code HOWJOL HOWJOL Howell-Jolly Bodies A measurement of the Howell-Jolly bodies (spherical, blue- Howell-Jolly Body Measurement Production black condensed DNA inclusions within the body of a red blood cell that appear under Wright-stain) in a biological specimen. C74705 C65047 Laboratory Test Code RBCNUC RBCNUC Nucleated Erythrocytes A measurement of the nucleated erythrocytes (large, Nucleated Red Blood Cell Count Production immature nucleated erythrocytes) in a biological specimen. C74706 C65047 Laboratory Test Code SCHISTO SCHISTO Schistocytes A measurement of the schistocytes (fragmented red blood Schistocyte Count Production cells) in a biological specimen. C74707 C65047 Laboratory Test Code SPHERO SPHERO Spherocytes A measurement of the spherocytes (small, sphere-shaped red Spherocyte Count Production blood cells) in a biological specimen. C74708 C65047 Laboratory Test Code STOMCY STOMCY Stomatocytes A measurement of the stomatocytes (red blood cells with an Stomatocyte Count Production oval or rectangular area of central pallor, producing the appearance of a cell mouth) in a biological specimen. C74709 C65047 Laboratory Test Code HEINZ HEINZ Heinz Bodies; Heinz-Erhlich A measurement of the Heinz bodies (small round inclusions Heinz-Ehrlich Body Production Bodies within the body of a red blood cell) in a biological specimen. Measurement C74710 C65047 Laboratory Test Code HASAB HASAB Hepatitis A Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis A Surface Antibody Production Antibody specimen to the Hepatitis A virus. Measurement C74711 C65047 Laboratory Test Code HBSAB HBSAB Hepatitis B Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis B Surface Antibody Production Antibody specimen to the Hepatitis B virus. Measurement C74712 C65047 Laboratory Test Code HCSAB HCSAB Hepatitis C Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis C Surface Antibody Production Antibody specimen to the Hepatitis C virus. Measurement C74713 C65047 Laboratory Test Code HIV1AB HIV1AB HIV-1 Antibody A measurement of the antibody reaction of a biological HIV-1 Antibody Measurement Production specimen to the HIV-1 virus. C74714 C65047 Laboratory Test Code HIV12AB HIV12AB HIV-1/2 Antibody A measurement of the antibody reaction of a biological HIV-1 HIV-2 Antibody Production specimen to the either the HIV-1 or HIV-2 virus. Measurement C74715 C65047 Laboratory Test Code HIV2AB HIV2AB HIV-2 Antibody A measurement of the antibody reaction of a biological HIV-2 Antibody Measurement Production specimen to the HIV-2 virus. C74716 C65047 Laboratory Test Code RPR RPR Rapid Plasma Reagin A measurement of the antibodies produced by cellular Rapid Plasma Reagin Production damage caused by Treponema pallidum (syphilis) in a Measurement biological specimen. C74717 C65047 Laboratory Test Code RF RF Rheumatoid Factor A measurement of the rheumatoid factor antibody in a Rheumatoid Factor MeasurementProduction biological specimen. C74718 C65047 Laboratory Test Code IBCT IBCT Total Iron Binding Capacity A measurement of the amount of iron needed to fully saturate Total Iron Binding Capacity Production the transferrin in a serum specimen. C74719 C65047 Laboratory Test Code IBCU IBCU Unsaturated Iron Binding A measurement of the binding capacity of unsaturated iron in Unsaturated Iron Binding Production Capacity a biological specimen. Capacity Measurement C74721 C65047 Laboratory Test Code MUCTHR MUCTHR Mucous Threads A measurement of the mucous threads present in a biological Mucous Thread Measurement Production specimen. C74723 C65047 Laboratory Test Code TURB TURB Turbidity A measurement of the opacity of a biological specimen. Turbidity Measurement Production C74724 C65047 Laboratory Test Code HAVPCR HAVPCR HAV PCR Viral Load A measurement of the hepatitis A viral load in a biological Hepatitis A Viral Load PCR Production specimen using polymerase chain reaction. Measurement C74725 C65047 Laboratory Test Code HBVPCR HBVPCR HBV PCR Viral Load A measurement of the hepatitis B viral load in a sample using Hepatitis B Viral Load PCR Production polymerase chain reaction. Measurement C74726 C65047 Laboratory Test Code HCVPCR HCVPCR HCV PCR Viral Load A measurement of the hepatitis C viral load in a sample using Hepatitis C Viral Load PCR Production polymerase chain reaction. Measurement C74727 C65047 Laboratory Test Code HIVPCR HIVPCR HIV PCR Viral Load A measurement of the HIV viral load in a specimen using HIV Viral Load PCR Production polymerase chain reaction. Measurement C74728 C65047 Laboratory Test Code PLATGNT PLATGNT Giant Platelets A measurement of the giant (larger than 7um in diameter) Giant Platelet Count Production platelets in a biological specimen. C74729 C65047 Laboratory Test Code PLATLRG PLATLRG Large Platelets A measurement of the large (between 4 um and 7um in Large Platelet Count Production diameter) platelets in a biological specimen. C74730 C65047 Laboratory Test Code MPV MPV Mean Platelet Volume A measurement of the average size of the platelets present in Mean Platelet Volume Production a blood sample. Measurement C74731 C65047 Laboratory Test Code ALDOLASE ALDOLASE Aldolase A measurement of the aldolase enzyme in a biological Aldolase Measurement Production specimen. C74732 C65047 Laboratory Test Code AFP AFP Alpha Fetoprotein A measurement of the alpha fetoprotein in a biological Alpha-fetoprotein Measurement Production specimen. C74733 C65047 Laboratory Test Code APOA1 APOA1 Apolipoprotein A1 A measurement of the apolipoprotein A1 in the high density Apolipoprotein A1 Measurement Production lipoproteins of a biological specimen. C74734 C65047 Laboratory Test Code APOB APOB Apolipoprotein B A measurement of the apolipoprotein B in the low density Apolipoprotein B Measurement Production lipoproteins of a biological specimen. C74735 C65047 Laboratory Test Code BNP BNP Brain Natriuretic Peptide; B- A measurement of the brain (B-type) natriuretic peptide in a Brain Natriuretic Peptide Production Type Natriuretic Peptide biological specimen. Measurement

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C74744 C65047 Laboratory Test Code OSTEOC OSTEOC Osteocalcin A measurement of the osteocalcin in a biological specimen. Osteocalcin Measurement Production C74745 C65047 Laboratory Test Code SHBG SHBG Sex Hormone Binding A measurement of the sex hormone binding (globulin) protein Sex Hormone Binding Protein Production Globulin; Sex Hormone in a biological specimen. Measurement Binding Protein C74746 C65047 Laboratory Test Code TBG TBG Thyroxine Binding Globulin A measurement of the thyroxine binding globulin protein in a Thyroxine Binding Globulin Production biological specimen. Protein Measurement C74747 C65047 Laboratory Test Code T3 T3 Triiodothyronine A measurement of the total (free and bound) triiodothyronine Triiodothyronine Measurement Production in a biological specimen. C74748 C65047 Laboratory Test Code T3UP T3UP Triiodothyronine Uptake A measurement of the binding of triiodothyonine to thyroxine Triiodothyronine Uptake Production binding globulin protein in a biological specimen. Measurement C74749 C65047 Laboratory Test Code TROPONI TROPONI Troponin I A measurement of the actin binding troponin in a biological Troponin I Measurement Production specimen. C74750 C65047 Laboratory Test Code TROPONT TROPONT Troponin T A measurement of the tropomyosin binding troponin in a Troponin T Measurement Production biological specimen. C74751 C65047 Laboratory Test Code TNF TNF Tumor Necrosis Factor A measurement of the total tumor necrosis factor (cachexin) Tumor Necrosis Factor Production cytokine in a biological specimen. Measurement C74753 C65047 Laboratory Test Code BUNCREAT BUNCREAT BUN/Creatinine Ratio A relative measurement (ratio or percentage) (ratio) of the Blood Urea Nitrogen To Production blood urea nitrogen (BUN) to the creatinine in a blood Creatinine Ratio Measurement specimen. C74754 C65047 Laboratory Test Code CYHIPPAC CYHIPPAC Hippuric Acid Crystals A measurement of the hippuric acid crystals present in a urine Hippuric Acid Crystal Production specimen. Measurement C74755 C65047 Laboratory Test Code CYSULFA CYSULFA Sulfa Crystals A measurement of the sulfa crystals present in a urine Sulfa Crystal Measurement Production specimen. C74756 C65047 Laboratory Test Code CYTRPHOS CYTRPHOS Triple Phosphate Crystals A measurement of the triple phosphate crystals present in a Triple Phosphate Crystal Production urine specimen. Measurement C74757 C65047 Laboratory Test Code CYUNCLA CYUNCLA Unclassified Crystals A measurement of the unclassifiable crystals present in a Unclassified Crystal Production urine specimen. Measurement C74758 C65047 Laboratory Test Code CYAMMBIU CYAMMBIU Ammonium Biurate Crystals A measurement of the ammonium biurate crystals present in aUrine Ammonium Biurate Crystal Production biological specimen. Measurement C74759 C65047 Laboratory Test Code CYAMMOX CYAMMOX Ammonium Oxalate Crystals A measurement of the ammonium oxalate crystals present in Urine Ammonium Oxalate Production a urine specimen. Crystal Measurement C74761 C65047 Laboratory Test Code ALBCREAT ALBCREAT Albumin/Creatinine Ratio; A relative measurement (ratio or percentage) of the albumin to Albumin To Creatinine Protein Production Microalbumin/Creatinine Ratio the creatinine in a urine specimen. Ratio Measurement C74762 C65047 Laboratory Test Code CSBACT CSBACT Bacterial Casts A measurement of the bacterial casts present in a urine Bacterial Cast Measurement Production specimen. C74763 C65047 Laboratory Test Code CASTS CASTS Casts A statement that indicates casts were looked for and not foundCast Present Or Absent Production in a biological specimen. C74764 C65047 Laboratory Test Code CSCELL CSCELL Cellular Casts A measurement of the cellular (white blood cell, red blood cell,Cellular Cast Measurement Production epithelial and bacterial) casts present in a urine specimen.

C74765 C65047 Laboratory Test Code CSGRANC CSGRANC Granular Coarse Casts A measurement of the coarse granular casts present in a urineCoarse Granular Cast Production specimen. Measurement C74766 C65047 Laboratory Test Code CSFAT CSFAT Fatty Casts A measurement of the fatty casts present in a urine specimen.Fatty Cast Measurement Production

C74767 C65047 Laboratory Test Code FGRANCS FGRANCS Fine Granular Casts A measurement of the fine granular casts present in a urine Fine Granular Cast MeasurementProduction specimen. C74768 C65047 Laboratory Test Code CSGRAN CSGRAN Granular Casts A measurement of the granular (course and fine) casts presenGranular Cast Measurement Production in a urine specimen. C74769 C65047 Laboratory Test Code CSGRANF CSGRANF Granular Fine Casts A measurement of the fine granular casts present in a urine Granular Fine Cast MeasurementProduction specimen. C74770 C65047 Laboratory Test Code CSHYAL CSHYAL Hyaline Casts A measurement of the hyaline casts present in a urine Hyaline Cast Measurement Production specimen. C74771 C65047 Laboratory Test Code CSMIX CSMIX Mixed Casts A measurement of the mixed (the cast contains a mixture of Mixed Cast Count Production cell types) casts present in a urine specimen. C74772 C65047 Laboratory Test Code CSRBC CSRBC RBC Casts A measurement of the red blood cell casts present in a urine Red Blood Cell Cast Production specimen. Measurement C74773 C65047 Laboratory Test Code EPISQCE EPISQCE Squamous Epithelial Cells A measurement of the squamous epithelial cells present in a Squamous Epithelial Cell Count Production urine specimen. C74774 C65047 Laboratory Test Code EPISQTCE EPISQTCE Squamous Transitional A measurement of the squamous transitional epithelial cells Squamous Transitional Epithelial Production Epithelial Cells; Epithelial Cells present in a urine specimen. Cell Count

C74775 C65047 Laboratory Test Code EPITUCE EPITUCE Tubular Epithelial Cells A measurement of the tubular epithelial cells present in a urineTubular Epithelial Cell Count Production specimen. C74776 C65047 Laboratory Test Code CSUNCLA CSUNCLA Unclassified Casts A measurement of the unclassifiable casts present in a urine Unclassified Cast Measurement Production specimen. C74777 C65047 Laboratory Test Code CSWAX CSWAX Waxy Casts A measurement of the waxy casts present in a urine Waxy Cell Cast Measurement Production specimen. C74778 C65047 Laboratory Test Code CSWBC CSWBC WBC Casts A measurement of the white blood cell casts present in a urineWhite Blood Cell Cast Production specimen. Measurement C74779 C65047 Laboratory Test Code CSEPI CSEPI Epithelial Casts A measurement of the epithelial cell casts present in a urine Epithelial-Cast Measurement Production specimen. C74780 C65047 Laboratory Test Code ACTH ACTH Adrenocorticotropic Hormone A measurement of the adrenocorticotropic hormone in a Adrenocorticotropic Hormone Production biological specimen. Measurement C74781 C65047 Laboratory Test Code CORTISOL CORTISOL Cortisol A measurement of the cortisol in a biological specimen. Cortisol Measurement Production C74782 C65047 Laboratory Test Code ESTRDIOL ESTRDIOL Estradiol A measurement of the estradiol in a biological specimen. Estradiol Measurement Production C74783 C65047 Laboratory Test Code FSH FSH Follicle Stimulating Hormone A measurement of the follicle stimulating hormone (FSH) in a Follicle Stimulating Hormone Production biological specimen. Measurement C74784 C65047 Laboratory Test Code PTHFG PTHFG Parathyroid Hormone, A measurement of the fragmented parathyroid hormone in a Fragmented Parathyroid Production Fragmented biological specimen. Hormone Measurement C74785 C65047 Laboratory Test Code TESTOSFR TESTOSFR Testosterone, Free A measurement of the free testosterone in a biological Free Testosterone Measurement Production specimen. C74786 C65047 Laboratory Test Code T4FR T4FR Thyroxin, Free; Free T4 A measurement of the free thyroxine in a biological specimen. Free Thyroxine Measurement Production

Covance Page 57 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74911 C65047 Laboratory Test Code PLSMCELY PLSMCELY Mature Plasma A relative measurement (ratio or percentage) of the mature Mature Plasma Cell to Production Cells/Lymphocytes plasma cells (plasmacytes) to all lymphocytes in a biological Lymphocyte Ratio Measurement specimen. C74912 C65047 Laboratory Test Code CYACIDU CYACIDU Acid Urate Crystals A measurement of the ammonium acid urate crystals present Acid Urate Crystal Measurement Production in a biological specimen. C74913 C65047 Laboratory Test Code ADSDNA ADSDNA Anti-Double Stranded DNA A measurement of the anti-double stranded DNA antibody in aAnti-Double Stranded DNA Production biological specimen. Measurement C74916 C65047 Laboratory Test Code ANA ANA Antinuclear Antibodies A measurement of the antinuclear antibodies (antibodies that Antinuclear Antibody Production attack the body's own tissue) in a biological specimen. Measurement C79437 C65047 Laboratory Test Code NCTD5P NCTD5P 5 Prime Nucleotidase, 5'- A measurement of the 5'-nucleotidase in a biological 5 Prime Nucleotidase Production Ribonucleotide specimen. Measurement Phosphohydrolase C74876 C65047 Laboratory Test Code SIXMAM SIXMAM 6-Monoacetylmorphine A measurement of the 6-monoacetylmorphine present in a 6-Monoacetylmorphine Production biological specimen. Measurement C74838 C65047 Laboratory Test Code ACH ACH Acetylcholine A measurement of the acetylcholine hormone in a biological Acetylcholine Measurement Production specimen. C74839 C65047 Laboratory Test Code ADPNCTN ADPNCTN Adiponectin A measurement of the adiponectin hormone in a biological Adiponectin Measurement Production specimen. C74894 C65047 Laboratory Test Code ALBGLOB ALBGLOB Albumin/Globulin Ratio The ratio of albumin to globulin in a blood specimen. Albumin to Globulin Ratio Production Measurement C74841 C65047 Laboratory Test Code ALDSTRN ALDSTRN Aldosterone A measurement of the aldosterone hormone in a biological Aldosterone Measurement Production specimen. C79438 C65047 Laboratory Test Code ALPCREAT ALPCREAT Alkaline A relative measurement (ratio or percentage) of the alkaline Alkaline Phosphatase to Production Phosphatase/Creatinine phosphatase to creatinine in a biological specimen. Creatinine Ratio Measurement C79433 C65047 Laboratory Test Code GSTAL GSTAL Alpha Glutathione-S- A measurement of the alpha form of glutathione S-transferase Alpha Glutathione-S-Transferase Production Transferase in a biological specimen. Measurement C74799 C65047 Laboratory Test Code AMMONIA AMMONIA Ammonia, NH3 A measurement of the ammonia in a biological specimen. Ammonia Measurement Production C74842 C65047 Laboratory Test Code ANDSTNDL ANDSTNDL Androstenediol A measurement of the androstenediol metabolite in a Androstenediol Metabolite Production biological specimen. Measurement C74843 C65047 Laboratory Test Code ANDSTNDN ANDSTNDN Androstenedione, 4- A measurement of the androstenedione hormone in a Androstenedione Measurement Production Androstenedione biological specimen. C74844 C65047 Laboratory Test Code ANGTNS1 ANGTNS1 Angiotensin I A measurement of the angiotensin I hormone in a biological Angiotensin I Measurement Production specimen. C74845 C65047 Laboratory Test Code ANGTNS2 ANGTNS2 Angiotensin II A measurement of the angiotensin II hormone in a biological Angiotensin II Measurement Production specimen. C74846 C65047 Laboratory Test Code ANGTNSGN ANGTNSGN Angiotensinogen, Angiotensin A measurement of the angiotensinogen hormone in a Angiotensinogen Measurement Production Precursor biological specimen. C74691 C65047 Laboratory Test Code ANTIDPRS ANTIDPRS Antidepressants A measurement of any antidepressant class drug present in a Antidepressant Measurement Production biological specimen. C74847 C65047 Laboratory Test Code ADH ADH Antidiuretic Hormone, A measurement of the antidiuretic hormone in a biological Antidiuretic Hormone Measurement Production Vasopressin specimen. C74886 C65047 Laboratory Test Code ANP ANP Atrial Natriuretic Peptide, A measurement of the atrial natriuretic peptide in a biological Atrial Natriuretic Peptide Production Atriopeptin specimen. Measurement C74692 C65047 Laboratory Test Code BNZDZPN BNZDZPN Benzodiazepine A measurement of any benzodiazepine class drug present in aBenzodiazepine Measurement Production biological specimen. C74800 C65047 Laboratory Test Code BILEAC BILEAC Bile Acid, Bile Salts, Bile A measurement of the total bile acids in a biological Bile Acid Measurement Production Acids, Bile Salt specimen. C74634 C65047 Laboratory Test Code BTECERBC BTECERBC Bite Cells/Erythrocytes A relative measurement of the bite cells (erythrocytes with the Bite Cell To Erythrocyte Ratio Production appearance of a bite having been removed, due to oxidative Measurement hemolysis) to all erythrocytes in a biological specimen.

C74848 C65047 Laboratory Test Code CLCTONN CLCTONN Calcitonin A measurement of the calcitonin hormone in a biological Calcitonin Measurement Production specimen. C74849 C65047 Laboratory Test Code CLCTRIOL CLCTRIOL Calcitriol A measurement of the calcitriol hormone in a biological Calcitriol Measurement Production specimen. C79439 C65047 Laboratory Test Code CACREAT CACREAT Calcium/Creatinine A relative measurement (ratio or percentage) of the calcium to Calcium to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79440 C65047 Laboratory Test Code CLCREAT CLCREAT Chloride/Creatinine A relative measurement (ratio or percentage) of the chloride to Chloride to Creatinine Ratio Production creatinine in a biological specimen. Measurement C74850 C65047 Laboratory Test Code CCK CCK Cholecystokinin, A measurement of the cholecystokinin hormone in a biological Cholecystokinin Measurement Production Pancreozymin specimen. C74877 C65047 Laboratory Test Code CODEINE CODEINE Codeine A measurement of the codeine present in a biological Codeine Measurement Production specimen. C79434 C65047 Laboratory Test Code CRTRONE CRTRONE Corticosterone A measurement of corticosterone in a biological specimen. Corticosterone Measurement Production C74851 C65047 Laboratory Test Code CRH CRH Corticotropin Releasing A measurement of the corticotropin releasing hormone in a Corticotropin Releasing Hormone Production Hormone, Corticotropin biological specimen. Measurement Releasing Factor C79466 C65047 Laboratory Test Code CKBBCK CKBBCK Creatine Kinase BB/Total A relative measurement (ratio or percentage) of the BB-type Creatine Kinase BB to Total Production Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement C79441 C65047 Laboratory Test Code CKMBCK CKMBCK Creatine Kinase MB/Total A relative measurement (ratio or percentage) of the MB-type Creatine Kinase MB to Total Production Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement C79442 C65047 Laboratory Test Code CKMMCK CKMMCK Creatine Kinase MM/Total A relative measurement (ratio or percentage) of the MM-type Creatine Kinase MM to Total Production Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement

Covance Page 58 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74858 C65047 Laboratory Test Code GASTRIN GASTRIN Gastrin A measurement of the gastrin hormone in a biological Gastrin Measurement Production specimen. C74859 C65047 Laboratory Test Code GLUCAGON GLUCAGON Glucagon A measurement of the glucagon hormone in a biological Glucagon Measurement Production specimen. C79447 C65047 Laboratory Test Code GLUCCRT GLUCCRT Glucose/Creatinine A relative measurement (ratio or percentage) of the glucose to Glucose to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79448 C65047 Laboratory Test Code GLDH GLDH Glutamate Dehydrogenase A measurement of the glutamate dehydrogenase in a Glutamate Dehydrogenase Production biological specimen. Measurement C79435 C65047 Laboratory Test Code GSTCREAT GSTCREAT Glutathione-S- A relative measurement (ratio or percentage) of the glutathion Glutathione-S-Transferase to Production Transferase/Creatinine S-transferase to creatinine in a biological specimen. Creatinine Ratio Measurement

C74860 C65047 Laboratory Test Code GNRH GNRH Gonadotropin Releasing A measurement of the gonadotropin releasing hormone in a Gonadotropin Releasing Hormone Production Hormone, Luteinising biological specimen. Measurement Hormone Releasing Hormone C74861 C65047 Laboratory Test Code GRWHIH GRWHIH Growth Hormone Inhibiting A measurement of the growth hormone inhibiting hormone in Growth Hormone Inhibiting Production Hormone, Somatostatin a biological specimen. Hormone Measurement C75386 C65047 Laboratory Test Code GRWH GRWH Growth Hormone, A measurement of the growth hormone in a biological Growth Hormone Measurement Production Somatotropin specimen. C74862 C65047 Laboratory Test Code GRWHRH GRWHRH Growth Hormone Releasing A measurement of the growth hormone releasing hormone in Growth Hormone Releasing Production Hormone, Somatocrinin a biological specimen. Hormone Measurement C74863 C65047 Laboratory Test Code HVA HVA Homovanillic Acid A measurement of the homovanillic acid metabolite in a Homovanillic Acid Measurement Production biological specimen. C74879 C65047 Laboratory Test Code HYDCDN HYDCDN Hydrocodone A measurement of the hydrocodone present in a biological Hydrocodone Measurement Production specimen. C74880 C65047 Laboratory Test Code HYDMRPHN HYDMRPHN Hydromorphone A measurement of the hydromorphone present in a biological Hydromorphone Measurement Production specimen. C74864 C65047 Laboratory Test Code IGF1 IGF1 Insulin-like Growth Factor-1 A measurement of the insulin-like growth factor-1 in a Insulin Like Growth Factor-1 Production biological specimen. Measurement C74865 C65047 Laboratory Test Code IGF2 IGF2 Insulin-like Growth Factor-2 A measurement of the insulin-like growth factor-2 in a Insulin Like Growth Factor-2 Production biological specimen. Measurement C74805 C65047 Laboratory Test Code INTLK1 INTLK1 Interleukin 1 A measurement of the interleukin 1 in a biological specimen. Interleukin 1 Measurement Production C74806 C65047 Laboratory Test Code INTLK10 INTLK10 Interleukin 10 A measurement of the interleukin 10 in a biological specimen. Interleukin 10 Measurement Production C74807 C65047 Laboratory Test Code INTLK11 INTLK11 Interleukin 11 A measurement of the interleukin 11 in a biological specimen. Interleukin 11 Measurement Production C74808 C65047 Laboratory Test Code INTLK12 INTLK12 Interleukin 12 A measurement of the interleukin 12 in a biological specimen. Interleukin 12 Measurement Production C74809 C65047 Laboratory Test Code INTLK13 INTLK13 Interleukin 13 A measurement of the interleukin 13 in a biological specimen. Interleukin 13 Measurement Production C74810 C65047 Laboratory Test Code INTLK14 INTLK14 Interleukin 14 A measurement of the interleukin 14 in a biological specimen. Interleukin 14 Measurement Production C74811 C65047 Laboratory Test Code INTLK15 INTLK15 Interleukin 15 A measurement of the interleukin 15 in a biological specimen. Interleukin 15 Measurement Production C74812 C65047 Laboratory Test Code INTLK16 INTLK16 Interleukin 16 A measurement of the interleukin 16 in a biological specimen. Interleukin 16 Measurement Production C74813 C65047 Laboratory Test Code INTLK17 INTLK17 Interleukin 17 A measurement of the interleukin 17 in a biological specimen. Interleukin 17 Measurement Production C74814 C65047 Laboratory Test Code INTLK18 INTLK18 Interleukin 18 A measurement of the interleukin 18 in a biological specimen. Interleukin 18 Measurement Production C74815 C65047 Laboratory Test Code INTLK19 INTLK19 Interleukin 19 A measurement of the interleukin 19 in a biological specimen. Interleukin 19 Measurement Production C74816 C65047 Laboratory Test Code INTLK2 INTLK2 Interleukin 2 A measurement of the interleukin 2 in a biological specimen. Interleukin 2 Measurement Production C74817 C65047 Laboratory Test Code INTLK20 INTLK20 Interleukin 20 A measurement of the interleukin 20 in a biological specimen. Interleukin 20 Measurement Production C74818 C65047 Laboratory Test Code INTLK21 INTLK21 Interleukin 21 A measurement of the interleukin 21 in a biological specimen. Interleukin 21 Measurement Production C74819 C65047 Laboratory Test Code INTLK22 INTLK22 Interleukin 22 A measurement of the interleukin 22 in a biological specimen. Interleukin 22 Measurement Production C74820 C65047 Laboratory Test Code INTLK23 INTLK23 Interleukin 23 A measurement of the interleukin 23 in a biological specimen. Interleukin 23 Measurement Production C74821 C65047 Laboratory Test Code INTLK24 INTLK24 Interleukin 24 A measurement of the interleukin 24 in a biological specimen. Interleukin 24 Measurement Production C74822 C65047 Laboratory Test Code INTLK25 INTLK25 Interleukin 25 A measurement of the interleukin 25 in a biological specimen. Interleukin 25 Measurement Production C74823 C65047 Laboratory Test Code INTLK26 INTLK26 Interleukin 26 A measurement of the interleukin 26 in a biological specimen. Interleukin 26 Measurement Production C74824 C65047 Laboratory Test Code INTLK27 INTLK27 Interleukin 27 A measurement of the interleukin 27 in a biological specimen. Interleukin 27 Measurement Production C74825 C65047 Laboratory Test Code INTLK28 INTLK28 Interleukin 28 A measurement of the interleukin 28 in a biological specimen. Interleukin 28 Measurement Production C74826 C65047 Laboratory Test Code INTLK29 INTLK29 Interleukin 29 A measurement of the interleukin 29 in a biological specimen. Interleukin 29 Measurement Production C74827 C65047 Laboratory Test Code INTLK3 INTLK3 Interleukin 3 A measurement of the interleukin 3 in a biological specimen. Interleukin 3 Measurement Production C74828 C65047 Laboratory Test Code INTLK30 INTLK30 Interleukin 30 A measurement of the interleukin 30 in a biological specimen. Interleukin 30 Measurement Production C74829 C65047 Laboratory Test Code INTLK31 INTLK31 Interleukin 31 A measurement of the interleukin 31 in a biological specimen. Interleukin 31 Measurement Production C74830 C65047 Laboratory Test Code INTLK32 INTLK32 Interleukin 32 A measurement of the interleukin 32 in a biological specimen. Interleukin 32 Measurement Production C74831 C65047 Laboratory Test Code INTLK33 INTLK33 Interleukin 33 A measurement of the interleukin 33 in a biological specimen. Interleukin 33 Measurement Production C74832 C65047 Laboratory Test Code INTLK4 INTLK4 Interleukin 4 A measurement of the interleukin 4 in a biological specimen. Interleukin 4 Measurement Production C74833 C65047 Laboratory Test Code INTLK5 INTLK5 Interleukin 5 A measurement of the interleukin 5 in a biological specimen. Interleukin 5 Measurement Production C74834 C65047 Laboratory Test Code INTLK6 INTLK6 Interleukin 6 A measurement of the interleukin 6 in a biological specimen. Interleukin 6 Measurement Production C74835 C65047 Laboratory Test Code INTLK7 INTLK7 Interleukin 7 A measurement of the interleukin 7 in a biological specimen. Interleukin 7 Measurement Production C74836 C65047 Laboratory Test Code INTLK8 INTLK8 Interleukin 8 A measurement of the interleukin 8 in a biological specimen. Interleukin 8 Measurement Production C74837 C65047 Laboratory Test Code INTLK9 INTLK9 Interleukin 9 A measurement of the interleukin 9 in a biological specimen. Interleukin 9 Measurement Production C74887 C65047 Laboratory Test Code LDH1 LDH1 LDH Isoenzyme 1 A measurement of the lactate dehydrogenase isoenzyme 1 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 1 Measurement C74888 C65047 Laboratory Test Code LDH2 LDH2 LDH Isoenzyme 2 A measurement of the lactate dehydrogenase isoenzyme 2 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 2 Measurement C74889 C65047 Laboratory Test Code LDH3 LDH3 LDH Isoenzyme 3 A measurement of the lactate dehydrogenase isoenzyme 3 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 3 Measurement C74890 C65047 Laboratory Test Code LDH4 LDH4 LDH Isoenzyme 4 A measurement of the lactate dehydrogenase isoenzyme 4 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 4 Measurement

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C79467 C65047 Laboratory Test Code LGLUCLE LGLUCLE Large Unstained A relative measure (ratio or percentage) of the large unstained Large Unstained Cells to Production Cells/Leukocytes cells to leukocytes in a biological specimen. Leukocytes Ratio Measurement C79451 C65047 Laboratory Test Code LDH1LDH LDH1LDH LDH Isoenzyme 1/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 1 to LDH Ratio Production dehydrogenase isoenzyme 1 to total lactate dehydrogenase in Measurement a biological specimen. C79452 C65047 Laboratory Test Code LDH2LDH LDH2LDH LDH Isoenzyme 2/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 2 to LDH Ratio Production dehydrogenase isoenzyme 2 to total lactate dehydrogenase in Measurement a biological specimen. C79453 C65047 Laboratory Test Code LDH3LDH LDH3LDH LDH Isoenzyme 3/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 3 to LDH Ratio Production dehydrogenase isoenzyme 3 to total lactate dehydrogenase in Measurement a biological specimen. C79454 C65047 Laboratory Test Code LDH4LDH LDH4LDH LDH Isoenzyme 4/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 4 to LDH Ratio Production dehydrogenase isoenzyme 4 to total lactate dehydrogenase in Measurement a biological specimen. C79455 C65047 Laboratory Test Code LDH5LDH LDH5LDH LDH Isoenzyme 5/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 5 to LDH Ratio Production dehydrogenase isoenzyme 5 to total lactate dehydrogenase in Measurement a biological specimen. C74866 C65047 Laboratory Test Code LEPTIN LEPTIN Leptin A measurement of the leptin hormone in a biological Leptin Measurement Production specimen. C79456 C65047 Laboratory Test Code MGCREAT MGCREAT Magnesium/Creatinine A relative measurement (ratio or percentage) of the Magnesium to Creatinine Ratio Production magnesium to creatinine in a biological specimen. Measurement C74867 C65047 Laboratory Test Code MLATONIN MLATONIN Melatonin A measurement of the melatonin hormone in a biological Melatonin Measurement Production specimen. C74881 C65047 Laboratory Test Code METHDN METHDN Methadone A measurement of the methadone present in a biological Methadone Measurement Production specimen. C74882 C65047 Laboratory Test Code METHQLDN METHQLDN Methaqualone A measurement of the methaqualone present in a biological Methaqualone Measurement Production specimen. C74883 C65047 Laboratory Test Code MORPHINE MORPHINE Morphine A measurement of the morphine present in a biological Morphine Measurement Production specimen. C79457 C65047 Laboratory Test Code GSTMU GSTMU Mu Glutathione-S-Transferase A measurement of the mu form of glutathione S-transferase in Mu Glutathione-S-Transferase Production a biological specimen. Measurement C79458 C65047 Laboratory Test Code GSTMUCRT GSTMUCRT Mu Glutathione-S- A relative measurement (ratio or percentage) of the mu Mu Glutathione-S-Transferase to Production Transferase/Creatinine gamma glutamyl transpeptidase to creatinine in a biological Creatinine Ratio Measurement specimen. C79436 C65047 Laboratory Test Code MGB MGB Myoglobin A measurement of myoglobin in a biological specimen. Myoglobin Measurement Production C79459 C65047 Laboratory Test Code NAG NAG N-Acetyl Glucosamide, N- A measurement of N-acetyl glucosamide in a biological N-Acetyl Glucosamide Production Acetyl Glucosamine specimen. Measurement C79460 C65047 Laboratory Test Code NAGCREAT NAGCREAT N-Acetyl A relative measurement (ratio or percentage) of the N-acetyl N-Acetyl Glucosamide to Production Glucosamide/Creatinine glucosamide to creatinine in a biological specimen. Creatinine Ratio Measurement C74892 C65047 Laboratory Test Code NPY NPY Neuropeptide Y A measurement of the neuropeptide Y in a biological Neuropeptide Y Measurement Production specimen. C74868 C65047 Laboratory Test Code NOREPIN NOREPIN Norepinephrine, Noradrenaline A measurement of the norepinephrine hormone in a biological Noradrenaline Measurement Production specimen. C74801 C65047 Laboratory Test Code OSMLTY OSMLTY Osmolality A measurement of the osmoles of solute per unit of biological Osmolality Measurement Production specimen. C74884 C65047 Laboratory Test Code OXYCDN OXYCDN Oxycodone, Oxycontin A measurement of the oxycodone present in a biological Oxycodone Measurement Production specimen. C74869 C65047 Laboratory Test Code OXYTOCIN OXYTOCIN Oxytocin, Oxytoxin A measurement of the oxytocin hormone in a biological Oxytocin Measurement Production specimen. C74694 C65047 Laboratory Test Code PCP PCP Phencyclidine, A measurement of the phencyclidine present in a biological Phencyclidine Measurement Production Phenylcyclohexylpiperidine specimen. C74695 C65047 Laboratory Test Code PHENTHZ PHENTHZ Phenothiazine, A measurement of the phenothiazine present in a biological Phenothiazine Measurement Production Dibenzothiazine specimen. C79461 C65047 Laboratory Test Code PHOSCRT PHOSCRT Phosphate/Creatinine A relative measurement (ratio or percentage) of the phosphatePhosphate to Creatinine Ratio Production to creatinine in a biological specimen. Measurement C79462 C65047 Laboratory Test Code KCREAT KCREAT Potassium/Creatinine A relative measurement (ratio or percentage) of the potassium Potassium to Creatinine Ratio Production to creatinine in a biological specimen. Measurement C74870 C65047 Laboratory Test Code PROLCTN PROLCTN Prolactin A measurement of the prolactin hormone in a biological Prolactin Measurement Production specimen. C74885 C65047 Laboratory Test Code PROPOX PROPOX Propoxyphene A measurement of the propoxyphene present in a biological Propoxyphene Measurement Production specimen. C79463 C65047 Laboratory Test Code PROTCRT PROTCRT Protein/Creatinine A relative measurement (ratio or percentage) of the protein to Protein to Creatinine Ratio Production creatinine in a biological specimen. Measurement C74696 C65047 Laboratory Test Code PSDEPHD PSDEPHD Pseudoephedrine A measurement of the pseudoephedrine present in a biologicaPseudoephedrine Measurement Production specimen. C74629 C65047 Laboratory Test Code LYMRCT LYMRCT Reactive Lymphocytes A measurement of the reactive lymphocytes (lymphocytes Reactive Lymphocyte Count Production which have become large due to an antigen reaction) in a Measurement biological specimen. C74893 C65047 Laboratory Test Code RENIN RENIN Renin, Angiotensinogenase A measurement of the renin in a biological specimen. Renin Measurement Production C74871 C65047 Laboratory Test Code SECRETIN SECRETIN Secretin A measurement of the secretin hormone in a biological Secretin Measurement Production specimen. C74872 C65047 Laboratory Test Code SRTONIN SRTONIN Serotonin A measurement of the serotonin hormone in a biological Serotonin Measurement Production specimen. C79464 C65047 Laboratory Test Code NACREAT NACREAT Sodium/Creatinine A relative measurement (ratio or percentage) of the sodium to Sodium to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79465 C65047 Laboratory Test Code SDH SDH Sorbitol Dehydrogenase A measurement of the sorbitol dehydrogenase in a biological Sorbitol Dehydrogenase Production specimen. Measurement C74873 C65047 Laboratory Test Code THRMPTN THRMPTN Thrombopoietin A measurement of the thrombopoietin hormone in a biological Thrombopoietin Measurement Production specimen. C74874 C65047 Laboratory Test Code TRH TRH Thyrotropin Releasing A measurement of the thyrotropin releasing hormone in a Thyrotropin Releasing Hormone Production Hormone, Thyrotropin biological specimen. Measurement Releasing Factor C74875 C65047 Laboratory Test Code VMA VMA Vanillyl Mandelic Acid, A measurement of the vanillyl mandelic acid metabolite in a Vanillyl Mandelic Acid Measurement Production Vanilmandelic Acid biological specimen. C74895 C65047 Laboratory Test Code VITA VITA Vitamin A, Retinol A measurement of the Vitamin A in a biological specimen. Vitamin A Measurement Production C74896 C65047 Laboratory Test Code VITB1 VITB1 Thiamine, Vitamin B1 A measurement of the thiamine in a biological specimen. Vitamin B1 Measurement Production C74897 C65047 Laboratory Test Code VITB17 VITB17 Vitamin B17, Amygdalin A measurement of the Vitamin B17 in a serum specimen. Vitamin B17 Measurement Production C74898 C65047 Laboratory Test Code VITB2 VITB2 Riboflavin, Vitamin B2 A measurement of the riboflavin in a biological specimen. Vitamin B2 Measurement Production C74899 C65047 Laboratory Test Code VITB3 VITB3 Niacin, Vitamin B3 A measurement of the niacin in a biological specimen. Vitamin B3 Measurement Production

Covance Page 60 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C35266 C67154 Laboratory Test Name Anisocytosis ANISO Anisocytosis A measurement of the inequality in the size of the red blood Anisocytosis Production cells in a whole blood specimen. C35267 C67154 Laboratory Test Name Poikilocytes POIKILO Poikilocytes A measurement of the odd-shaped erythrocytes in a whole Poikilocytosis Production blood specimen. C38037 C67154 Laboratory Test Name Bilirubin BILI Bilirubin A measurement of the total bilirubin in a biological specimen. Total Bilirubin Production C38462 C67154 Laboratory Test Name Activated Partial Thromboplastin APTT Activated Partial A measurement of the length of time that it takes for clotting toPartial Thromboplastin Time Production Time Thromboplastin Time occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. C41376 C67154 Laboratory Test Name Glucose GLUC Glucose A measurement of the glucose in a biological specimen. Plasma Glucose Measurement Production C45997 C67154 Laboratory Test Name pH PH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 pH Production to 14. C51946 C67154 Laboratory Test Name Erythrocytes RBC Erythrocytes A count of the total erythrocytes per unit of a biological Erythrocyte Count Production specimen. C51947 C67154 Laboratory Test Name Reticulocytes RETI Reticulocytes A count of the reticulocytes per unit of a biological specimen. Reticulocyte Count Production C51948 C67154 Laboratory Test Name Leukocytes WBC Leukocytes A count of the leukocytes per unit of a biological specimen. Leukocyte Count Production C51949 C67154 Laboratory Test Name Lymphocytes LYM Lymphocytes A count of the lymphocytes per unit of a biological specimen. Lymphocyte Count Production C51951 C67154 Laboratory Test Name Platelet PLAT Platelet A count of the platelets per unit of a biological specimen. Platelet Count Production C61019 C67154 Laboratory Test Name Blood Urea Nitrogen BUN Blood Urea Nitrogen A measurement of the urea nitrogen in a blood specimen. Blood Urea Nitrogen Production Measurement C61032 C67154 Laboratory Test Name Cholesterol CHOL Cholesterol A measurement of the cholesterol in a biological specimen. Serum Total Cholesterol Production Measurement C61041 C67154 Laboratory Test Name HDL Cholesterol HDL HDL Cholesterol A measurement of the high density lipoprotein cholesterol in a Serum HDL Cholesterol Production biological specimen. Measurement C61042 C67154 Laboratory Test Name LDL Cholesterol LDL LDL Cholesterol A measurement of the low density lipoprotein cholesterol in a Serum LDL Cholesterol Production biological specimen. Measurement C62656 C67154 Laboratory Test Name Prothrombin Time PT Prothrombin Time A blood clotting measurement that evaluates the extrinsic Prothrombin Time Production pathway of coagulation and is expressed in units of time or percent activity. C63321 C67154 Laboratory Test Name Neutrophils NEUT Neutrophils A count of the neutrophils per unit of a biological specimen. Absolute Neutrophil Count Production C64431 C67154 Laboratory Test Name Albumin ALB Albumin A measurement of the albumin protein in a biological Albumin Measurement Production specimen. C64432 C67154 Laboratory Test Name Alkaline Phosphatase ALP Alkaline Phosphatase A measurement of the alkaline phosphatase in a biological Alkaline Phosphatase Production specimen. Measurement C64433 C67154 Laboratory Test Name Alanine Aminotransferase ALT Alanine Aminotransferase A measurement of the alanine aminotransferase in a biologicalAlanine Aminotransferase Production specimen. Measurement C64434 C67154 Laboratory Test Name Amylase AMYLASE Amylase A measurement of the pancreatic enzyme amylase in a Amylase Measurement Production biological specimen. C64467 C67154 Laboratory Test Name Aspartate Aminotransferase AST Aspartate Aminotransferase A measurement of the aspartate aminotransferase in a Aspartate Aminotransferase Production biological specimen. Measurement C64469 C67154 Laboratory Test Name Bacteria BACT Bacteria A measurement of the bacteria in a biological specimen. Bacterial Count Production C64470 C67154 Laboratory Test Name Basophils BASO Basophils A count of the basophils per unit of a biological specimen. Total Basophil Count Production C64471 C67154 Laboratory Test Name Basophils/Leukocytes BASOLE Basophils/Leukocytes A relative measure (ratio or percentage) of the basophils to Basophil To Leukocyte Ratio Production leukocytes in a biological specimen. C64481 C67154 Laboratory Test Name Direct Bilirubin BILDIR Direct Bilirubin A measurement of the conjugated or water-soluble bilirubin in Direct Bilirubin Measurement Production a biological specimen. C64483 C67154 Laboratory Test Name Indirect Bilirubin BILIND Indirect Bilirubin A measurement of the unconjugated or non-water-soluble Indirect Bilirubin Measurement Production bilirubin in a biological specimen. C64487 C67154 Laboratory Test Name Blasts/Leukocytes BLASTLE Blasts/Leukocytes A relative measure (ratio or percentage) of the blasts to Blast To Leukocyte Ratio Production leukocytes in a biological specimen. C64488 C67154 Laboratory Test Name Calcium CA Calcium A measurement of the calcium in a biological specimen. Calcium Measurement Production C64489 C67154 Laboratory Test Name Creatine Kinase CK Creatine Kinase A measurement of the total creatine kinase in a biological Creatine Kinase Measurement Production specimen. C64490 C67154 Laboratory Test Name Creatine Kinase BB CKBB Creatine Kinase BB A measurement of the homozygous B-type creatine kinase in Creatine Kinase BB Production a biological specimen. Measurement C64491 C67154 Laboratory Test Name Creatine Kinase MB CKMB Creatine Kinase MB A measurement of the heterozygous MB-type creatine kinase Creatine Kinase MB Production in a biological specimen. Measurement C64494 C67154 Laboratory Test Name Creatine Kinase MM CKMM Creatine Kinase MM A measurement of the homozygous M-type creatine kinase in Creatine Kinase MM Production a biological specimen. Measurement C64495 C67154 Laboratory Test Name Chloride CL Chloride A measurement of the chloride in a biological specimen. Chloride Measurement Production C64545 C67154 Laboratory Test Name Carbon Dioxide CO2 Carbon Dioxide A measurement of the carbon dioxide gas in a biological Carbon Dioxide Measurement Production specimen. C64546 C67154 Laboratory Test Name Color COLOR Color A measurement of the color of a biological specimen. Color Assessment Production C64547 C67154 Laboratory Test Name Creatinine CREAT Creatinine A measurement of the creatinine in a biological specimen. Creatinine Measurement Production C64548 C67154 Laboratory Test Name C Reactive Protein CRP C Reactive Protein A measurement of the C reactive protein in a biological C-Reactive Protein Measurement Production specimen. C64549 C67154 Laboratory Test Name Elliptocytes ELLIPCY Elliptocytes A count of the elliptocytes per unit of a biological specimen. Elliptocyte Count Production C64550 C67154 Laboratory Test Name Eosinophils EOS Eosinophils A count of the eosinophils per unit of a biological specimen. Eosinophil Count Production C64604 C67154 Laboratory Test Name Eosinophils/Leukocytes EOSLE Eosinophils/Leukocytes A relative measure (ratio or percentage) of the eosinophils to Eosinophil To Leukocyte Ratio Production leukocytes in a biological specimen. C64605 C67154 Laboratory Test Name Epithelial Cells EPIC Epithelial Cells A measurement of the epithelial cells in a biological specimen.Epithelial Cell Count Production

C64606 C67154 Laboratory Test Name Fibrinogen FIBRINO Fibrinogen A measurement of the fibrinogen in a biological specimen. Fibrinogen Measurement Production C64796 C67154 Laboratory Test Name Hematocrit HCT Hematocrit The percentage of a whole blood specimen that is composed Hematocrit Production of red blood cells (erythrocytes). C64797 C67154 Laboratory Test Name Ery. Mean Corpuscular Hemoglobin MCH Ery. Mean Corpuscular A quantitative measurement of the mean amount of Erythrocyte Mean Corpuscular Production Hemoglobin hemoglobin per erythrocyte in a biological specimen. Hemoglobin C64798 C67154 Laboratory Test Name Ery. Mean Corpuscular HB MCHC Ery. Mean Corpuscular HB A quantitative measurement of the mean amount of Erythrocyte Mean Corpuscular Production Concentration Concentration hemoglobin per erythrocytes in a specified volume of a Hemoglobin Concentration biological specimen. C64799 C67154 Laboratory Test Name Ery. Mean Corpuscular Volume MCV Ery. Mean Corpuscular A quantitative measurement of the mean volume of Erythrocyte Mean Corpuscular Production Volume erythrocytes in a biological specimen. Volume

Covance Page 61 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64800 C67154 Laboratory Test Name Erythrocytes Distribution Width RDW Erythrocytes Distribution A value derived from mean corpuscular volume and the Erythrocyte Distribution Width Production Width standard deviation of the red blood cell volume in a whole Measurement blood specimen. C64801 C67154 Laboratory Test Name Dacryocytes TEARDCY Dacryocytes A count of dacryocytes in unit of a biological specimen. Dacryocyte Analysis Production C64802 C67154 Laboratory Test Name Hypochromia HYPO Hypochromia An observation which indicates that the hemoglobin Hypochromia Production concentration in a red blood cell specimen has fallen below a specified level. C64803 C67154 Laboratory Test Name Polychromasia POLYCHR Polychromasia A measurement of the blue-staining characteristic of newly Polychromasia Production generated erythrocytes. C64805 C67154 Laboratory Test Name Prothrombin Intl. Normalized Ratio INR Prothrombin Intl. Normalized A ratio that represents the prothrombin time for a plasma International Normalized Ratio of Production Ratio specimen, divided by the result for a control plasma Prothrombin Time specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test.

C64806 C67154 Laboratory Test Name VLDL Cholesterol VLDL VLDL Cholesterol A measurement of the very low density lipoprotein cholesterol Serum VLDL Cholesterol Production in a biological specimen. Measurement C64807 C67154 Laboratory Test Name Triacylglycerol Lipase LIPASE Triacylglycerol Lipase A measurement of the pancreatic lipase in a biological Triacylglycerol Lipase Production specimen. Measurement C64809 C67154 Laboratory Test Name Sodium SODIUM Sodium A measurement of the sodium in a biological specimen. Sodium Measurement Production C64810 C67154 Laboratory Test Name Nitrite NITRITE Nitrite A measurement of the nitrite in a urine specimen. Nitrite Measurement Production C64812 C67154 Laboratory Test Name Triglycerides TRIG Triglycerides A measurement of the triglycerides in a biological specimen. Triglyceride Measurement Production C64813 C67154 Laboratory Test Name Thyrotropin TSH Thyrotropin A measurement of the thyrotropin in a biological specimen. Thyrotropin Measurement Production C64814 C67154 Laboratory Test Name Urate URATE Urate A measurement of the urate in a biological specimen. Urate Measurement Production C64815 C67154 Laboratory Test Name Urea UREA Urea A measurement of the urea in a biological specimen. Urea Measurement Production C64816 C67154 Laboratory Test Name Urobilinogen UROBIL Urobilinogen A measurement of the urobilinogen in a biological specimen. Urobilinogen Measurement Production C64817 C67154 Laboratory Test Name Vitamin B12 VITB12 Vitamin B12 A measurement of the Vitamin B12 in a serum specimen. Vitamin B12 Measurement Production C64818 C67154 Laboratory Test Name Lymphocytes Atypical LYMAT Lymphocytes Atypical A count of the atypical lymphocytes per unit of a biological Atypical Lymphocyte Count Production specimen. C64819 C67154 Laboratory Test Name Lymphocytes Atypical/Leukocytes LYMATLE Lymphocytes A relative measure (ratio or percentage) of the atypical Atypical Lymphocyte To Production Atypical/Leukocytes lymphocytes to leukocytes in a biological specimen. Leukocyte Ratio C64820 C67154 Laboratory Test Name Lymphocytes/Leukocytes LYMLE Lymphocytes/Leukocytes A relative measure (ratio or percentage) of the lymphocytes to Lymphocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64821 C67154 Laboratory Test Name Macrocytes MACROCY Macrocytes A count of the macrocytes per unit of a biological specimen. Macrocyte Count Production C64822 C67154 Laboratory Test Name Microcytes MICROCY Microcytes A count of the microcytes per unit of a biological specimen. Microcyte Count Production C64823 C67154 Laboratory Test Name Monocytes MONO Monocytes A count of the monocytes per unit of a biological specimen. Monocyte Count Production C64824 C67154 Laboratory Test Name Monocytes/Leukocytes MONOLE Monocytes/Leukocytes A relative measure (ratio or percentage) of the monocytes to Monocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64825 C67154 Laboratory Test Name Myeloblasts/Leukocytes MYBLALE Myeloblasts/Leukocytes A relative measure (ratio or percentage) of the myeloblasts to Myeloblast To Leukocyte Ratio Production leukocytes in a biological specimen. C64826 C67154 Laboratory Test Name Myelocytes/Leukocytes MYCYLE Myelocytes/Leukocytes A relative measure (ratio or percentage) of the myelocytes to Myelocyte To Leukocyte Ratio Production leukocytes in a biological specimen. C64827 C67154 Laboratory Test Name Neutrophils/Leukocytes NEUTLE Neutrophils/Leukocytes The determination of the ratio of neutrophils compared to Neutrophil To Leukocyte Ratio Production leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. C64828 C67154 Laboratory Test Name Reticulocytes/Erythrocytes RETIRBC Reticulocytes/Erythrocytes A relative measure (ratio or percentage) of reticulocytes to Reticulocyte To Erythrocyte RatioProduction erythrocytes in a biological specimen. C64829 C67154 Laboratory Test Name Prolymphocytes/Leukocytes PRLYMLE Prolymphocytes/Leukocytes A relative measure (ratio or percentage) of prolymphocytes to Prolymphocyte To Leukocyte Production leukocytes in a biological specimen. Ratio C64830 C67154 Laboratory Test Name Neutrophils Band Form NEUTB Neutrophils Band Form A count of the banded neutrophils per unit of a biological Neutrophil Band Form Count Production specimen. C64831 C67154 Laboratory Test Name Neutrophils Band Form/Leukocytes NEUTBLE Neutrophils Band A relative measure (ratio or percentage) of the banded Neutrophil Band Form To Production Form/Leukocytes neutrophils to leukocytes in a biological specimen. Leukocyte Ratio C64832 C67154 Laboratory Test Name Specific Gravity SPGRAV Specific Gravity A ratio of the density of a fluid to the density of water. Specific Gravity Production C64840 C67154 Laboratory Test Name Magnesium MG Magnesium A measurement of the magnesium in a biological specimen. Magnesium Measurement Production C64847 C67154 Laboratory Test Name Gamma Glutamyl Transferase GGT Gamma Glutamyl Transferase A measurement of the gamma glutamyl transpeptidase in a Gamma Glutamyl Production biological specimen. Transpeptidase Measurement C64848 C67154 Laboratory Test Name Hemoglobin HGB Hemoglobin A measurement of the hemoglobin in a biological specimen. Hemoglobin Measurement Production C64849 C67154 Laboratory Test Name Hemoglobin A1C HBA1C Hemoglobin A1C A measurement of the glycosylated hemoglobin in a biological Glycosylated Hemoglobin Production specimen. Measurement C64850 C67154 Laboratory Test Name Hepatitis B Virus Surface Antigen HBSAG Hepatitis B Virus Surface A measurement of the surface antigen reaction of a biological Hepatitis B Virus Surface Production Antigen specimen to the Hepatitis B virus. Antigen Measurement C64851 C67154 Laboratory Test Name Choriogonadotropin Beta HCG Choriogonadotropin Beta A measurement of the Choriogonadotropin Beta in a biological Choriogonadotropin Beta Production specimen. Measurement C64853 C67154 Laboratory Test Name Potassium K Potassium A measurement of the potassium in a biological specimen. Potassium Measurement Production C64854 C67154 Laboratory Test Name Ketones KETONES Ketones A measurement of the ketones in a biological specimen. Ketone Measurement Production C64855 C67154 Laboratory Test Name Lactate Dehydrogenase LDH Lactate Dehydrogenase A measurement of the lactate dehydrogenase in a biological Lactate Dehydrogenase Production specimen. Measurement C64856 C67154 Laboratory Test Name Leukocyte Esterase LEUKASE Leukocyte Esterase A measurement of the enzyme which indicates the presence Leukocyte Esterase Production of white blood cells in a biological specimen. Measurement C64857 C67154 Laboratory Test Name Phosphate PHOS Phosphate A measurement of the phosphate in a biological specimen. Phosphate Measurement Production C64858 C67154 Laboratory Test Name Protein PROT Protein A measurement of a group of complex organic Total Protein Measurement Production macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. C17634 C67154 Laboratory Test Name Prostate Specific Antigen PSA Prostate Specific Antigen A measurement of the prostate specific antigen in a biological Prostate Specific Antigen Production specimen. Measurement C25747 C67154 Laboratory Test Name Creatinine Clearance CREATCLR Creatinine Clearance A measurement of the volume of serum or plasma that would Creatinine Clearance Production be cleared of creatinine by excretion of urine for a specified unit of time (e.g. one minute). C74604 C67154 Laboratory Test Name Hairy Cells HAIRYCE Hairy Cells A measurement of the hairy cells (b-cell lymphocytes with Hairy Cell Count Production hairy projections from the cytoplasm) in a biological specimen.

C74605 C67154 Laboratory Test Name Blasts BLAST Blasts A measurement of the blast cells in a biological specimen. Blast Count Production C74606 C67154 Laboratory Test Name CD19 CD19 CD19 A count of the CD19 B cells per unit of a biological specimen. CD19 Expressing B Cell Count Production

C74607 C67154 Laboratory Test Name CD3 CD3 CD3 A count of the CD3 T cells per unit of a biological specimen. CD3 Expressing T Cell Count Production C74608 C67154 Laboratory Test Name CD4 CD4 CD4 A count of the CD4 T cells per unit of a biological specimen. CD4 Expressing T Cell Count Production C74609 C67154 Laboratory Test Name CD8 CD8 CD8 A count of the CD8 T cells per unit of a biological specimen. CD8 Expressing T Cell Count Production C74610 C67154 Laboratory Test Name Dohle Bodies DOHLE Dohle Bodies A measurement of the Dohle bodie (blue-gray, basophilic, Dohle Body Measurement Production leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. C74611 C67154 Laboratory Test Name Erythrocyte Sedimentation Rate ESR Erythrocyte Sedimentation The distance (e.g. millimeters) that red blood cells settle in Erythrocyte Sedimentation Rate Production Rate unclotted blood over a specified unit of time (e.g. one hour). Measurement C74612 C67154 Laboratory Test Name Hypersegmented Cells HYPSEGCE Hypersegmented Cells A measurement of the hypersegmented (more than five lobes) Hypersegmented Neutrophil Production neutrophils in a biological specimen. Measurement C74613 C67154 Laboratory Test Name Lymphoma Cells LYMMCE Lymphoma Cells A measurement of the malignant lymphocytes in a biological Lymphoma Cell Count Production specimen.

Covance Page 62 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74645 C67154 Laboratory Test Name Metamyelocytes/Leukocytes METAMYLE Metamyelocytes/Leukocytes A relative measurement (ratio or percentage) of the Metamyelocyte to Leukocyte Production metamyelocytes (small, myelocytic neutrophils with an Ratio Measurement indented nucleus) to all leukocytes in a biological specimen. C74646 C67154 Laboratory Test Name Monoblasts/Leukocytes MONOBLLE Monoblasts/Leukocytes A relative measurement (ratio or percentage) of monoblast Monoblast to Leukocyte Ratio Production cells to all leukocytes in a biological specimen. Measurement C74647 C67154 Laboratory Test Name Nucleated Erythrocytes/Erythrocytes RBCNURBC Nucleated A relative measurement (ratio or percentage) of the nucleated Nucleated Red Blood Cell to Production Erythrocytes/Erythrocytes erythrocytes (large, immature nucleated erythrocytes) to all Erythrocyte Ratio Measurement erythrocytes in a biological specimen. C74648 C67154 Laboratory Test Name Plasmacytoid LYMPLLY Plasmacytoid A relative measurement (ratio or percentage) of the Plasmacytoid Lymphocyte to Production Lymphocytes/Lymphocytes Lymphocytes/Lymphocytes plasmacytoid lymphocytes (lymphocytes with peripherally Lymphocyte Ratio Measurement clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) to all lymphocytes in a biological specimen. C74649 C67154 Laboratory Test Name Poikilocytes/Erythrocytes POIKRBC Poikilocytes/Erythrocytes A relative measurement (ratio or percentage) of the Poikilocyte to Erythrocyte Ratio Production poikilocytes irregularly shaped erythrocytes) to all erythrocytes Measurement in a biological specimen. C74650 C67154 Laboratory Test Name Precursor Plasma PLSPCELY Precursor Plasma A relative measurement (ratio or percentage) of the precursor Precursor Plasma Cell to Production Cells/Lymphocytes Cells/Lymphocytes (blast stage) plasma cells (antibody secreting cells derived Lymphocyte Ratio Measurement from B cells via antigen stimulation) to all lymphocytes in a biological specimen. C74651 C67154 Laboratory Test Name Prolymphocytes/Lymphocytes PROLYMLY Prolymphocytes/Lymphocytes A relative measurement (ratio or percentage) of the Prolymphocyte to Lymphocyte Production prolymphocytes to all lymphocytes in a biological specimen. Ratio Measurement C74652 C67154 Laboratory Test Name Promonocytes/Leukocytes PROMONLE Promonocytes/Leukocytes A relative measurement (ratio or percentage) of the Promonocyte to Lymphocyte Production promonocytes to all leukocytes in a biological specimen. Ratio Measurement C74653 C67154 Laboratory Test Name Promyelocytes/Leukocytes PROMYLE Promyelocytes/Leukocytes A relative measurement (ratio or percentage) of the Promyelocyte to Lymphocyte Production promyelocytes (immature myelocytes) to all leukocytes in a Ratio Measurement biological specimen.

Covance Page 63 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74666 C67154 Laboratory Test Name Amorphous Sediment AMORPHSD Amorphous Sediment A measurement of the amorphous sediment present in a Amorphous Sediment Production biological specimen. Measurement C74667 C67154 Laboratory Test Name Bicarbonate BICARB Bicarbonate; HCO3 A measurement of the bicarbonate in a biological specimen Bicarbonate Measurement Production C74668 C67154 Laboratory Test Name Bilirubin Crystals CYBILI Bilirubin Crystals A measurement of the bilirubin crystals present in a biological Bilirubin Crystal Measurement Production specimen. C74669 C67154 Laboratory Test Name Calcium Carbonate Crystals CYCACAR Calcium Carbonate Crystals A measurement of the calcium carbonate crystals present in a Calcium Carbonate Crystal Production biological specimen. Measurement C74670 C67154 Laboratory Test Name Calcium Oxalate Crystals CYCAOXA Calcium Oxalate Crystals A measurement of the calcium oxalate crystals present in a Calcium Oxalate Crystal Production biological specimen. Measurement C74671 C67154 Laboratory Test Name Calcium Phosphate Crystals CYCAPHOS Calcium Phosphate Crystals A measurement of the calcium phosphate crystals present in aCalcium Phosphate Crystal Production biological specimen. Measurement C74672 C67154 Laboratory Test Name Cholesterol Crystals CYCHOL Cholesterol Crystals A measurement of the cholesterol crystals present in a Cholesterol Crystal MeasurementProduction biological specimen. C74673 C67154 Laboratory Test Name Crystals CRYSTALS Crystals A statement that indicates crystals were looked for and not Crystal Present Or Absent Production found in a biological specimen. C74674 C67154 Laboratory Test Name Cystine Crystals CYCYSTIN Cystine Crystals A measurement of the cystine crystals present in a biological Cystine Crystal Measurement Production specimen. C74676 C67154 Laboratory Test Name Folic Acid FOLICAC Folic Acid; Vitamin B9 A measurement of the folic acid in a biological specimen. Folic Acid Measurement Production C74677 C67154 Laboratory Test Name Carnitine, Free CARNITF Carnitine, Free A measurement of the free carnitine in a biological specimen. Free Carnitine Measurement Production C74678 C67154 Laboratory Test Name Fructosamine FRUCT Fructosamine; Glycated A measurement of the fructosamine in a biological specimen. Fructosamine Measurement Production Serum Protein C74679 C67154 Laboratory Test Name Iron IRON Iron; FE A measurement of the iron in a biological specimen. Iron Measurement Production C74680 C67154 Laboratory Test Name Leucine Crystals CYLEUC Leucine Crystals A measurement of the leucine crystals present in a biological Leucine Crystal Measurement Production specimen. C74681 C67154 Laboratory Test Name Monosodium Urate Crystals CYMSU Monosodium Urate Crystals A measurement of the monosodium urate crystals present in aMonosodium Urate Crystal Production biological specimen. Measurement C74682 C67154 Laboratory Test Name Carnitine CARNIT Carnitine A measurement of the total carnitine in a biological specimen. Total Carnitine Measurement Production

C74683 C67154 Laboratory Test Name Tyrosine Crystals CYTYRO Tyrosine Crystals A measurement of the triple phosphate crystals present in a Tyrosine Crystal Measurement Production biological specimen. C74684 C67154 Laboratory Test Name Uric Acid Crystals CYURIAC Uric Acid Crystals A measurement of the uric acid crystals present in a biological Uric Acid Crystal Measurement Production specimen. C74685 C67154 Laboratory Test Name Anion Gap ANIONG Anion Gap A computed estimate of the unmeasured anions (those other Anion Gap Measurement Production than the chloride and bicarbonate anions) in a biological specimen. C74686 C67154 Laboratory Test Name Occult Blood OCCBLD Occult Blood A measurement of the blood in body products such as a stool Occult Blood Measurement Production sample, not detectable on gross examination. C74687 C67154 Laboratory Test Name Amphetamine AMPHET Amphetamine A measurement of any amphetamine class drug present in a Amphetamine Drug Class Production biological specimen. Measurement C74688 C67154 Laboratory Test Name Barbiturate BARB Barbiturate A measurement of any barbiturate class drug present in a Barbiturate Drug Class Production biological specimen. Measurement C74689 C67154 Laboratory Test Name Cannabinoids CANNAB Cannabinoids A measurement of any cannabinoid class drug present in a Cannabinoid Drug Class Production biological specimen. Measurement C74690 C67154 Laboratory Test Name Cocaine COCAINE Cocaine A measurement of the cocaine present in a biological Cocaine Measurement Production specimen. C74698 C67154 Laboratory Test Name Round Epithelial Cells EPIROCE Round Epithelial Cells A measurement of the round epithelial cells present in a urine Round Epithelial Cell Count Production specimen. C74699 C67154 Laboratory Test Name Acanthocytes ACANT Acanthocytes A measurement of the acanthocytes per unit of a biological Acanthocyte Count Production specimen. C74700 C67154 Laboratory Test Name Bite Cells BITECE Bite Cells A measurement of the bite cells (erthrocytes with the Bite Cell Count Production appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen . C74701 C67154 Laboratory Test Name Burr Cells BURRCE Burr Cells; Keratocytes A measurement of the Burr cells (erythrocytes characterized Burr Cell Count Production by the presence of small, blunt projections evenly distributed across the cell surface) in a biological specimen. C74702 C67154 Laboratory Test Name Cabot Rings CABOT Cabot Rings A measurement of the Cabot rings (red-purple staining, Cabot Ring Count Production threadlike, ring or figure 8 shaped filaments in an erythrocyte) in a biological specimen. C74703 C67154 Laboratory Test Name Crenated Cells CRENCE Crenated Cells; Echinocytes A measurement of the Burr cells (erythrocytes characterized Crenated Cell Measurement Production by the presence of multiple small, sharp projections evenly distributed across the cell surface) in a biological specimen.

Covance Page 64 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C74704 C67154 Laboratory Test Name Howell-Jolly Bodies HOWJOL Howell-Jolly Bodies A measurement of the Howell-Jolly bodies (spherical, blue- Howell-Jolly Body Measurement Production black condensed DNA inclusions within the body of a red blood cell that appear under Wright-stain) in a biological specimen. C74705 C67154 Laboratory Test Name Nucleated Erythrocytes RBCNUC Nucleated Erythrocytes A measurement of the nucleated erythrocytes (large, Nucleated Red Blood Cell Count Production immature nucleated erythrocytes) in a biological specimen. C74706 C67154 Laboratory Test Name Schistocytes SCHISTO Schistocytes A measurement of the schistocytes (fragmented red blood Schistocyte Count Production cells) in a biological specimen. C74707 C67154 Laboratory Test Name Spherocytes SPHERO Spherocytes A measurement of the spherocytes (small, sphere-shaped red Spherocyte Count Production blood cells) in a biological specimen. C74708 C67154 Laboratory Test Name Stomatocytes STOMCY Stomatocytes A measurement of the stomatocytes (red blood cells with an Stomatocyte Count Production oval or rectangular area of central pallor, producing the appearance of a cell mouth) in a biological specimen. C74709 C67154 Laboratory Test Name Heinz Bodies HEINZ Heinz Bodies; Heinz-Erhlich A measurement of the Heinz bodies (small round inclusions Heinz-Ehrlich Body Production Bodies within the body of a red blood cell) in a biological specimen. Measurement C74710 C67154 Laboratory Test Name Hepatitis A Virus Surface Antibody HASAB Hepatitis A Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis A Surface Antibody Production Antibody specimen to the Hepatitis A virus. Measurement C74711 C67154 Laboratory Test Name Hepatitis B Virus Surface Antibody HBSAB Hepatitis B Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis B Surface Antibody Production Antibody specimen to the Hepatitis B virus. Measurement C74712 C67154 Laboratory Test Name Hepatitis C Virus Surface Antibody HCSAB Hepatitis C Virus Surface A measurement of the surface antibody reaction of a biologicaHepatitis C Surface Antibody Production Antibody specimen to the Hepatitis C virus. Measurement C74713 C67154 Laboratory Test Name HIV-1 Antibody HIV1AB HIV-1 Antibody A measurement of the antibody reaction of a biological HIV-1 Antibody Measurement Production specimen to the HIV-1 virus. C74714 C67154 Laboratory Test Name HIV-1/2 Antibody HIV12AB HIV-1/2 Antibody A measurement of the antibody reaction of a biological HIV-1 HIV-2 Antibody Production specimen to the either the HIV-1 or HIV-2 virus. Measurement C74715 C67154 Laboratory Test Name HIV-2 Antibody HIV2AB HIV-2 Antibody A measurement of the antibody reaction of a biological HIV-2 Antibody Measurement Production specimen to the HIV-2 virus. C74716 C67154 Laboratory Test Name Rapid Plasma Reagin RPR Rapid Plasma Reagin A measurement of the antibodies produced by cellular Rapid Plasma Reagin Production damage caused by Treponema pallidum (syphilis) in a Measurement biological specimen. C74717 C67154 Laboratory Test Name Rheumatoid Factor RF Rheumatoid Factor A measurement of the rheumatoid factor antibody in a Rheumatoid Factor MeasurementProduction biological specimen. C74718 C67154 Laboratory Test Name Total Iron Binding Capacity IBCT Total Iron Binding Capacity A measurement of the amount of iron needed to fully saturate Total Iron Binding Capacity Production the transferrin in a serum specimen. C74719 C67154 Laboratory Test Name Unsaturated Iron Binding Capacity IBCU Unsaturated Iron Binding A measurement of the binding capacity of unsaturated iron in Unsaturated Iron Binding Production Capacity a biological specimen. Capacity Measurement C74721 C67154 Laboratory Test Name Mucous Threads MUCTHR Mucous Threads A measurement of the mucous threads present in a biological Mucous Thread Measurement Production specimen. C74723 C67154 Laboratory Test Name Turbidity TURB Turbidity A measurement of the opacity of a biological specimen. Turbidity Measurement Production C74724 C67154 Laboratory Test Name HAV PCR Viral Load HAVPCR HAV PCR Viral Load A measurement of the hepatitis A viral load in a biological Hepatitis A Viral Load PCR Production specimen using polymerase chain reaction. Measurement C74725 C67154 Laboratory Test Name HBV PCR Viral Load HBVPCR HBV PCR Viral Load A measurement of the hepatitis B viral load in a sample using Hepatitis B Viral Load PCR Production polymerase chain reaction. Measurement C74726 C67154 Laboratory Test Name HCV PCR Viral Load HCVPCR HCV PCR Viral Load A measurement of the hepatitis C viral load in a sample using Hepatitis C Viral Load PCR Production polymerase chain reaction. Measurement C74727 C67154 Laboratory Test Name HIV PCR Viral Load HIVPCR HIV PCR Viral Load A measurement of the HIV viral load in a specimen using HIV Viral Load PCR Production polymerase chain reaction. Measurement C74728 C67154 Laboratory Test Name Giant Platelets PLATGNT Giant Platelets A measurement of the giant (larger than 7um in diameter) Giant Platelet Count Production platelets in a biological specimen. C74729 C67154 Laboratory Test Name Large Platelets PLATLRG Large Platelets A measurement of the large (between 4 um and 7um in Large Platelet Count Production diameter) platelets in a biological specimen. C74730 C67154 Laboratory Test Name Mean Platelet Volume MPV Mean Platelet Volume A measurement of the average size of the platelets present in Mean Platelet Volume Production a blood sample. Measurement C74731 C67154 Laboratory Test Name Aldolase ALDOLASE Aldolase A measurement of the aldolase enzyme in a biological Aldolase Measurement Production specimen. C74732 C67154 Laboratory Test Name Alpha Fetoprotein AFP Alpha Fetoprotein A measurement of the alpha fetoprotein in a biological Alpha-fetoprotein Measurement Production specimen. C74733 C67154 Laboratory Test Name Apolipoprotein A1 APOA1 Apolipoprotein A1 A measurement of the apolipoprotein A1 in the high density Apolipoprotein A1 Measurement Production lipoproteins of a biological specimen. C74734 C67154 Laboratory Test Name Apolipoprotein B APOB Apolipoprotein B A measurement of the apolipoprotein B in the low density Apolipoprotein B Measurement Production lipoproteins of a biological specimen. C74735 C67154 Laboratory Test Name Brain Natriuretic Peptide BNP Brain Natriuretic Peptide; B- A measurement of the brain (B-type) natriuretic peptide in a Brain Natriuretic Peptide Production Type Natriuretic Peptide biological specimen. Measurement C74736 C67154 Laboratory Test Name C-peptide CPEPTIDE C-peptide A measurement of the C (connecting) peptide of insulin in a C-peptide Measurement Production biological specimen. C74737 C67154 Laboratory Test Name Ferritin FERRITIN Ferritin A measurement of the ferritin in a biological specimen. Ferritin Measurement Production C74738 C67154 Laboratory Test Name Globulin GLOBUL Globulin A measurement of the globulin protein in a biological Globulin Protein Measurement Production specimen. C74739 C67154 Laboratory Test Name Glutamate GLUTAM Glutamate A measurement of the glutamate in a biological specimen. Glutamate Measurement Production C74740 C67154 Laboratory Test Name Haptoglobin HAPTOG Haptoglobin A measurement of the haptoglobin protein in a biological Haptoglobin Protein Production specimen. Measurement C74741 C67154 Laboratory Test Name Homocysteine HOMOCY Homocysteine A measurement of the homocysteine amino acid in a Homocysteine Acid Production biological specimen. Measurement C74743 C67154 Laboratory Test Name N-telopeptide NTELOP N-telopeptide A measurement of the N-telopeptide in a biological specimen. N-telopeptide Measurement Production

C74744 C67154 Laboratory Test Name Osteocalcin OSTEOC Osteocalcin A measurement of the osteocalcin in a biological specimen. Osteocalcin Measurement Production C74745 C67154 Laboratory Test Name Sex Hormone Binding Globulin SHBG Sex Hormone Binding A measurement of the sex hormone binding (globulin) protein Sex Hormone Binding Protein Production Globulin; Sex Hormone in a biological specimen. Measurement Binding Protein C74746 C67154 Laboratory Test Name Thyroxine Binding Globulin TBG Thyroxine Binding Globulin A measurement of the thyroxine binding globulin protein in a Thyroxine Binding Globulin Production biological specimen. Protein Measurement C74747 C67154 Laboratory Test Name Triiodothyronine T3 Triiodothyronine A measurement of the total (free and bound) triiodothyronine Triiodothyronine Measurement Production in a biological specimen. C74748 C67154 Laboratory Test Name Triiodothyronine Uptake T3UP Triiodothyronine Uptake A measurement of the binding of triiodothyonine to thyroxine Triiodothyronine Uptake Production binding globulin protein in a biological specimen. Measurement C74749 C67154 Laboratory Test Name Troponin I TROPONI Troponin I A measurement of the actin binding troponin in a biological Troponin I Measurement Production specimen. C74750 C67154 Laboratory Test Name Troponin T TROPONT Troponin T A measurement of the tropomyosin binding troponin in a Troponin T Measurement Production biological specimen. C74751 C67154 Laboratory Test Name Tumor Necrosis Factor TNF Tumor Necrosis Factor A measurement of the total tumor necrosis factor (cachexin) Tumor Necrosis Factor Production cytokine in a biological specimen. Measurement C74753 C67154 Laboratory Test Name BUN/Creatinine Ratio BUNCREAT BUN/Creatinine Ratio A relative measurement (ratio or percentage) (ratio) of the Blood Urea Nitrogen To Production blood urea nitrogen (BUN) to the creatinine in a blood Creatinine Ratio Measurement specimen. C74754 C67154 Laboratory Test Name Hippuric Acid Crystals CYHIPPAC Hippuric Acid Crystals A measurement of the hippuric acid crystals present in a urine Hippuric Acid Crystal Production specimen. Measurement

Covance Page 65 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74765 C67154 Laboratory Test Name Granular Coarse Casts CSGRANC Granular Coarse Casts A measurement of the coarse granular casts present in a urineCoarse Granular Cast Production specimen. Measurement C74766 C67154 Laboratory Test Name Fatty Casts CSFAT Fatty Casts A measurement of the fatty casts present in a urine specimen.Fatty Cast Measurement Production

C74767 C67154 Laboratory Test Name Fine Granular Casts FGRANCS Fine Granular Casts A measurement of the fine granular casts present in a urine Fine Granular Cast MeasurementProduction specimen. C74768 C67154 Laboratory Test Name Granular Casts CSGRAN Granular Casts A measurement of the granular (course and fine) casts presenGranular Cast Measurement Production in a urine specimen. C74769 C67154 Laboratory Test Name Granular Fine Casts CSGRANF Granular Fine Casts A measurement of the fine granular casts present in a urine Granular Fine Cast MeasurementProduction specimen. C74770 C67154 Laboratory Test Name Hyaline Casts CSHYAL Hyaline Casts A measurement of the hyaline casts present in a urine Hyaline Cast Measurement Production specimen. C74771 C67154 Laboratory Test Name Mixed Casts CSMIX Mixed Casts A measurement of the mixed (the cast contains a mixture of Mixed Cast Count Production cell types) casts present in a urine specimen. C74772 C67154 Laboratory Test Name RBC Casts CSRBC RBC Casts A measurement of the red blood cell casts present in a urine Red Blood Cell Cast Production specimen. Measurement C74773 C67154 Laboratory Test Name Squamous Epithelial Cells EPISQCE Squamous Epithelial Cells A measurement of the squamous epithelial cells present in a Squamous Epithelial Cell Count Production urine specimen. C74774 C67154 Laboratory Test Name Squamous Transitional Epithelial EPISQTCE Squamous Transitional A measurement of the squamous transitional epithelial cells Squamous Transitional Epithelial Production Cells Epithelial Cells; Epithelial Cells present in a urine specimen. Cell Count

C74775 C67154 Laboratory Test Name Tubular Epithelial Cells EPITUCE Tubular Epithelial Cells A measurement of the tubular epithelial cells present in a urineTubular Epithelial Cell Count Production specimen. C74776 C67154 Laboratory Test Name Unclassified Casts CSUNCLA Unclassified Casts A measurement of the unclassifiable casts present in a urine Unclassified Cast Measurement Production specimen. C74777 C67154 Laboratory Test Name Waxy Casts CSWAX Waxy Casts A measurement of the waxy casts present in a urine Waxy Cell Cast Measurement Production specimen. C74778 C67154 Laboratory Test Name WBC Casts CSWBC WBC Casts A measurement of the white blood cell casts present in a urineWhite Blood Cell Cast Production specimen. Measurement C74779 C67154 Laboratory Test Name Epithelial Casts CSEPI Epithelial Casts A measurement of the epithelial cell casts present in a urine Epithelial-Cast Measurement Production specimen. C74780 C67154 Laboratory Test Name Adrenocorticotropic Hormone ACTH Adrenocorticotropic Hormone A measurement of the adrenocorticotropic hormone in a Adrenocorticotropic Hormone Production biological specimen. Measurement C74781 C67154 Laboratory Test Name Cortisol CORTISOL Cortisol A measurement of the cortisol in a biological specimen. Cortisol Measurement Production C74782 C67154 Laboratory Test Name Estradiol ESTRDIOL Estradiol A measurement of the estradiol in a biological specimen. Estradiol Measurement Production C74783 C67154 Laboratory Test Name Follicle Stimulating Hormone FSH Follicle Stimulating Hormone A measurement of the follicle stimulating hormone (FSH) in a Follicle Stimulating Hormone Production biological specimen. Measurement C74784 C67154 Laboratory Test Name Parathyroid Hormone, Fragmented PTHFG Parathyroid Hormone, A measurement of the fragmented parathyroid hormone in a Fragmented Parathyroid Production Fragmented biological specimen. Hormone Measurement C74785 C67154 Laboratory Test Name Testosterone, Free TESTOSFR Testosterone, Free A measurement of the free testosterone in a biological Free Testosterone Measurement Production specimen. C74786 C67154 Laboratory Test Name Thyroxin, Free T4FR Thyroxin, Free; Free T4 A measurement of the free thyroxine in a biological specimen. Free Thyroxine Measurement Production

C74787 C67154 Laboratory Test Name Triiodothyronine, Free T3FR Triiodothyronine, Free; Free A measurement of the free triiodothyronine in a biological Free Triiodothyronine Production T3 specimen. Measurement C74788 C67154 Laboratory Test Name Insulin INSULIN Insulin A measurement of the insulin in a biological specimen. Insulin Measurement Production C74789 C67154 Laboratory Test Name Parathyroid Hormone, Intact PTHI Parathyroid Hormone, Intact A measurement of the intact parathyroid hormone in a Intact Parathyroid Hormone Production biological specimen. Measurement C74790 C67154 Laboratory Test Name Luteinizing Hormone LH Luteinizing Hormone A measurement of the luteinizing hormone in a biological Luteinizing Hormone Production specimen. Measurement C74791 C67154 Laboratory Test Name Progesterone PROGEST Progesterone A measurement of the progesterone hormone in a biological Progesterone Measurement Production specimen. C74792 C67154 Laboratory Test Name Somatotropin SOMATRO Somatotropin; Growth A measurement of the somatotropin (growth) hormone in a Somatotropin Measurement Production Hormone; biological specimen. C74793 C67154 Laboratory Test Name Testosterone TESTOS Testosterone A measurement of the total (free and bound) testosterone in a Total Testosterone Measurement Production biological specimen. C74794 C67154 Laboratory Test Name Thyroxine T4 Thyroxine A measurement of the total (free and bound) thyroxine in a Total Thyroxine Measurement Production biological specimen. C74796 C67154 Laboratory Test Name Opiate OPIATE Opiate A measurement of any opiate class drug present in a Opiate Measurement Production biological specimen. C74910 C67154 Laboratory Test Name Lymphoma Cells/Lymphocytes LYMMCELY Lymphoma Cells/Lymphocytes A relative measurement (ratio or percentage) of the malignant Lymphoma Cell to Lymphocyte Production lymphocytes to all lymphocytes in a biological specimen. Ratio Measurement

C74911 C67154 Laboratory Test Name Mature Plasma Cells/Lymphocytes PLSMCELY Mature Plasma A relative measurement (ratio or percentage) of the mature Mature Plasma Cell to Production Cells/Lymphocytes plasma cells (plasmacytes) to all lymphocytes in a biological Lymphocyte Ratio Measurement specimen. C74912 C67154 Laboratory Test Name Acid Urate Crystals CYACIDU Acid Urate Crystals A measurement of the ammonium acid urate crystals present Acid Urate Crystal Measurement Production in a biological specimen. C74913 C67154 Laboratory Test Name Anti-Double Stranded DNA ADSDNA Anti-Double Stranded DNA A measurement of the anti-double stranded DNA antibody in aAnti-Double Stranded DNA Production biological specimen. Measurement C74916 C67154 Laboratory Test Name Antinuclear Antibodies ANA Antinuclear Antibodies A measurement of the antinuclear antibodies (antibodies that Antinuclear Antibody Production attack the body's own tissue) in a biological specimen. Measurement C79437 C67154 Laboratory Test Name 5 Prime Nucleotidase NCTD5P 5 Prime Nucleotidase, 5'- A measurement of the 5'-nucleotidase in a biological 5 Prime Nucleotidase Production Ribonucleotide specimen. Measurement Phosphohydrolase C74876 C67154 Laboratory Test Name 6-Monoacetylmorphine SIXMAM 6-Monoacetylmorphine A measurement of the 6-monoacetylmorphine present in a 6-Monoacetylmorphine Production biological specimen. Measurement

Covance Page 66 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

C74848 C67154 Laboratory Test Name Calcitonin CLCTONN Calcitonin A measurement of the calcitonin hormone in a biological Calcitonin Measurement Production specimen. C74849 C67154 Laboratory Test Name Calcitriol CLCTRIOL Calcitriol A measurement of the calcitriol hormone in a biological Calcitriol Measurement Production specimen. C79439 C67154 Laboratory Test Name Calcium/Creatinine CACREAT Calcium/Creatinine A relative measurement (ratio or percentage) of the calcium to Calcium to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79440 C67154 Laboratory Test Name Chloride/Creatinine CLCREAT Chloride/Creatinine A relative measurement (ratio or percentage) of the chloride to Chloride to Creatinine Ratio Production creatinine in a biological specimen. Measurement C74850 C67154 Laboratory Test Name Cholecystokinin CCK Cholecystokinin, A measurement of the cholecystokinin hormone in a biological Cholecystokinin Measurement Production Pancreozymin specimen. C74877 C67154 Laboratory Test Name Codeine CODEINE Codeine A measurement of the codeine present in a biological Codeine Measurement Production specimen. C79434 C67154 Laboratory Test Name Corticosterone CRTRONE Corticosterone A measurement of corticosterone in a biological specimen. Corticosterone Measurement Production C74851 C67154 Laboratory Test Name Corticotropin Releasing Hormone CRH Corticotropin Releasing A measurement of the corticotropin releasing hormone in a Corticotropin Releasing Hormone Production Hormone, Corticotropin biological specimen. Measurement Releasing Factor C79466 C67154 Laboratory Test Name Creatine Kinase BB/Total Creatine CKBBCK Creatine Kinase BB/Total A relative measurement (ratio or percentage) of the BB-type Creatine Kinase BB to Total Production Kinase Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement C79441 C67154 Laboratory Test Name Creatine Kinase MB/Total Creatine CKMBCK Creatine Kinase MB/Total A relative measurement (ratio or percentage) of the MB-type Creatine Kinase MB to Total Production Kinase Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement C79442 C67154 Laboratory Test Name Creatine Kinase MM/Total Creatine CKMMCK Creatine Kinase MM/Total A relative measurement (ratio or percentage) of the MM-type Creatine Kinase MM to Total Production Kinase Creatine Kinase creatine kinase to total creatine kinase in a biological Creatine Kinase Ratio specimen. Measurement C74852 C67154 Laboratory Test Name Dehydroepiandrosterone DHEA Dehydroepiandrosterone, A measurement of the dehydroepiandrosterone hormone in a Dehydroepiandrosterone Production Dehydroisoandrosterone biological specimen. Measurement C79443 C67154 Laboratory Test Name Deoxypyridinoline DPD Deoxypyridinoline A measurement of the deoxypyridinoline in a biological Deoxypyridinoline Measurement Production specimen. C79444 C67154 Laboratory Test Name Deoxypyridinoline/Creatinine DPDCREAT Deoxypyridinoline/Creatinine A relative measurement (ratio or percentage) of the Deoxypyridinoline to Creatinine Production deoxypyridinoline to creatinine in a biological specimen. Ratio Measurement C74878 C67154 Laboratory Test Name Dihydrocodeine DIHYDCDN Dihydrocodeine A measurement of the dihydrocodeine present in a biological Dihydrocodeine Measurement Production specimen. C74853 C67154 Laboratory Test Name Dihydrotestosterone DHT Dihydrotestosterone, A measurement of the dihydrotestosterone hormone in a Dihydrotestosterone Measurement Production Androstanalone biological specimen. C74854 C67154 Laboratory Test Name Dopamine DOPAMINE Dopamine A measurement of the dopamine hormone in a biological Dopamine Measurement Production specimen. C79445 C67154 Laboratory Test Name Epinephrine EPIN Epinephrine, Adrenaline A measurement of the epinephrine hormone in a biological Epinephrine Measurement Production specimen. C74855 C67154 Laboratory Test Name Erythropoietin EPO Erythropoietin, Hematopoietin A measurement of the erythropoietin hormone in a biological Erythropoietin Measurement Production specimen. C74856 C67154 Laboratory Test Name Estriol ESTRIOL Estriol, Oestriol A measurement of the estriol hormone in a biological Estriol Measurement Production specimen. C74857 C67154 Laboratory Test Name Estrone ESTRONE Estrone, Oestrone A measurement of the estrone hormone in a biological Estrone Measurement Production specimen. C74693 C67154 Laboratory Test Name Ethanol ETHANOL Ethanol, Alcohol A measurement of the ethanol present in a biological Ethanol Measurement Production specimen. C79446 C67154 Laboratory Test Name Gamma Glutamyl GGTCREAT Gamma Glutamyl A relative measurement (ratio or percentage) of the gamma Gamma Glutamyl Transferase to Production Transferase/Creatinine Transferase/Creatinine glutamyl transferase to creatinine in a biological specimen. Creatinine Ratio Measurement

C74858 C67154 Laboratory Test Name Gastrin GASTRIN Gastrin A measurement of the gastrin hormone in a biological Gastrin Measurement Production specimen. C74859 C67154 Laboratory Test Name Glucagon GLUCAGON Glucagon A measurement of the glucagon hormone in a biological Glucagon Measurement Production specimen. C79447 C67154 Laboratory Test Name Glucose/Creatinine GLUCCRT Glucose/Creatinine A relative measurement (ratio or percentage) of the glucose to Glucose to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79448 C67154 Laboratory Test Name Glutamate Dehydrogenase GLDH Glutamate Dehydrogenase A measurement of the glutamate dehydrogenase in a Glutamate Dehydrogenase Production biological specimen. Measurement

Covance Page 67 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C79435 C67154 Laboratory Test Name Glutathione-S-Transferase/CreatinineGSTCREAT Glutathione-S- A relative measurement (ratio or percentage) of the glutathion Glutathione-S-Transferase to Production Transferase/Creatinine S-transferase to creatinine in a biological specimen. Creatinine Ratio Measurement

C74860 C67154 Laboratory Test Name Gonadotropin Releasing Hormone GNRH Gonadotropin Releasing A measurement of the gonadotropin releasing hormone in a Gonadotropin Releasing Hormone Production Hormone, Luteinising biological specimen. Measurement Hormone Releasing Hormone C74861 C67154 Laboratory Test Name Growth Hormone Inhibiting Hormone GRWHIH Growth Hormone Inhibiting A measurement of the growth hormone inhibiting hormone in Growth Hormone Inhibiting Production Hormone, Somatostatin a biological specimen. Hormone Measurement C75386 C67154 Laboratory Test Name Growth Hormone GRWH Growth Hormone, A measurement of the growth hormone in a biological Growth Hormone Measurement Production Somatotropin specimen. C74862 C67154 Laboratory Test Name Growth Hormone Releasing GRWHRH Growth Hormone Releasing A measurement of the growth hormone releasing hormone in Growth Hormone Releasing Production Hormone Hormone, Somatocrinin a biological specimen. Hormone Measurement C74863 C67154 Laboratory Test Name Homovanillic Acid HVA Homovanillic Acid A measurement of the homovanillic acid metabolite in a Homovanillic Acid Measurement Production biological specimen. C74879 C67154 Laboratory Test Name Hydrocodone HYDCDN Hydrocodone A measurement of the hydrocodone present in a biological Hydrocodone Measurement Production specimen. C74880 C67154 Laboratory Test Name Hydromorphone HYDMRPHN Hydromorphone A measurement of the hydromorphone present in a biological Hydromorphone Measurement Production specimen. C74864 C67154 Laboratory Test Name Insulin-like Growth Factor-1 IGF1 Insulin-like Growth Factor-1 A measurement of the insulin-like growth factor-1 in a Insulin Like Growth Factor-1 Production biological specimen. Measurement C74865 C67154 Laboratory Test Name Insulin-like Growth Factor-2 IGF2 Insulin-like Growth Factor-2 A measurement of the insulin-like growth factor-2 in a Insulin Like Growth Factor-2 Production biological specimen. Measurement C74805 C67154 Laboratory Test Name Interleukin 1 INTLK1 Interleukin 1 A measurement of the interleukin 1 in a biological specimen. Interleukin 1 Measurement Production C74806 C67154 Laboratory Test Name Interleukin 10 INTLK10 Interleukin 10 A measurement of the interleukin 10 in a biological specimen. Interleukin 10 Measurement Production C74807 C67154 Laboratory Test Name Interleukin 11 INTLK11 Interleukin 11 A measurement of the interleukin 11 in a biological specimen. Interleukin 11 Measurement Production C74808 C67154 Laboratory Test Name Interleukin 12 INTLK12 Interleukin 12 A measurement of the interleukin 12 in a biological specimen. Interleukin 12 Measurement Production C74809 C67154 Laboratory Test Name Interleukin 13 INTLK13 Interleukin 13 A measurement of the interleukin 13 in a biological specimen. Interleukin 13 Measurement Production C74810 C67154 Laboratory Test Name Interleukin 14 INTLK14 Interleukin 14 A measurement of the interleukin 14 in a biological specimen. Interleukin 14 Measurement Production C74811 C67154 Laboratory Test Name Interleukin 15 INTLK15 Interleukin 15 A measurement of the interleukin 15 in a biological specimen. Interleukin 15 Measurement Production C74812 C67154 Laboratory Test Name Interleukin 16 INTLK16 Interleukin 16 A measurement of the interleukin 16 in a biological specimen. Interleukin 16 Measurement Production C74813 C67154 Laboratory Test Name Interleukin 17 INTLK17 Interleukin 17 A measurement of the interleukin 17 in a biological specimen. Interleukin 17 Measurement Production C74814 C67154 Laboratory Test Name Interleukin 18 INTLK18 Interleukin 18 A measurement of the interleukin 18 in a biological specimen. Interleukin 18 Measurement Production C74815 C67154 Laboratory Test Name Interleukin 19 INTLK19 Interleukin 19 A measurement of the interleukin 19 in a biological specimen. Interleukin 19 Measurement Production C74816 C67154 Laboratory Test Name Interleukin 2 INTLK2 Interleukin 2 A measurement of the interleukin 2 in a biological specimen. Interleukin 2 Measurement Production C74817 C67154 Laboratory Test Name Interleukin 20 INTLK20 Interleukin 20 A measurement of the interleukin 20 in a biological specimen. Interleukin 20 Measurement Production C74818 C67154 Laboratory Test Name Interleukin 21 INTLK21 Interleukin 21 A measurement of the interleukin 21 in a biological specimen. Interleukin 21 Measurement Production C74819 C67154 Laboratory Test Name Interleukin 22 INTLK22 Interleukin 22 A measurement of the interleukin 22 in a biological specimen. Interleukin 22 Measurement Production C74820 C67154 Laboratory Test Name Interleukin 23 INTLK23 Interleukin 23 A measurement of the interleukin 23 in a biological specimen. Interleukin 23 Measurement Production C74821 C67154 Laboratory Test Name Interleukin 24 INTLK24 Interleukin 24 A measurement of the interleukin 24 in a biological specimen. Interleukin 24 Measurement Production C74822 C67154 Laboratory Test Name Interleukin 25 INTLK25 Interleukin 25 A measurement of the interleukin 25 in a biological specimen. Interleukin 25 Measurement Production C74823 C67154 Laboratory Test Name Interleukin 26 INTLK26 Interleukin 26 A measurement of the interleukin 26 in a biological specimen. Interleukin 26 Measurement Production C74824 C67154 Laboratory Test Name Interleukin 27 INTLK27 Interleukin 27 A measurement of the interleukin 27 in a biological specimen. Interleukin 27 Measurement Production C74825 C67154 Laboratory Test Name Interleukin 28 INTLK28 Interleukin 28 A measurement of the interleukin 28 in a biological specimen. Interleukin 28 Measurement Production C74826 C67154 Laboratory Test Name Interleukin 29 INTLK29 Interleukin 29 A measurement of the interleukin 29 in a biological specimen. Interleukin 29 Measurement Production C74827 C67154 Laboratory Test Name Interleukin 3 INTLK3 Interleukin 3 A measurement of the interleukin 3 in a biological specimen. Interleukin 3 Measurement Production C74828 C67154 Laboratory Test Name Interleukin 30 INTLK30 Interleukin 30 A measurement of the interleukin 30 in a biological specimen. Interleukin 30 Measurement Production C74829 C67154 Laboratory Test Name Interleukin 31 INTLK31 Interleukin 31 A measurement of the interleukin 31 in a biological specimen. Interleukin 31 Measurement Production C74830 C67154 Laboratory Test Name Interleukin 32 INTLK32 Interleukin 32 A measurement of the interleukin 32 in a biological specimen. Interleukin 32 Measurement Production C74831 C67154 Laboratory Test Name Interleukin 33 INTLK33 Interleukin 33 A measurement of the interleukin 33 in a biological specimen. Interleukin 33 Measurement Production C74832 C67154 Laboratory Test Name Interleukin 4 INTLK4 Interleukin 4 A measurement of the interleukin 4 in a biological specimen. Interleukin 4 Measurement Production C74833 C67154 Laboratory Test Name Interleukin 5 INTLK5 Interleukin 5 A measurement of the interleukin 5 in a biological specimen. Interleukin 5 Measurement Production C74834 C67154 Laboratory Test Name Interleukin 6 INTLK6 Interleukin 6 A measurement of the interleukin 6 in a biological specimen. Interleukin 6 Measurement Production C74835 C67154 Laboratory Test Name Interleukin 7 INTLK7 Interleukin 7 A measurement of the interleukin 7 in a biological specimen. Interleukin 7 Measurement Production C74836 C67154 Laboratory Test Name Interleukin 8 INTLK8 Interleukin 8 A measurement of the interleukin 8 in a biological specimen. Interleukin 8 Measurement Production C74837 C67154 Laboratory Test Name Interleukin 9 INTLK9 Interleukin 9 A measurement of the interleukin 9 in a biological specimen. Interleukin 9 Measurement Production C74887 C67154 Laboratory Test Name LDH Isoenzyme 1 LDH1 LDH Isoenzyme 1 A measurement of the lactate dehydrogenase isoenzyme 1 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 1 Measurement C74888 C67154 Laboratory Test Name LDH Isoenzyme 2 LDH2 LDH Isoenzyme 2 A measurement of the lactate dehydrogenase isoenzyme 2 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 2 Measurement C74889 C67154 Laboratory Test Name LDH Isoenzyme 3 LDH3 LDH Isoenzyme 3 A measurement of the lactate dehydrogenase isoenzyme 3 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 3 Measurement C74890 C67154 Laboratory Test Name LDH Isoenzyme 4 LDH4 LDH Isoenzyme 4 A measurement of the lactate dehydrogenase isoenzyme 4 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 4 Measurement C74891 C67154 Laboratory Test Name LDH Isoenzyme 5 LDH5 LDH Isoenzyme 5 A measurement of the lactate dehydrogenase isoenzyme 5 in Lactate Dehydrogenase Isoenzyme Production a biological specimen. 5 Measurement C79449 C67154 Laboratory Test Name Lactate Dehydrogenase/Creatinine LDHCREAT Lactate A relative measurement (ratio or percentage) of the lactate Lactate Dehydrogenase to Production Dehydrogenase/Creatinine dehydrogenase to creatinine in a biological specimen. Creatinine Ratio Measurement C79450 C67154 Laboratory Test Name Lactic Acid LACTICAC Lactic Acid, 2- A measurement of the lactic acid in a biological specimen. Lactic Acid Measurement Production hydroxypropanoic acid, Lactate

C79467 C67154 Laboratory Test Name Large Unstained Cells/Leukocytes LGLUCLE Large Unstained A relative measure (ratio or percentage) of the large unstained Large Unstained Cells to Production Cells/Leukocytes cells to leukocytes in a biological specimen. Leukocytes Ratio Measurement C79451 C67154 Laboratory Test Name LDH Isoenzyme 1/LDH LDH1LDH LDH Isoenzyme 1/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 1 to LDH Ratio Production dehydrogenase isoenzyme 1 to total lactate dehydrogenase in Measurement a biological specimen. C79452 C67154 Laboratory Test Name LDH Isoenzyme 2/LDH LDH2LDH LDH Isoenzyme 2/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 2 to LDH Ratio Production dehydrogenase isoenzyme 2 to total lactate dehydrogenase in Measurement a biological specimen. C79453 C67154 Laboratory Test Name LDH Isoenzyme 3/LDH LDH3LDH LDH Isoenzyme 3/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 3 to LDH Ratio Production dehydrogenase isoenzyme 3 to total lactate dehydrogenase in Measurement a biological specimen. C79454 C67154 Laboratory Test Name LDH Isoenzyme 4/LDH LDH4LDH LDH Isoenzyme 4/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 4 to LDH Ratio Production dehydrogenase isoenzyme 4 to total lactate dehydrogenase in Measurement a biological specimen. C79455 C67154 Laboratory Test Name LDH Isoenzyme 5/LDH LDH5LDH LDH Isoenzyme 5/LDH A relative measurement (ratio or percentage) of the lactate LDH Isoenzyme 5 to LDH Ratio Production dehydrogenase isoenzyme 5 to total lactate dehydrogenase in Measurement a biological specimen. C74866 C67154 Laboratory Test Name Leptin LEPTIN Leptin A measurement of the leptin hormone in a biological Leptin Measurement Production specimen. C79456 C67154 Laboratory Test Name Magnesium/Creatinine MGCREAT Magnesium/Creatinine A relative measurement (ratio or percentage) of the Magnesium to Creatinine Ratio Production magnesium to creatinine in a biological specimen. Measurement C74867 C67154 Laboratory Test Name Melatonin MLATONIN Melatonin A measurement of the melatonin hormone in a biological Melatonin Measurement Production specimen. C74881 C67154 Laboratory Test Name Methadone METHDN Methadone A measurement of the methadone present in a biological Methadone Measurement Production specimen.

Covance Page 68 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C74882 C67154 Laboratory Test Name Methaqualone METHQLDN Methaqualone A measurement of the methaqualone present in a biological Methaqualone Measurement Production specimen. C74883 C67154 Laboratory Test Name Morphine MORPHINE Morphine A measurement of the morphine present in a biological Morphine Measurement Production specimen. C79457 C67154 Laboratory Test Name Mu Glutathione-S-Transferase GSTMU Mu Glutathione-S-Transferase A measurement of the mu form of glutathione S-transferase in Mu Glutathione-S-Transferase Production a biological specimen. Measurement C79458 C67154 Laboratory Test Name Mu Glutathione-S- GSTMUCRT Mu Glutathione-S- A relative measurement (ratio or percentage) of the mu Mu Glutathione-S-Transferase to Production Transferase/Creatinine Transferase/Creatinine gamma glutamyl transpeptidase to creatinine in a biological Creatinine Ratio Measurement specimen. C79436 C67154 Laboratory Test Name Myoglobin MGB Myoglobin A measurement of myoglobin in a biological specimen. Myoglobin Measurement Production C79459 C67154 Laboratory Test Name N-Acetyl Glucosamide NAG N-Acetyl Glucosamide, N- A measurement of N-acetyl glucosamide in a biological N-Acetyl Glucosamide Production Acetyl Glucosamine specimen. Measurement C79460 C67154 Laboratory Test Name N-Acetyl Glucosamide/Creatinine NAGCREAT N-Acetyl A relative measurement (ratio or percentage) of the N-acetyl N-Acetyl Glucosamide to Production Glucosamide/Creatinine glucosamide to creatinine in a biological specimen. Creatinine Ratio Measurement C74892 C67154 Laboratory Test Name Neuropeptide Y NPY Neuropeptide Y A measurement of the neuropeptide Y in a biological Neuropeptide Y Measurement Production specimen. C74868 C67154 Laboratory Test Name Norepinephrine NOREPIN Norepinephrine, Noradrenaline A measurement of the norepinephrine hormone in a biological Noradrenaline Measurement Production specimen. C74801 C67154 Laboratory Test Name Osmolality OSMLTY Osmolality A measurement of the osmoles of solute per unit of biological Osmolality Measurement Production specimen. C74884 C67154 Laboratory Test Name Oxycodone OXYCDN Oxycodone, Oxycontin A measurement of the oxycodone present in a biological Oxycodone Measurement Production specimen. C74869 C67154 Laboratory Test Name Oxytocin OXYTOCIN Oxytocin, Oxytoxin A measurement of the oxytocin hormone in a biological Oxytocin Measurement Production specimen. C74694 C67154 Laboratory Test Name Phencyclidine PCP Phencyclidine, A measurement of the phencyclidine present in a biological Phencyclidine Measurement Production Phenylcyclohexylpiperidine specimen. C74695 C67154 Laboratory Test Name Phenothiazine PHENTHZ Phenothiazine, A measurement of the phenothiazine present in a biological Phenothiazine Measurement Production Dibenzothiazine specimen. C79461 C67154 Laboratory Test Name Phosphate/Creatinine PHOSCRT Phosphate/Creatinine A relative measurement (ratio or percentage) of the phosphatePhosphate to Creatinine Ratio Production to creatinine in a biological specimen. Measurement C79462 C67154 Laboratory Test Name Potassium/Creatinine KCREAT Potassium/Creatinine A relative measurement (ratio or percentage) of the potassium Potassium to Creatinine Ratio Production to creatinine in a biological specimen. Measurement C74870 C67154 Laboratory Test Name Prolactin PROLCTN Prolactin A measurement of the prolactin hormone in a biological Prolactin Measurement Production specimen. C74885 C67154 Laboratory Test Name Propoxyphene PROPOX Propoxyphene A measurement of the propoxyphene present in a biological Propoxyphene Measurement Production specimen. C79463 C67154 Laboratory Test Name Protein/Creatinine PROTCRT Protein/Creatinine A relative measurement (ratio or percentage) of the protein to Protein to Creatinine Ratio Production creatinine in a biological specimen. Measurement C74696 C67154 Laboratory Test Name Pseudoephedrine PSDEPHD Pseudoephedrine A measurement of the pseudoephedrine present in a biologicaPseudoephedrine Measurement Production specimen. C74629 C67154 Laboratory Test Name Reactive Lymphocytes LYMRCT Reactive Lymphocytes A measurement of the reactive lymphocytes (lymphocytes Reactive Lymphocyte Count Production which have become large due to an antigen reaction) in a Measurement biological specimen. C74893 C67154 Laboratory Test Name Renin RENIN Renin, Angiotensinogenase A measurement of the renin in a biological specimen. Renin Measurement Production C74871 C67154 Laboratory Test Name Secretin SECRETIN Secretin A measurement of the secretin hormone in a biological Secretin Measurement Production specimen. C74872 C67154 Laboratory Test Name Serotonin SRTONIN Serotonin A measurement of the serotonin hormone in a biological Serotonin Measurement Production specimen. C79464 C67154 Laboratory Test Name Sodium/Creatinine NACREAT Sodium/Creatinine A relative measurement (ratio or percentage) of the sodium to Sodium to Creatinine Ratio Production creatinine in a biological specimen. Measurement C79465 C67154 Laboratory Test Name Sorbitol Dehydrogenase SDH Sorbitol Dehydrogenase A measurement of the sorbitol dehydrogenase in a biological Sorbitol Dehydrogenase Production specimen. Measurement C74873 C67154 Laboratory Test Name Thrombopoietin THRMPTN Thrombopoietin A measurement of the thrombopoietin hormone in a biological Thrombopoietin Measurement Production specimen. C74874 C67154 Laboratory Test Name Thyrotropin Releasing Hormone TRH Thyrotropin Releasing A measurement of the thyrotropin releasing hormone in a Thyrotropin Releasing Hormone Production Hormone, Thyrotropin biological specimen. Measurement Releasing Factor C74875 C67154 Laboratory Test Name Vanillyl Mandelic Acid VMA Vanillyl Mandelic Acid, A measurement of the vanillyl mandelic acid metabolite in a Vanillyl Mandelic Acid Measurement Production Vanilmandelic Acid biological specimen. C74895 C67154 Laboratory Test Name Vitamin A VITA Vitamin A, Retinol A measurement of the Vitamin A in a biological specimen. Vitamin A Measurement Production C74896 C67154 Laboratory Test Name Thiamine VITB1 Thiamine, Vitamin B1 A measurement of the thiamine in a biological specimen. Vitamin B1 Measurement Production C74897 C67154 Laboratory Test Name Vitamin B17 VITB17 Vitamin B17, Amygdalin A measurement of the Vitamin B17 in a serum specimen. Vitamin B17 Measurement Production C74898 C67154 Laboratory Test Name Riboflavin VITB2 Riboflavin, Vitamin B2 A measurement of the riboflavin in a biological specimen. Vitamin B2 Measurement Production C74899 C67154 Laboratory Test Name Niacin VITB3 Niacin, Vitamin B3 A measurement of the niacin in a biological specimen. Vitamin B3 Measurement Production C74900 C67154 Laboratory Test Name Vitamin B5 VITB5 Vitamin B5, Pantothenic Acid A measurement of the Vitamin B5 in a biological specimen. Vitamin B5 Measurement Production C74901 C67154 Laboratory Test Name Vitamin B6 VITB6 Vitamin B6, Pyridoxine A measurement of the Vitamin B6 in a biological specimen. Vitamin B6 Measurement Production C74902 C67154 Laboratory Test Name Vitamin B7 VITB7 Vitamin B7, Biotin A measurement of the Vitamin B7 in a biological specimen. Vitamin B7 Measurement Production C74903 C67154 Laboratory Test Name Vitamin C VITC Vitamin C, Ascorbic Acid A measurement of the Vitamin C in a biological specimen. Vitamin C Measurement Production C74904 C67154 Laboratory Test Name Vitamin D2 VITD2 Vitamin D2, Ergocalciferol A measurement of the Vitamin D2 in a biological specimen. Vitamin D2 Measurement Production C74905 C67154 Laboratory Test Name Vitamin D3 VITD3 Vitamin D3, Cholecalciferol A measurement of the Vitamin D3 in a biological specimen. Vitamin D3 Measurement Production C74906 C67154 Laboratory Test Name Vitamin E VITE Vitamin E, Tocopherol A measurement of the Vitamin E in a biological specimen. Vitamin E Measurement Production C74907 C67154 Laboratory Test Name Vitamin K VITK Vitamin K, Naphthoquinone A measurement of the Vitamin K in a biological specimen. Vitamin K Measurement Production C74720 C67154 Laboratory Test Name Volume VOLUME Volume A measurement of the volume of a biological specimen. Volume Measurement Production C71113 Yes Frequency FREQ FREQ Frequency The terminology that includes terms pertaining to frequency CDISC SDTM Frequency Production within CDISC. Terminology C17649 C71113 Frequency OTHER OTHER Other Different than the one(s) previously specified or mentioned. Other Production (NCI) C17998 C71113 Frequency UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C53279 C71113 Frequency CONTINUOUS CONTINUOUS Continuous Remain in force or carry on without letup; keep or maintain in Continue Production unaltered condition; exist in time or space without stop or interruption. (NCI) C64496 C71113 Frequency BID BID Twice per day Two times per day, at unspecified times. (NCI) Twice Daily Production C64497 C71113 Frequency BIS BIS Twice per week Two times per week. (NCI) Twice Weekly Production C64498 C71113 Frequency QM QM Every Month Every month. (NCI) Monthly Production C64499 C71113 Frequency PRN PRN As needed As needed. (NCI) As Necessary Production C64500 C71113 Frequency Q10H Q10H Every 10 hours Every ten hours. (NCI) Every Ten Hours Production C64501 C71113 Frequency Q11H Q11H Every 11 hours Every eleven hours. (NCI) Every Eleven Hours Production C64502 C71113 Frequency Q12H Q12H Every 12 hours Every twelve hours. (NCI) Every Twelve Hours Production C64503 C71113 Frequency Q13H Q13H Every 13 hours Every thirteen hours. (NCI) Every Thirteen Hours Production C64504 C71113 Frequency Q14H Q14H Every 14 hours Every fourteen hours. (NCI) Every Fourteen Hours Production C64505 C71113 Frequency Q15H Q15H Every 15 hours Every fifteen hours. (NCI) Every Fifteen Hours Production C64506 C71113 Frequency Q16H Q16H Every 16 hours Every sixteen hours. (NCI) Every Sixteen Hours Production C64507 C71113 Frequency Q17H Q17H Every 17 hours Every seventeen hours. (NCI) Every Seventeen Hours Production C64508 C71113 Frequency Q18H Q18H Every 18 hours Every eighteen hours. (NCI) Every Eighteen Hours Production C64509 C71113 Frequency Q19H Q19H Every 19 hours Every nineteen hours. (NCI) Every Nineteen Hours Production C64510 C71113 Frequency QH QH Every hour Every hour. (NCI) Every Hour Production

Covance Page 69 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64511 C71113 Frequency Q20H Q20H Every 20 hours Every twenty hours. (NCI) Every Twenty Hours Production C64512 C71113 Frequency Q21H Q21H Every 21 hours Every twenty-one hours. (NCI) Every Twenty-One Hours Production C64513 C71113 Frequency Q22H Q22H Every 22 hours Every twenty-two hours. (NCI) Every Twenty-Two Hours Production C64514 C71113 Frequency Q23H Q23H Every 23 hours Every twenty-three hours. (NCI) Every Twenty-Three Hours Production C64515 C71113 Frequency Q24H Q24H Every 24 hours Every twenty-four hours. (NCI) Every Twenty-Four Hours Production C64516 C71113 Frequency Q2H Q2H Every 2 hours Every two hours. (NCI) Every Two Hours Production C64517 C71113 Frequency Q3H Q3H Every 3 hours Every three hours. (NCI) Every Three Hours Production C64518 C71113 Frequency Q4H Q4H Every 4 hours Every four hours. (NCI) Every Four Hours Production C64519 C71113 Frequency Q5H Q5H Every 5 hours Every five hours. (NCI) Every Five Hours Production C64520 C71113 Frequency Q6H Q6H Every 6 hours Every six hours. (NCI) Every Six Hours Production C64521 C71113 Frequency Q7H Q7H Every 7 hours Every seven hours. (NCI) Every Seven Hours Production C64523 C71113 Frequency Q8H Q8H Every 8 hours Every eight hours. (NCI) Every Eight Hours Production C64524 C71113 Frequency Q9H Q9H Every 9 hours Every nine hours. (NCI) Every Nine Hours Production C64525 C71113 Frequency QOD QOD Every other day Every other day. (NCI) Every Other Day Production C64527 C71113 Frequency TID TID 3 times per day Three times per day. (NCI) Three Times Daily Production C64528 C71113 Frequency TIS TIS Three times a week Three times per week. (NCI) Three Times Weekly Production C64529 C71113 Frequency Q4S Q4S Every 4 weeks Every four weeks. (NCI) Every Four Weeks Production C64530 C71113 Frequency QID QID 4 times per day Four times per day. (NCI) Four Times Daily Production C64531 C71113 Frequency QIS QIS 4 times per week Four times per week. (NCI) Four Times Weekly Production C64533 C71113 Frequency Q3D Q3D Every 3 days Every three days. (NCI) Every Three Days Production C64534 C71113 Frequency Q4D Q4D Every 4 days Every four days. (NCI) Every Four Days Production C64535 C71113 Frequency Q3S Q3S Every 3 weeks Every three weeks. (NCI) Every Three Weeks Production C64536 C71113 Frequency Q2M Q2M Every two months Every two months. (NCI) Every Two Months Production C64537 C71113 Frequency Q3M Q3M Every 3 months Every three months. (NCI) Every Three Months Production C64538 C71113 Frequency Q4M Q4M Every 4 months Every four months. (NCI) Every Four Months Production C64576 C71113 Frequency ONCE ONCE Once A one time intervention. (NCI) Once Production C67069 C71113 Frequency QS QS Every week Every week. (NCI) Weekly Production C71124 C71113 Frequency Q5D Q5D Every 5 days Every five days. (NCI) Every Five Days Production C71127 C71113 Frequency Q2S Q2S Every 2 weeks. Every two weeks. (NCI) Every Two Weeks Production C71129 C71113 Frequency BIM BIM Twice per month Twice per month. (NCI) Twice Per Month Production C71325 C71113 Frequency INTERMITTENT INTERMITTENT Intermittent Periodically stoping and starting. (NCI) Intermittent Production C71148 Yes Position POSITION POSITION Position Terminology codelist used with Body Position within CDISC. CDISC SDTM Body Position Production Terminology

C62122 C71148 Position SITTING SITTING Sitting The state or act of one who sits; the posture of one who Sitting Production occupies a seat. (NCI) C62165 C71148 Position PRONE PRONE Prone An anterior recumbent body position whereby the person lies Prone Position Production on its stomach and faces downward. (NCI) C62166 C71148 Position STANDING STANDING Standing The act of assuming or maintaining an erect upright position. Standing Production (NCI) C62167 C71148 Position SUPINE SUPINE Supine A posterior recumbent body position whereby the person lies Supine Position Production on its back and faces upward. (NCI) C62168 C71148 Position TRENDELENBURG TRENDELENBURG Trendelenburg A supine position with the person inclined at an angle of 45 Trendelenburg Production degrees so that the pelvis is higher than the head. (NCI) C62169 C71148 Position REVERSE TRENDELENBURG REVERSE TRENDELENBURG Reverse Trendelenburg A supine position with the person inclined at an angle of 45 Reverse Trendelenburg Production degrees so that the head is higher than the pelvis. (NCI) C62171 C71148 Position RIGHT LATERAL DECUBITUS RIGHT LATERAL DECUBITUS Right lateral decubitus A recumbent right lateral side position. (NCI) Right Lateral Decubitus Position Production C62172 C71148 Position LEFT LATERAL DECUBITUS LEFT LATERAL DECUBITUS Left lateral decubitus A recumbent left lateral side position. (NCI) Left Lateral Decubitus Position Production C62173 C71148 Position FOWLERS FOWLERS Fowlers A semi-sitting position whereby the head of an adjustable bed Fowler's Position Production is elevated to the desired height, about 60-90 cm, to produce angulation of the body, usually 45 degrees to 60 degrees. Knees may or may not be bent. (NCI) C62174 C71148 Position SEMI-FOWLERS SEMI-FOWLERS Semi-Fowlers A semi-sitting or semi-reclined body position whereby the Semi-Fowler's Position Production head is elevated on an angle of approximately 30 degrees. (NCI) C71150 Yes ECG Result EGSTRESC EGSTRESC ECG Result Terminology codelist used with ECG Findings and CDISC SDTM ECG Finding Production Abnormalities within CDISC. Terminology C26889 C71150 ECG Result SINUS TACHYCARDIA SINUS TACHYCARDIA Sinus tachycardia A heart rate of more than 100 beats per minute, with its origin Sinus Tachycardia Production in the sinus node. (NCI) C26923 C71150 ECG Result SINUS BRADYCARDIA SINUS BRADYCARDIA Sinus bradycardia A heart rate of less than 60 beats per minute, with its origin in Sinus Bradycardia Production the sinus node. (NCI) C34786 C71150 ECG Result VENTRICULAR ARRHYTHMIA VENTRICULAR ARRHYTHMIA Ventricular arrhythmia A ventricular arrhythmia characterized by syncopal episodes Long QT Syndrome Production ASSOCIATED WITH LONG QT ASSOCIATED WITH LONG QT associated with long QT and a long QT interval, sometimes leading to sudden death SYNDROME SYNDROME syndrome due to paroxysmal ventricular arrhythmia. This arrhythmia is associated with a prolongation of repolarisation following depolarization of C34940 C71150 ECG Result PRE-EXCITATION PRE-EXCITATION Pre-excitation A condition characterized by the activation of the whole or Pre-Excitation Syndrome Production some part of the ventricle by the transmission of an atrial impulse along an accessory pathway rather than by way of the normal specific conduction system which includes a delay at the atrioventr C35058 C71150 ECG Result AV NODE RE-ENTRY AV NODE RE-ENTRY AV node re-entry A supraventricular tachycardia due to reentry along a circuit Atrioventricular Nodal Reentry Production contained within the AV node. AVNRT is the most common Tachycardia form of supraventricular tachycardia and usually presents as a narrow QRS complex tachycardia at a rate between 150 and 250 beats per minu C35059 C71150 ECG Result JUNCTIONAL TACHYCARDIA JUNCTIONAL TACHYCARDIA Junctional tachycardia An automatic tachycardia originating in the atrioventricular Junctional Tachycardia Production junction, typically arising in the conduction tissues surrounding the atrioventricular node. A junctional tachycardia tends to be a regular, narrow complex tachycardia and usually occurs during C35061 C71150 ECG Result SUPRAVENTRICULAR SUPRAVENTRICULAR Supraventricular tachycardia A generic expression for any tachycardia that originates in the Supraventricular Tachycardia Production TACHYCARDIA TACHYCARDIA atria or the atrioventricular node. (NCI) C35132 C71150 ECG Result WOLFF-PARKINSON-WHITE WOLFF-PARKINSON-WHITE Wolff-Parkinson-White A type of ventricular pre-excitation resulting from the activationWolff-Parkinson-White Production SYNDROME SYNDROME syndrome of an accessory pathway known as the Bundle of Kent. This Syndrome pathway presents an abnormal electrical communication from the atria to the ventricles. Wolff-Parkinson-White syndrome is characte C35481 C71150 ECG Result ATRIAL TACHYCARDIA ATRIAL TACHYCARDIA Atrial tachycardia Any rapid heart rhythm originating in the atria. Atrial fibrillation Atrial Tachycardia Production and atrial flutter are varieties of atrial tachycardia. Atrial tachycardia is an electrical circuit originating in the upper or atrial chambers. This electrical circuit or focus takes ov

Covance Page 70 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C50466 C71150 ECG Result ATRIAL FIBRILLATION ATRIAL FIBRILLATION Atrial fibrillation A supraventricular arrhythmia characterized by uncoordinated Atrial Fibrillation Production atrial myocardium activation due to multiple reentry circuits with consequent deterioration of atrial mechanical function. Instead of intermittently contracting, the atria quiver continuously in C50501 C71150 ECG Result 3RD DEGREE AV BLOCK 3RD DEGREE AV BLOCK 3rd degree AV block Complete failure of atrial electrical impulse conduction throughAV Block Third Degree Production the AV node to the ventricles. (NCI) C50779 C71150 ECG Result TORSADES DE POINTES TORSADES DE POINTES Torsades de pointes An atypical rapid polymorphic ventricular tachycardia with a Torsades De Pointes Production characteristic rotation of the QRS complex around the isoelectric baseline. In addition the QRS complex displays a periodic waxing and waning of amplitude on the electrogram. (NCI) C50799 C71150 ECG Result VENTRICULAR FIBRILLATION VENTRICULAR FIBRILLATION Ventricular fibrillation An arrhythmia characterized by an irregular pattern of high or Ventricular Fibrillation Production low-amplitude waves that cannot be differentiated into QRS complexes or T waves. These electrocardiographic waves occur as a result of fibrillary contractions of the ventricular muscle due to C50800 C71150 ECG Result VENTRICULAR FLUTTER VENTRICULAR FLUTTER Ventricular flutter A ventricular tachyarrhythmia characterized by a high Ventricular Flutter Production ventricular rate (180 and 250 beats per minute) with a regular rhythm. The electrocardiogram shows large oscillating sine wave-like complexes occurring as a result of QRS complexes and T waves being me C50802 C71150 ECG Result VENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA Ventricular tachycardia A tachycardia arising distal to bundle of His, with a rate Ventricular Tachycardia Production greater than 100 beats per minute. (NCI) C51224 C71150 ECG Result ATRIAL FLUTTER ATRIAL FLUTTER Atrial flutter An electrocardiographic finding of an organized rhythmic Atrial Flutter Production contraction of the atria which generally at a rate of 200-300 beats per minute. (NCI) C61395 C71150 ECG Result R ON T PHENOMENON R ON T PHENOMENON R on T phenomenon An electrocardiographic finding phenomena in which the R R On T Phenomenon Production wave occurs on top of the T wave; this can trigger ventricular fibrillation or ventricular tachycardia. (NCI) C62015 C71150 ECG Result 1ST DEGREE AV BLOCK 1ST DEGREE AV BLOCK 1st degree AV block A delay in the time required for the conduction of an electrical AV Block First Degree Production impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval beyond 200 milliseconds. (NCI) C62016 C71150 ECG Result 2ND DEGREE AV BLOCK 2ND DEGREE AV BLOCK 2nd degree AV block Intermittent failure of atrial electrical impulse conduction AV Block Second Degree Production through the atrioventricular (AV) node to the ventricles. (NCI) C62234 C71150 ECG Result VENTRICULAR TACHYCARDIA, VENTRICULAR TACHYCARDIA, Ventricular tachycardia, A ventricular tachycardia in which the ventricular activation Monomorphic Ventricular Production MONOMORPHIC MONOMORPHIC monomorphic sequence is constant. The morphology of the Tachycardia electrocardiographic waveform is unchanging and is referred to as monomorphic. (NCI) C62236 C71150 ECG Result VENTRICULAR TACHYCARDIA, VENTRICULAR TACHYCARDIA, Ventricular tachycardia, A ventricular tachycardia in which the ventricular activation Polymorphic Ventricular Production POLYMORPHIC POLYMORPHIC polymorphic sequence is variable. The morphology of the Tachycardia electrocardiographic waveform is variable and is referred to as polymorphic. (NCI) C62239 C71150 ECG Result SINUS ARRHYTHMIA SINUS ARRHYTHMIA Sinus arrhythmia Irregularity of the heartbeat due to a variation in the sinus Sinus Arrhythmia Production rhythm resulting in cyclic changes in the heart rate during breathing. This rhythm is most commonly seen with breathing due to fluctuations in parasympathetic vagal tone. During inspiration str C62240 C71150 ECG Result WANDERING ATRIAL WANDERING ATRIAL Wandering atrial pacemaker A condition characterized by the site of origin of impulses, Wandering Atrial Pacemaker Production PACEMAKER PACEMAKER controlling the heart rate, changing within the atria, including the sinus node. Variations within P waves and PR intervals occur and an irregular rate of impulse formation is observed. (NCI) C62242 C71150 ECG Result SINUS ARREST/PAUSE SINUS ARREST/PAUSE Sinus arrest/pause A failure of impulse formation in the sinus node. Sinus arrest Sinus Arrest Production is indistinguishable from third degree sinoatrial exit block on the standard ECG. (NCI) C62243 C71150 ECG Result SINUS NODE DYSFUNCTION SINUS NODE DYSFUNCTION Sinus node dysfunction A derangement in the normal functioning of the sinoatrial Sinus Node Dysfunction Production (BRADYCARDIA) (BRADYCARDIA) (bradycardia) node. Typically, SA node dysfunction is manifest as sinoatrial exit block or sinus arrest, but may present as an absolute or relative bradycardia in the presence of a stressor. It may be associated C62244 C71150 ECG Result SICK SINUS SYNDROME SICK SINUS SYNDROME Sick sinus syndrome A constellation of signs and symptoms which may include Sick Sinus Syndrome Production syncope, fatigue, dizziness, and alternating periods of bradycardia and atrial tachycardia, which is caused by sinoatrial node dysfunction. (NCI) C62245 C71150 ECG Result ECTOPIC ATRIAL RHYTHM ECTOPIC ATRIAL RHYTHM Ectopic atrial rhythm A cardiac rhythm resulting from either an abnormal electrical Ectopic Atrial Rhythm Production focus in the atria or intra-atrial reentry. Atrial ectopic beats (AEB) refer to a contraction of the upper heart chamber which occurs before it would be expected. Atrial ectopic beats are also C62246 C71150 ECG Result SHORT PR INTERVAL SHORT PR INTERVAL Short PR interval A PR interval of less than 0.12 seconds. (NCI) Short PR Interval Production C62247 C71150 ECG Result PR PROLONGATION PR PROLONGATION PR prolongation A PR interval of more than 0.20 seconds in adults. (NCI) Prolonged PR Interval Production C62248 C71150 ECG Result ISORHYTHMIC DISSOCIATION ISORHYTHMIC DISSOCIATION Isorhythmic dissociation A type of atrioventricular dissociation characterized by atria Isorhythmic Atrioventricular Production and ventricles beating at similar rates, although independently Dissociation (NCI) C62250 C71150 ECG Result PAROXYSMAL AV BLOCK PAROXYSMAL AV BLOCK Paroxysmal AV block Sudden onset AV block, often associated with preexisting Paroxysmal Atrioventricular Production conduction disorders. (NCI) Block C62253 C71150 ECG Result INAPPROPRIATE SINUS INAPPROPRIATE SINUS Inappropriate sinus Inappropriate sinus tachycardia (IST) is a rare form of Inappropriate Sinus Tachycardia Production TACHYCARDIA TACHYCARDIA tachycardia supraventricular tachycardia involving the sinus node, in which a patient has an abnormally high heart rate, occurring both at rest and in response to stressors (such as physical activity). (NCI) C62256 C71150 ECG Result PREMATURE VENTRICULAR PREMATURE VENTRICULAR PVC Ectopic impulses originating in the ventricles. (NCI) Ventricular Premature Complex Production COMPLEX COMPLEX C62257 C71150 ECG Result PREMATURE ATRIAL PREMATURE ATRIAL Premature atrial complexes Ectopic impulses originating in the atria. (NCI) Atrial Premature Complex Production COMPLEXES COMPLEXES C62258 C71150 ECG Result DELTA WAVE DELTA WAVE Delta wave An initial slurring (delta wave) of the QRS complex due to the EKG Delta Wave Production presence of an accessory pathway. This characteristic EKG pattern is typically seen in Wolff-Parkinson-White syndrome. (NCI) C62259 C71150 ECG Result VENTRICULAR COUPLET VENTRICULAR COUPLET Ventricular couplet Two sequential ventricular premature complexes. An Ventricular Couplet Production otherwise normal finding, but possibly indicative of electrical heart disease particularly in comparison with a single ventricular premature complexes. (NCI)

Covance Page 71 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C62261 C71150 ECG Result AV RE-ENTRANT TACHYCARDIA AV RE-ENTRANT TACHYCARDIA AV re-entrant tachycardia A supraventricular tachycardia due to reentry along a circuit Atrioventricular Reentrant Production including a concealed AV nodal bypass tract. This tachycardiaTachycardia circuit proceeds in an antegrade fashion through the AV node and then is conducted retrograde through the bypass tract into the atr C62266 C71150 ECG Result ACCELERATED ACCELERATED Accelerated idioventricular The term accelerated idioventricular rhythm describes an Accelerated Idioventricular Production IDIOVENTRICULAR RHYTHM IDIOVENTRICULAR RHYTHM rhythm ectopic ventricular rhythm with 3 or more consecutive Rhythm ventricular premature beats with a rate faster than the normal ventricular intrinsic escape rate of 30 to 40 beats per minute, but slower than v C62267 C71150 ECG Result LEFT ANTERIOR FASCICULAR LEFT ANTERIOR FASCICULAR Left anterior fascicular block An impairment of transmission of the cardiac electrical Left Anterior Fascicular Block Production BLOCK BLOCK impulse along the fibers of the left anterior fascicle. In left anterior fascicular block (LAFB) the posteroinferior regions of the left ventricular endocardium are activated abnormally before the an C62268 C71150 ECG Result LEFT POSTERIOR FASCICULAR LEFT POSTERIOR FASCICULAR Left posterior fascicular block An impairment of transmission of the cardiac electrical Left Posterior Fascicular Block Production BLOCK BLOCK impulse along the fibers of the left posterior fascicle. In pure left posterior fascicular block (LPFB), the impulse emerges from the unblocked anterosuperior division, thus producing small q waves i C62269 C71150 ECG Result LEFT BUNDLE BRANCH BLOCK LEFT BUNDLE BRANCH BLOCK Left bundle branch block An impairment of transmission of the cardiac electrical Left Bundle Branch Block Production impulse along the fibers of the left main bundle branch, or both the left anterior fascicle and left posterior fascicle. This conduction disturbance is characterized by wide (greater than 0.11s) QRS C62270 C71150 ECG Result RIGHT BUNDLE BRANCH BLOCK RIGHT BUNDLE BRANCH BLOCK Right Bundle Branch Block An impairment of transmission of the cardiac electrical Right Bundle Branch Block Production impulse along the fibers of the right bundle branch. A "complete RBBB pattern" (with QRS duration > 0.11s) does not necessarily reflect the existence of a total conduction block in the right branch. C62271 C71150 ECG Result INTRAVENTRICULAR INTRAVENTRICULAR Intraventricular conduction A delay in transmission of cardiac electrical impulses in the Nonspecific Intraventricular Production CONDUCTION DELAY, CONDUCTION DELAY, delay, nonspecific His-Purkinje system, diagnosed when the QRS is modestly Conduction Delay NONSPECIFIC NONSPECIFIC prolonged (< 120 msec) and the QRS pattern and axis are not typical of a hemiblock. The conduction delay is considered to occur beyond th C71026 C71150 ECG Result ST SEGMENT ABNORMALITY ST SEGMENT ABNORMALITY ST segment abnormality An electrocardiographic finding of the ST segment elevation o ST Segment Abnormality Production depression which is not indicative of ischemia or infarction. (NCI) C71027 C71150 ECG Result ST DEPRESSION ST DEPRESSION ST depression An electrocardiographic finding of ST segment depression ST Depression Production below the baseline, often described as up sloping, down sloping or horizontal. (NCI) C71028 C71150 ECG Result ST ELEVATION ST ELEVATION ST elevation An electrocardiographic finding of ST segment elevation aboveST Elevation Production the baseline. (NCI) C71029 C71150 ECG Result ST ELEVATION PERICARDITIS ST ELEVATION PERICARDITIS ST elevation pericarditis An electrocardiographic finding of ST changes consistent with ST Elevation Pericarditis Production pericarditis. (NCI) C71030 C71150 ECG Result J POINT ELEVATION J POINT ELEVATION J point elevation Elevation of the J point above the baseline; the J point J Point Elevation Production represents the end of ventricular depolarization and located at the terminus of the QRS complex. (NCI) C71031 C71150 ECG Result NON-SPECIFIC ST-T CHANGES NON-SPECIFIC ST-T CHANGES Non-specific ST-T changes An electrocardiographic finding of changes in the ST segment Non-Specific ST-T Changes Production and T wave that do not meet criteria for ischemia or infarction. (NCI) C71032 C71150 ECG Result NOTCHED T-WAVES NOTCHED T-WAVES Notched T-waves Any depression occuring in a positive t wave. (NCI) Notched T-Waves Production C71033 C71150 ECG Result POOR R WAVE PROGRESSION POOR R WAVE PROGRESSION Poor R Wave Progression Lack of progression of R wave height across precordial leads. Poor R Wave Progression Production (NCI) C71034 C71150 ECG Result PROLONGED QT PROLONGED QT Prolonged QT A QT interval that is prolonged. The length of the QT interval Prolonged QT Interval Production varies with the heart rate. (NCI) C71035 C71150 ECG Result ELECTRICAL ALTERNANS ELECTRICAL ALTERNANS Electrical alternans An electrocardiographic finding in which there is an alternatingElectrical Alternans Production pattern of any of the waveform components. (NCI)

C71038 C71150 ECG Result SINOATRIAL EXIT BLOCK SINOATRIAL EXIT BLOCK Sinoatrial exit block A blockage of electrical conduction within the sinoatrial node Sinoatrial Node Exit Block Production resulting in the failure of impulse transmission from the sinoatrial node. (NCI) C71039 C71150 ECG Result ATRIAL ENLARGEMENT ATRIAL ENLARGEMENT Atrial Enlargement An electrocardiographic finding which comprises left, right or EKG Finding Atrial Enlargement Production bilateral atrial enlargement. (NCI) C71040 C71150 ECG Result LEFT ATRIAL ENLARGEMENT LEFT ATRIAL ENLARGEMENT P-mitrale An electrocardiographic finding suggesting underlying P-mitrale Production hypertrophy or dilatation of the left atrium. Electrocardiographic criteria used for the diagnosis of left atrial abnormality may include a bifid p wave, a biphasic p wave and/or a p wave duration of g C71041 C71150 ECG Result RIGHT ATRIAL ABNORMALITY RIGHT ATRIAL ABNORMALITY P-pulmonale An electrocardiographic finding suggesting underlying P-pulmonale Production hypertrophy or dilatation of the right atrium. Electrocardiographic criteria used for the diagnosis of right atrial abnormality may include a peaked p wave greater than 2.5 millimeters in amplitude in C71042 C71150 ECG Result ECTOPIC VENTRICULAR ECTOPIC VENTRICULAR Ectopic ventricular rhythm A cardiac rhythm resulting from either an abnormal electrical Ectopic Ventricular Rhythm Production RHYTHM RHYTHM focus in the ventricle. Ventricular ectopic beats (VEB) refer to a contraction of the lower heart chamber which occurs before it would be expected. Ventricular ectopic beats are also known as p C71043 C71150 ECG Result ECTOPIC SUPRAVENTRICULAR ECTOPIC SUPRAVENTRICULAR Ectopic supraventricular An electrocardiographic finding of a rhythm originating at a Ectopic Supraventricular Rhythm Production RHYTHM RHYTHM rhythm site other than the sinoatrial node, which is also above the atrioventricular node. (NCI) C71044 C71150 ECG Result 2:1 AV BLOCK 2:1 AV BLOCK 2:1 AV block A electrocardiographic finding of an electrical phenomenon in 2:1 Atrioventricular Block Production which the ratio of electrical impulse generated above the atrioventricular node to the number of impulses conducted through to the ventricles is 2:1. (NCI) C71045 C71150 ECG Result ATRIOVENTRICULAR ATRIOVENTRICULAR Atrioventricular dissociation An electrocardiographic finding in which the electrical activity Atrioventricular Dissociation Production DISSOCIATION DISSOCIATION of the atria and ventricles are causally independent of one another. (NCI) C71046 C71150 ECG Result BIFASCICULAR BLOCK BIFASCICULAR BLOCK Bifascicular block An electrocardiographic finding comprising right bundle Bifascicular Block Production branch block and left anterior fascicular block, or right bundle branch block and left posterior fascicular block. Defects occuring in two of the three divisions of the conduction system of the heart C71047 C71150 ECG Result INCOMPLETE LEFT BUNDLE INCOMPLETE LEFT BUNDLE Incomplete left bundle branch An partial impairment of transmission of the cardiac electrical Incomplete Left Bundle Branch Production BRANCH BLOCK BRANCH BLOCK block impulse along the fibers of the left bundle branch. (NCI) Block

Covance Page 72 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C71048 C71150 ECG Result INCOMPLETE RIGHT BUNDLE INCOMPLETE RIGHT BUNDLE Incomplete right bundle Various mechanisms may result in a pattern showing an Incomplete Right Bundle Branch Production BRANCH BLOCK BRANCH BLOCK branch block incomplete right bundle branch block (RBBB). These include Block different degrees of conduction delay through the main trunk o the right bundle branch; increased conduction time through an elongated right C71049 C71150 ECG Result INCOMPLETE BUNDLE BRANCH INCOMPLETE BUNDLE BRANCH Incomplete bundle branch An electrocardiographic finding of bundle branch block which Incomplete Bundle Branch Block Production BLOCK BLOCK block does not meet the criteria for a more specific bundle branch block. (NCI) C71050 C71150 ECG Result MULTIFOCAL ATRIAL MULTIFOCAL ATRIAL Multifocal atrial tachycardia An electrocardiographic finding in which the electrical axis of Multifocal Atrial Tachycardia Production TACHYCARDIA TACHYCARDIA the p wave is variable and the rate is greater than 100 beats per minute. To meet criteria for multifocal atrial tachycardia, the p wave must exhibit three distinct morphologies on the rhythm C71051 C71150 ECG Result JUNCTIONAL RHYTHM JUNCTIONAL RHYTHM Junctional rhythm An electrocardiographic finding in which the pacer of the heart Junctional Rhythm Production is located in the AV junction, normally presenting with a narrow QRS complex and a rate of 60-100 beats per minute. (NCI) C71052 C71150 ECG Result SUSTAINED VENTRICULAR SUSTAINED VENTRICULAR Sustained ventricular An electrocardiographic finding of ventricular tachycardia Sustained Ventricular Production TACHYCARDIA TACHYCARDIA tachycardia greater than 30 seconds in duration. (NCI) Tachycardia C71053 C71150 ECG Result NON-SUSTAINED VENTRICULAR NON-SUSTAINED VENTRICULAR Non-sustained ventricular An electrocardiographic finding of ventricular tachycardia less Non-Sustained Ventricular Production TACHYCARDIA TACHYCARDIA tachycardia than 30 seconds in duration. (NCI) Tachycardia C71054 C71150 ECG Result BIGEMINY BIGEMINY Bigeminy An electrocardiographic finding of a normal QRS followed by aBigeminy Production premature ventricular contraction; a rhythmic pairing of norma and abnormal beats originating in the ventricles in a 1-1 ratio. (NCI) C71055 C71150 ECG Result TRIGEMINY TRIGEMINY Trigeminy An electrocardiographic finding of normal QRS followed by a Trigeminy Production premature ventricular contraction; a rhythmic pairing of norma and abnormal beats originating from the ventricles in a 1-2 ratio. (NCI) C71056 C71150 ECG Result VENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA Ventricular tachycardia storm Multiple, temporally related, episodes of ventricular Ventricular Tachycardia Storm Production STORM STORM tachycardia or fibrillation, occurring three or more times in a 24 hour period. (NCI) C71057 C71150 ECG Result ADENOSINE-SENSITIVE ADENOSINE-SENSITIVE Adenosine-sensitive ventricularA condition that occurs as a result of cAMP-mediated Adenosine-Sensitive Ventricular Production VENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA tachycardia triggered activity and typically originates from the right Tachycardia ventricular outflow tract (RVOT). This type of tachycardia occurs in patients with apparently normal hearts. (NCI) C71058 C71150 ECG Result VERAPAMIL-SENSITIVE VERAPAMIL-SENSITIVE Verapamil-sensitive ventricular A well-recognized condition that is believed to result from Verapamil-Sensitive Ventricular Production VENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA tachycardia triggered activity. Despite its uniform response to verapamil, Tachycardia however, this uncommon form of ventricular tachycardia may not be as homogeneous a condition as first believed. (NCI) C71059 C71150 ECG Result VENTRICULAR ARRHYTHMIA VENTRICULAR ARRHYTHMIA Ventricular arrhythmia A condition characterized by a pattern of right bundle branch Brugada Syndrome Production ASSOCIATED WITH BRUGADA ASSOCIATED WITH BRUGADA associated with Brugada block (RBBB) and ST-segment elevation within SYNDROME SYNDROME syndrome electrocardiogram (ECG) leads V1-V3 . This pattern emerges as a result of a defect in ion channel genes, resulting in abnormal electrophysiological C71060 C71150 ECG Result VENTRICULAR ARRHYTHMIA VENTRICULAR ARRHYTHMIA Ventricular arrhythmia Ventricular tachyarrhythmias occurring in association with Short QT Syndrome Production ASSOCIATED WITH SHORT QT ASSOCIATED WITH SHORT QT associated with short QT short QT syndrome. (NCI) SYNDROME SYNDROME syndrome C71061 C71150 ECG Result FASCICULAR TACHYCARDIA FASCICULAR TACHYCARDIA Fascicular tachycardia A distinct subgroup of idiopathic ventricular tachycardia (VT) Fascicular Tachycardia Production that may be confused with either typical VT or supraventricular tachycardia (SVT). It is characterised by the absence of structural heart disease and classic electrocardiographic and electroph C71062 C71150 ECG Result BUNDLE BRANCH REENTRANT BUNDLE BRANCH REENTRANT Bundle branch reentrant An uncommon form of ventricular tachycardia (VT) Bundle Branch Re-Entrant Production TACHYCARDIA TACHYCARDIA tachycardia incorporating both bundle branches into the reentry circuit. Ventricular Tachycardia Surface electrocardiogram (ECG) of sinus rhythm (SR) characteristically shows intraventricular conduction defects. Patients typically present wit C71063 C71150 ECG Result IDIOPATHIC RIGHT BUNDLE IDIOPATHIC RIGHT BUNDLE Idiopathic right bundle branch Idiopathic ventricular tachycardia (VT) is a type of ventricular Idiopathic Right Bundle Branch Production BRANCH BLOCK VENTRICULAR BRANCH BLOCK VENTRICULAR block ventricular tachycardia tachycardia occurring unrelated to any organic cardiac Block TACHYCARDIA TACHYCARDIA disease. The abnormality is probably congenital, be it a focus of abnormal automaticity or myocardial tissue that can sustain re-entry. C71064 C71150 ECG Result OUTFLOW TRACT VENTRICULAR OUTFLOW TRACT VENTRICULAR Outflow tract ventricular Right ventricular outflow tract tachycardia (RVOT) is the most Right Ventricular Outflow Tract Production TACHYCARDIA TACHYCARDIA tachycardia common with a female predominance. It is often exercise Tachycardia induced or enhanced. The site of origin is the right ventricular outflow tract and hence the electrocardiographic appearance is that of C71065 C71150 ECG Result ACUTE ANTERIOR WALL MI ACUTE ANTERIOR WALL MI Acute Anterior Wall Electrocardiographic finding showing a current of injury in Acute Anterior Wall Myocardial Production Myocardial Infarction leads corresponding to the anatomic region of the anterior wallInfarction of the heart. (NCI) C71066 C71150 ECG Result ACUTE INFERIOR WALL MI ACUTE INFERIOR WALL MI Acute Inferior Wall Myocardial Electrocardiographic finding showing a current of injury in Acute Inferior Wall Myocardial Production Infarction leads corresponding to the anatomic region of the inferior wall Infarction of the heart. (NCI) C71067 C71150 ECG Result ACUTE LATERAL WALL MI ACUTE LATERAL WALL MI Acute Lateral Wall Myocardial Electrocardiographic finding showing a current of injury in Acute Lateral Wall Myocardial Production Infarction leads corresponding to the anatomic region of the lateral wall Infarction of the heart. (NCI) C71068 C71150 ECG Result ACUTE POSTERIOR WALL MI ACUTE POSTERIOR WALL MI Acute Posterior Wall Electrocardiographic finding showing a current of injury in Acute Posterior Wall Myocardial Production Myocardial Infarction leads corresponding to the anatomic region of the posterior Infarction wall of the heart. (NCI) C71069 C71150 ECG Result ANTERIOR WALL MYOCARDIAL ANTERIOR WALL MYOCARDIAL Anterior Wall Myocardial Electrocardiographic finding showing an injury in leads Anterior Wall Myocardial Production INFARCTION INFARCTION Infarction corresponding to the anatomic region of the anterior wall of theInfarction heart. (NCI) C71070 C71150 ECG Result INFERIOR WALL MYOCARDIAL INFERIOR WALL MYOCARDIAL Inferior Wall Myocardial Electrocardiographic finding showing an injury in leads Inferior Wall Myocardial InfarctionProduction INFARCTION INFARCTION Infarction corresponding to the anatomic region of the inferior wall of the heart. (NCI) C71073 C71150 ECG Result INTRAATRIAL CONDUCTION INTRAATRIAL CONDUCTION Intraatrial Conduction Delay A delay in impulse propagation through the atria. (NCI) Intra-Atrial Conduction Delay Production DELAY DELAY C71074 C71150 ECG Result JUNCTIONAL BRADYCARDIA JUNCTIONAL BRADYCARDIA Junctional bradycardia An electrocardiographic finding in which the pacer of the heart Junctional Bradycardia Production is located in the AV junction, normally presenting with a narrow QRS complex at a rate less than 60 beats per minute. (NCI) C71075 C71150 ECG Result LATERAL WALL MYOCARDIAL LATERAL WALL MYOCARDIAL Lateral Wall Myocardial Electrocardiographic finding showing an injury in leads Lateral Wall Myocardial Infarction Production INFARCTION INFARCTION Infarction corresponding to the anatomic region of the lateral wall of the heart. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C71076 C71150 ECG Result LEFT VENTRICULAR LEFT VENTRICULAR Left Ventricular Hypertrophy Electrocardiographic findings suggestive of a hypertrophic left Left Ventricular Hypertrophy Production HYPERTROPHY HYPERTROPHY ventricle. (NCI) C71077 C71150 ECG Result RIGHT VENTRICULAR RIGHT VENTRICULAR Right ventricular Hypertrophy Electrocardiographic findings suggestive of an enlarged right Right Ventricular Hypertrophy Production HYPERTROPHY HYPERTROPHY ventricle. (NCI) C71078 C71150 ECG Result LOW QRS VOLTAGE LOW QRS VOLTAGE Low QRS voltage An electrocardiographic finding of a QRS amplitude less than Low QRS Voltage Production or equal to 5mm in the limb leads or QRS amplitude less than or equal to 10mm in the precordial leads. (NCI) C71080 C71150 ECG Result NON Q WAVE MYOCARDIAL NON Q WAVE MYOCARDIAL Non Q Wave Myocardial A myocardial infarction in the absence of observable Q wave Non Q Wave Myocardial Production INFARCTION INFARCTION Infarction abnormalities in the ECG. (NCI) Infarction C71081 C71150 ECG Result POSTERIOR WALL MYOCARDIAL POSTERIOR WALL MYOCARDIAL Posterior Wall Myocardial Electrocardiographic finding showing an injury in leads Posterior Wall Myocardial Production INFARCTION INFARCTION Infarction corresponding to the anatomic region of the posterior wall of Infarction the heart. (NCI) C71082 C71150 ECG Result SEPTAL MYOCARDIAL SEPTAL MYOCARDIAL Septal myocardial infarction Electrocardiographic findings suggesting an infarction in the Septal Myocardial Infarction Production INFARCTION INFARCTION anatomic location of the cardiac septum. (NCI) C71083 C71150 ECG Result T WAVE ABNORMALITY T WAVE ABNORMALITY T wave abnormality An electrocardiographic finding of a T wave which appears T Wave Abnormality Production peaked, inverted, flattened or biphasic. (NCI) C71084 C71150 ECG Result VENTRICULAR HYPERTROPHY VENTRICULAR HYPERTROPHY Ventricular Hypertrophy Electrocardiographic findings suggestive of enlarged cardiac Ventricular Hypertrophy Production ventricles. (NCI) C71085 C71150 ECG Result T WAVE INVERSION T WAVE INVERSION T Wave Inversion An electrocardiographic finding of an inversion of the T wave T Wave Inversion Production from the expected axis. (NCI) C71086 C71150 ECG Result T WAVE PEAKED T WAVE PEAKED T wave peaked An electrocardiographic finding in which the T wave appears T Wave Peaked Production increased in amplitude and cresting at a point. (NCI) C71087 C71150 ECG Result T WAVES BIPHASIC T WAVES BIPHASIC T waves biphasic An electrocardiographic finding in which the T wave is T Waves Biphasic Production asymmetric. (NCI) C71088 C71150 ECG Result T WAVES FLAT T WAVES FLAT T waves flat An electrocardiographic finding in which the T wave appears T Waves Flat Production decreased in amplitude. (NCI) C71089 C71150 ECG Result U WAVES U WAVES U waves An electrocardiographic finding of a small hump following the U Waves Production T wave occuring during the final phase of Purkinje repolarization. (NCI) C71090 C71150 ECG Result WIDE QRS TACHYCARDIA WIDE QRS TACHYCARDIA Wide QRS tachycardia An electrocardiographic finding of a QRS complex. (NCI) Wide QRS Tachycardia Production C71094 C71150 ECG Result Q AXIS, LEFT AXIS DEVIATION Q AXIS, LEFT AXIS DEVIATION Q Axis, Left axis deviation Q axis from -30 to -90 degrees. (NCI) Q Axis Left Axis Deviation Production C71095 C71150 ECG Result Q AXIS, RIGHT AXIS DEVIATION Q AXIS, RIGHT AXIS DEVIATION Q Axis, Right axis deviation Q axis from +90 to +180 degrees. (NCI) Q Axis Right Axis Deviation Production C71096 C71150 ECG Result QTCB PROLONGATION >500 QTCB PROLONGATION >500 QTcB prolongation >500 msec Corrected QT interval longer than 500 msec, in accordance QTcB Prolongation Greater Than Production MSEC MSEC with Bazett's correction formula. (NCI) 500 msec C71097 C71150 ECG Result QTCF PROLONGATION >500 QTCF PROLONGATION >500 QTcF prolongation >500 msec Corrected QT interval greater than 500 msec, in accordance QTcF Prolongation Greater Than Production MSEC MSEC with Fridericia's correction formula. (NCI) 500 msec C71153 Yes ECG Test Code EGTESTCD EGTESTCD ECG Test Code Terminology codelist used with ECG Tests within CDISC. CDISC SDTM ECG Test Production Terminology by Code C39779 C71153 ECG Test Code HRMAX HRMAX Summary (Max) Heart Rate The minimum time between successive cycles of contraction Maximum Heart Rate Production and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62086 C71153 ECG Test Code PRMEAN PRMEAN Summary (Mean) PR Duration The average (mean) duration (time) of the PR interval, EKG Mean PR Duration Production obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of th C62087 C71153 ECG Test Code QRSDUR QRSDUR Summary (Mean) QRS The average (mean) duration (time) of the QRS interval, EKG Mean QRS Duration Production Duration obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes fo C62089 C71153 ECG Test Code QTMEAN QTMEAN Summary (Mean) QT Duration The average (mean) duration (time) of the QT interval, EKG Mean QT Duration Production obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ve C62090 C71153 ECG Test Code RRMEAN RRMEAN Summary (Mean) RR Duration The average (mean) duration (time) of the RR interval, EKG Mean RR Duration Production obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. (NCI) C62093 C71153 ECG Test Code RRMIN RRMIN Summary (Min) RR Duration The minimum duration (time) between successive peaks of R EKG Minimum RR Duration Production waves in a particular set of RR intervals. (NCI) C62094 C71153 ECG Test Code RRMAX RRMAX Summary (Max) RR Duration The maximum duration (time) between successive peaks of R EKG Maximum RR Duration Production waves in a particular set of RR intervals. (NCI) C62095 C71153 ECG Test Code HRMEAN HRMEAN Summary (Mean) Heart Rate The average (mean) number of cycles of contraction and Mean Heart Rate Production subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62096 C71153 ECG Test Code HRMIN HRMIN Summary (Min) Heart Rate The maximum time between successive cycles of contraction Minimum Heart Rate Production and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62112 C71153 ECG Test Code QTCB QTCB QTcB - Bazett's Correction A formula which takes into account the physiologic shortening QTcB-Bazett's Correction Production Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcB = QT/SqRootRR(seconds) and t C62113 C71153 ECG Test Code QTCF QTCF QTcF - Fridericia's Correction A formula which takes into account the physiologic shortening QTcF-Fridericia's Correction Production Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcF = QT/CubeRootRR(seconds) and C62114 C71153 ECG Test Code QTCLC QTCLC QTcLC - Linear Correction A formula which takes into account the physiologic shortening QTcLC-Linear Correction Production Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. The linear correction formula uses population-based data obtained C62115 C71153 ECG Test Code JTMEAN JTMEAN Summary (Mean) JT Interval The average (mean) duration (time) of the JT interval, EKG Mean JT Duration Production obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C62116 C71153 ECG Test Code JTMIN JTMIN Summary (Min) JT Interval The minimum duration (time) of the JT interval, obtained from EKG Minimum JT Duration Production a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end C62117 C71153 ECG Test Code JTMAX JTMAX Summary (Max) JT Interval The maximum duration (time) of the JT interval, obtained from EKG Maximum JT Duration Production a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end C62118 C71153 ECG Test Code JTCB JTCB JTcB - Bazett's Correction A formula which takes into account the physiologic shortening JTcB-Bazett's Correction Production Formula of the JT interval which occurs as the heart rate increases, Formula permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcB = JT/SqRootRR(seconds) and t C62119 C71153 ECG Test Code JTCF JTCF JTcF - Fridericia's Correction A formula which takes into account the physiologic shortening JTcF-Fridericia's Correction Production Formula of the JT interval which occurs as the heart rate increases, Formula permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcF = JT/CubeRootRR(seconds) and C62120 C71153 ECG Test Code JTCLC JTCLC JTcLC - Linear Correction A formula which takes into account the physiologic shortening JTcLC-Linear Correction FormulaProduction Formula of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. The linear correction formula uses population-based data obtained C62121 C71153 ECG Test Code PAXIS PAXIS Summary (Mean) P Axis The mean (average) direction (range -180 degrees to 180 EKG Mean P Axis Production degrees) of the electrical potential generated by atrial depolarization in a particular plane (usually the frontal plane). (NCI) C62123 C71153 ECG Test Code PWAVEDUR PWAVEDUR Summary (Mean) P Wave The average (mean) duration (time) from the onset of atrial EKG Mean P Wave Duration Production Duration depolarization to the completion of atrial depolarization (length of the P wave), obtained from a set of measurements of the time from beginning to end of atrial depolarization. (NCI)

C62124 C71153 ECG Test Code PWAVEHT PWAVEHT Summary (Mean) P Wave The average (mean) height (usually measured in mm) of the EKG Mean P Wave Height Production Height maximum deflection from baseline of the P wave (representing atrial depolarization), obtained from a set of measurements of the P wave, from a single lead or set of leads. Typically this measuremen C62125 C71153 ECG Test Code PRMIN PRMIN Summary (Min) PR Duration The minimum duration (time) of the PR interval, obtained from EKG Minimum PR Duration Production a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wav C62131 C71153 ECG Test Code PRMAX PRMAX Summary (Max) PR Duration The maximum duration (time) of the PR interval, obtained EKG Maximum PR Duration Production from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wav C62132 C71153 ECG Test Code QRSAXIS QRSAXIS Summary (Mean) QRS Axis The mean (average) direction of the electrical potential Mean QRS Axis Production generated by ventricular depolarization. (NCI) C62133 C71153 ECG Test Code QTMIN QTMIN Summary (Min) QT Duration The minimum duration (time) of the QT interval, obtained from Minimum QT Duration Production a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricle C62135 C71153 ECG Test Code QTMAX QTMAX Summary (Max) QT Duration The maximum duration (time) of the QT interval, obtained EKG Maximum QT Duration Production from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricle C62136 C71153 ECG Test Code RWAVEAMP RWAVEAMP Summary (Mean) R Wave The average (mean) amplitude (usually in mm) of the R wave, EKG Mean R Wave Amplitude Production Amplitude obtained from a set of measurements of the R wave, in a particular lead or set of leads. (NCI) C62137 C71153 ECG Test Code SWAVEAMP SWAVEAMP Summary (Mean) S Wave The average (mean) amplitude (usually in mm) of the S wave, EKG Mean S Wave Amplitude Production Amplitude obtained from a set of measurements of the S wave, in a particular lead or set of leads. (NCI) C62144 C71153 ECG Test Code RSAMP RSAMP Summary (Mean) R+S The average (mean) amplitude (usually in mm) of the EKG Mean R+S Amplitude Production Amplitude summation of the R and S waves, obtained from a set of measurements of the R and S waves, in a particular lead or set of leads. (NCI) C62145 C71153 ECG Test Code STSEGDUR STSEGDUR Summary (Mean) ST Segment The duration (time) of the ST segment, measured from the J EKG Mean ST Segment Production Duration point at the end of the QRS complex to the beginning of the T Duration wave. (NCI) C62146 C71153 ECG Test Code TAXIS TAXIS Summary (Mean) T Wave Axis The mean (average) direction of the electrical potential EKG Mean T Wave Axis Production generated by ventricular repolarization. (NCI) C62147 C71153 ECG Test Code TWAVEDUR TWAVEDUR Summary (Mean) T Wave The average (mean) duration (time) from the onset of EKG Mean T Wave Duration Production Duration ventricular repolarization to the completion of ventricular repolarization (length of the T wave), obtained from a set of measurements of the time from beginning to end of ventricular repolarization. (N C62148 C71153 ECG Test Code TWAVAREA TWAVAREA Summary (Mean) T Wave The average (mean) area under the curve of the deflection EKG Mean T Wave Area Production Area from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) C62149 C71153 ECG Test Code TWAVEHT TWAVEHT Summary (Mean) T Wave The average (mean) height (usually measured in mm) of the EKG Mean T Wave Height Production Height maximum deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) C62152 C71153 ECG Test Code VRMEAN VRMEAN Summary (Mean) Ventricular The average (mean) number of cycles of contraction and Mean Ventricular Heart Rate Production Rate subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C62153 C71153 ECG Test Code VRMIN VRMIN Summary (Min) Ventricular The minimum time between successive cycles of contraction Minimum Ventricular Heart Rate Production Rate and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) C62154 C71153 ECG Test Code VRMAX VRMAX Summary (Max) Ventricular The maximum time between successive cycles of contraction Maximum Ventricular Heart Rate Production Rate and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) C62155 C71153 ECG Test Code STDVMEAN STDVMEAN Summary (Mean) ST The average (mean) deviation (distance from baseline, positiv EKG Mean ST Deviation Production Deviation or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62156 C71153 ECG Test Code STDVMIN STDVMIN Summary (Min) ST Deviation The minimum deviation (distance from baseline, positive or EKG Minimum ST Deviation Production negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62157 C71153 ECG Test Code STDVMAX STDVMAX Summary (Max) ST Deviation The maximum deviation (distance from baseline, positive or EKG Maximum ST Deviation Production negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62158 C71153 ECG Test Code STELMEAN STELMEAN Summary (Mean) ST Elevation The average (mean) elevation (positive deflection from EKG Mean ST Segment Production baseline, usually measured in mm) of the ST segment, Elevation obtained from a set of measurements of the elevation of the ST segment. (NCI) C62159 C71153 ECG Test Code STELMIN STELMIN Summary (Min) ST Elevation The minimum elevation (positive deflection from baseline, EKG Minimum ST Segment Production usually measured in mm) of the ST segment, obtained from a Elevation set of measurements of the elevation of the ST segment. (NCI) C62160 C71153 ECG Test Code STELMAX STELMAX Summary (Max) ST Elevation The maximum elevation (positive deflection from baseline, EKG Maximum ST Segment Production usually measured in mm) of the ST segment, obtained from a Elevation set of measurements of the elevation of the ST segment. (NCI) C62161 C71153 ECG Test Code STDPMEAN STDPMEAN Summary (Mean) ST The average (mean) depression (negative deflection from EKG Mean ST Segment Production Depression baseline, usually measured in mm) of the ST segment, Depression obtained from a set of measurements of the depression of the ST segment. (NCI) C62162 C71153 ECG Test Code STDPMIN STDPMIN Summary (Min) ST The minimum depression (negative deflection from baseline, EKG Minimum ST Segment Production Depression usually measured in mm) of the ST segment, obtained from a Depression set of measurements of the depression of the ST segment. (NCI) C62163 C71153 ECG Test Code STDPMAX STDPMAX Summary (Max) ST The maximum depression (negative deflection from baseline, EKG Maximum ST Segment Production Depression usually measured in mm) of the ST segment, obtained from a Depression set of measurements of the depression of the ST segment. (NCI) C71152 Yes ECG Test Name EGTEST EGTEST ECG Test Name Terminology codelist used with ECG Test Names within CDISC SDTM ECG Test Name Production CDISC. Terminology C39779 C71152 ECG Test Name Summary (Max) Heart Rate HRMAX Summary (Max) Heart Rate The minimum time between successive cycles of contraction Maximum Heart Rate Production and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62086 C71152 ECG Test Name Summary (Mean) PR Duration PRMEAN Summary (Mean) PR Duration The average (mean) duration (time) of the PR interval, EKG Mean PR Duration Production obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of th C62087 C71152 ECG Test Name Summary (Mean) QRS Duration QRSDUR Summary (Mean) QRS The average (mean) duration (time) of the QRS interval, EKG Mean QRS Duration Production Duration obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes fo C62089 C71152 ECG Test Name Summary (Mean) QT Duration QTMEAN Summary (Mean) QT Duration The average (mean) duration (time) of the QT interval, EKG Mean QT Duration Production obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ve C62090 C71152 ECG Test Name Summary (Mean) RR Duration RRMEAN Summary (Mean) RR Duration The average (mean) duration (time) of the RR interval, EKG Mean RR Duration Production obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. (NCI) C62093 C71152 ECG Test Name Summary (Min) RR Duration RRMIN Summary (Min) RR Duration The minimum duration (time) between successive peaks of R EKG Minimum RR Duration Production waves in a particular set of RR intervals. (NCI) C62094 C71152 ECG Test Name Summary (Max) RR Duration RRMAX Summary (Max) RR Duration The maximum duration (time) between successive peaks of R EKG Maximum RR Duration Production waves in a particular set of RR intervals. (NCI) C62095 C71152 ECG Test Name Summary (Mean) Heart Rate HRMEAN Summary (Mean) Heart Rate The average (mean) number of cycles of contraction and Mean Heart Rate Production subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62096 C71152 ECG Test Name Summary (Min) Heart Rate HRMIN Summary (Min) Heart Rate The maximum time between successive cycles of contraction Minimum Heart Rate Production and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) C62112 C71152 ECG Test Name QTcB - Bazett's Correction Formula QTCB QTcB - Bazett's Correction A formula which takes into account the physiologic shortening QTcB-Bazett's Correction Production Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcB = QT/SqRootRR(seconds) and t C62113 C71152 ECG Test Name QTcF - Fridericia's Correction QTCF QTcF - Fridericia's Correction A formula which takes into account the physiologic shortening QTcF-Fridericia's Correction Production Formula Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcF = QT/CubeRootRR(seconds) and

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C62114 C71152 ECG Test Name QTcLC - Linear Correction Formula QTCLC QTcLC - Linear Correction A formula which takes into account the physiologic shortening QTcLC-Linear Correction Production Formula of the QT interval which occurs as the heart rate increases, Formula permitting comparison of the QT interval across a range of rates. The linear correction formula uses population-based data obtained C62115 C71152 ECG Test Name Summary (Mean) JT Interval JTMEAN Summary (Mean) JT Interval The average (mean) duration (time) of the JT interval, EKG Mean JT Duration Production obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to C62116 C71152 ECG Test Name Summary (Min) JT Interval JTMIN Summary (Min) JT Interval The minimum duration (time) of the JT interval, obtained from EKG Minimum JT Duration Production a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end C62117 C71152 ECG Test Name Summary (Max) JT Interval JTMAX Summary (Max) JT Interval The maximum duration (time) of the JT interval, obtained from EKG Maximum JT Duration Production a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end C62118 C71152 ECG Test Name JTcB - Bazett's Correction Formula JTCB JTcB - Bazett's Correction A formula which takes into account the physiologic shortening JTcB-Bazett's Correction Production Formula of the JT interval which occurs as the heart rate increases, Formula permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcB = JT/SqRootRR(seconds) and t C62119 C71152 ECG Test Name JTcF - Fridericia's Correction JTCF JTcF - Fridericia's Correction A formula which takes into account the physiologic shortening JTcF-Fridericia's Correction Production Formula Formula of the JT interval which occurs as the heart rate increases, Formula permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcF = JT/CubeRootRR(seconds) and C62120 C71152 ECG Test Name JTcLC - Linear Correction Formula JTCLC JTcLC - Linear Correction A formula which takes into account the physiologic shortening JTcLC-Linear Correction FormulaProduction Formula of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. The linear correction formula uses population-based data obtained C62121 C71152 ECG Test Name Summary (Mean) P Axis PAXIS Summary (Mean) P Axis The mean (average) direction (range -180 degrees to 180 EKG Mean P Axis Production degrees) of the electrical potential generated by atrial depolarization in a particular plane (usually the frontal plane). (NCI) C62123 C71152 ECG Test Name Summary (Mean) P Wave Duration PWAVEDUR Summary (Mean) P Wave The average (mean) duration (time) from the onset of atrial EKG Mean P Wave Duration Production Duration depolarization to the completion of atrial depolarization (length of the P wave), obtained from a set of measurements of the time from beginning to end of atrial depolarization. (NCI)

C62124 C71152 ECG Test Name Summary (Mean) P Wave Height PWAVEHT Summary (Mean) P Wave The average (mean) height (usually measured in mm) of the EKG Mean P Wave Height Production Height maximum deflection from baseline of the P wave (representing atrial depolarization), obtained from a set of measurements of the P wave, from a single lead or set of leads. Typically this measuremen C62125 C71152 ECG Test Name Summary (Min) PR Duration PRMIN Summary (Min) PR Duration The minimum duration (time) of the PR interval, obtained from EKG Minimum PR Duration Production a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wav C62131 C71152 ECG Test Name Summary (Max) PR Duration PRMAX Summary (Max) PR Duration The maximum duration (time) of the PR interval, obtained EKG Maximum PR Duration Production from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wav C62132 C71152 ECG Test Name Summary (Mean) QRS Axis QRSAXIS Summary (Mean) QRS Axis The mean (average) direction of the electrical potential Mean QRS Axis Production generated by ventricular depolarization. (NCI) C62133 C71152 ECG Test Name Summary (Min) QT Duration QTMIN Summary (Min) QT Duration The minimum duration (time) of the QT interval, obtained from Minimum QT Duration Production a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricle C62135 C71152 ECG Test Name Summary (Max) QT Duration QTMAX Summary (Max) QT Duration The maximum duration (time) of the QT interval, obtained EKG Maximum QT Duration Production from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricle C62136 C71152 ECG Test Name Summary (Mean) R Wave RWAVEAMP Summary (Mean) R Wave The average (mean) amplitude (usually in mm) of the R wave, EKG Mean R Wave Amplitude Production Amplitude Amplitude obtained from a set of measurements of the R wave, in a particular lead or set of leads. (NCI) C62137 C71152 ECG Test Name Summary (Mean) S Wave Amplitude SWAVEAMP Summary (Mean) S Wave The average (mean) amplitude (usually in mm) of the S wave, EKG Mean S Wave Amplitude Production Amplitude obtained from a set of measurements of the S wave, in a particular lead or set of leads. (NCI) C62144 C71152 ECG Test Name Summary (Mean) R+S Amplitude RSAMP Summary (Mean) R+S The average (mean) amplitude (usually in mm) of the EKG Mean R+S Amplitude Production Amplitude summation of the R and S waves, obtained from a set of measurements of the R and S waves, in a particular lead or set of leads. (NCI) C62145 C71152 ECG Test Name Summary (Mean) ST Segment STSEGDUR Summary (Mean) ST Segment The average (mean) duration (time) from the end of ventricula EKG Mean ST Segment Production Duration Duration depolarization (end of QRS complex) to the end of ventricular Duration repolarization (end of the T wave). (NCI) C62146 C71152 ECG Test Name Summary (Mean) T Wave Axis TAXIS Summary (Mean) T Wave Axis The mean (average) direction of the electrical potential EKG Mean T Wave Axis Production generated by ventricular repolarization. (NCI) C62147 C71152 ECG Test Name Summary (Mean) T Wave Duration TWAVEDUR Summary (Mean) T Wave The average (mean) duration (time) from the onset of EKG Mean T Wave Duration Production Duration ventricular repolarization to the completion of ventricular repolarization (length of the T wave), obtained from a set of measurements of the time from beginning to end of ventricular repolarization. (N C62148 C71152 ECG Test Name Summary (Mean) T Wave Area TWAVAREA Summary (Mean) T Wave The average (mean) area under the curve of the deflection EKG Mean T Wave Area Production Area from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C62149 C71152 ECG Test Name Summary (Mean) T Wave Height TWAVEHT Summary (Mean) T Wave The average (mean) height (usually measured in mm) of the EKG Mean T Wave Height Production Height maximum deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) C62152 C71152 ECG Test Name Summary (Mean) Ventricular Rate VRMEAN Summary (Mean) Ventricular The average (mean) number of cycles of contraction and Mean Ventricular Heart Rate Production Rate subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) C62153 C71152 ECG Test Name Summary (Min) Ventricular Rate VRMIN Summary (Min) Ventricular The minimum time between successive cycles of contraction Minimum Ventricular Heart Rate Production Rate and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) C62154 C71152 ECG Test Name Summary (Max) Ventricular Rate VRMAX Summary (Max) Ventricular The maximum time between successive cycles of contraction Maximum Ventricular Heart Rate Production Rate and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) C62155 C71152 ECG Test Name Summary (Mean) ST Deviation STDVMEAN Summary (Mean) ST The average (mean) deviation (distance from baseline, positiv EKG Mean ST Deviation Production Deviation or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62156 C71152 ECG Test Name Summary (Min) ST Deviation STDVMIN Summary (Min) ST Deviation The minimum deviation (distance from baseline, positive or EKG Minimum ST Deviation Production negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62157 C71152 ECG Test Name Summary (Max) ST Deviation STDVMAX Summary (Max) ST Deviation The maximum deviation (distance from baseline, positive or EKG Maximum ST Deviation Production negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) C62158 C71152 ECG Test Name Summary (Mean) ST Elevation STELMEAN Summary (Mean) ST Elevation The average (mean) elevation (positive deflection from EKG Mean ST Segment Production baseline, usually measured in mm) of the ST segment, Elevation obtained from a set of measurements of the elevation of the ST segment. (NCI) C62159 C71152 ECG Test Name Summary (Min) ST Elevation STELMIN Summary (Min) ST Elevation The minimum elevation (positive deflection from baseline, EKG Minimum ST Segment Production usually measured in mm) of the ST segment, obtained from a Elevation set of measurements of the elevation of the ST segment. (NCI) C62160 C71152 ECG Test Name Summary (Max) ST Elevation STELMAX Summary (Max) ST Elevation The maximum elevation (positive deflection from baseline, EKG Maximum ST Segment Production usually measured in mm) of the ST segment, obtained from a Elevation set of measurements of the elevation of the ST segment. (NCI) C62161 C71152 ECG Test Name Summary (Mean) ST Depression STDPMEAN Summary (Mean) ST The average (mean) depression (negative deflection from EKG Mean ST Segment Production Depression baseline, usually measured in mm) of the ST segment, Depression obtained from a set of measurements of the depression of the ST segment. (NCI) C62162 C71152 ECG Test Name Summary (Min) ST Depression STDPMIN Summary (Min) ST The minimum depression (negative deflection from baseline, EKG Minimum ST Segment Production Depression usually measured in mm) of the ST segment, obtained from a Depression set of measurements of the depression of the ST segment. (NCI) C62163 C71152 ECG Test Name Summary (Max) ST Depression STDPMAX Summary (Max) ST The maximum depression (negative deflection from baseline, EKG Maximum ST Segment Production Depression usually measured in mm) of the ST segment, obtained from a Depression set of measurements of the depression of the ST segment. (NCI) C71151 Yes ECG Test Method EGMETHOD EGMETHOD ECG Test Method Terminology codelist used with ECG Test Methods within CDISC SDTM ECG Test Method Production CDISC. Terminology C71101 C71151 ECG Test Method 12 LEAD UNSPECIFIED 12 LEAD UNSPECIFIED 12 Lead Unspecified An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Unspecified Production leadpoints are recorded but the position of the leads is unspecified. (NCI) C71102 C71151 ECG Test Method 12 LEAD STANDARD 12 LEAD STANDARD 12 Lead Standard An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Standard Production leads are recorded, with each lead representing an electrical view of the heart. The six leads recorded in the frontal plane are derived from the placement of 3 electrodes (RA or Right Arm, LA, or Left C71103 C71151 ECG Test Method 12 LEAD MASON LIKAR 12 LEAD MASON LIKAR 12 Lead Mason Likar An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Mason Likar Production leadpoints are recorded but the standard lead positions have been modified for ECG recording during exercise. Exercise stress testing requires moving the limb electrodes to more central positions on the C71110 C71151 ECG Test Method 12 LEAD MODIFIED MASON 12 LEAD MODIFIED MASON 12 Lead Modified Mason Likar An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Mason Likar Production LIKAR LIKAR leadpoints are recorded but the Mason Likar lead positions Modified have been modified so that V1 to V6 on the chest are part of a single electrode pad. In addition, lead CM5 is substituted for lead aVR. (NCI) C71112 C71151 ECG Test Method 12 LEAD SINGLE PAD 12 LEAD SINGLE PAD 12 Lead Single Pad An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Chest Production leadpoints are recorded but the standard lead positions have been modified so that all leads on the chest are part of a single electrode pad. (NCI) C71114 C71151 ECG Test Method 12 LEAD NON-STANDARD 12 LEAD NON-STANDARD 12 Lead Non-Standard An electrocardiogram (ECG) lead placement whereby the limb12 Lead Placement Non- Production leads are placed on the torso for easier and faster application Standard in emergency situations. (NCI) C71115 C71151 ECG Test Method STANDARD LEADS FOR BICYCLE STANDARD LEADS FOR BICYCLE Standard leads for bicycle Limb leads on the back (shoulder and on the hips). (NCI) Lead Placement Bicycle Production EXERCISE EXERCISE exercise. Limb leads on the back (shoulder and on the hips) C71116 C71151 ECG Test Method 12 LEAD CABRERA 12 LEAD CABRERA 12 Lead Cabrera An electrocardiogram (ECG) lead placement whereby the 12 Lead Placement Cabrera Production display of the 12 standard ECG leads is in an orderly sequence in a single horizontal display of: aVL, I, -aVR, II, aVF, III, V1 to V6. In the Cabrera display the limb lead aVR is inverted (-aVR) to ob C71117 C71151 ECG Test Method STANDARD LEADS ONE STANDARD LEADS ONE Standard leads one intercostal An electrocardiographic lead placement schema in which the Lead Placement Standard Production INTERCOSTAL SPACE HIGHER INTERCOSTAL SPACE HIGHER space higher V leads are placed one intercostal space cephalad to the Intercostal Space Higher position they would have in the standard lead placement schema. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C71118 C71151 ECG Test Method FRANK LEAD SYSTEM FRANK LEAD SYSTEM Frank lead system An electrocardiogram (ECG) lead placement for determining 3 Lead Placement Frank Production orthogonal components X (right to left direction), Y (foot to head direction) and Z (back to front direction) of the heart. For this method a minimum of 4 electrodes are needed that represent the C71119 C71151 ECG Test Method MCFEE-PARUNGAO LEAD MCFEE-PARUNGAO LEAD McFee-Parungao lead system An electrocardiogram (ECG) lead placement for determining 3 Lead Placement McFee- Production SYSTEM SYSTEM orthogonal components X (back to front), Y (right to left) and ZParungao (foot to head) of the heart. This system places the electrodes closer to the heart to achieve better orthogonality and a homogeneo C71120 C71151 ECG Test Method CUBE LEAD SYSTEM CUBE LEAD SYSTEM Cube lead system An electrocardiogram (ECG) lead placement that is a type of Lead Placement Cube Production uncorrected vectorcardiograph. This lead system is based on a rectangular body axis. It uses an extra number of electrodes to make it three-dimensional. (NCI) C71121 C71151 ECG Test Method BIPOLAR UNCORRECTED XYZ BIPOLAR UNCORRECTED XYZ Bipolar uncorrected XYZ lead An electrocardiogram (ECG) lead placement whereby the X+ Lead Placement Bipolar Production LEAD SYSTEM LEAD SYSTEM system lead is placed at the right mid-axillary line ate the 4th Uncorrected XYZ intercostal space, X- at the left mid-axillary line at he 4th intercostal space, Y+ at the proximal left leg, Y- at the superio aspect of t C71122 C71151 ECG Test Method PSEUDO-ORTHOGONAL XYZ PSEUDO-ORTHOGONAL XYZ Pseudo-orthogonal XYZ lead An electrocardiogram (ECG) lead placement that allows Lead Placement Pseudo Production LEAD SYSTEM LEAD SYSTEM system monitoring and recording of cardiac electrical activity. A V1- Orthogonal XYZ type lead is used whose positive electrode is localized in the 4th intercostal space, 2.5cm from the sternum. Its negative electrode is pla C71123 C71151 ECG Test Method 12 LEAD EASI DOWER 12 LEAD EASI DOWER 12 Lead EASI Dower An electrocardiogram (ECG) lead placement whereby 4 chest Lead Placement EASI Dower Production TRANSFORMATION TRANSFORMATION Transformation electrodes and 1 reference electrode are used to allow for Transformation continuous monitoring at the clinical level. This placement creates a 12 lead ECG that allows the acquisition of simultaneous events in th C71125 C71151 ECG Test Method 12 LEAD 1 LEAD MISSING 12 LEAD 1 LEAD MISSING 12 Lead 1 Lead Missing An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement 1 Lead Production leadpoints are recorded but one standard lead position is Missing missing therefore requiring a Mortara source consistency filter. (NCI) C71126 C71151 ECG Test Method STANDARD 12-LEAD AND CM5- STANDARD 12-LEAD AND CM5- Standard 12-lead and CM5- An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Standard Production CC5-CH5 CC5-CH5 CC5-CH5 leadpoints are recorded but the standard lead positions have And CC5-CM5-CH5 been modified so that the bipolar lead groups place the negative of the reference electrode over the manubrium (CM5), the right scapula (CB5) C71128 C71151 ECG Test Method STANDARD 12-LEAD AND CC5- STANDARD 12-LEAD AND CC5- Standard 12-lead and CC5- An electrocardiogram (ECG) lead placement whereby 12 12 Lead Placement Standard Production CM5-ML CM5-ML CM5-ML leadpoints are recorded but the standard lead positions have And CC5-CM5-ML been modified so that the negative reference is at CM5 and the active electrode is at the left leg position. (NCI) C71130 C71151 ECG Test Method STANDARD 12-LEAD EXTENDED STANDARD 12-LEAD EXTENDED Standard 12-lead extended to An electrocardiogram (ECG) lead placement whereby the 12 Lead Placement Standard Production RIGHT RIGHT the right by V5R, V4R, V3R rightward oriented V leads progress from V1R, placed instead Extended Right of the standard V2, to V6R. The V3 lead in the standard placement is replaced by V4R. (NCI) C71131 C71151 ECG Test Method STANDARD 12-LEAD EXTENDED STANDARD 12-LEAD EXTENDED Standard 12-lead extended to An electrocardiogram (ECG) lead placement whereby the 12 Lead Placement Standard Production LEFT LEFT the left by V7, V8, V9 standard lead placement is modified by having leads V7, V8 Extended Left and V9. (NCI) C71092 C71151 ECG Test Method VECTORCARDIOGRAPH VECTORCARDIOGRAPH Vectorcardiograph Corrected A recording of the electrical activity of the heart displayed in Vectorcardiograph Corrected Production CORRECTED CORRECTED the form of a vector loop, corrected for anatomic inconsistencies. (NCI) C71093 C71151 ECG Test Method VECTORCARDIOGRAPH VECTORCARDIOGRAPH Vectorcardiograph A recording of the electrical activity of the heart displayed in Vectorcardiograph Uncorrected Production UNCORRECTED UNCORRECTED Uncorrected the form of a vector loop, uncorrected for anatomic inconsistencies. (NCI) C71620 Yes Unit UNIT UNIT Unit Terminology codelist used for units within CDISC. CDISC SDTM Unit of Measure Production Terminology

C18063 C71620 Unit Gy Gy Gray A unit of absorbed radiation dose. One gray is equal to an Gray Production absorbed dose of one joule per kilogram of matter, or to 100 rads.(NCI) C18064 C71620 Unit Rad Rad Rad The special unit for absorbed radiation dose, which is the Rad Production amount of energy from any type of ionizing radiation (e.g., alpha, beta, gamma, neutrons, etc.) deposited in any medium (e.g., water, tissue, air). A dose of one rad means the absorption of 100 er C25301 C71620 Unit DAYS DAYS Day The time for Earth to make a complete rotation on its axis; Day Production ordinarily divided into twenty-four hours. This also refers to a specific day. (NCI) C25529 C71620 Unit HOURS HOURS Hour A unit measure of time equal to 3,600 seconds or 60 minutes. Hour Production It is approximately 1/24 of a median day.(NCI) C25613 C71620 Unit % % Percentage A fraction or ratio with 100 understood as the Percentage Production denominator.(NCI) C28251 C71620 Unit mm mm Millimeter A unit of measure equal to one thousandth of a meter.(NCI) Millimeter Production C28252 C71620 Unit kg kg Kilogram The basic SI unit of mass. It is defined as the mass of an Kilogram Production international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in terms of a material object, and also the only one with a pr C28253 C71620 Unit mg mg Milligram The unit of mass equal to one thousandth of a gram or 1000 Milligram Production micrograms. One milligram equals approximately 0.015432 grain or 35.274 x 10E-6 ounce.(NCI) C28254 C71620 Unit mL mL Milliliter The unit of volume equal to one thousandth of a liter, one Milliliter Production cubic centimeter, 10E-6 cubic meter, or approximately to 0.061 023 7 cubic inch.(NCI) C29844 C71620 Unit WEEKS WEEKS Week Any period of seven consecutive days.(NCI) Week Production C29846 C71620 Unit MONTHS MONTHS Month One of the 12 divisions of a year as determined by a calendar Month Production It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks.(NCI)

C29848 C71620 Unit YEARS YEARS Year The period of time that it takes for earth to make a complete Year Production revolution around the sun, approximately 365 days; a specific one year period.(NCI) C41139 C71620 Unit m m Meter A meter is defined as the length of the path traveled by light in Meter Production a vacuum during a time interval of 1/299 792 458 of a second and is equal to 1.093 61 yards.(NCI)

Covance Page 79 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C41140 C71620 Unit msec msec Millisecond A unit of time, which is equal to one thousandth of a Millisecond Production second.(NCI) C42535 C71620 Unit sec sec Second The second is a unit of time with a duration of 919 263 177 0 Second Production periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. According to the convention, 60 seco C42536 C71620 Unit amp amp Ampere A unit of electric current, named after the French physicist Ampere Production Andre Ampere. It is that constant current which, if maintained in two straight parallel conductors of infinite length and zero diameter separated by one meter in a vacuum, would produce between C42538 C71620 Unit cd cd Candela The candela is the basic unit of luminous intensity. It is the Candela Production luminous intensity in a given direction of a small monochromatic light source at 540 terahertz emitting 1/683 watt per steradian in that direction. This is dependent upon the definitions of th C42539 C71620 Unit mol mol Mole A unit defined as the amount of substance that contains as Mole Production many elementary units as there are atoms in 0.012 kg of carbon-12. When the mole is used, the elementary entities must be specified and may be atoms, molecules, ions, electrons, other particles, o C42545 C71620 Unit Hz Hz Hertz A unit of frequency equal to one cycle per second.(NCI) Hertz Production C42546 C71620 Unit Newton Newton Newton A unit of force which, when applied in a vacuum to a body Newton Production having a mass of one kilogram, causes an acceleration of one meter/sec(2). It is equal to 10E5 dynes.(NCI) C42547 C71620 Unit Pa Pa Pascal A unit of pressure equivalent to one Newton per square meter Pascal Production or 10 bars or to 1.45x10(E-4) pounds per square inch.(NCI)

C42548 C71620 Unit Joule Joule Joule A unit of electrical, mechanical, and thermal energy (as well Joule Production as work and quantity of heat), equal to the work done when the point of application of a force of one Newton is displaced through a distance of one meter in the direction of the force or the wo C42549 C71620 Unit Watt Watt Watt A unit of power equal to the power which in one second Watt Production produces or transfers the energy of one joule. The unit is used in measurements of power emitted, transferred or received as radiation, sound waves, heat flow rate, and rate of energy transfer. Equal C42550 C71620 Unit Coulomb Coulomb Coulomb A unit of quantity of electricity, equal to the quantity of charge Coulomb Production transferred in one second across a conductor in which there is a constant current of one Ampere.(NCI) C42551 C71620 Unit V V Volt A unit of electric potential and electromotive force, equal to theVolt Production difference of electric potential between two points on a conducting wire carrying a constant current of one Ampere when the power dissipated between the points is one watt. This is equival C42552 C71620 Unit Farad Farad Farad A unit of capacitance equal to the capacitance of a capacitor Farad Production having an equal and opposite charge of one coulomb on each plate and a potential difference of one volt between the plates.(NCI) C42553 C71620 Unit Sv Sv Sievert A unit of equivalent radiation dose. One Sv is received when Sievert Production the actual absorbed dose of ionizing radiation, after being multiplied by the dimensionless factors Q (the relative biological efficiency or quality factor) and N (the product of any other multi C42554 C71620 Unit ohm ohm Ohm A unit of electrical resistance equal to the resistance between Ohm Production two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A C42555 C71620 Unit Siemens Siemens Siemens A unit of electrical conductance, admittance, and Siemens Production susceptance. A conductor has a conductance of one siemens if an electrical potential difference of one volt produces a one Ampere current in it. The conductance in siemens is the reciprocal of its resistan C42556 C71620 Unit Weber Weber Weber A unit of magnetic flux, equal to the flux that produces in a Weber Production circuit of one turn an electromotive force of one volt, when the flux is uniformly reduced to zero within one second.(NCI) C42557 C71620 Unit Tesla Tesla Tesla A unit of magnetic flux density equal to the magnitude of the Tesla Production magnetic field vector necessary to produce a force of one Newton on a charge of one coulomb moving perpendicular to the direction of the magnetic field vector with a velocity of one meter per s C42558 C71620 Unit Henry Henry Henry A unit of electric inductance. A coil with an inductance of one Henry Production Henry requires a flux of one weber for each Ampere of induce current. If it is the current which changes, then the induced field will generate a potential difference within the coil: if the

C42559 C71620 Unit C C Degree Celsius A unit of temperature, named after the Swedish astronomer Degree Celsius Production Anders Celsius, who first proposed the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current C42560 C71620 Unit lm lm Lumen A unit of luminous flux. It is the amount of light that falls on a Lumen Production unit area at unit distance from a source of one candela.(NCI) C42561 C71620 Unit lx lx Lux A unit of illuminance equal to the direct illumination on a Lux Production surface that is everywhere one meter from a uniform point source of one candela; a unit of illuminance that is equal to one lumen per square meter.(NCI) C42562 C71620 Unit Bq Bq Becquerel A unit of activity of a radionuclide, equal to one nuclear Becquerel Production disintegration or other nuclear transition from a particular energy state occurring in an amount of a radionuclide during one second-long time interval.(NCI)

Covance Page 80 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C42566 C71620 Unit kat kat Katal A unit for measuring catalytic (e.g. enzymatic) activity, the Katal Production ability of the compound to accelerate the chemical reaction by providing a lower energy pathway between the reactants and the products. One katal is that catalytic activity which will raise the C42569 C71620 Unit m2 m2 Square Meter The SI unit of area measurement equal to a square whose Square Meter Production sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 are; 1.196 square yards; 10.76 square feet; 1550 square inches. (NCI) C42570 C71620 Unit m3 m3 Cubic Meter A unit of volume or capacity equal to the volume of a cube Cubic Meter Production with edges one meter in length. It is equal to 1,000 liters; 1,000 cubic decimeters; 10(E6) cubic centimeters; 25.3 cubic feet; 6.29 barrels.(NCI) C42571 C71620 Unit m/sec m/sec Meter Per Second A unit of both speed (scalar) and velocity (vector), defined as Meter Per Second Production the distance of one meter travelled per unit time equal to one second.(NCI) C42576 C71620 Unit kg/m3 kg/m3 Kilogram per Cubic Meter; g/L; A unit of mass concentration defined as the concentration of Kilogram per Cubic Meter Production Gram per Liter; ug/uL; one kilogram of a substance per unit volume of the mixture Microgram per Microliter; equal to one cubic meter, or the concentration of one Milligram per Milliliter milligram of a substance per unit volume of the mixture equal to one milliliter, C44277 C71620 Unit F F Degree Fahrenheit The Fahrenheit temperature scale is named after the German Degree Fahrenheit Production physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and C45997 C71620 Unit pH pH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 pH Production to 14.(NCI) C48152 C71620 Unit ug ug Microgram The unit of mass equal to one millionth of a gram or one Microgram Production thousandth of a milligram.(NCI) C48154 C71620 Unit min min Minute Unit of Time A unit measure of time equal to 60 seconds.(NCI) Minute Production C48155 C71620 Unit g g Gram A metric unit of mass equal to one one thousandth of a Gram Production kilogram. (NCI) C48460 C71620 Unit cm2 cm2 Square Centimeter A unit of area measurement equal to a square measuring one Square Centimeter Production centimeter on each side. One square centimeter is equal to 10E-4 square meter.(NCI) C48461 C71620 Unit ft2 ft2 Square Foot A unit of area equal to 144 square inches, 929.0304 square Square Foot Production centimeters, or 9.290304E-2 square meters.(NCI) C48466 C71620 Unit Ci Ci Curie A unit of radioactivity defined as 3.7 E10 atomic Curie Production disintegrations or other nuclear transformations per second. One Curie is equal to 37 gigabecquerels.(NCI) C48473 C71620 Unit AMPULE AMPULE Ampule Dosing Unit A dosing measurement based on the ampule unit.(NCI) Ampule Dosing Unit Production C48474 C71620 Unit BAG BAG Bag Dosing Unit A dosing measurement based on the bag unit.(NCI) Bag Dosing Unit Production C48475 C71620 Unit BAR BAR Bar Dosing Unit A dosing measurement based on the bar unit.(NCI) Bar Dosing Unit Production C48476 C71620 Unit BOLUS BOLUS Bolus Dosing Unit A dosing measurement based on the bolus unit.(NCI) Bolus Dosing Unit Production C48477 C71620 Unit BOTTLE BOTTLE Bottle Dosing Unit A dosing measurement based on the bottle unit.(NCI) Bottle Dosing Unit Production C48478 C71620 Unit BOX BOX Box Dosing Unit A dosing measurement based on the box unit.(NCI) Box Dosing Unit Production C48479 C71620 Unit CAN CAN Can Dosing Unit A dosing measurement based on the can unit.(NCI) Can Dosing Unit Production C48480 C71620 Unit CAPSULE CAPSULE Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit Production C48481 C71620 Unit CARTRIDGE CARTRIDGE Cartridge Dosing Unit A dosing measurement based on the cartridge unit.(NCI) Cartridge Dosing Unit Production C48483 C71620 Unit COAT COAT Coat Dosing Unit A dosing measurement based on the coat unit.(NCI) Coat Dosing Unit Production C48484 C71620 Unit CONTAINER CONTAINER Container Dosing Unit A dosing measurement based on the container unit.(NCI) Container Dosing Unit Production C48489 C71620 Unit CYLINDER CYLINDER Cylinder Dosing Unit A dosing measurement based on the cylinder unit.(NCI) Cylinder Dosing Unit Production C48490 C71620 Unit DISK DISK Disk Dosing Unit A dosing measurement based on the disk unit.(NCI) Disk Dosing Unit Production C48492 C71620 Unit DRUM DRUM Drum Dosing Unit A dosing measurement based on the drum unit.(NCI) Drum Dosing Unit Production C48497 C71620 Unit grain grain Grain A unit of mass derived from the weight of a grain and equal to Grain Production one seven-thousandth of a pound, or 1/480 troy ounce, or 64.79891 milligrams. The original English grain unit based on the mass of a ripe grain barleycorn was larger the corresponding grain un C48498 C71620 Unit HOMEOPATHIC DILUTION HOMEOPATHIC DILUTION Homeopathic Dilution Unit A dosing measurement based on the homeopathic dilution Homeopathic Dilution Unit Production unit.(NCI) C48499 C71620 Unit IMPLANT IMPLANT Implant Dosing Unit A dosing measurement based on the implant unit.(NCI) Implant Dosing Unit Production C48500 C71620 Unit IN IN Inch A traditional unit of length equal to 2.54 centimeters. (NCI) Inch Production C48501 C71620 Unit INHALATION INHALATION Inhalation Dosing Unit A dosing measurement based on the inhalation unit.(NCI) Inhalation Dosing Unit Production C48502 C71620 Unit JAR JAR Jar Dosing Unit A dosing measurement based on the jar unit.(NCI) Jar Dosing Unit Production C48503 C71620 Unit KALLIKREIN INHIBITOR UNIT KALLIKREIN INHIBITOR UNIT Kallikrein Inhibitor Unit A dosing measurement based on the Kallikrein inhibitor Kallikrein Inhibitor Unit Production unit.(NCI) C48504 C71620 Unit KIT KIT Kit Dosing Unit A dosing measurement based on the kit unit.(NCI) Kit Dosing Unit Production C48505 C71620 Unit L L Liter A unit of volume equal to a cubic decimeter, or one Liter Production thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches.(NCI) C48506 C71620 Unit LOZENGE LOZENGE Lozenge Dosing Unit A dosing measurement based on the lozenge unit.(NCI) Lozenge Dosing Unit Production C48507 C71620 Unit uCi uCi Microcurie A unit of radioactivity equal to one millionth of a Curie or 37 Microcurie Production kilobecquerels, and corresponding to a radioactivity of 37 000 atomic disintegrations per second.(NCI) C48509 C71620 Unit umol umol Micromole A unit of amount of substance equal to one millionth (10E-6) Micromole Production of a mole.(NCI) C48510 C71620 Unit um um Micron A unit of length in metric system equal to 10E-6 meter, or Micron Production micrometer.(NCI) C48511 C71620 Unit mCi mCi Millicurie A unit of radioactivity equal to one thousandth of a Curie or 37 Millicurie Production megabecquerels, and corresponding to a radioactivity of 37 millions of atomic disintegrations per second.(NCI) C48512 C71620 Unit mEq mEq Milliequivalent A unit of relative amount of a substance equal to one Milliequivalent Production thousandth of an equivalent weight.(NCI) C48513 C71620 Unit mmol mmol Millimole A unit of amount of substance equal to 0.001 mole.(NCI) Millimole Production C48516 C71620 Unit ng ng Nanogram A unit of mass equal to one billionth (10E-9) of a gram, or one Nanogram Production millionth (10E-6) of a milligram.(NCI) C48517 C71620 Unit nmol nmol Nanomole A unit of amount of substance equal to one billionth (10E-9) of Nanomole Production a mole.(NCI) C48519 C71620 Unit oz oz Ounce A unit of mass, the avoirdupois ounce is equal to 1/16 pound, Ounce Production or 28.3495 grams, or 0.911 457 troy ounce.(NCI) C48520 C71620 Unit PACKAGE PACKAGE Package Dosing Unit A dosing measurement based on the package unit.(NCI) Package Dosing Unit Production C48521 C71620 Unit PACKET PACKET Packet Dosing Unit A dosing measurement based on the packet unit.(NCI) Packet Dosing Unit Production C48523 C71620 Unit ppm ppm Part per Million A unit of measurement referring to one entity counted per one Part Per Million Production million entities.(NCI)

Covance Page 81 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C48524 C71620 Unit PATCH PATCH Patch Dosing Unit A dosing measurement based on the patch unit.(NCI) Patch Dosing Unit Production C48525 C71620 Unit PELLET PELLET Pellet Dosing Unit A dosing measurement based on the pellet unit.(NCI) Pellet Dosing Unit Production C48527 C71620 Unit %(w/v) %(w/v) Percent Weight per Volume A percent ratio of weight to volume, defined by the equation: Percent Mass per Volume Production [weight of solute (in gm)/volume of solution (in dl)](100). Since the numerator and denominator of this ratio have different units, it is not a true percentage. A 1% w/v solution is defined as C48528 C71620 Unit %(w/w) %(w/w) Percent Weight per Weight A percent ratio of weight to weight, defined by the equation: Percent Mass per Mass Production [weight of solute (in gm)/weight of solution (in gm)](100).(NCI)

C48530 C71620 Unit POUCH POUCH Pouch Dosing Unit A dosing measurement based on the pouch unit.(NCI) Pouch Dosing Unit Production C48531 C71620 Unit LB LB Pound A traditional unit of mass. By international agreement, one Pound Production avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI) C48532 C71620 Unit PRESSOR UNITS PRESSOR UNITS Pressor Unit A dosing measurement based on the pressor unit.(NCI) Pressor Unit Production C48536 C71620 Unit SCOOPFUL SCOOPFUL Scoopful Dosing Unit A dosing measurement based on the scoopful unit.(NCI) Scoopful Dosing Unit Production C48537 C71620 Unit SPRAY SPRAY Spray Dosing Unit A dosing measurement based on the spray unit.(NCI) Spray Dosing Unit Production C48538 C71620 Unit STRIP STRIP Strip Dosing Unit A dosing measurement based on the strip unit.(NCI) Strip Dosing Unit Production C48539 C71620 Unit SUPPOSITORY SUPPOSITORY Suppository Dosing Unit A dosing measurement based on the suppository unit.(NCI) Suppository Dosing Unit Production C48540 C71620 Unit SYRINGE SYRINGE Syringe Dosing Unit A dosing measurement based on the syringe unit.(NCI) Syringe Dosing Unit Production C48541 C71620 Unit Tbsp Tbsp Tablespoon Dosing Unit A unit of volume informally used in pharmacy. The tablespoon Tablespoon Dosing Unit Production has been standardized at 15 milliliters in US, Britain, Canada, and New Zealand, and at 20 milliliters in Australia and some European countries.(NCI) C48542 C71620 Unit TABLET TABLET Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit Production C48543 C71620 Unit TAMPON TAMPON Tampon Dosing Unit A dosing measurement based on the tampon unit.(NCI) Tampon Dosing Unit Production C48544 C71620 Unit tsp tsp Teaspoon Dosing Unit A unit of volume used in pharmacy equal to 5 milliliters.(NCI) Teaspoon Dosing Unit Production C48547 C71620 Unit TRACE TRACE Trace Dosing Unit An extremely small amount.(NCI) Trace Dosing Unit Production C48548 C71620 Unit TROCHE TROCHE Troche Dosing Unit A dosing measurement based on the troche unit.(NCI) Troche Dosing Unit Production C48549 C71620 Unit TUBE TUBE Tube Dosing Unit A dosing measurement based on the tube unit.(NCI) Tube Dosing Unit Production C48551 C71620 Unit VIAL VIAL Vial Dosing Unit A dosing measurement based on the vial unit.(NCI) Vial Dosing Unit Production C48552 C71620 Unit WAFER WAFER Wafer Dosing Unit A dosing measurement based on the wafer unit.(NCI) Wafer Dosing Unit Production C48553 C71620 Unit yd yd Yard A unit of length equal to 3 feet, or 36 inches, or 0.9144 Yard Production meter.(NCI) C48555 C71620 Unit mol/L mol/L Mole per Liter A unit of concentration (molarity unit) equal to one mole of Mole per Liter Production solute in one liter of solution.(NCI) C48571 C71620 Unit % (v/v) % (v/v) Percent Volume per Volume A percent ratio of volume to volume, defined by the equation: Percent Volume per Volume Production [volume of solute (in ml)/ volume of solution (in ml)](100), typically used for admixtures of solutions.(NCI) C48579 C71620 Unit IU IU International Unit The unitage assigned by the WHO (World Health International Unit Production Organization) to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vac C48590 C71620 Unit QUANTITY SUFFICIENT QUANTITY SUFFICIENT Quantity Sufficient A quantity of an ingredient or product needed to bring up a Quantity Sufficient Production volume or weight of the preparation to a final amount as it is indicated in the prescription; also refers to a determination of an adequate supply of medicine to fulfill either a prescribed amoun C49668 C71620 Unit cm cm Centimeter A basic unit of length equal to one hundredth of a meter or Centimeter Production approximately 0.393 700 787 inch (NCI) C49670 C71620 Unit mmHg mmHg Millimeter of Mercury A unit of pressure equal to 0.001316 atmosphere and equal to Millimeter of Mercury Production the pressure indicated by one millimeter rise of mercury in a barometer at the Earth's surface.(NCI) C49671 C71620 Unit kg/m2 kg/m2 Kilogram per Square Meter A unit expressed as kilogram of mass per square meter of Kilogram Per Square Meter Production area.(NCI) C49673 C71620 Unit BEATS/MIN BEATS/MIN Beats per Minute The number of heartbeats measured per minute time.(NCI) Beats per Minute Production C49674 C71620 Unit BREATHS/MIN BREATHS/MIN Breaths per Minute The number of breaths (inhalation and exhalation) taken per Breaths per Minute Production minute time.(NCI) C54703 C71620 Unit CUP CUP Cup Dosing Unit A dosing measurement based on the cup unit.(NCI) Cup Dosing Unit Production C54711 C71620 Unit atm atm Atmosphere A unit of pressure, equal to a barometer reading of 760 mm Atmosphere Production Hg. 1 atmosphere is 101325 pascals and 1.01325 bar. This unit of pressure is roughly equal to the average atmospheric pressure at sea level on the earth.(NCI) C62609 C71620 Unit RING RING Ring Dosing Unit A dosing measurement based on the ring unit.(NCI) Ring Dosing Unit Production C64387 C71620 Unit mmol/L mmol/L Millimole per Liter; umol/mL; A unit of concentration (molarity unit) equal to one thousandth Millimole per Liter Production Micromole per Milliliter; of a mole (10E-3 mole) of solute per one liter of solution.(NCI) mol/m3; Mole per Cubic Meter

C64551 C71620 Unit pg pg Picogram A unit of mass equal to one trillionth of a gram (10E-12 Picogram Production gram).(NCI) C64552 C71620 Unit fg fg Femtogram A unit of mass equal to one quadrillionth of a gram (10E-15 Femtogram Production gram).(NCI) C64553 C71620 Unit ag ag Attogram A unit of mass equal to one quintillionth of a gram (10E-18 Attogram Production gram).(NCI) C64554 C71620 Unit cg cg Centigram A unit of mass equal to one hundredth of a gram.(NCI) Centigram Production C64564 C71620 Unit dram dram Dram A unit of mass equal to 1/16 Avoirdupois ounce or 1/256 Dram Mass Unit Production Avoirdupois pound. One dram equals approximately 1.7718451953125 grams.(NCI) C64566 C71620 Unit kg/L kg/L Kilogram per Liter; g/mL; A unit of mass concentration defined as the concentration of Kilogram per Liter Production Gram per Milliliter one kilogram of a substance in unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass eq C64572 C71620 Unit g/m3 g/m3 Gram per Cubic Meter; ug/mL; A unit of mass concentration equal to the concentration of one Microgram per Milliliter Production Microgram per Milliliter; mg/L; gram of a substance per unit volume of the mixture equal to Milligram per Liter one cubic meter. The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which C64777 C71620 Unit mL/min mL/min Milliliters per Minute A metric unit of volumetric flow rate defined as the rate at Milliliter per Minute Production which one milliliter of matter travels during the period of time equal to one minute.(NCI)

Covance Page 82 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C64783 C71620 Unit g/dL g/dL Gram per Deciliter A unit of mass concentration defined as the concentration of Gram per Deciliter Production one gram of a substance per unit volume of the mixture equal to one deciliter (100 milliliters). The concept also refers to the metric unit of mass density (volumic mass) defined as the density C65045 C71620 Unit pmol pmol Picomole A unit of amount of substance equal to a trillionth (10E-12) of Picomole Production a mole.(NCI) C65060 C71620 Unit PUFF PUFF Puff A means of delivering a defined dose of a therapeutic aerolize Puff Dosing Unit Production solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NC C65104 C71620 Unit mm2 mm2 Square Millimeter A unit of area measurement equal to a square measuring one Square Millimeter Production millimeter on each side. One square millimeter is equal to 10(E-2) square centimeter and 10(E-6) square meter.(NCI)

C65132 C71620 Unit tuberculin unit tuberculin unit Tuberculin Unit An arbitrary unit of tuberculin dosage defined by comparison Tuberculin Unit Production of clinical response with a preparation of the purified protein derivative standardized for use in humans for tuberculin skin test reaction.(NCI) C66962 C71620 Unit mL/h mL/h Milliliters per Hour A unit of volumetric flow rate defined as the rate at which one Milliliter per Hour Production milliliter of matter travels during the period of time equal to one hour.(NCI) C66965 C71620 Unit per sec per sec Per Second The number of occurrences of something within a second of Per Second Production time.(NCI) C66967 C71620 Unit per min per min Per Minute The number of occurrences of something within a minute of Per Minute Production time.(NCI) C66969 C71620 Unit mg/h mg/h Milligram per Hour A unit of mass flow rate equivalent to the rate at which one Milligram per Hour Production thousandth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) C67015 C71620 Unit mg/dL mg/dL Milligram per Deciliter A unit of mass concentration defined as the concentration of Milligram per Deciliter Production one milligram of a substance in unit volume of the mixture equal to one cubic deciliter or 100 cubic centimeters. It is also a unit of mass density (volumic mass) defined as the density of subst C67193 C71620 Unit cal cal Calorie A measurement of nutritional energy. The quantity of thermal calorie Production energy required to raise one gram of water one degree Centigrade under standard conditions. 1 calorie equals 4.186 joules. (NCI) C67194 C71620 Unit kcal kcal Kilogram-Calorie A unit of energy defined as the amount of heat required to Calorie Production raise the temperature of one kilogram of pure water by one degree Centigrade under standard conditions (the specific heat of the water at 15 degrees Celsius and the constant pressure of 101.325 ki C67264 C71620 Unit PFU PFU Plaque Forming Unit A measure of viable infectious entities (e.g. viral particle or Plaque Forming Unit Production group of particles) in the specimen or product defined as the smallest quantity that can produce a cytopathic effect in the host cell culture challenged with the defined inoculum, visible und C67273 C71620 Unit eq eq Equivalent Weight A unit of relative amount of a substance that combines with or Equivalent Weight Production displaces 8.0 grams of oxygen or 1.008 gram of hydrogen. The unit is usually expressed in grams and is equal to the amount of substance that gains or loses one mole of electrons in a redox rea C67274 C71620 Unit HPF HPF High Power Field The area visible under the maximum magnification power of High Power Field Production the objective being used in microscopy.(NCI) C67282 C71620 Unit g/m2 g/m2 Gram per Square Meter A unit of area density defined as a spread rate at which one Gram per Square Meter Production gram of a substance is spread over the area of one square meter. It is equal to approximately 0.029 4935 ounce per square yard. Also used as a dose calculation unit.(NCI) C67306 C71620 Unit ug/L ug/L Microgram per Liter; mg/m3; A unit of mass concentration defined as the concentration of Microgram per Liter Production Milligram per Cubic Meter; one microgram of a substance per unit volume of the mixture ng/mL; Nanogram per Milliliter equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass C67307 C71620 Unit LPF LPF Low Power Field The area visible in one view field of the microscope under the Low Power Field Production low magnification of the objective being used in microscopy.(NCI) C67324 C71620 Unit mV mV Millivolt A unit of electric potential and electromotive force equal to oneMillivolt Production thousandth of a volt.(NCI) C67326 C71620 Unit ng/dL ng/dL Nanogram per Deciliter A unit of mass concentration defined as the concentration of Nanogram per Deciliter Production one nanogram of a substance in unit volume of the mixture equal to one deciliter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mas C67327 C71620 Unit ug/m3 ug/m3 Microgram per Cubic Meter A unit of mass concentration defined as the concentration of Nanogram per Liter Production one nanogram of a substance per one liter of the mixture, or one picogram of a substance in unit volume of the mixture equal to one milliliter, or one microgram of a substance per one cubic mete C67328 C71620 Unit nm nm Nanometer A unit of length equal to one billionth of a meter (10E-9 Nanometer Production meter). Nanometer is used as a unit for light wavelength measurement.(NCI) C67330 C71620 Unit osm osm Osmole A unit of osmotic pressure equal to that of an ideal solution of Osmole Production a nondissociating substance that has a concentration of one mole of solute per liter of solution.(NCI) C67334 C71620 Unit psi psi Pounds per Square Inch A unit of pressure equivalent to 6.894757 kilopascals, or Pound per Square Inch Production 703.0696 kilograms per square meter, or 51.71507 millimeters of mercury.(NCI) C67335 C71620 Unit million IU million IU Million International Units A unit of biological activity equal to one million international Million International Units Production units.(NCI) C67352 C71620 Unit nCi nCi Nanocurie A unit of radioactivity equal to one billionth of Curie or 37 Nanocurie Production Becquerels, and corresponding to a radioactivity of 37 atomic disintegrations per second.(NCI)

Covance Page 83 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C67376 C71620 Unit IU/L IU/L International Unit per Liter Unit of arbitrary substance concentration (biologic activity International Unit per Liter Production concentration) defined as the concentration of one international unit per one liter of system volume.(NCI) C67377 C71620 Unit IU/mL IU/mL International Unit per Milliliter; Unit of arbitrary substance concentration (biologic activity International Unit per Milliliter Production kIU/L; Kilo International Unit concentration) defined as the concentration of one per Liter international unit per one milliliter of system volume.(NCI) C67379 C71620 Unit IU/kg IU/kg International Unit per Kilogram An arbitrary unit of substance content expressed in International Unit per Kilogram Production international units of biological activity per one kilogram of mass of the system. It is also used as a dose calculation unit expressed in international units of biological activity per one kilogram of b C67380 C71620 Unit IU/mg IU/mg International Unit per Milligram Unit of arbitrary substance concentration (biologic activity International Unit per Milligram Production concentration) defined as the concentration of one international unit per one milligram of substance.(NCI) C67388 C71620 Unit L/min L/min Liters per Minute A unit of volumetric flow rate defined as the rate at which one Liter per Minute Production liter of matter travels during the period of time equal to one minute.(NCI) C67394 C71620 Unit ug/h ug/h Micrograms per Hour A unit of mass flow rate equivalent to the rate at which one Microgram per Hour Production millionth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) C67396 C71620 Unit ug/kg ug/kg Microgram per Kilogram A unit of a mass fraction expressed as a number of Microgram per Kilogram Production micrograms of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) C67397 C71620 Unit ukat/L ukat/L Microkatal per Liter Unit of catalytic activity concentration defined as activity equal Microkatal per Liter Production to one millionth of katal per one liter of the system volume.(NCI) C67399 C71620 Unit mg/day mg/day Milligram per Day A unit of measure referring to the ratio between mass Milligram per 24 Hours Production expressed in milligrams per day.(NCI) C67401 C71620 Unit mg/kg mg/kg Milligram per Kilogram A unit of a mass fraction expressed as a number of milligrams Milligram per Kilogram Production of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) C67402 C71620 Unit mg/m2 mg/m2 Milligram per Square Meter A unit of area density equal to approximately 2.94935E-5 Milligram per Square Meter Production ounce per square yard. Also used as a dose calculation unit.(NCI) C67406 C71620 Unit umol/day umol/day Micromoles per Day A unit of amount of substance flow rate equivalent to the rate Micromole per 24 Hours Production at which one millionth of a mole of substance travels to a given object or space over a period of time equal to 24 hours.(NCI) C67419 C71620 Unit mm/h mm/h Millimeter per Hour A unit of both speed (scalar) and velocity (vector), defined as Millimeter per Hour Production the distance of one millimeter travels per unit time equal to one hour.(NCI) C67420 C71620 Unit mmol/day mmol/day Millimole per 24 Hours A unit of amount of substance flow rate equivalent to the rate Millimole per 24 Hours Production at which one thousandth of a mole of substance travels or is delivered to a given object or space over a period of time equa to 24 hours.(NCI) C67432 C71620 Unit nmol/L nmol/L Nanomole per Liter A unit of concentration (molarity unit) equal to one billionth of Nanomole per Liter Production a mole (10E-9 mole) of solute in one liter of solution.(NCI) C67434 C71620 Unit pmol/L pmol/L Picomole per Liter A unit of concentration (molarity unit) equal to one trillionth of Picomole per Liter Production a mole (10E-12 mole) in one liter of solution.(NCI) C67441 C71620 Unit RNA copies/mL RNA copies/mL RNA Copies per Milliliter The unit of concentration of Ribonucleic Acid (RNA) copies RNA Copy per Milliliter Production expressed as a number of copies in unit volume equal to one milliliter.(NCI) C67471 C71620 Unit mEq/day mEq/day Milliequivalents per Day A unit of relative amount of substance flow rate equivalent to Milliequivalent per 24 Hours Production the rate at which one thousandth of an equivalent of substance travels to a given object or space over a period of time equal t twenty four hours.(NCI) C67474 C71620 Unit mEq/L mEq/L Milliequivalent Per Liter A concentration unit measured as a number of milliequivalentsMilliequivalent per Liter Production of solute per liter of solution.(NCI) C67475 C71620 Unit mEq/kg mEq/kg Milliequivalent Per Kilogram A unit of relative amount of substance content equivalent to Milliequivalent per Kilogram Production the content at which one kilogram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) C68667 C71620 Unit deg deg Degree Unit of Plane Angle A unit of plane angle measurement equal to the length of the Degree Unit of Plane Angle Production arc cut out by the angle, divided by the circumference of the circle, and multiplied by 360. The symbol for degrees is a small superscript circle. One radian is about 57 degrees and one degree i C68685 C71620 Unit dmol dmol Decimole A unit of amount of substance equal to one tenth of a mole Decimole Production (10E-1 mole).(NCI) C68687 C71620 Unit cmol cmol Centimole A unit of amount of substance equal to one hundredth of a Centimole Production mole (10E-2 mole).(NCI) C68740 C71620 Unit mmol/g mmol/g Millimole per Gram A unit amount of substance content (molality unit) defined as Mole per Kilogram Production one mole of solute per one kilogram of solvent.(NCI) C68854 C71620 Unit fmol fmol Femtomole A unit of amount of substance equal to one quadrillionth of a Femtomole Production mole (10E-15 mole).(NCI) C68855 C71620 Unit amol amol Attomole A unit of amount of substance equal to one quintillionth of a Attomole Production mole (10E-18 mole).(NCI) C68859 C71620 Unit ft3 ft3 Standard Cubic Foot A unit used in physical chemistry to express the amount of Standard Cubic Foot Production substance of an ideal gas in one cubic foot at 60 degrees Fahrenheit and pressure of one atmosphere.(NCI) C68871 C71620 Unit in2 in2 Square Inch A unit of area equal to the area of a square with sides of one Square Inch Production inch. It is equal to 6.4516 square centimeters.(NCI) C68875 C71620 Unit ELISA unit ELISA unit Enzyme-Linked A unit for measuring concentration or/and reactivity of a test Enzyme-Linked Immunosorbent Production Immunosorbent Assay Unit substance (an antigen or antibody of interest) as defined in theAssay Unit literature reference standard for the particular quantitative enzyme-linked immunosorbent assay method. The enzyme- linked immun C68876 C71620 Unit ELISA unit/dose ELISA unit/dose Enzyme-Linked A unit for measuring potency of immunologically active Enzyme-Linked Immunosorbent Production Immunosorbent Assay Unit substance in a product determined as reactivity in a Assay Unit per Dose per Dose quantitative immunoassay for particular antigen or antibody and expressed per quantity of preparation used as a single dose.(NCI) C68877 C71620 Unit ELISA unit/mL ELISA unit/mL Enzyme-Linked A unit for measuring potency of immunologically active Enzyme-Linked Immunosorbent Production Immunosorbent Assay Unit substance in a product determined as reactivity in a Assay Unit per Milliliter per Milliliter quantitative immunoassay for particular antigen or antibody and expressed per unit volume equal to one milliliter.(NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C68878 C71620 Unit Log10 ELISA unit Log10 ELISA unit Log10 Enzyme-Linked A logarithmic-scale (base 10) unit for measuring concentrationLog10 Enzyme-Linked Production Immunosorbent Assay Unit and/or reactivity of a test substance (an antigen or antibody of Immunosorbent Assay Unit interest) as defined in the literature reference for the particular quantitative enzyme-linked immunosorbent assay method.(NCI) C68879 C71620 Unit Log10 ELISA unit/dose Log10 ELISA unit/dose Log10 Enzyme-Linked A logarithmic-scale (base 10) unit for measuring potency of Log10 Enzyme-Linked Production Immunosorbent Assay Unit immunologically active substance in a product determined as Immunosorbent Assay Unit per per Dose reactivity in a quantitative immunoassay for particular antigen Dose or antibody and expressed per quantity of preparation used as a single C68891 C71620 Unit mol/mL mol/mL Mole per Milliliter A unit of concentration (molarity unit) equal to one mole of Mole per Milliliter Production solute in one milliliter of solution.(NCI) C68892 C71620 Unit mmol/kg mmol/kg Millimole per Kilogram A unit of amount of substance content (molality unit) defined Millimole per Kilogram Production as one thousandth of mole (10E-3 mole) of solute per one kilogram of solvent.(NCI) C68893 C71620 Unit mol/g mol/g Mole per Gram A unit of amount of substance content (molality unit) defined Mole per Gram Production as one mole of solute per one gram of solvent.(NCI) C68894 C71620 Unit mol/mg mol/mg Mole per Milligram A unit of amount of substance content (molality unit) defined Mole per Milligram Production as one mole of solute per one milligram of solvent.(NCI) C68895 C71620 Unit thousand CFU thousand CFU Thousand Colony Forming A unit of measurement of viable bacterial numbers equal to Thousand Colony Forming Units Production Units 10E3 colony forming units.(NCI) C68896 C71620 Unit million CFU million CFU Million Colony Forming Units A unit of measurement of viable bacterial numbers equal to Million Colony Forming Units Production 10E6 colony forming units.(NCI) C68897 C71620 Unit billion CFU billion CFU Billion Colony Forming Units A unit of measurement of viable bacterial numbers equal to Billion Colony Forming Units Production 10E9 colony forming units.(NCI) C68898 C71620 Unit CFU/g CFU/g Colony Forming Unit per Gram A unit of measurement of viable bacterial organisms in a unit Colony Forming Unit per Gram Production mass of substance of interest defined as the number of colony forming units in one gram of substance.(NCI) C68899 C71620 Unit thousand CFU/g thousand CFU/g Thousand Colony Forming A unit of measurement of viable bacterial organisms in a unit Thousand Colony Forming Units Production Units per Gram mass of substance of interest defined as the number of per Gram thousand colony forming units (10E3CFU) in one gram of substance.(NCI) C68900 C71620 Unit million CFU/g million CFU/g Million Colony Forming Units A unit of measurement of viable bacterial organisms in a unit Million Colony Forming Units per Production per Gram mass of substance of interest defined as the number of million Gram colony forming units (10E6CFU) in one gram of substance.(NCI) C68901 C71620 Unit billion CFU/g billion CFU/g Billion Colony Forming Units A unit of measurement of viable bacterial organisms in a unit Billion Colony Forming Units per Production per Gram mass of substance of interest defined as the number of billion Gram colony forming units (10E9CFU) in one gram of substance.(NCI) C68902 C71620 Unit CFU/mL CFU/mL Colony Forming Unit per A unit of measurement of viable bacterial organisms in a unit Colony Forming Unit per Milliliter Production Milliliter volume of substance of interest defined as the number of colony forming units in one milliliter of substance.(NCI) C68903 C71620 Unit thousand CFU/mL thousand CFU/mL Thousand Colony Forming A unit of measurement of viable bacterial organisms in a unit Thousand Colony Forming Units Production Units per Milliliter volume of substance of interest defined as the number of per Milliliter thousand colony forming units (10E3CFU) in one milliliter of substance.(NCI) C68904 C71620 Unit million CFU/mL million CFU/mL Million Colony Forming Units A unit of measurement of viable bacterial organisms in a unit Million Colony Forming Units per Production per Milliliter volume of substance of interest defined as the number of Milliliter million colony forming units (10E6CFU) in one milliliter of substance.(NCI) C68905 C71620 Unit billion CFU/mL billion CFU/mL Billion Colony Forming Units A unit of measurement of viable bacterial organisms in a unit Billion Colony Forming Units per Production per Milliliter volume of substance of interest defined as the number of Milliliter billion colony forming units (10E9CFU) in one milliliter of substance.(NCI) C68915 C71620 Unit Gauss Gauss Gauss The unit of magnetic flux density. A field of one Gauss exerts aGauss Production force on a conductor, placed in the field of 0.1 dyne per Ampere of current per centimeter of conductor. One Gauss represents a magnetic flux of one Maxwell per square centimeter of cross-se C69094 C71620 Unit kg/cm2 kg/cm2 Kilogram per Square A unit of spread rate of a substance by mass expressed in Kilogram Per Square Centimeter Production Centimeter kilograms per area unit equal to one square centimeter, used also as a measure of area density and as a dose calculation unit.(NCI) C69104 C71620 Unit g/kg g/kg Gram per Kilogram; mg/g; A unit of a mass fraction expressed as a number of grams of Gram per Kilogram Production Milligram per Gram substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) C69112 C71620 Unit ppth ppth Part per Thousand A unit of proportion equal to 10E-3.(NCI) Part per Thousand Production C69148 C71620 Unit pm pm Picometer A unit of length equal to one trillionth of a meter (10E-12 Picometer Production meter).(NCI) C69175 C71620 Unit uL/mL uL/mL Microliter per Milliliter A unit of volume fraction expressed as a number of microliters Microliter per Milliliter Production of the constituent per the volume of the system represented in milliliters.(NCI) C69188 C71620 Unit nL nL Nanoliter A unit of volume equal to one billionth of a liter (10E-9 Nanoliter Production liter).(NCI) C69442 C71620 Unit gtt gtt Drop A unit of volume equal to 0.05 milliliter (20 drops/ml).(NCI) Medical Drop Production C70455 C71620 Unit mol/mol mol/mol Mole per Mole A unit of fraction expressed as the ratio of the amount of Mole per Mole Production substance of solute in moles to the amount of substance of the mixture in moles.(NCI) C70469 C71620 Unit rpm rpm Revolution per Minute A unit of frequency equal to one revolution per unit of time Revolution per Minute Production equal to one minute.(NCI) C70470 C71620 Unit dyn dyn Dyne A unit of force defined as the force that accelerates a mass of Dyne Production one gram at the rate of one centimeter per second squared. One dyne is equal to 10E-5 Newton and 2.248E-6 pounds of force.(NCI) C70479 C71620 Unit log10 EID 50 log10 EID 50 Log10 50 Percent Embryo A potency unit for measuring infectious activity of a biologic Log10 50 Percent Embryo Production Infective Dose product or infectious agent equal to a base-10 logarithm of Infective Dose amount of product or agent preparation that causes infection in the 50% of embryos (such as chicken embryos) used in the product pot C70480 C71620 Unit log EID 50/dose log EID 50/dose Log10 50 Percent Embryo A logarithmic-scale (base 10) potency unit for measuring Log10 50 Percent Embryo Production Infective Dose per Dose infectious activity of a biologic product or infectious agent Infective Dose per Dose preparation equal to the potency at which one dose of infectious material contains one 50 percent embryo infective dose.(NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C70484 C71620 Unit log10 CCID 50 log10 CCID 50 Log10 50 Percent Cell Culture A potency unit for measuring infectious activity of a biologic Log10 50 Percent Cell Culture Production Infective Dose product or infectious agent preparation equal to a base-10 Infective Dose logarithm of amount of product or agent preparation that causes infection in the 50% of the cell culture-containing vessels inoculate C70485 C71620 Unit log10 CCID 50/dose log10 CCID 50/dose Log10 50 Percent Cell Culture A logarithmic-scale (base 10) potency unit for measuring Log10 50 Percent Cell Culture Production Infective Dose per Dose infectious activity of a biologic product or infectious agent Infective Dose per Dose preparation equal to the potency at which one dose of infectious material contains one 50 percent cell culture infective dose.(NCI) C70488 C71620 Unit log10 TCID 50 log10 TCID 50 Log10 50 Percent Tissue A potency unit for measuring infectious activity of a biologic Log10 50 Percent Tissue Culture Production Culture Infective Dose product or infectious agent preparation equal to a base-10 Infective Dose logarithm of amount of product or agent preparation that causes infection in the 50% of the tissue culture-containing flasks inoculat C70489 C71620 Unit log10 TCID 50/dose log10 TCID 50/dose Log10 50 Percent Tissue A logarithmic-scale (base 10) potency unit for measuring Log10 50 Percent Tissue Culture Production Culture Infective Dose per infectious activity of a biologic product or infectious agent Infective Dose per Dose Dose preparation equal to the potency at which one dose of infectious material contains one 50 percent tissue culture infective dose.(NCI) C70492 C71620 Unit kIU kIU Kilo International Unit A unit equal to one thousand international units.(NCI) Kilointernational Unit Production C70493 C71620 Unit IU/g IU/g International Unit per Gram A unit of measure of quantity of substance per unit mass, International Unit per Gram Production expressed in terms of the International Unit per grams.(NCI) C70497 C71620 Unit anti-Xa IU anti-Xa IU Anti-Xa Activity International A unit of unfractionated or low molecular weight heparin Anti-Xa Activity International Unit Production Unit anticoagulation potency determined as the amount that neutralizes one unit of coagulation factor Xa preparation defined as an international biological standard by WHO (World Health Organization) Fir C70498 C71620 Unit anti-Xa IU/mL anti-Xa IU/mL Anti-Xa Activity International A specific anticoagulation activity of unfractionated or low Anti-Xa Activity International Unit Production Unit per Milliliter molecular weight heparin on factor Xa, expressed as a numbeper Milliliter of international anti-Xa heparin units per one milliliter of plasma.(NCI) C70500 C71620 Unit AgU/mL AgU/mL Antigen Unit per Milliliter A measure of an antigen potency defined as a number of Antigen Unit per Milliliter Production antigen units per one milliliter of product.(NCI) C70501 C71620 Unit DAgU DAgU D Antigen Unit A unit of potency of poliovirus vaccine used for poliomyelitis D Antigen Unit Production prevention. The unit is poliovirus type-specific.(NCI) C70502 C71620 Unit DAgU/mL DAgU/mL D Antigen Unit per Milliliter A unit of potency of poliovirus vaccine expressed as a number D Antigen Unit per Milliliter Production of D antigen units per one milliliter of vaccine formulation.(NCI) C70504 C71620 Unit AU/mL AU/mL Allergy Unit per Milliliter Unit of measure of potency of allergenic product expressed as Allergy Unit per Milliliter Production a number of allergy units per one milliliter of formulation.(NCI)

C70505 C71620 Unit BAU BAU Bioequivalent Allergy Unit A unit used for standardization of an allergenic product based Bioequivalent Allergy Unit Production on evaluation of product potency against reference standard in combined in vivo (skin test) and in vitro (IgE-based ELISA) testing.(NCI) C70506 C71620 Unit tuberculin unit/mL tuberculin unit/mL Tuberculin Unit per Milliliter A unit of biologic activity of tuberculin expressed as a number Tuberculin Unit per Milliliter Production of arbitrary units of tuberculin in one milliliter of preparation.(NCI) C70507 C71620 Unit mkat mkat Millikatal A unit of catalytic activity measurement equal to one Millikatal Production thousandth of one katal (10E-3 katal).(NCI) C70508 C71620 Unit nkat nkat Nanokatal A unit of catalytic activity measurement equal to one billionth Nanokatal Production of one katal (10E-9 katal).(NCI) C70509 C71620 Unit pkat pkat Picokatal A unit of catalytic activity measurement equal to trillionth of Picokatal Production one katal (10E-12 katal).(NCI) C70510 C71620 Unit nkat/L nkat/L Nanokatal per Liter A unit of catalytic activity concentration defined as the Nanokatal per Liter Production catalytic activity of the component equal to one billionth of one katal (10E-9 katal) in the unit volume of the system equal to one liter.(NCI) C70511 C71620 Unit kBq kBq Kilobecquerel A unit of radioactivity equal to one thousand nuclear Kilobecquerel Production disintegrations or other nuclear transformations per second, or to 10E3 becquerels.(NCI) C70512 C71620 Unit MBq MBq Megabecquerel A unit of radioactivity equal to one million nuclear Megabecquerel Production disintegrations or other nuclear transformations per second, or to 10E6 becquerels.(NCI) C70513 C71620 Unit GBq GBq Gigabecquerel A unit of radioactivity equal to one billion nuclear Gigabecquerel Production disintegrations or other nuclear transformations per second, or to 10E9 becquerels.(NCI) C70521 C71620 Unit Bq/kg Bq/kg Becquerel per Kilogram A unit of specific radioactivity (massic activity) equal to activity Becquerel per Kilogram Production of one Becquerel of the sample with total mass of one kilogram.(NCI) C70522 C71620 Unit Bq/g Bq/g Becquerel per Gram A unit of specific radioactivity (massic activity) equal to activity Becquerel per Gram Production of one Becquerel of the sample with total mass of one gram.(NCI) C70523 C71620 Unit Bq/ug Bq/ug Becquerel per Microgram; A unit of specific radioactivity (massic activity) equal to activity Becquerel per Microgram Production kBq/mg; Kilobecquerel per of one Becquerel of the sample with total mass of one Milligram; MBq/g; microgram.(NCI) Megabecquerel per Gram

C70524 C71620 Unit Bq/mg Bq/mg Becquerel per Milligram; A unit of specific radioactivity (massic activity) equal to activity Becquerel per Milligram Production kBq/g; Kilobecquerel per Gram of one Becquerel of the sample with total mass of one milligram.(NCI) C70525 C71620 Unit GBq/g GBq/g Gigabecquerel per Gram; A unit of specific radioactivity (massic activity) equal to activity Gigabecquerel per Gram Production kBq/ug; Kilobecquerel per of one gigabecquerel of the sample with total mass of one Microgram gram.(NCI) C70526 C71620 Unit GBq/ug GBq/ug Gigabecquerel per Microgram; A unit of specific radioactivity (massic activity) equal to activity Gigabecquerel per Microgram Production MBq/ug; Megabecquerel per of one gigabecquerel of the sample with total mass of one Microgram microgram.(NCI)

C70527 C71620 Unit GBq/mg GBq/mg Gigabecquerel per Milligram; A unit of specific radioactivity (massic activity) equal to activity Gigabecquerel per Milligram Production MBq/mg; Megabecquerel per of one gigabecquerel of the sample with total mass of one Milligram milligram.(NCI)

Covance Page 86 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C70528 C71620 Unit Ci/g Ci/g Curie per Gram; uCi/ug; A unit of specific radioactivity (massic activity) equal to activity Curie per Gram Production Microcurie per Microgram; of one Curie of the sample with total mass of one gram.(NCI) mCi/mg; Millicurie per Milligram C70529 C71620 Unit Ci/kg Ci/kg Curie per Kilogram; uCi/mg; A unit of specific radioactivity (massic activity) equal to activity Curie per Kilogram Production Microcurie per Milligram; of one Curie of the sample with total mass of one mCi/g; Millicurie per Gram kilogram.(NCI) C70530 C71620 Unit Ci/ug Ci/ug Curie per Microgram A unit of specific radioactivity (massic activity) equal to activity Curie per Microgram Production of one Curie of the sample with total mass of one microgram.(NCI) C70531 C71620 Unit Ci/mg Ci/mg Curie per Milligram; mCi/ug; A unit of specific radioactivity (massic activity) equal to activity Curie per Milligram Production Millicurie per Microgram of one Curie of the sample with total mass of one milligram.(NCI) C70532 C71620 Unit EID 50 EID 50 50 Percent Embryo Infective Amount of infectious agent or biological product that causes 50 Percent Embryo Infective Production Dose infection in the 50% of embryos such as chicken embryos Dose used in the product potency assay or pathogen activity assay.(NCI) C70533 C71620 Unit EID 50/dose EID 50/dose 50 Percent Embryo Infective A potency unit for measuring infectious activity of a biologic 50 Percent Embryo Infective Production Dose per Dose product or an infectious agent preparation equal to the potencyDose per Dose at which one dose of infectious material contains one 50 percent embryo infective dose.(NCI) C70534 C71620 Unit CCID 50 CCID 50 50 Percent Cell Culture A potency unit defined as a minimal dose of infectious 50 Percent Cell Culture Infective Production Infective Dose material at which preparation causes cytopathic effects Dose (changes in the morphology and metabolism of cell culture cells, indicating cell death, due to suspected infection) in the 50% of the cell cultu C70535 C71620 Unit CCID 50/dose CCID 50/dose 50 Percent Cell Culture A potency unit equal to the potency at which one dose of 50 Percent Cell Culture Infective Production Infective Dose per Dose preparation contains one 50 percent cell culture infective Dose per Dose dose.(NCI) C70537 C71620 Unit TCID 50/dose TCID 50/dose 50 Percent Tissue Culture A potency unit equal to the potency at which one dose of 50 Percent Tissue Culture Production Infective Dose per Dose preparation contains one 50 percent tissue culture infective Infective Dose per Dose dose.(NCI) C70562 C71620 Unit ukat ukat Microkatal A unit of catalytic activity measurement equal to one millionth Microkatal Production of katal (10E-6 katal).(NCI) C70565 C71620 Unit ppb ppb Part per Billion A unit of measure referring to one entity counted per one Per Billion Production billion entities.(NCI) C70566 C71620 Unit pptr pptr Parts per Trillion A unit of measure referring to one entity counted per one Per Trillion Production trillion entities.(NCI) C70570 C71620 Unit mCi/kg mCi/kg Millicurie per Kilogram; uCi/g; A unit of specific radioactivity (massic activity) equal to activity Millicurie per Kilogram Production Microcurie per Gram of one millicurie of the sample with total mass of one kilogram.(NCI) C70571 C71620 Unit uCi/kg uCi/kg Microcurie per Kilogram A unit of specific radioactivity (massic activity) equal to activity Microcurie per Kilogram Production of one microcurie of the sample with total mass of one kilogram.(NCI) C70575 C71620 Unit Roentgen Roentgen Roentgen A unit of exposure to ionizing radiation. One Roentgen is the Roentgen Production amount of gamma or x-rays required to produce ions resulting in a charge of 2.58E-4 Coulombs/kilogram of air under standard conditions.(NCI) C70578 C71620 Unit mEq/uL mEq/uL Milliequivalent Per Microliter A concentration unit measured as a number of milliequivalentsMilliequivalent per Microliter Production of solute per microliter of solution.(NCI) C70580 C71620 Unit mEq/g mEq/g Milliequivalent Per Gram A unit of relative amount of substance content equivalent to Milliequivalent per Gram Production the content at which one gram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) C70581 C71620 Unit mEq/ug mEq/ug Milliequivalent Per Microgram A unit of relative amount of substance content equivalent to Milliequivalent per Microgram Production the content at which one millionth of a gram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) C71165 C71620 Unit Bq/L Bq/L Becquerel per Liter A unit of volumetric radioactivity concentration defined as a Becquerel per Liter Production concentration of a radionuclide with an activity equal to one Becquerel per unit volume equal to one liter.(NCI) C71166 C71620 Unit Bq/uL Bq/uL Becquerel per Microliter; A unit of volumetric radioactivity concentration defined as a Becquerel per Microliter Production kBq/mL; Kilobecquerel per concentration of a radionuclide with an activity equal to one Milliliter; MBq/L; Becquerel per unit volume equal to one millionth of a Megabecquerel per Liter liter.(NCI) C71167 C71620 Unit Bq/mL Bq/mL Becquerel per Milliliter; kBq/L; A unit of volumetric radioactivity concentration defined as a Becquerel per Milliliter Production Kilobecquerel per Liter concentration of a radionuclide with an activity equal to one Becquerel per unit volume equal to one milliliter or one kilobecquerel per liter.(NCI) C71168 C71620 Unit kBq/uL kBq/uL Kilobecquerel per Microliter; A unit of volumetric radioactivity concentration defined as a Kilobecquerel per Microliter Production GBq/L; Gigabecquerel per concentration of a radionuclide with an activity equal to one Liter; MBq/mL; Megabecquerel thousand becquerels per unit volume equal to one millionth of per Milliliter a liter.(NCI) C71169 C71620 Unit MBq/uL MBq/uL Megabecquerel per Microliter; A unit of volumetric radioactivity concentration defined as a Megabecquerel per Microliter Production GBq/mL; Gigabecquerel per concentration of a radionuclide with an activity equal to one Milliliter million Becquerels per unit volume equal to one millionth of a liter.(NCI) C71170 C71620 Unit Ci/L Ci/L Curie per Liter; uCi/uL; A unit of volumetric radioactivity concentration defined as a Curie per Liter Production Microcurie per Microliter concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one liter.(NCI) C71171 C71620 Unit Ci/uL Ci/uL Curie per Microliter A unit of volumetric radioactivity concentration defined as a Curie per Microliter Production concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one millionth of a liter.(NCI) C71172 C71620 Unit Ci/mL Ci/mL Curie per Milliliter A unit of volumetric radioactivity concentration defined as a Curie per Milliliter Production concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one milliliter.(NCI) C71173 C71620 Unit uCi/L uCi/L Microcurie per Liter A unit of volumetric radioactivity concentration defined as a Microcurie per Liter Production concentration of a radionuclide with an activity equal to one millionth of a Curie per unit volume equal to one liter.(NCI) C71174 C71620 Unit mCi/L mCi/L Millicurie per Liter; uCi/mL; A unit of volumetric radioactivity concentration defined as a Millicurie per Liter Production Microcurie per Milliliter concentration of a radionuclide with an activity equal to one thousandth of a Curie per unit volume equal to one liter.(NCI) C71175 C71620 Unit uV uV Microvolt A unit of an electric potential and electromotive force equal to Microvolt Production one millionth of a volt.(NCI)

Covance Page 87 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C71176 C71620 Unit cycle/min cycle/min Cycle per Minute A unit of frequency equal to the frequency at which one Cycle per Minute Production complete execution of a periodically repeated phenomenon, alternation, event, or sequence of events occurs per unit of time equal to one minute.(NCI) C71177 C71620 Unit km km Kilometer A unit of distance equal to 1000 meters, 0.621 miles, 1094 Kilometer Production yards, or 3281 feet.(NCI) C71183 C71620 Unit Mile Mile International Mile A unit of distance equal to 5280 international feet, 1760 Mile Production international yards, or 1609.344 meters.(NCI) C71185 C71620 Unit 100 IU/mL 100 IU/mL 100 International units/Milliliter A unit of arbitrary substance concentration (biologic activity 100 International Units per Production concentration) defined as the concentration of one hundred Milliliter international units per one milliliter of system volume.(NCI) C71187 C71620 Unit thousand organisms thousand organisms Thousand Organisms A unit of measure of quantity of organisms expressed in Thousand Organisms Production thousands.(NCI) C71188 C71620 Unit million organisms million organisms Million Organisms A unit of measure of quantity of organisms expressed in Million Organisms Production millions.(NCI) C71189 C71620 Unit billion organisms billion organisms Billion Organisms A unit of measure of quantity of organisms expressed in Billion Organisms Production billions.(NCI) C71190 C71620 Unit thousand organisms/g thousand organisms/g Thousand Organisms per A unit of measure of organism content expressed in thousandsThousand Organisms per Gram Production Gram of organisms per unit of mass equal to one gram.(NCI)

C71191 C71620 Unit million organisms/g million organisms/g Million Organisms per Gram A unit of measure of organism content expressed in millions of Million Organisms per Gram Production organisms per unit of mass equal to one gram.(NCI) C71192 C71620 Unit billion organisms/g billion organisms/g Billion Organisms per Gram A unit of measure of organism content expressed in billions of Billion Organisms per Gram Production organisms per unit of mass equal to one gram.(NCI) C71193 C71620 Unit million organisms/mg million organisms/mg Million Organisms per A unit of measure of organism content expressed in millions of Million Organisms per Milligram Production Milligram organisms per unit of mass equal to one milligram.(NCI) C71194 C71620 Unit billion organisms/mg billion organisms/mg Billion Organisms per A unit of measure of organism content expressed in billions of Billion Organisms per Milligram Production Milligram organisms per unit of mass equal to one milligram.(NCI) C71195 C71620 Unit thousand organisms/mL thousand organisms/mL Thousand Organisms per A unit of measure of organism concentration expressed in Thousand Organisms per Production Milliliter thousands of organisms per unit of volume equal to one Milliliter milliliter.(NCI) C71196 C71620 Unit million organisms/mL million organisms/mL Million Organisms per Milliliter A unit of measure of organism concentration expressed in Million Organisms per Milliliter Production millions of organisms per unit of volume equal to one milliliter.(NCI) C71197 C71620 Unit billion organisms/mL billion organisms/mL Billion Organisms per Milliliter A unit of measure of organism concentration expressed in Billion Organisms per Milliliter Production billions of organisms per unit of volume equal to one milliliter.(NCI) C71198 C71620 Unit PFU/dose PFU/dose Plaque Forming Unit per Dose A unit of potency of a biological product expressed as a Plaque Forming Unit per Dose Production quantity of viable infectious entities capable to produce a cytopathic effect in the appropriate cell culture per a single dose of the preparation.(NCI) C71199 C71620 Unit PFU/mL PFU/mL Plaque Forming Unit per A unit of potency of a biological product expressed as a Plaque Forming Unit per Milliliter Production Milliliter quantity of viable infectious entities capable to produce a cytopathic effect in the appropriate cell culture per one millilite of the preparation.(NCI) C71200 C71620 Unit bel bel Bel A logarithmic ratio unit (base-10 logarithms) used to express Bel Production relative magnitude of a physical quantity (usually power or intensity) in comparison with a specified or implied reference level. Particularly, Bel is used as a unit of relative sound intensity C71201 C71620 Unit g/cm2 g/cm2 Gram per Square Centimeter A unit of area density defined as a spread rate at which one Gram per Square Centimeter Production gram of a substance is spread over the area of one square centimeter. The unit is also used as a dose calculation unit.(NCI) C71202 C71620 Unit kUSP kUSP Kilo United States A unit of potency equal to one thousand US Pharmacopoeia Kilo United States Production Pharmacopoeia Unit Units.(NCI) Pharmacopoeia Unit C71203 C71620 Unit km/h km/h Kilometer Per Hour A unit of both speed (scalar) and velocity (vector), defined as Kilometer per Hour Production the distance of one thousand meters travelled per unit time equal to one hour.(NCI) C71204 C71620 Unit NEBULE NEBULE Nebule A unit of measurement based on the nebule dosing unit.(NCI) Nebule Dosing Unit Production C71205 C71620 Unit ug/day ug/day Microgram per Day A unit of mass flow rate equivalent to the rate at which one Microgram per Day Production millionth of a gram of matter travels to a given object or space over a period of time equal to twenty four hours. Microgram per day is also a dose administration rate unit equal to the rate at C71207 C71620 Unit mg/kg/min mg/kg/min Milligram per Kilogram per A dose calculation unit equal to one thousandth of a gram of a Milligram per Kilogram per Production Minute preparation per one kilogram of body mass administered per Minute unit of time equal to one minute.(NCI) C71209 C71620 Unit IU/kg/h IU/kg/h International units per A dose calculation unit equal to one international unit (an International Unit per Kilogram Production Kilogram per Hour arbitrary unit of biological activity) of a product per one per Hour kilogram of body mass administered per unit of time equal to one hour.(NCI) C71210 C71620 Unit ug/kg/min ug/kg/min Microgram per Kilogram per A dose calculation unit equal to one millionth of a gram of a Microgram per Kilogram per Production Minute; Gamma per Kilogram preparation per one kilogram of body mass administered per Minute per Minute; gamma/kg/min unit of time equal to one minute.(NCI) C71211 C71620 Unit ug/min ug/min Micrograms per Minute A unit of mass flow rate equivalent to the rate at which one Microgram per Minute Production millionth of a gram of matter travels to a given object or space over a period of time equal to one minute. Microgram per minute is also a dose administration rate unit equal to the rate at whic C71253 C71620 Unit ft ft Foot A unit of length defined by the U.S. National Bureau of International Foot Production Standards as 30.48 centimeters. It is equal to 0.3048 meter, 12 inches, or to approximately 0.999998 survey foot.(NCI) C71321 C71620 Unit FINGERTIP UNIT FINGERTIP UNIT Fingertip Unit An arbitrary dosing unit used predominantly for semisolid Fingertip Unit Production topical formulations such as cream, ointment, paste, etc. One fingertip unit is the amount of a product that is squeezed out from a standard tube with 5-millimeter diameter nozzle along an adult's C71324 C71620 Unit SACHET SACHET Sachet dosing unit A dosing unit that contains a solid pharmaceutical preparation Sachet Dosing Unit Production in the form of a small packet or bag made from a flexible, often porous material.(NCI) C71362 C71620 Unit mg/kg/h mg/kg/h Milligram per Kilogram per A dose calculation unit equal to one thousandth of a gram of a Milligram per Kilogram per Hour Production Hour preparation per one kilogram of body mass administered per unit of time equal to one hour.(NCI)

Covance Page 88 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C71480 C71620 Unit cycle/sec cycle/sec Cycle per Second A unit of frequency equal to the frequency at which one Cycle per Second Production complete execution of a periodically repeated phenomenon, alternation, event, or sequence of events occurs per unit of time equal to one second.(NCI) C74456 Yes Anatomical Location LOC LOC Anatomical Location Terminology codelist used for anatomical location within CDISC SDTM Anatomical Production CDISC. Location Terminology

C12220 C74456 Anatomical Location LIP LIP Lip Fleshy fold which surrounds the opening of the mouth. (NCI) Lip Production

C12230 C74456 Anatomical Location HARD PALATE HARD PALATE Hard Palate The bony anterior part of the roof of the mouth separating the Hard Palate Production nose from the mouth. (NCI) C12246 C74456 Anatomical Location HYPOPHARYNX HYPOPHARYNX Hypopharynx The lower part of the pharynx that connects to the esophagus. Hypopharynx Production (NCI) C12256 C74456 Anatomical Location GASTRIC CARDIA GASTRIC CARDIA Gastric Cardia The area around the esophagogastric mucosal junction where Gastric Cardia Production the esophageal mucosa transitions into the gastric mucosa. (NCI) C12257 C74456 Anatomical Location FUNDUS OF THE STOMACH FUNDUS OF THE STOMACH Fundus of the Stomach The portion of the stomach that lies above the cardiac notch. I Fundus of the Stomach Production allows for the accumulation of gases produced by chemical digestion. (NCI) C12258 C74456 Anatomical Location BODY OF STOMACH BODY OF STOMACH Body of Stomach The main section of the digestive tube that connects the Body of Stomach Production esophagus to the small intestine. The body proper excludes the upper and lower sections of the fundus and pyloric portion respectively. (NCI) C12259 C74456 Anatomical Location ANTRUM PYLORI ANTRUM PYLORI Antrum Pylori The initial part of the pyloric canal of the stomach. This site Antrum Pylori Production contains endocrine cells that produce gastrin and somatostatin. (NCI) C12262 C74456 Anatomical Location GREATER CURVATURE OF THE GREATER CURVATURE OF THE Greater Curvature of the The lateral and inferior border of the stomach. Attached to it is Greater Curvature of the Production STOMACH STOMACH Stomach the greater omentum. (NCI) Stomach C12274 C74456 Anatomical Location MIDDLE EAR MIDDLE EAR Middle Ear The part of the ear including the eardrum and ossicles. The Middle Ear Production middle ear leads to the inner ear. (NCI) C12275 C74456 Anatomical Location MAXILLARY SINUS MAXILLARY SINUS Maxillary Sinus A pyramidal-shaped, thin-walled, air-filled cavity located in the Maxillary Sinus Production maxilla. It is lined by mucus membrane and periosteum (mucoperiosteum) which contains cilia. It is adjacent to the nasal cavity and communicates with the middle meatus of the nose. It is th C12276 C74456 Anatomical Location ETHMOID SINUS ETHMOID SINUS Ethmoid Sinus A sinus of the meatuses of the nasal cavity. (NCI) Ethmoid Sinus Production C12277 C74456 Anatomical Location FRONTAL SINUS FRONTAL SINUS Frontal Sinus The paired, mucosal lined air spaces located above the orbit Frontal Sinus Production and communicating with the nasal passages. (NCI) C12280 C74456 Anatomical Location SUBGLOTTIS SUBGLOTTIS Subglottis The area of the larynx below the vocal cords down to the Subglottis Production trachea. (NCI) C12290 C74456 Anatomical Location MANDIBLE MANDIBLE Mandible The lower jaw bone holding the lower teeth. (NCI) Mandible Production C12295 C74456 Anatomical Location SKIN OF THE TRUNK SKIN OF THE TRUNK Skin of the Trunk The skin or integument surrounding the trunk of the body. Skin of the Trunk Production (NCI) C12299 C74456 Anatomical Location NIPPLE NIPPLE Nipple The pigmented protuberance on the surface of the breast Nipple Production through which milk is drawn from the breast. (NCI) C12311 C74456 Anatomical Location CERVIX UTERI CERVIX UTERI Cervix Uteri The lower part of the uterus occupying the region between the Cervix Uteri Production isthmus of the uterus and the vagina. It is divided into supravaginal and vaginal portions. (NCI) C12314 C74456 Anatomical Location MYOMETRIUM MYOMETRIUM Myometrium The smooth muscle lining the uterus. (NCI) Myometrium Production C12320 C74456 Anatomical Location PARAMETRIUM PARAMETRIUM Parametrium The subserous connective tissue of the pelvic floor of the Parametrium Production supracervical portion of the uterus. The parametrium extends laterally between the layers of the broad ligament. (NCI) C12341 C74456 Anatomical Location CONJUNCTIVA CONJUNCTIVA Conjunctiva A thin, transparent tissue divided into the palpebral Conjunctiva Production conjunctiva (covering the inner side of the eye lid) and the bulbar conjunctiva (covering the eyeball). (NCI) C12342 C74456 Anatomical Location CORNEA CORNEA Cornea A dome-shaped, transparent, avascular tissue covering the Cornea Production front of the eye. It is composed of five layers: squamous epithelium, Bowman's membrane, stroma, Descemet's membrane, and endothelium. Refraction of light contributing to eye's focusing ability is C12343 C74456 Anatomical Location RETINA RETINA Retina A light-sensitive membrane that lines the back wall of the Retina Production eyeball. The retina is continuous with the optic nerve and this way transmits optical images to the brain. (NCI) C12347 C74456 Anatomical Location ORBIT ORBIT Orbit The bony cavity of the skull which contains the eye, anterior Orbit Production portion of the optic nerve, ocular muscles and ocular adnexa. Seven bones contribute to the structure of the orbit: the frontal, maxillary, zygomatic, sphenoid, lacrimal, ethmoid, and palatine C12352 C74456 Anatomical Location FRONTAL LOBE FRONTAL LOBE Frontal Lobe The part of the brain located anterior to the parietal lobes at Frontal Lobe Production the front of each cerebral hemisphere. (NCI) C12354 C74456 Anatomical Location PARIETAL LOBE PARIETAL LOBE Parietal Lobe One of the lobes of the cerebral hemisphere located superiorlyParietal Lobe Production to the occipital lobe and posteriorly to the frontal lobe. Cognition and visuospatial processing are its main function. (NCI) C12356 C74456 Anatomical Location BRAIN VENTRICLE BRAIN VENTRICLE Brain Ventricle The four connected cavities (hollow spaces) centrally located Brain Ventricle Production within the brain that connect posteriorly with the central canal of the spinal cord. (NCI) C12363 C74456 Anatomical Location PELVIC LYMPH NODE PELVIC LYMPH NODE Pelvic Lymph Node Any lymph node within the pelvic region. (NCI) Pelvic Lymph Node Production C12366 C74456 Anatomical Location BONE BONE Bone Connective tissue that forms the skeletal components of the Bone Production body. (NCI) C12372 C74456 Anatomical Location ARTERY ARTERY Artery A blood vessel that carries blood away from the heart. (NCI) Artery Production C12377 C74456 Anatomical Location GALLBLADDER GALLBLADDER Gallbladder A pear-shaped organ located under the liver that stores and Gallbladder Production concentrates bile secreted by the liver. From the gallbladder the bile is delivered through the bile ducts into the intestine thereby aiding the digestion of fat-containing foods. (NCI) C12378 C74456 Anatomical Location GASTROINTESTINAL SYSTEM GASTROINTESTINAL SYSTEM Gastrointestinal System The system that includes the esophagus, stomach, small and Gastrointestinal System Production large intestine, anus, liver, biliary tract, and pancreas. (NCI) C12379 C74456 Anatomical Location LARGE INTESTINE LARGE INTESTINE Large Intestine A muscular tube that extends from the end of the small Large Intestine Production intestine to the anus. (NCI) C12380 C74456 Anatomical Location APPENDIX APPENDIX Appendix Small tissue projection existing as a cecal diverticulum with a Appendix Production questionable history of vestigial versus specialized organ. (NCI)

Covance Page 89 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C12382 C74456 Anatomical Location COLON COLON Colon The part of the large intestine measured from the cecum to Colon Production the rectum consisting of ascending, transverse, descending and sigmoid portions. The purpose of the colon is to remove water from digested food prior to excretion. (NCI) C12386 C74456 Anatomical Location SMALL INTESTINE SMALL INTESTINE Small Intestine The section of the intestines between the pylorus and cecum. Small Intestine Production The small intestine is approximately 20 feet long and consists of the duodenum, the jejunum, and the ileum. Its main function is to absorb nutrients from food as the food is transported to the l C12387 C74456 Anatomical Location ILEUM ILEUM Ileum The final section of the small intestine. (NCI) Ileum Production C12388 C74456 Anatomical Location JEJUNUM JEJUNUM Jejunum The portion of the small intestine that extends from the Jejunum Production duodenum to the ileum. (NCI) C12389 C74456 Anatomical Location ESOPHAGUS ESOPHAGUS Esophagus The portion of the digestive canal between the pharynx and Esophagus Production stomach. It is about 25 cm long and consists of three parts: the cervical part, from the cricoid cartilage to the thoracic inlet; thoracic part, from thoracic inlet to the diaphragm; and abdominal C12391 C74456 Anatomical Location STOMACH STOMACH Stomach An organ located under the diaphragm, between the liver and Stomach Production the spleen as well as between the esophagus and the small intestine. The stomach is the primary organ of food digestion. (NCI) C12392 C74456 Anatomical Location LIVER LIVER Liver A triangular-shaped organ located under the diaphragm in the Liver Production right hypochondrium. It is the largest internal organ of the body, weighting up to 2 kg. Metabolism and bile secretion are its main functions. It is composed of cells which have the ability to r C12393 C74456 Anatomical Location PANCREAS PANCREAS Pancreas An organ behind the lower part of the stomach that is the Pancreas Production shape of a fish and about the size of a hand. It is a compound gland composed of both exocrine and endocrine tissues. The endocrine pancreas makes insulin so that the body can use glucose (sugar) f

C12394 C74456 Anatomical Location EAR EAR Ear A sense organ needed for the detection of sound and for Ear Production establishing balance. The outer ear consists of the auricle, the ear canal as well as the tympanic membrane. The middle ear is made up of an air-filled cavity behind the tympanic membrane that contai C12400 C74456 Anatomical Location THYROID GLAND THYROID GLAND Thyroid Gland An endocrine gland located at the base of the neck that Thyroid Gland Production produces and secretes thyroxine and other hormones. Thyroxine is important for metabolic control. (NCI) C12401 C74456 Anatomical Location EYE EYE Eye The organ of sight or vision. (NCI) Eye Production C12403 C74456 Anatomical Location FALLOPIAN TUBE FALLOPIAN TUBE Fallopian Tube One of a pair of tubes that extend from the uterus to each of Fallopian Tube Production the ovaries. Following ovulation the egg travels down the fallopian tube to the uterus where fertilization may or may not occur. (NCI) C12404 C74456 Anatomical Location OVARY OVARY Ovary One of the paired female reproductive glands containing the Ovary Production ova or germ cells; the ovary's stroma is a vascular connective tissue containing numbers of ovarian follicles enclosing the ova. (NCI) C12405 C74456 Anatomical Location UTERUS UTERUS Uterus A hollow, thick-walled, muscular organ located within the Uterus Production pelvic cavity of a woman. Within the uterus the fertilized egg implants and the fetus develops during pregnancy. (NCI) C12407 C74456 Anatomical Location VAGINA VAGINA Vagina The female genital canal, extending from the uterus to the Vagina Production vulva. (NCI) C12408 C74456 Anatomical Location VULVA VULVA Vulva The external, visible part of the female genitalia surrounding Vulva Production the urethral and vaginal opening. The vulva includes the clitoris and inner as well as outer labia. (NCI) C12409 C74456 Anatomical Location PENIS PENIS Penis The male organ of urination and copulation. (NCI) Penis Production C12410 C74456 Anatomical Location PROSTATE GLAND PROSTATE GLAND Prostate Gland The walnut shaped accessory sex gland of the male Prostate Gland Production reproductive system. It is located in the pelvis just below the bladder, surrounding the prostatic part of the urethra. The prostate gland secretes a fluid which is part of the semen. (NCI) C12412 C74456 Anatomical Location TESTIS TESTIS Testis Either of the paired male reproductive glands that produce the Testis Production male germ cells and the male hormones. (NCI) C12413 C74456 Anatomical Location URINARY SYSTEM URINARY SYSTEM Urinary System The organs involved in the creation and excretion of urine. Urinary System Production (NCI) C12414 C74456 Anatomical Location BLADDER BLADDER Bladder The distensible sac-like organ that functions as a reservoir of Bladder Production urine, collecting from the kidneys and eliminating via the urethra. (NCI) C12415 C74456 Anatomical Location KIDNEY KIDNEY Kidney One of the two bean-shaped organs located on each side of Kidney Production the spine in the retroperitoneum. The right kidney is located below the liver and the left kidney below the diaphragm. The kidneys filter and secret the metabolic products and minerals from the blo C12416 C74456 Anatomical Location URETER URETER Ureter The thick-walled tube that carries urine from each kidney to Ureter Production the bladder. (NCI) C12417 C74456 Anatomical Location URETHRA URETHRA Urethra The tube carrying urine from the bladder to outside of the Urethra Production body. (NCI) C12419 C74456 Anatomical Location HEAD HEAD Head The anterior and superior part of a human or animal bearing Head Production the mouth, the brain and sensory organs. C12420 C74456 Anatomical Location LARYNX LARYNX Larynx The cartilaginous structure of the respiratory tract between the Larynx Production pharynx and the trachea. It contains elastic vocal cords required for sound production. (NCI) C12421 C74456 Anatomical Location ORAL CAVITY ORAL CAVITY Oral Cavity The cavity located at the upper end of the alimentary canal, Oral Cavity Production behind the teeth and gums that is bounded on the outside by the lips, above by the hard and soft palates and below by the tongue. (NCI)

Covance Page 90 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C12422 C74456 Anatomical Location TONGUE TONGUE Tongue The muscular organ located in the floor of the mouth and Tongue Production serving as the principal organ of taste and modification of the voice in speech. (NCI) C12423 C74456 Anatomical Location NASOPHARYNX NASOPHARYNX Nasopharynx The part of the pharynx in the back of the throat, at and above Nasopharynx Production the soft palate. The nasopharynx is continuous with the nasal passages. (NCI) C12424 C74456 Anatomical Location NASAL CAVITY NASAL CAVITY Nasal Cavity The proximal portion of the respiratory passages on either sideNasal Cavity Production of the nasal septum lying between the floor of the cranium and the roof of the mouth and extending from the face to the pharynx. The nasal cavity is lined with ciliated mucosa, extending from C12425 C74456 Anatomical Location PHARYNX PHARYNX Pharynx A hollow tube that starts posterior to the mouth and nasal Pharynx Production cavity and ends superior to the trachea and esophagus. (NCI)

C12427 C74456 Anatomical Location PAROTID GLAND PAROTID GLAND Parotid Gland The largest of the three paired salivary glands, located in front Parotid Gland Production of the ear. (NCI) C12428 C74456 Anatomical Location TRACHEA TRACHEA Trachea The fibrocartilaginous, mucous-lined tube passing from the Trachea Production larynx to the bronchi. (NCI) C12429 C74456 Anatomical Location LIMB LIMB Limb A body region referring to an upper or lower extremity. (NCI) Limb Production C12432 C74456 Anatomical Location SPLEEN SPLEEN Spleen An organ that is part of the hematopoietic and immune Spleen Production systems. It is composed of the white pulp and the red pulp and is surrounded by a capsule. It is located in the left hypochondriac region. Its functions include lymphocyte production, blood cell storag C12433 C74456 Anatomical Location THYMUS GLAND THYMUS GLAND Thymus Gland A bi-lobed organ surrounded by a connective tissue capsule. Thymus Gland Production It is located in the upper anterior portion of the chest, behind the sternum. It is composed predominantly of lymphocytes and fewer epithelial cells. Connective tissue septa separate the lobes i C12434 C74456 Anatomical Location BLOOD BLOOD Blood A liquid tissue; its major function is to transport oxygen Blood Production throughout the body. It also supplies the tissues with nutrients removes waste products, and contains various components of the immune system defending the body against infection. Several hormone C12435 C74456 Anatomical Location MUSCLE TISSUE MUSCLE TISSUE Muscle Tissue Tissue responsible for the body movements and the shape Muscle Tissue Production and size changes of interna organs. Muscle tissue is composed of specialized contractile cells. There are two types of muscle tissue recognized: striated and smooth muscle. The striated muscle tissue C12439 C74456 Anatomical Location BRAIN BRAIN Brain An organ composed of grey and white matter containing Brain Production billions of neurons that is the center for intelligence and reasoning. It is protected by the bony cranium. (NCI) C12442 C74456 Anatomical Location MEDULLA OBLONGATA MEDULLA OBLONGATA Medulla Oblongata The lower portion of the brainstem located between the pons Medulla Oblongata Production and brainstem. This structure contains several descending and ascending tracts, lower cranial nerve nuclei, a significant proportion of the reticular system of the brainstem and other structures. C12447 C74456 Anatomical Location BASAL GANGLIA BASAL GANGLIA Basal Ganglia Clusters of neurons comprising the globus pallidus, putamen, Basal Ganglia Production caudate, nucleus accumbens, substantia nigra and subthalamic nucleus. They are involved with high level aspects of inhibitory motor activity in coordination with the excitation commands issued f C12452 C74456 Anatomical Location PUTAMEN PUTAMEN Putamen The largest and most lateral of the basal ganglia lying betweenPutamen Production the lateral medullary lamina of the globus pallidus and the external capsule. It is part of the neostriatum and forms part of the lentiform nucleus along with the globus pallidus. (MeSH) (NCI C12459 C74456 Anatomical Location THALAMUS THALAMUS Thalamus An ovoid mass composed predominantly of gray substance Thalamus Production and associated laminae of white substance. The thalamus is divided into anterior, medial, and lateral parts. The function of the thalamus is to relay sensory impulses and cerebellar and basal ganglia C12468 C74456 Anatomical Location LUNG LUNG Lung One of a pair of viscera occupying the pulmonary cavities of Lung Production the thorax, the organs of respiration in which aeration of the blood takes place. As a rule, the right lung is slightly larger than the left and is divided into three lobes (an upper, a middle, C12470 C74456 Anatomical Location SKIN SKIN Skin An organ that constitutes the external surface of the body. It Skin Production consists of the epidermis, dermis, and skin appendages. (NCI)

C12502 C74456 Anatomical Location TYMPANIC MEMBRANE TYMPANIC MEMBRANE Tympanic Membrane A thin membrane that separates the external auditory canal Tympanic Membrane Production from the middle ear. The movement of the tympanic membrane in response to air pressure changes in the external ear facilitates the transmission of sound energy by causing vibration of the ossicula C12503 C74456 Anatomical Location MASTOID PROCESS MASTOID PROCESS Mastoid Process A honeycombed section of bone located near the base of the Mastoid Process Production skull, protruding behind the outer ear. It is connected to the middle ear. (NCI) C12664 C74456 Anatomical Location ABDOMINAL CAVITY ABDOMINAL CAVITY Abdominal Cavity The portion of the body that lies between the thorax and the Abdominal Cavity Production pelvis. (NCI) C12666 C74456 Anatomical Location ADRENAL GLAND ADRENAL GLAND Adrenal Gland Suprarenal gland. A flattened, roughly triangular body resting Adrenal Gland Production upon the upper end of each kidney; it is one of the ductless glands furnishing internal secretions (epinephrine and norepinephrine from the medulla and steroid hormones from the cortex). (NCI) C12669 C74456 Anatomical Location AORTA AORTA Aorta The major arterial trunk that carries oxygenated blood from theAorta Production left ventricle into the ascending aorta behind the heart, the aortic arch, through the thorax as the descending aorta and through the abdomen as the abdominal aorta; it bifurcates into the le C12674 C74456 Anatomical Location AXILLA AXILLA Axilla The underside concavity where the arm and the shoulder are Axilla Production joined. (NCI)

Covance Page 91 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C12678 C74456 Anatomical Location BILIARY TRACT BILIARY TRACT Biliary Tract The duct system that transports bile from its origination by Biliary Tract Production hepatocytes in the liver to the small intestine. It is comprised of the common bile duct that connects the liver and gall bladder to the small intestine and the cystic duct that connects the gal C12679 C74456 Anatomical Location BLOOD VESSEL BLOOD VESSEL Blood Vessel A tubular structure through which the blood circulates in the Blood Vessel Production body. Blood vessels constitute a network composed of arteries, arterioles, capillaries, venules, and veins. (NCI) C12681 C74456 Anatomical Location BRACHIAL ARTERY BRACHIAL ARTERY Brachial Artery An artery originating at the axillary artery and branching into Brachial Artery Production the radial and ulnar arteries. (NCI) C12682 C74456 Anatomical Location BRACHIAL PLEXUS BRACHIAL PLEXUS Brachial Plexus A nerve network originating from C5 to T1 that supplies Brachial Plexus Production cutaneous and muscular innervation to the arm and hand. (NCI) C12683 C74456 Anatomical Location BRONCHUS BRONCHUS Bronchus Tubular structure in continuation with the trachea, serving as Bronchus Production air passage. It terminates in the lung (terminal bronchiole). (NCI) C12687 C74456 Anatomical Location CAROTID ARTERY CAROTID ARTERY Carotid Artery One of two arteries that supply oxygenated blood to the head Carotid Artery Production and neck; the left common carotid branches from the aorta and the right common carotid from the innominate (brachiocephalic artery). (NCI) C12693 C74456 Anatomical Location CERVICAL VERTEBRA CERVICAL VERTEBRA Cervical Vertebra Any one of the seven vertebrae that start with C1, connecting Cervical Vertebra Production the skull to the spine, and ends with C7, which joins the cervical with the thoracic spine. (NCI) C12695 C74456 Anatomical Location CLAVICLE CLAVICLE Clavicle One of a pair of bones linking the scapula and the sternum. Clavicle Production The clavicle is part of the pectoral girdle. (NCI) C12696 C74456 Anatomical Location COCCYX COCCYX Coccyx A small bone located at the bottom of the spine. The coccyx isCoccyx Production a result of 3-5 fused rudimentary vertebrae. (NCI) C12709 C74456 Anatomical Location EPIGLOTTIS EPIGLOTTIS Epiglottis A small cartilagenous flap-like valve that closes over the larynxEpiglottis Production during swallowing to prevent food entering the lungs. (NCI)

C12711 C74456 Anatomical Location ETHMOID BONE ETHMOID BONE Ethmoid Bone A light and spongy bone that is cubical in shape. This bone is Ethmoid Bone Production positioned at the anterior part of the cranium, sitting between the two orbits, at the roof of the nose. It consists of four parts: a horizontal or cribriform plate; a perpendicular plate; and

C12713 C74456 Anatomical Location EYELID EYELID Eyelid A thin membrane of skin with the purpose of covering and Eyelid Production protecting an eye. (NCI) C12715 C74456 Anatomical Location FEMORAL ARTERY FEMORAL ARTERY Femoral Artery An artery that starts within the inguinal region and extends to Femoral Artery Production the lower extremities. (NCI) C12716 C74456 Anatomical Location FEMORAL VEIN FEMORAL VEIN Femoral Vein A vein that starts within the inguinal region and extends to the Femoral Vein Production lower extremities. (NCI) C12717 C74456 Anatomical Location FEMUR FEMUR Femur The upper leg bone positioned between the pelvis and the Femur Production knee. (NCI) C12718 C74456 Anatomical Location FIBULA FIBULA Fibula The small, lateral calf bone extending from the knee to the Fibula Production ankle. (NCI) C12719 C74456 Anatomical Location GANGLION GANGLION Ganglion A cluster of nervous tissue principally composed of neuronal Ganglion Production cell bodies external to the central nervous system (CNS). (NCI) C12724 C74456 Anatomical Location GLOTTIS GLOTTIS Glottis The space in which the vocal cords are located. (NCI) Glottis Production C12726 C74456 Anatomical Location INGUINAL REGION INGUINAL REGION Inguinal Region The lower region of the anterior abdominal wall located Inguinal Region Production laterally to the pubic region. (NCI) C12727 C74456 Anatomical Location HEART HEART Heart A hollow muscular organ which receives the blood from the Heart Production veins and propels it into the arteries. It is divided by a musculomembranous septum into two halves -- right or venous and left or arterial -- each of which consists of a receiving chamber (atrium) C12731 C74456 Anatomical Location HUMERUS HUMERUS Humerus The upper arm bone between the shoulder and elbow. (NCI) Humerus Production C12736 C74456 Anatomical Location INTESTINE INTESTINE Intestine The portion of the gastrointestinal tract between the stomach Intestine Production and the anus. It includes the small intestine and large intestine. (NCI) C12743 C74456 Anatomical Location LENS LENS Lens A biconvex transparent structure of the eye through which Lens Production light is focused on the retina. The lens sits behind the iris and is supported by the zonule, which connects it to the ciliary body. The lens is an avascular structure. (NCI) C12744 C74456 Anatomical Location LUMBAR VERTEBRA LUMBAR VERTEBRA Lumbar Vertebra One of the five bones situated between the thoracic vertebrae Lumbar Vertebra Production and the sacrum in the lower part of the spine. (NCI)

C12745 C74456 Anatomical Location LYMPH NODE LYMPH NODE Lymph Node A bean-shaped organ surrounded by a connective tissue Lymph Node Production capsule. It is part of the lymphatic system and is found through out the body. It is composed predominantly of lymphocytes and its main function is immune protection. (NCI) C12748 C74456 Anatomical Location MEDIASTINUM MEDIASTINUM Mediastinum A group of organs surrounded by loose connective tissue, Mediastinum Production separating the two pleural sacs, between the sternum anteriorly and the vertebral column posteriorly as well as from the thoracic inlet superiorly to the diaphragm inferiorly. The mediastinum contai C12752 C74456 Anatomical Location METATARSAL BONE METATARSAL BONE Metatarsal Bone A bone belonging to the middle part of the foot located Metatarsal Bone Production between toes and ankle. There are 5 metatarsal bones and they are numbered from the medial side. (NCI) C12756 C74456 Anatomical Location NOSE NOSE Nose A structure of special sense serving as an organ of the sense Nose Production of smell and as an entrance to the respiratory tract. (NCI)

C12761 C74456 Anatomical Location OPTIC NERVE OPTIC NERVE Optic Nerve The second cranial nerve. (NCI) Optic Nerve Production C12763 C74456 Anatomical Location PARANASAL SINUS PARANASAL SINUS Paranasal Sinus An air-filled cavity adjacent to the nasal cavity lined by a Paranasal Sinus Production mucous membrane and located in the bones of the skull. There are four paranasal sinuses on each side of the face: ethmoid, frontal, maxillary, and sphenoid sinus. (NCI) C12767 C74456 Anatomical Location PELVIS PELVIS Pelvis The bony, basin-shaped structure formed by the hipbones and Pelvis Production the base of the backbone supporting the lower limbs in humans. (NCI) C12768 C74456 Anatomical Location PERIPHERAL NERVE PERIPHERAL NERVE Peripheral Nerve Any nerve outside the brain or spinal cord that connects with Peripheral Nerve Production peripheral receptors or effectors. (NCI)

Covance Page 92 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C12770 C74456 Anatomical Location PERITONEUM PERITONEUM Peritoneum The tissue that lines the wall of the abdominal cavity, Peritoneum Production intestine, and mesentery. It consists of the parietal peritoneum that covers the inside of the abdominal wall and the visceral peritoneum that covers the surface of the intestine and mesentery. (NCI) C12782 C74456 Anatomical Location RIB RIB Rib Any one of the paired bones, 12 on either side, extending fromRib Production the thoracic vertebrae toward the median line on the ventral aspect of the trunk. The long curved bones which form the rib cage. Generally, ribs 1 to 7 are connected to the sternum' by their c C12783 C74456 Anatomical Location SCAPULA SCAPULA Scapula The flat triangle-shaped bone that connects the humerus with Scapula Production the clavicle in the back of the shoulder. (NCI) C12785 C74456 Anatomical Location SCROTUM SCROTUM Scrotum The musculocutaneous pouch that encloses the testicles. Scrotum Production (NCI) C12786 C74456 Anatomical Location LUNATE BONE LUNATE BONE Lunate Bone The bone in the proximal row of carpal bones that lies betweenLunate Bone Production the scaphoid and triquetral bones. (NCI) C12789 C74456 Anatomical Location SKULL SKULL Skull The bones that form the head, made up of the bones of the Skull Production braincase and face. (NCI) C12793 C74456 Anatomical Location STERNUM STERNUM Sternum The long, flat bone connecting with the cartilages of the first Sternum Production seven ribs and the clavicle. (NCI) C12797 C74456 Anatomical Location TEMPORAL BONE TEMPORAL BONE Temporal Bone A large irregular bone situated at the base and side of the Temporal Bone Production skull, connected with the mandible via the temporomandibular joint. The temporal bone consists of the squamous, tympanic and petrous parts. The petrous portion of the temporal bone contains the v C12798 C74456 Anatomical Location THORACIC VERTEBRA THORACIC VERTEBRA Thoracic Vertebra One of 12 vertebrae in the human vertebral column. The Thoracic Vertebra Production thoracic vertebrae are situated between the seventh cervical vertebra down to the first lumbar vertebra. (NCI) C12799 C74456 Anatomical Location THORAX THORAX Thorax The division of the body lying between the neck and the Thorax Production abdomen. (NCI) C12800 C74456 Anatomical Location TIBIA TIBIA Tibia A bone located between the femur and the tarsus, being part Tibia Production of the lower leg. (NCI) C12802 C74456 Anatomical Location TONSIL TONSIL Tonsil The two organs situated in the throat on either side of the Tonsil Production narrow passage from the mouth to the pharynx. They are composed of lymphoid tissues. (NCI) C12808 C74456 Anatomical Location TROCHLEAR NERVE TROCHLEAR NERVE Trochlear Nerve The cranial nerve that controls the superior oblique muscle of Trochlear Nerve Production the eye. (NCI) C12811 C74456 Anatomical Location UVEA UVEA Uvea The pigmented layer of the eyeball between the tough, white Uvea Production outer coat of the eye and the retina. (NCI) C12814 C74456 Anatomical Location VEIN VEIN Vein A blood vessel that carries blood towards the heart. Vein Production C12817 C74456 Anatomical Location VENA CAVA VENA CAVA Vena Cava A large vein which returns blood from the head, neck and Vena Cava Production extremities to the heart. (NCI) C12822 C74456 Anatomical Location VOCAL CORD VOCAL CORD Vocal Cord A pair of small bands of muscle that stretch from the thyroid Vocal Cord Production cartilage in front to the arytenoid cartilage in back of the larynx The vocal cords help prevent food entering the lungs and produce sound through vibration. (NCI) C12838 C74456 Anatomical Location RADIAL ARTERY RADIAL ARTERY Radial Artery The branch of the brachial artery that passes down the Radial Artery Production forearm. (NCI) C12840 C74456 Anatomical Location PLEURAL CAVITY PLEURAL CAVITY Pleural Cavity The cavity lined by the pleura, located in the thorax and Pleural Cavity Production contains heart and lungs. (NCI) C12843 C74456 Anatomical Location CORONARY ARTERY CORONARY ARTERY Coronary Artery A principal artery that originates in the aorta. It supplies blood Coronary Artery Production to the muscular tissue of the heart. (NCI) C12853 C74456 Anatomical Location SACRAL VERTEBRA SACRAL VERTEBRA Sacral Vertebra One of the usually five fused vertebrae forming the triangular Sacral Vertebra Production bone just below the lumbar vertebrae. (NCI) C12854 C74456 Anatomical Location SCAPHOID BONE SCAPHOID BONE Scaphoid Bone A nut-shaped bone of the wrist located in the radial site of the Scaphoid Bone Production hand. It is one of the eight carpal bones. (NCI) C12855 C74456 Anatomical Location PISIFORM BONE PISIFORM BONE Pisiform Bone The medial bone of the proximal row of carpal bones. (NCI) Pisiform Bone Production C12856 C74456 Anatomical Location CAPITATE BONE CAPITATE BONE Capitate Bone The largest of eight carpal bones, located in the center of the Capitate Bone Production hand. (NCI) C12857 C74456 Anatomical Location TRAPEZIAL BONE TRAPEZIAL BONE Trapezial Bone A carpal bone on the thumb side of the hand that articulates Trapezial Bone Production with the 1st and 2nd metacarpals. (NCI) C12858 C74456 Anatomical Location TRIANGULAR BONE TRIANGULAR BONE Triangular Bone A carpal bone located between the lunate and pisiform bones. Triangular Bone Production (NCI) C12859 C74456 Anatomical Location TRAPEZOID BONE TRAPEZOID BONE Trapezoid Bone A carpal bone located between the trapezium and capitate Trapezoid Bone Production bones. (NCI) C12860 C74456 Anatomical Location HAMATE BONE HAMATE BONE Hamate Bone The medial bone in the distal row of carpal bones. (NCI) Hamate Bone Production C12903 C74456 Anatomical Location SUPRACLAVICULAR LYMPH SUPRACLAVICULAR LYMPH Supraclavicular Lymph Node A lymph node which is located above the clavicle. (NCI) Supraclavicular Lymph Node Production NODE NODE C12904 C74456 Anatomical Location AXILLARY LYMPH NODE AXILLARY LYMPH NODE Axillary Lymph Node One of approximately 20-30 lymph nodes in chain formation Axillary Lymph Node Production that traverse the concavity of the underarm to the clavicle. (NCI) C12971 C74456 Anatomical Location BREAST BREAST Breast One of two hemispheric projections of variable size situated in Breast Production the subcutaneous layer over the pectoralis major muscle on either side of the chest. (NCI) C12998 C74456 Anatomical Location VERTEBRAL COLUMN VERTEBRAL COLUMN Vertebral Column A series of bones, muscles, tendons, and other tissues Vertebral Column Production reaching from the base of the skull to the tailbone. The vertebral column forms the axis of the skeleton and encloses as well as protects the spinal cord and the fluid surrounding the spinal cord. (NC C13005 C74456 Anatomical Location PERICARDIUM PERICARDIUM Pericardium A conical membranous sac filled with serous fluid in which the Pericardium Production heart as well as the roots of the aorta and other large blood vessels are contained. (NCI) C13041 C74456 Anatomical Location BODY BODY Body The entire physical structure of an organism. It is composed ofBody Production anatomic systems, regions, cavities, and spaces. (NCI) C13044 C74456 Anatomical Location JOINT JOINT Joint The connection point between two bones or skeletal elements Joint Production The joint may be fixed or movable. (NCI) C13046 C74456 Anatomical Location LIGAMENT LIGAMENT Ligament Band of fibrous tissue connecting bone to bone or cartilage to Ligament Production bone thereby supporting or strengthening a joint. (NCI) C13050 C74456 Anatomical Location SKELETAL MUSCLE TISSUE SKELETAL MUSCLE TISSUE Skeletal Muscle Tissue Striated muscles that are under voluntary control of the Skeletal Muscle Tissue Production organism. They are connected at either or both ends to a bone and are utilized for locomotion and other movements. (NCI)

C13062 C74456 Anatomical Location BACK BACK Back The dorsal area between the base of the neck and the sacrumBack Production (NCI) C13063 C74456 Anatomical Location NECK NECK Neck The region that connects the head to the rest of the body. Neck Production (NCI)

Covance Page 93 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C13071 C74456 Anatomical Location FACE FACE Face The anterior portion of the head extending from the forehead t Face Production the chin and ear to ear. The facial structures contain the eyes, nose and mouth, cheeks and jaws. (NCI) C13166 C74456 Anatomical Location MUCOSA MUCOSA Mucosa Mucous membrane. (NCI) Mucosa Production C13307 C74456 Anatomical Location GASTRIC GASTRIC Gastric Relating to the stomach. (NCI) Gastric Production C13308 C74456 Anatomical Location HEPATIC HEPATIC Hepatic Pertaining to, affecting, or associated with the liver. (NCI) Hepatic Production C15609 C74456 Anatomical Location ANASTOMOSIS ANASTOMOSIS Anastomosis A natural or surgically-induced connection between tubular Anastomosis Production structures in the body. (NCI) C25203 C74456 Anatomical Location SHOULDER SHOULDER Shoulder The region of the body between the neck and the upper arm. Shoulder Production (NCI) C25389 C74456 Anatomical Location CHEST CHEST Chest The anterior side of the thorax from the neck to the abdomen. Chest Production The shape of the chest is often regarded as potential insight into a disease process, as in the case of barrel chest and respiratory dysfunction. (NCI) C25724 C74456 Anatomical Location HILAR HILAR Hilar Refers to the area associated with the hilum. (NCI) Hilar Production C26465 C74456 Anatomical Location CORPUS LUTEUM CORPUS LUTEUM Corpus Luteum A group of cells that remain of the Graafian follicle following Corpus Luteum Production ovulation. This structure is composed of endocrine tissue and produces progesterone. This is needed to prepare the uterine lining for implantation by the fertilized egg. (NCI) C26470 C74456 Anatomical Location MAXILLA MAXILLA Maxilla The upper jawbone in vertebrates: it is fused to the cranium. Maxilla Production (NCI) C32042 C74456 Anatomical Location ACETABULUM ACETABULUM Acetabulum Two cup shaped areas, one each on the lateral side of the Acetabulum Production lower pelvis that house the head of the femur to form the ball and socket joint of the hip. (NCI) C32047 C74456 Anatomical Location ACROMIOCLAVICULAR JOINT ACROMIOCLAVICULAR JOINT Acromioclavicular Joint The junction of the upper distal end of the scapula to the distal Acromioclavicular Joint Production edge of the collarbone, also known as the acromion and the clavicle. (NCI) C32048 C74456 Anatomical Location ACROMION ACROMION Acromion The upper distal process of the scapula. (NCI) Acromion Production C32078 C74456 Anatomical Location ANKLE JOINT ANKLE JOINT Ankle Joint A gliding joint between the distal ends of the tibia and fibula Ankle Joint Production and the proximal end of the talus. (NCI) C32123 C74456 Anatomical Location AORTIC ARCH AORTIC ARCH Aortic Arch The curved section of the aorta between the ascending and Aortic Arch Production the descending tracts. The brachiocephalic, left common carotid and left subclavian arteries branch from the aorta at this section. (NCI) C32141 C74456 Anatomical Location ARM ARM Arm The portion of the upper extremity between the shoulder and Arm Production the elbow. For clinical purposes this term is also used to refer to the whole superior limb. (NCI) C32197 C74456 Anatomical Location BASILIC VEIN BASILIC VEIN Basilic Vein One of the moderately large superficial veins of the forearm Basilic Vein Production that transports blood from the hand and the medial aspect of the forearm to the axillary vein. (NCI) C32239 C74456 Anatomical Location C1 VERTEBRA C1 VERTEBRA C1 Vertebra The first of the seven cervical vertebrae. (NCI) C1 Vertebra Production C32240 C74456 Anatomical Location C2 VERTEBRA C2 VERTEBRA C2 Vertebra The second of the seven cervical vertebrae. (NCI) C2 Vertebra Production C32241 C74456 Anatomical Location C3 VERTEBRA C3 VERTEBRA C3 Vertebra The third of the seven cervical vertebrae. (NCI) C3 Vertebra Production C32242 C74456 Anatomical Location C4 VERTEBRA C4 VERTEBRA C4 Vertebra The fourth of the seven cervical vertebrae. (NCI) C4 Vertebra Production C32243 C74456 Anatomical Location C5 VERTEBRA C5 VERTEBRA C5 Vertebra The fifth of the seven cervical vertebrae. (NCI) C5 Vertebra Production C32244 C74456 Anatomical Location C6 VERTEBRA C6 VERTEBRA C6 Vertebra The sixth of the seven cervical vertebrae. (NCI) C6 Vertebra Production C32245 C74456 Anatomical Location C7 VERTEBRA C7 VERTEBRA C7 Vertebra The seventh of the seven cervical vertebrae. (NCI) C7 Vertebra Production C32258 C74456 Anatomical Location CANINE TOOTH CANINE TOOTH Canine Tooth A single-cusped (pointed) and usually single-rooted tooth Canine Tooth Production located between the incisors and premolars. (NCI) C32286 C74456 Anatomical Location CEPHALIC VEIN CEPHALIC VEIN Cephalic Vein One of five superficial veins of the upper extremity, beginning Cephalic Vein Production at the radial aspect of the wrist area, wrapping around the forearm and emptying into the axillary vein. (NCI) C32298 C74456 Anatomical Location CERVICAL LYMPH NODE CERVICAL LYMPH NODE Cervical Lymph Node Any of the lymph nodes located in the neck. (NCI) Cervical Lymph Node Production C32334 C74456 Anatomical Location COCCYGEAL VERTEBRA COCCYGEAL VERTEBRA Coccygeal Vertebra Four vertebral segments positioned at the base of the spine Coccygeal Vertebra Production that are fused. (NCI) C32391 C74456 Anatomical Location COSTAL CARTILAGE COSTAL CARTILAGE Costal Cartilage The cartilage positioned between the anterior end of the rib Costal Cartilage Production and the sternum. Its elasticity allows the ribcage to expand while breathing. (NCI) C32414 C74456 Anatomical Location CUBOID BONE CUBOID BONE Cuboid Bone A bone on the lateral side of the tarsus between the calcaneusCuboid Bone Production and the fourth and fifth metatarsal bones. (NCI) C32478 C74456 Anatomical Location DORSALIS PEDIS ARTERY DORSALIS PEDIS ARTERY Dorsalis Pedis Artery An artery of the dorsal surface of the foot, originating from the Dorsalis Pedis Artery Production anterior tibial artery of the lower leg. The following arterial branches originate from the dorsalis pedis artery: the arcuate artery of the foot and deep plantar artery. (NCI) C32497 C74456 Anatomical Location ELBOW JOINT ELBOW JOINT Elbow Joint A type of hinge joint located between the forearm and upper Elbow Joint Production arm. (NCI) C32514 C74456 Anatomical Location ENDOMETRIAL CAVITY ENDOMETRIAL CAVITY Endometrial Cavity A space inside the uterus lined by a layer of mucus Endometrial Cavity Production membranes called the endometrium. (NCI) C32577 C74456 Anatomical Location FACET JOINT FACET JOINT Facet Joint A synovial joint between two adjacent vertebrae. The facet Facet Joint Production joint links the articular process of one vertebra and the inferior articular process of the adjacent vertebra. (NCI) C32608 C74456 Anatomical Location FINGER FINGER Finger Any of the digits of the hand. (NCI) Finger Production C32609 C74456 Anatomical Location FINGERNAIL FINGERNAIL Fingernail The nail at the end of a finger. (NCI) Fingernail Production C32622 C74456 Anatomical Location FOOT FOOT Foot The structure found below the ankle joint required for Foot Production locomotion. (NCI) C32628 C74456 Anatomical Location FOREARM FOREARM Forearm The structure on the upper limb, between the elbow and the Forearm Production wrist. (NCI) C32668 C74456 Anatomical Location GASTROESOPHAGEAL GASTROESOPHAGEAL Gastroesophageal Junction The anatomical location where the esophagus joins to the Gastroesophageal Junction Production JUNCTION JUNCTION stomach. (NCI) C32677 C74456 Anatomical Location GINGIVA GINGIVA Gingiva The soft tissue surrounding the neck of individual teeth as well Gingiva Production as covering the alveolar bone. The tissue is fibrous and continuous with the periodontal ligament and mucosal covering. (NCI) C32682 C74456 Anatomical Location GLENOID FOSSA GLENOID FOSSA Glenoid Fossa The trough in the head of the scapula that receives the head oGlenoid Fossa Production the humerus to form the shoulder joint. (NCI) C32698 C74456 Anatomical Location GREAT TROCHANTER GREAT TROCHANTER Great Trochanter A large, irregular, quadrilateral area of bone found at the neck Great Trochanter Production of the femur. (NCI) C32705 C74456 Anatomical Location HAIR HAIR Hair The filamentous outgrowth of the epidermis. (NCI) Hair Production C32712 C74456 Anatomical Location HAND HAND Hand The distal portion of the upper extremity. It consists of the Hand Production carpus, metacarpus, and digits. (NCI) C32720 C74456 Anatomical Location HEAD OF THE HUMERUS HEAD OF THE HUMERUS Head of the Humerus The upper rounded part of the humerus that fits into the Head of the Humerus Production glenoid cavity of the scapula. (NCI) C32742 C74456 Anatomical Location HIP JOINT HIP JOINT Hip Joint A ball-and-socket joint between the head of the femur and the Hip Joint Production acetabulum. (NCI)

Covance Page 94 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C32752 C74456 Anatomical Location HYOID BONE HYOID BONE Hyoid Bone A U-shaped bone supporting the tongue. This bone is located Hyoid Bone Production at the base of the tongue and is suspended from the tips of the styloid processes of the temporal bones by the stylohyoid ligaments. (NCI) C32761 C74456 Anatomical Location ILIAC LYMPH NODE ILIAC LYMPH NODE Iliac Lymph Node One of the three lymph nodes of the pelvis: the superior Iliac Lymph Node Production gluteal, interior gluteal or sacral. (NCI) C32765 C74456 Anatomical Location ILIUM ILIUM Ilium The broad, dorsal, upper, and widest of the three principal Ilium Production bones composing either half of the pelvis. (NCI) C32769 C74456 Anatomical Location INCISOR INCISOR Incisor One of the teeth in front of the canines in either jaw designed Incisor Production for cutting or gnawing. (NCI) C32770 C74456 Anatomical Location INCUS INCUS Incus One of the three bones comprising the middle ear. This anvil- Incus Production shaped bone is positioned between the malleus and the stapes. (NCI) C32801 C74456 Anatomical Location INGUINAL LYMPH NODE INGUINAL LYMPH NODE Inguinal Lymph Node A superficial or deep lymph node located in the inguinal area. Inguinal Lymph Node Production (NCI) C32868 C74456 Anatomical Location INTERPHALANGEAL JOINT OF INTERPHALANGEAL JOINT OF Interphalangeal Joint of the The hinge synovial joints between the phalanges of the Interphalangeal Joint of the Hand Production THE HAND THE HAND Hand fingers. (NCI) C32884 C74456 Anatomical Location ISCHIUM ISCHIUM Ischium The most posterior and ventral bone making up the pelvis. Ischium Production (NCI) C32888 C74456 Anatomical Location JAW JOINT JAW JOINT Jaw Joint The joint between the head of the lower mandible and the Jaw Joint Production temporal bone. (NCI) C32898 C74456 Anatomical Location KNEE JOINT KNEE JOINT Knee Joint A joint connecting the lower part of the femur with the upper Knee Joint Production part of the tibia. The lower part of the femur and the upper par of the tibia are attached to each other by ligaments. Other structures of the knee joint include the upper part of the fibula,

C32899 C74456 Anatomical Location L1 VERTEBRA L1 VERTEBRA L1 Vertebra The first lumbar vertebra counting from the top down. (NCI) L1 Vertebra Production C32900 C74456 Anatomical Location L2 VERTEBRA L2 VERTEBRA L2 Vertebra The second lumbar vertebra counting from the top down. L2 Vertebra Production (NCI) C32901 C74456 Anatomical Location L3 VERTEBRA L3 VERTEBRA L3 Vertebra The third lumbar vertebra counting from the top down. (NCI) L3 Vertebra Production C32902 C74456 Anatomical Location L4 VERTEBRA L4 VERTEBRA L4 Vertebra The fourth lumbar vertebra counting from the top down. (NCI) L4 Vertebra Production

C32903 C74456 Anatomical Location L5 VERTEBRA L5 VERTEBRA L5 Vertebra The fifth lumbar vertebra counting from the top down. (NCI) L5 Vertebra Production C32906 C74456 Anatomical Location LACRIMAL BONE LACRIMAL BONE Lacrimal Bone A small rectangular thin plate forming part of the medial orbit Lacrimal Bone Production wall. It is located posterior to the frontal process of the maxilla and articulates with the inferior nasal concha, ethmoid, frontal, and maxillary bones. (NCI) C32974 C74456 Anatomical Location LEG LEG Leg One of the two lower extremities in humans used for Leg Production locomotion and support. (NCI) C32996 C74456 Anatomical Location LIVER FISSURE LIVER FISSURE Liver Fissure The transverse fissure on the visceral surface of the liver Liver Fissure Production where the portal vein and hepatic artery enter and the hepatic ducts leave. (NCI) C33031 C74456 Anatomical Location LYMPH NODE HILUM LYMPH NODE HILUM Lymph Node Hilum The concave side of the lymph node. (NCI) Lymph Node Hilum Production C33051 C74456 Anatomical Location MALLEUS MALLEUS Malleus A hammer-shaped bone, part of three interconnected small Malleus Production bones located in the middle ear. It is attached to the inner surface of the tympanic membrane and its function is to transmit sound vibrations. (NCI) C33073 C74456 Anatomical Location MEDIASTINAL LYMPH NODE MEDIASTINAL LYMPH NODE Mediastinal Lymph Node A lymph node located in the mediastinum. Mediastinal lymph Mediastinal Lymph Node Production nodes are arranged in three groups, one on the lateral, anothe on the medial, and a third on the anterior aspect of the vessels; the third group is, however, sometimes absent. (NCI)

C33108 C74456 Anatomical Location METATARSOPHALANGEAL JOINT METATARSOPHALANGEAL JOINT Metatarsophalangeal Joint A spheroid joint located between the heads of the metatarsal Metatarsophalangeal Joint Production bone and the base of the proximal phalanx of the toe. (NCI) C33156 C74456 Anatomical Location NAIL NAIL Nail The cutaneous plate on the dorsal surface of the distal end of Nail Production a finger or toe. (NCI) C33157 C74456 Anatomical Location NASAL BONE NASAL BONE Nasal Bone One of two small oblong bones placed side by side at the Nasal Bone Production middle and upper part of the face. (NCI) C33160 C74456 Anatomical Location NASAL SEPTUM NASAL SEPTUM Nasal Septum The thin wall between the two nasal cavities. (NCI) Nasal Septum Production C33162 C74456 Anatomical Location NAVICULAR BONE NAVICULAR BONE Navicular Bone An oval-shaped bone of the tarsus found on the medial side of Navicular Bone Production the foot. (NCI) C33178 C74456 Anatomical Location NOSTRIL NOSTRIL Nostril One of the two channels of the nose, from the point where Nostril Production they divide to the external opening. (NCI) C33200 C74456 Anatomical Location OLECRANON OLECRANON Olecranon A prominence at the proximal end of the ulna. It forms the tip Olecranon Production of the elbow. (NCI) C33205 C74456 Anatomical Location OLFACTORY MUCOSA OLFACTORY MUCOSA Olfactory Mucosa The part of the nasal mucosa composed of neuroepithelial Olfactory Mucosa Production tissue and mucus-producing Bowman's glands. The mucus moistens the epithelium and helps dissolve odor-containing gases. (NCI) C33278 C74456 Anatomical Location PAROTID GLAND LYMPH NODE PAROTID GLAND LYMPH NODE Parotid Gland Lymph Node A lymph node located close to, on, or within the parotid gland. Parotid Gland Lymph Node Production (NCI) C33282 C74456 Anatomical Location PATELLA PATELLA Patella A small flat triangular bone in front of the knee that articulates Patella Production with the femur and protects the knee joint. (NCI) C33287 C74456 Anatomical Location PELVIC BONE PELVIC BONE Pelvic Bone The caudal portion of the trunk, bounded anteriorly and Pelvic Bone Production laterally by the two hip bones incorporating the socket portion of the hip joint for each leg. Posteriorly it is bounded by the sacrum and coccyx. (NCI) C33301 C74456 Anatomical Location PERINEUM PERINEUM Perineum The area located between the anus and vulva in females, and Perineum Production anus and scrotum in males. (NCI) C33318 C74456 Anatomical Location PHARYNGEAL TONSIL PHARYNGEAL TONSIL Pharyngeal Tonsil A fold of lymphatic tissue covered by ciliated epithelium at the Pharyngeal Tonsil Production very back of the nose, in the roof of the nasopharynx. (NCI)

C33343 C74456 Anatomical Location PORTAL VEIN PORTAL VEIN Portal Vein A short thick trunk vein that transports blood containing the Portal Vein Production absorbed products of digestion from the intestine directly to the liver. (NCI) C33433 C74456 Anatomical Location PYLORIC SPHINCTER PYLORIC SPHINCTER Pyloric Sphincter The muscular structure at the distal portion of the stomach, Pyloric Sphincter Production opening into the duodenum. (NCI) C33507 C74456 Anatomical Location SACROILIAC JOINT SACROILIAC JOINT Sacroiliac Joint The joint located between the sacrum and the ilium. (NCI) Sacroiliac Joint Production C33508 C74456 Anatomical Location SACRUM SACRUM Sacrum The triangular bone, made up of 5 fused bones of the spine, Sacrum Production located in the lower area of the spine between the fifth lumbar vertebra and the coccyx. (NCI) C33548 C74456 Anatomical Location SHOULDER JOINT SHOULDER JOINT Shoulder Joint A ball-and-socket joint at the upper end of the humerus, Shoulder Joint Production located at the junction of humerus and scapula. (NCI) C33556 C74456 Anatomical Location SINUS SINUS Sinus A recess, cavity, or channel. (NCI) Sinus Production C33615 C74456 Anatomical Location STERNOCLAVICULAR JOINT STERNOCLAVICULAR JOINT Sternoclavicular Joint The synovial juncture between the medial end of the clavicle Sternoclavicular Joint Production and the anterior segment of the sternum. (NCI)

Covance Page 95 of 100 Confidential CDISC SDTM Terminology DATASET DEFINITIONS

Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C33718 C74456 Anatomical Location SYNOVIAL FLUID SYNOVIAL FLUID Synovial Fluid A viscid fluid secreted by the synovial membrane, serving as aSynovial Fluid Production lubricant. (NCI) C33720 C74456 Anatomical Location T1 VERTEBRA T1 VERTEBRA T1 Vertebra The first thoracic vertebra counting from the top down. (NCI) T1 Vertebra Production C33721 C74456 Anatomical Location T10 VERTEBRA T10 VERTEBRA T10 Vertebra The tenth thoracic vertebra counting from the top down. (NCI) T10 Vertebra Production

C33722 C74456 Anatomical Location T11 VERTEBRA T11 VERTEBRA T11 Vertebra The eleventh thoracic vertebra counting from the top down. T11 Vertebra Production (NCI) C33723 C74456 Anatomical Location T12 VERTEBRA T12 VERTEBRA T12 Vertebra The twelfth thoracic vertebra counting from the top down. T12 Vertebra Production (NCI) C33724 C74456 Anatomical Location T2 VERTEBRA T2 VERTEBRA T2 Vertebra The second thoracic vertebra counting from the top down. T2 Vertebra Production (NCI) C33725 C74456 Anatomical Location T3 VERTEBRA T3 VERTEBRA T3 Vertebra The third thoracic vertebra counting from the top down. (NCI) T3 Vertebra Production C33726 C74456 Anatomical Location T4 VERTEBRA T4 VERTEBRA T4 Vertebra The fourth thoracic vertebra counting from the top down. (NCI)T4 Vertebra Production

C33727 C74456 Anatomical Location T5 VERTEBRA T5 VERTEBRA T5 Vertebra The fifth thoracic vertebra counting from the top down. (NCI) T5 Vertebra Production C33728 C74456 Anatomical Location T6 VERTEBRA T6 VERTEBRA T6 Vertebra The sixth thoracic vertebra counting from the top down. (NCI) T6 Vertebra Production

C33729 C74456 Anatomical Location T7 VERTEBRA T7 VERTEBRA T7 Vertebra The seventh thoracic vertebra counting from the top down. T7 Vertebra Production (NCI) C33730 C74456 Anatomical Location T8 VERTEBRA T8 VERTEBRA T8 Vertebra The eighth thoracic vertebra counting from the top down. T8 Vertebra Production (NCI) C33731 C74456 Anatomical Location T9 VERTEBRA T9 VERTEBRA T9 Vertebra The ninth thoracic vertebra counting from the top down. (NCI) T9 Vertebra Production

C33737 C74456 Anatomical Location TARSUS BONE TARSUS BONE Tarsus Bone Any one of the seven bones forming the instep of the foot. Tarsus Bone Production (NCI) C33763 C74456 Anatomical Location THIGH THIGH Thigh A part of the lower limb, located between hip and knee. (NCI) Thigh Production

C33788 C74456 Anatomical Location TOE TOE Toe One of the terminal digits of the foot. (NCI) Toe Production C33790 C74456 Anatomical Location TOENAIL TOENAIL Toenail A thin, horny translucent plate covering the end of each toe. Toenail Production (NCI) C33809 C74456 Anatomical Location TRAPEZIUS MUSCLE TRAPEZIUS MUSCLE Trapezius Muscle One of a pair of flat, large, triangular muscles that extend from Trapezius Muscle Production the external occipital protuberance and the medial third of the superior nuchal line of the occipital bone to the middle of the back. The trapezius muscle is involved in moving the shoulder

C33814 C74456 Anatomical Location TROCHANTER TROCHANTER Trochanter A bony protrusion on the femoral bone to which muscles are Trochanter Production attached. (NCI) C33816 C74456 Anatomical Location TRUNK TRUNK Trunk The body excluding the head and neck and limbs. (NCI) Trunk Production C33820 C74456 Anatomical Location TUNICA INTIMA TUNICA INTIMA Tunica Intima The inner most layer of the blood vessel wall. The consistency Tunica Intima Production of the intima will vary depending on the type of blood vessel, but will always have an endothelial layer with a basal lamina. It may contain collagen and elastic fibers. (NCI)

C33888 C74456 Anatomical Location VOMER VOMER Vomer A thin, paired or unpaired, trapezoidal bone of the skull locatedVomer Production in the floor of the nasal cavity. The vomer forms the posterior and inferior parts of the nasal septum. (NCI) C33894 C74456 Anatomical Location WRIST JOINT WRIST JOINT Wrist Joint A joint between the distal end of the radius and the proximal Wrist Joint Production row of carpal bones. (NCI) C33895 C74456 Anatomical Location XIPHOID PROCESS XIPHOID PROCESS Xiphoid Process The cartilage just below the sternal body. (NCI) Xiphoid Process Production C34082 C74456 Anatomical Location GASTROINTESTINAL TRACT GASTROINTESTINAL TRACT Gastrointestinal Tract The upper gastrointestinal (GI) tract is comprised of mouth, Gastrointestinal Tract Production pharynx, esophagus and stomach while the lower GI tract consists of intestines and anus. The primary function of the GI tract is to ingest, digest, absorb and ultimately excrete food stuff. (NCI C43362 C74456 Anatomical Location ANUS ANUS Anus The lower opening of the digestive tract, lying in the cleft Anus Production between the buttocks, through which fecal matter is extruded. (NCI) C49018 C74456 Anatomical Location REGIONAL LYMPH NODE REGIONAL LYMPH NODE Regional Lymph Node A lymph node that drains lymph from a region of interest. Regional Lymph Node Production (NCI) C52730 C74456 Anatomical Location STERNAL MANUBRIUM STERNAL MANUBRIUM Sternal Manubrium The upper segment of the sternum, quadrangular in shape, as Sternal Manubrium Production well as wider superiorly and narrower inferiorly. The sternal manubrium articulates with the clavicle and first two ribs. (NCI) C52745 C74456 Anatomical Location PALATINE BONE PALATINE BONE Palatine Bone An irregularly shaped bone positioned at the back part of the Palatine Bone Production nasal cavity between the maxilla and the pterygoid process of the sphenoid. It forms the posterior part of the hard palate and the lateral wall of the nasal fossa and helps to form the floor of

C52749 C74456 Anatomical Location LEG SKIN LEG SKIN Leg Skin The skin or integument surrounding the leg. (NCI) Leg Skin Production C52754 C74456 Anatomical Location ARM SKIN ARM SKIN Arm Skin The skin or integument covering the arm. (NCI) Arm Skin Production C52758 C74456 Anatomical Location ABDOMINAL SKIN ABDOMINAL SKIN Abdominal Skin The skin or integument surrounding the abdomen. (NCI) Abdominal Skin Production C52759 C74456 Anatomical Location RIB 9 RIB 9 Rib 9 The ninth rib counting from the top of the rib cage down. (NCI)Rib 9 Production

C52760 C74456 Anatomical Location RIB 8 RIB 8 Rib 8 The eighth rib counting from the top of the rib cage down. Rib 8 Production (NCI) C52761 C74456 Anatomical Location RIB 7 RIB 7 Rib 7 The seventh rib counting from the top of the rib cage down. Rib 7 Production (NCI) C52762 C74456 Anatomical Location RIB 6 RIB 6 Rib 6 The sixth rib counting from the top of the rib cage down. (NCI) Rib 6 Production

C52763 C74456 Anatomical Location RIB 5 RIB 5 Rib 5 The fifth rib counting from the top of the rib cage down. (NCI) Rib 5 Production

C52764 C74456 Anatomical Location RIB 4 RIB 4 Rib 4 The fourth rib counting from the top of the rib cage down. Rib 4 Production (NCI) C52765 C74456 Anatomical Location RIB 3 RIB 3 Rib 3 The third rib counting from the top of the rib cage down. (NCI) Rib 3 Production

C52766 C74456 Anatomical Location RIB 2 RIB 2 Rib 2 The second rib counting from the top of the rib cage down. Rib 2 Production (NCI) C52767 C74456 Anatomical Location RIB 12 RIB 12 Rib 12 The twelfth rib counting from the top of the rib cage down. Rib 12 Production (NCI) C52768 C74456 Anatomical Location RIB 11 RIB 11 Rib 11 The eleventh rib counting from the top of the rib cage down. Rib 11 Production (NCI) C52769 C74456 Anatomical Location RIB 10 RIB 10 Rib 10 The tenth rib counting from the top of the rib cage down. (NCI)Rib 10 Production

C52770 C74456 Anatomical Location RIB 1 RIB 1 Rib 1 The first rib counting from the top of the rib cage down. (NCI) Rib 1 Production

C52771 C74456 Anatomical Location HAND PHALANX HAND PHALANX Hand Phalanx A bone of the hand. (NCI) Hand Phalanx Production

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C52772 C74456 Anatomical Location FOOT PHALANX FOOT PHALANX Foot Phalanx A bone of the foot. (NCI) Foot Phalanx Production C52799 C74456 Anatomical Location TALUS TALUS Talus The bone of the foot that connects with the tibia and fibula to Talus Production form the ankle joint. (NCI) C52810 C74456 Anatomical Location SCIATIC NERVE SCIATIC NERVE Sciatic Nerve The longest single nerve that is formed by the merging of the Sciatic Nerve Production ventral rami of the L4, L5, and S1 in the pelvis and passes down the lower limb where it divides into the common peroneal and tibial nerves. (NCI) C54272 C74456 Anatomical Location THROAT THROAT Throat The narrow passage from the mouth to the cavity at the back Throat Production of the mouth. (NCI) C61563 C74456 Anatomical Location FEMORAL NECK FEMORAL NECK Femoral Neck The short, constricted portion of the thigh bone between the Femoral Neck Production femur head and the trochanter. (NCI) C61599 C74456 Anatomical Location MALE GENITALIA MALE GENITALIA Male Genitalia Male internal and external organs of reproduction. Male Genitalia Production C61600 C74456 Anatomical Location FEMALE GENITALIA FEMALE GENITALIA Female Genitalia Female internal and external organs of reproduction. Female Genitalia Production C62432 C74456 Anatomical Location UNCINATE PROCESS OF UNCINATE PROCESS OF Uncinate Process of Pancreas A portion of the pancreas that extends behind the superior Uncinate Process of Pancreas Production PANCREAS PANCREAS mesenteric artery and superior mesenteric vein. (NCI) C62484 C74456 Anatomical Location CHEST WALL CHEST WALL Chest Wall The total system of structures outside the lungs that move as Chest Wall Production a part of breathing; it includes all structures from the skin to the parietal pleura. (NCI) C63705 C74456 Anatomical Location INFRACLAVICULAR LYMPH NODE INFRACLAVICULAR LYMPH NODE Infraclavicular Lymph Node A lymph node located in the area below the clavicle. (NCI) Infraclavicular Lymph Node Production C63706 C74456 Anatomical Location FACIAL BONE FACIAL BONE Facial Bone Any bone that contributes to the facial structures, except thoseFacial Bone Production bones that are part of the braincase. (NCI) C64192 C74456 Anatomical Location WAIST WAIST Waist The abdominal circumference at the navel. (NCI) Waist Production C64193 C74456 Anatomical Location HIP HIP Hip The lateral prominence of the pelvis from the waist to the Hip Production thigh. (NCI) C65166 C74456 Anatomical Location CELIAC LYMPH NODE CELIAC LYMPH NODE Celiac Lymph Node A lymph node at the base of the celiac artery. (NCI) Celiac Lymph Node Production C66864 C74456 Anatomical Location TOOTH CANAL TOOTH CANAL Tooth Canal The anatomic space in the root of a tooth that contains nerves Tooth Canal Production blood vessels, and connective tissue. (NCI) C69300 C74456 Anatomical Location EPICONDYLE EPICONDYLE Epicondyle A bone prominence to which ligaments and tendons of the Epicondyle Production joints are attached. (NCI) C74558 Yes Category for Disposition Event DSCAT DSCAT Category for Disposition Event Classifications that describe and group pertinent events that CDISC SDTM Category For Production occur throughout the conduct of a clinical trial. Disposition Event Terminology

C74588 C74558 Category for Disposition Event PROTOCOL MILESTONE PROTOCOL MILESTONE Protocol Milestone Occurrences within some epochs that are initiated by a Protocol Milestone Production protocol-specified event. The most common protocol milestone is "Informed Consent Obtained" which usually documents the start of the study. C74589 C74558 Category for Disposition Event OTHER EVENT OTHER EVENT Other Event Other important events that occur during a trial but are not Protocol Event Production driven by protocol requirements. C74590 C74558 Category for Disposition Event DISPOSITION EVENT DISPOSITION EVENT Disposition Event The group of incidents that occur during a clinical trial and Protocol Disposition Event Production describe whether a subject completed the study epoch or the reason this event did not occur. The subject's disposition is often described for each phase of the study. C76351 Yes Skin Classification SKINCLAS SKINCLAS Skin Classification A classification system used to categorize the sensitivity of a CDISC SDTM Fitzpatrick Skin Production subject's skin to sunlight. Classification Terminology

C74569 C76351 Skin Classification TYPE1 TYPE1 Individuals who never tan and always sunburn if exposed to Fitzpatrick Skin Type I Production any appreciable amount of sunlight, primarily red headed individuals and lightly complected blondes. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through C74570 C76351 Skin Classification TYPE2 TYPE2 Individuals who frequently burn but are able to tan to a small Fitzpatrick Skin Type II Production degree after extended sun exposure. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) C74571 C76351 Skin Classification TYPE3 TYPE3 Individuals who burn infrequently and tan readily. (Reference: Fitzpatrick Skin Type III Production Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) C74572 C76351 Skin Classification TYPE4 TYPE4 Individuals who rarely burn and tan heavily with moderate sun Fitzpatrick Skin Type IV Production exposures, especially individuals of Asian, American Indian, Mediterranean and Latin American descent. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I thr C74573 C76351 Skin Classification TYPE5 TYPE5 Individuals who have dark constitutive pigmentation but Fitzpatrick Skin Type V Production become noticeably darker with sun exposure, especially light complected black individuals, those of Indian descent. (Reference: Fitzpatrick TB: The validity and practicality of sun- reactive skin type C74574 C76351 Skin Classification TYPE6 TYPE6 Individuals who have the heaviest constitutive pigmentation, Fitzpatrick Skin Type VI Production especially dark skinned black individuals. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) C74561 Yes Skin Type SKINTYP SKINTYP Skin Type A distinctive characteristic of the skin marked by the amount CDISC SDTM Skin Type Production of sebum secreted by sebaceous glands. Terminology

C74591 C74561 Skin Type OILY OILY The pores of the skin are generally large and visible with a Oily Skin Production coarse or thick texture. It has a tendency to look dull and greasy and feels oily to the touch. C74592 C74561 Skin Type DRY DRY The pores are generally fine with a papery thin texture that Dry Skin Production feels dry to the touch. Usually flaky and dull looking. C74593 C74561 Skin Type NORMAL NORMAL The pores are visible but not large. The texture is neither fine Normal Skin Production or thick and it neither feels dry or oily to the touch. C74559 Yes Subject Characteristic Code SCCD SCCD Subject Characteristic Code A unique code representing each Subject Characteristic. CDISC SDTM Subject Production Characteristic Code Terminology

C17953 C74559 Subject Characteristic Code EDLEVEL EDLEVEL Education Level Years of education that a person has completed. Education Level Production C25188 C74559 Subject Characteristic Code MARISTAT MARISTAT Marital Status A demographic parameter indicating a person's current Marital Status Production conjugal status. C25193 C74559 Subject Characteristic Code EMPJOB EMPJOB Employee Job A code specifying the job performed by the employee for the Occupation Production employer. For example, accountant, programmer analyst, patient care associate, staff nurse, etc. C74563 C74559 Subject Characteristic Code SKINCLAS SKINCLAS Skin Classification A classification system used to categorize the sensitivity of a Fitzpatrick Classification Scale Production subject's skin to sunlight. C74580 C74559 Subject Characteristic Code SKINTYP SKINTYP Skin Type A distinctive characteristic of the skin marked by the amount Skin Type Production of sebum secreted by sebaceous glands.

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C74565 C74559 Subject Characteristic Code JOBCLAS JOBCLAS Employee Job Class A code qualifying the employment in various ways, such as, Employee Job Class Production full-time vs. part time, etc. C74566 C74559 Subject Characteristic Code SALTYP SALTYP Employee Salary Type A code specifying the method used by the employer to Employee Salary Type Production compute the employee's salary or wages. For example, hourly annual, or commission. C76348 Yes Marital Status MARISTAT MARISTAT Marital Status A demographic parameter indicating a person's current Marital Status Terminology Production conjugal status. C76240 C76348 Marital Status ANNULLED ANNULLED Marriage contract has been declared null and to not have Annulled Production existed. (HL7) C51776 C76348 Marital Status DIVORCED DIVORCED Marrige contract has been declared dissolved and inactive. Divorced Production (HL7) C76241 C76348 Marital Status INTERLOCUTORY INTERLOCUTORY Temporary order issued during the course of litigation. (HL7) Interlocutory Production C51777 C76348 Marital Status LEGALLY SEPARATED LEGALLY SEPARATED A person living apart from his/her spouse by legal Separated Production arrangement. (HL7) C51773 C76348 Marital Status MARRIED MARRIED A current marriage contract is active. (HL7) Married Production C51774 C76348 Marital Status NEVER MARRIED NEVER MARRIED No marriage contract has ever been entered. (HL7) Never Married Production C51775 C76348 Marital Status WIDOWED WIDOWED The spouse has died. (HL7) Widowed Production C76242 C76348 Marital Status POLYGAMOUS POLYGAMOUS More than 1 current spouse. (HL7) Polygamous Production C53262 C76348 Marital Status DOMESTIC PARTNER DOMESTIC PARTNER Person declares that a domestic partnership relationship Domestic Partnership Production exists. (HL7) C74457 Yes Race RACE RACE Race Terminology codelist used to identify the race of an individual CDISC SDTM Race Terminology Production within the Clinical Data Interchange Standards Consortium Study Data Tabulation Model. C16352 C74457 Race BLACK OR AFRICAN AMERICAN BLACK OR AFRICAN AMERICAN A person having origins in any of the black racial groups of African American Production Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American." (FDA) C41259 C74457 Race AMERICAN INDIAN OR ALASKA AMERICAN INDIAN OR ALASKA A person having origins in any of the original peoples of North American Indian or Alaska Native Production NATIVE NATIVE and South America (including Central America), and who maintains tribal affiliation or community attachment. (FDA)

C41260 C74457 Race ASIAN ASIAN A person having origins in any of the original peoples of the Asian Production Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (FDA) C41219 C74457 Race NATIVE HAWAIIAN OR OTHER NATIVE HAWAIIAN OR OTHER Denotes a person having origins in any of the original peoples Native Hawaiian or Other Pacific Production PACIFIC ISLANDER PACIFIC ISLANDER of Hawaii, Guam, Samoa, or other Pacific Islands. The term Islander covers particularly people who identify themselves as part- Hawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian, Samoan, Chuu C41261 C74457 Race WHITE WHITE Denotes a person with European, Middle Eastern, or North White Production African ancestral origin who identifies, or is identified, as White. (FDA) C78731 Yes Drug Accountability Test Name DATEST DATEST Drug Accountability Test The name of the test for the drug accountability assessment. CDISC SDTM Drug Production Name Accountability Test Terminology C78721 C78731 Drug Accountability Test Name Dispensed Amount DISPAMT Dispensed Amount The quantity of a product that has been dispensed. (NCI) DispensedbN Amount Production C78722 C78731 Drug Accountability Test Name Returned Amount RETAMT Returned Amount The quantity of a product that has been returned. (NCI) Returned Amount Production C78732 Yes Drug Accountability Test Code DATESTCD DATESTCD Drug Accountability Test Code The short name, or code, of the test for the drug accountabilityCDISC SDTM Drug Production assessment. Accountability Test Terminology C78721 C78732 Drug Accountability Test Code DISPAMT DISPAMT Dispensed Amount The quantity of a product that has been dispensed. (NCI) Dispensed Amount Production C78722 C78732 Drug Accountability Test Code RETAMT RETAMT Returned Amount The quantity of a product that has been returned. (NCI) Returned Amount Production C78733 Yes Specimen Condition SPECCOND SPECCOND Specimen Condition The physical state or quality of a biological specimen. CDISC SDTM Specimen Production Condition Terminology C70717 C78733 Specimen Condition FROZEN FROZEN Frozen Specimen A specimen that has been subjected to and immobilized by Frozen Specimen Production severe cold. (NCI) C70720 C78733 Specimen Condition HEMOLIZED HEMOLIZED Hemolysis in Specimen A specimen that has undergone the destruction of red blood Hemolysis in Specimen Production cells followed by the release of the hemoglobin. (NCI) C70715 C78733 Specimen Condition LIPEMIC LIPEMIC Lipemic Specimen A specimen that consists of or contains excessive amounts of Lipemic Specimen Production fat and fatty substances. (NCI) C70718 C78733 Specimen Condition REFRIGERATED REFRIGERATED Refrigerated Specimen A specimen that has been kept or preserved at a low Refrigerated Specimen Production temperature in a refrigerator. (NCI) C70719 C78733 Specimen Condition ROOM TEMPERATURE ROOM TEMPERATURE Specimen at Room A specimen that has been subjected to and adjusted to the Specimen at Room Temperature Production Temperature average ambient temperature of a room, usually considered to be around 20° C (68° F). (NCI) C78723 C78733 Specimen Condition CALCIFIED CALCIFIED Calcified Specimen A specimen that has undergone calcification. (NCI) Calcified Specimen Production C78724 C78733 Specimen Condition CLOTTED CLOTTED Clotted Specimen A specimen that has become coagulated. (NCI) Clotted Specimen Production C78725 C78733 Specimen Condition AUTOLIZED AUTOLIZED Autolized Specimen A specimen that has undergone autolysis, or self-digestion by Autolized Specimen Production the specimen's own digestive enzymes. (NCI) C78734 Yes Specimen Type SPECTYPE SPECTYPE Specimen Type The name and description of a biological specimen. CDISC SDTM Specimen Type Production Terminology C12472 C78734 Specimen Type ADIPOSE TISSUE ADIPOSE TISSUE A specialized form of connective tissue consisting primarily of Adipose Tissue Production adipocytes (fat cells), surrounded by a meshwork of collagen fibers. (NCI) C13188 C78734 Specimen Type AMNIOTIC FLUID AMNIOTIC FLUID The fluid within the amniotic cavity which surrounds and Amniotic Fluid Production protects the developing embryo. (NCI) C13190 C78734 Specimen Type AQUEOUS HUMOR AQUEOUS HUMOR The watery fluid which is present in the anterior and posterior Aqueous Humor Production chambers of the eye. (NCI) C78729 C78734 Specimen Type ARTERIAL BLOOD ARTERIAL BLOOD Oxygenated blood which is transported with nutrients to body Arterial Blood Production tissues through the arterial system. The exception is blood within the pulmonary artery which carries deoxygenated blood to the lungs. (NCI) C78739 C78734 Specimen Type ATHEROSCLEROTIC PLAQUE ATHEROSCLEROTIC PLAQUE Fatty tissue which is deposited in the inner lining of the arteria Atherosclerotic Plaque Production wall. (NCI) C13192 C78734 Specimen Type BILE BILE Fluid composed of waste products, bile acids, salts, Bile Production cholesterol, and electrolytes. It is secreted by the liver parenchyma and stored in the gallbladder. (NCI) C12434 C78734 Specimen Type BLOOD BLOOD A liquid tissue with the primary function of transporting oxygenBlood Production and carbon dioxide. It supplies the tissues with nutrients, removes waste products, and contains various components of the immune system defending the body against infection.

C12366 C78734 Specimen Type BONE BONE Calcified connective tissue that forms the skeletal componentsBone Production of the body. (NCI)

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C12431 C78734 Specimen Type BONE MARROW BONE MARROW The tissue occupying the spaces of bone. It consists of blood Bone Marrow Production vessel sinuses and a network of hematopoietic cells which give rise to the red cells, white cells, and megakaryocytes. (NCI) C13257 C78734 Specimen Type BREAST MILK BREAST MILK Milk produced by females for the purpose of feeding their Breast Milk Production young. (NCI) C35708 C78734 Specimen Type CALCULUS CALCULUS Accumulated material from the secretions of an organ. It is Stone Production solid and representative examples include gallbladder stones, kidney stones, and salivary gland stones. (NCI) C12692 C78734 Specimen Type CEREBROSPINAL FLUID CEREBROSPINAL FLUID The fluid that is contained within the brain ventricles, the Cerebrospinal Fluid Production subarachnoid space and the central canal of the spinal cord. (NCI) C32293 C78734 Specimen Type CERUMEN CERUMEN A wax secreted by glands in the ear canal. Cerumen Production C32348 C78734 Specimen Type COLOSTRUM COLOSTRUM A thick, protein-rich substance secreted by the breasts during Colostrum Production the second half of pregnancy and for a few days after birth before the breast milk comes in. C77666 C78734 Specimen Type EMESIS EMESIS Vomit Stomach contents that have returned to the mouth or are Vomitus Production ejected beyond the mouth. (NCI) C78741 C78734 Specimen Type EXPIRED AIR EXPIRED AIR The air that moves out of the chest during expiration. It Expired Air Production contains a higher percentage of carbon dioxide and a lower percentage of oxygen compared to the inhaled air. (NCI) C13233 C78734 Specimen Type EXUDATE EXUDATE Fluid, cells or cellular debris that escapes from the blood Exudate Production vessels and accumulates in nearby tissues. It is the result of inflammation and is rich in proteins. C13236 C78734 Specimen Type FLUID FLUID Liquid substances produced by the body. Body Fluid or Substance Production C32705 C78734 Specimen Type HAIR HAIR The filamentous outgrowth of the epidermis. (NCI) Hair Production C78742 C78734 Specimen Type LOCHIA LOCHIA Vaginal discharge occurring during the post-partum period. It Lochia Production consists of a mixture of blood, mucus, and placental remnants. (NCI) C13273 C78734 Specimen Type LUNG SURFACTANT LUNG SURFACTANT Surfactant Pulmonary surfactant lines the lung epithelium and lowers Lung Surfactant Production surface tension to prevent collapse at end-expiration. Deficiency of pulmonary surfactant results in respiratory distress syndrome (RDS) in premature infants. Lung surfactant is synthesized in alve C13252 C78734 Specimen Type LYMPH LYMPH A clear, transparent, sometimes faintly yellow and slightly Lymph Production opalescent fluid that is collected from the tissues throughout the body, flows in the lymphatic vessels (through the lymph nodes), and is eventually added to the venous blood circulation. Lymph c C78743 C78734 Specimen Type MECONIUM MECONIUM The newborn’s first intestinal discharge. It is a dark-green, Meconium Production thick substance composed of mucus, intestinal secretions, hair, and intestinal mucosa cells. (NCI) C78740 C78734 Specimen Type MENSTRUAL BLOOD MENSTRUAL BLOOD The discharged blood from the uterus during the reproductive Menstrual Blood Production years. The discharge occurs approximately once a month. (NCI) C13259 C78734 Specimen Type MUCUS MUCUS The thick fluid secreted by the mucus glands in the Mucus Production aerodigestive tract and the vagina. (NCI) C33156 C78734 Specimen Type NAIL NAIL The cutaneous plate on the dorsal surface of the distal end of Nail Production a finger or toe. (NCI) C13356 C78734 Specimen Type PLASMA PLASMA Plasma is the fluid (acellular) portion of the circulating blood, Plasma Production as distinguished from the serum that is the fluid portion of the blood obtained by removal of the fibrin clot and blood cells after coagulation. C50718 C78734 Specimen Type PUS PUS A yellowish substance produced during bacterial Pus Production inflammation. It contains necrotic cells and cells fighting the infection. (NCI) C13275 C78734 Specimen Type SALIVA SALIVA A clear liquid secreted into the mouth by the salivary glands Saliva Production and mucous glands of the mouth; moistens the mouth and starts the digestion of starches. (NCI) C13276 C78734 Specimen Type SEBUM SEBUM A thick, oily substance produced by the sebaceous glands Sebum Production located in the dermis. (NCI) C13277 C78734 Specimen Type SEMEN SEMEN Seminal Plasma The thick, whitish secretion of the male reproductive organs. ItSemen Production is composed of spermatozoa in their nutrient plasma, secretions from the prostate, seminal vesicles, and various other glands, epithelial cells, and minor constituents. C33529 C78734 Specimen Type SEMINAL FLUID SEMINAL FLUID Part of the ejaculated fluid. It contains secretions from the Seminal Fluid Production seminal vesicles, Cowper gland, and prostate gland. C13325 C78734 Specimen Type SERUM SERUM The clear portion of the blood that remains after the removal ofSerum Production the blood cells and the clotting proteins. (NCI) C33574 C78734 Specimen Type SMEGMA SMEGMA A white secretion of the sebaceous glands of the foreskin. Smegma Production (NCI) C13278 C78734 Specimen Type SPUTUM SPUTUM Material containing mucus, cellular debris, microorganisms Sputum Production and sometimes blood or pus. It is ejected through the mouth from the lungs, bronchi, and trachea. (NCI) C13234 C78734 Specimen Type STOOL STOOL Feces The material discharged from the bowel during defecation. It Feces Production consists of undigested food, intestinal mucus, epithelial cells, and bacteria. (NCI) C13280 C78734 Specimen Type PERSPIRATION PERSPIRATION Sweat The liquid secreted by the sweat glands. (NCI) Sweat Production C12801 C78734 Specimen Type TISSUE TISSUE An anatomical structure consisting of similarly specialized Tissue Production cells and intercellular matrix, aggregated according to genetically determined spatial relationships, performing a specific function. (NCI) C78744 C78734 Specimen Type TRANSUDATE TRANSUDATE The fluid that passes through the wall of the veins and Transudate Production capillaries to the surrounding tissues because of increased intravascular pressure. It has low protein content. (NCI) C13283 C78734 Specimen Type URINE URINE The fluid that is excreted by the kidneys. It is stored in the Urine Production bladder and discharged through the urethra. (NCI) C78730 C78734 Specimen Type VENOUS BLOOD VENOUS BLOOD Deoxygenated blood containing urea and other waste product Venous Blood Production which is transported through the venous system to the heart and lungs. The exception is blood within the pulmonary vein which is oxygenated and travels from the lungs to the left atrium of the he C78735 Yes Evaluator EVAL EVAL Evaluator The role that the individual or entity plays with respect to a CDISC SDTM Evaluator Production specific situation or person. Terminology

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Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Notes (Reference for CDISC PT) Code Extensible Production (Yes/No) C17445 C78735 Evaluator CAREGIVER CAREGIVER The primary person in charge of the care of a patient, usually aCaregiver Production family member or a designated health care professional. (NCI) C42708 C78735 Evaluator CHILD CHILD A son or a daughter. Child Production C42708 C78735 Evaluator PARENT PARENT A mother or a father. Parent Production C51811 C78735 Evaluator CLINICAL RESEARCH CLINICAL RESEARCH A person to whom a clinical investigator delegates routine Clinical Coordinator Production COORDINATOR COORDINATOR administrative requirements of a protocol. The duties and responsibilities of a clinical research coordinator may vary across different infrastructures. Generally, the coordinator manages the subj

C25465 C78735 Evaluator CLINICAL RESEARCH CLINICAL RESEARCH Research Associate A person who is employed by a study sponsor or by a contractClinical Research Associate Production ASSOCIATE ASSOCIATE research organization (CRO), operates independently from the clinical study site and functions as a monitor, and/or auditor, and/or a project director within a particular trial or institution. (

C70793 C78735 Evaluator CLINICAL STUDY SPONSOR CLINICAL STUDY SPONSOR Study Sponsor, Sponsor An entity that is responsible for the initiation, management, Clinical Study Sponsor Production and/or financing of a clinical study. C53287 C78735 Evaluator HEALTH CARE PROFESSIONAL HEALTH CARE PROFESSIONAL A person qualified to be engaged in activity directed at Health Care Professional Production preservation of mental and physical health by diseases prevention and treatment as a source of livelihood. (NCI) C78720 C78735 Evaluator INDEPENDENT ASSESSOR INDEPENDENT ASSESSOR An individual qualified to perform an evaluation who is maskedIndependent Rater Production from a subject's data in order to minimize bias or maximize consistency and quality. (NCI) C25936 C78735 Evaluator INVESTIGATOR INVESTIGATOR A person responsible for the conduct of the clinical trial at a Investigator Production trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principle investigator. C72884 C78735 Evaluator FRIEND FRIEND A person whom an individual knows, likes, and trusts. (NCI) Friend Production C41189 C78735 Evaluator STUDY SUBJECT STUDY SUBJECT An individual who is observed, analyzed, examined, Study Subject Production investigated, experimented upon, or/and treated in the course of a particular study. C62649 C78735 Evaluator SPOUSE SPOUSE A person's partner in marriage. (NCI) Spouse Production C53262 C78735 Evaluator DOMESTIC PARTNER DOMESTIC PARTNER A person who is a member of an unmarried couple, including Domestic Partnership Production same sex couples living together in longstanding relationships that are registered or unregistered. (NCI) C78726 C78735 Evaluator ADJUDICATION COMMITTEE ADJUDICATION COMMITTEE An external committee whose purpose is to evaluate study Adjudication Committee Production data and decide whether a study endpoint or other criterion has been met. (NCI) C51828 C78735 Evaluator GUARDIAN GUARDIAN An individual who is authorized under applicable State or local Guardian Production law to consent on behalf of a child or incapable person to general medical care including participation in clinical research. (NCI) C78736 Yes Reference Range Indicator NRIND NRIND Reference Range Indicator A description of the results relative to the normal or expected CDISC SDTM Reference Range Production range of values. Indicator C78727 C78736 Reference Range Indicator NORMAL NORMAL Reported values within the typical or expected range. (NCI) Normal Reference Range Production C78802 C78736 Reference Range Indicator ABNORMAL ABNORMAL Reported values outside the typical or expected range. (NCI) Abnormal Reference Range Production C78800 C78736 Reference Range Indicator HIGH HIGH Reported values above the typical or expected range. (NCI) Value Above Reference Range Production C78801 C78736 Reference Range Indicator LOW LOW Reported values below the typical or expected range. (NCI) Value Below Reference Range Production C78737 No Relationship Type RELTYPE RELTYPE Relationship Type The description of relationship types between a record or set CDISC SDTM Relationship Type Production of records. Terminology C66832 C78737 Relationship Type ONE ONE A textual representation of the numeral 1. One Production C78728 C78737 Relationship Type MANY MANY More than one. (NCI) Many Production C78738 Yes Never/Current/Former Classification NCF NCF Never/Current/Former A classification of usage or experience that falls into three CDISC SDTM Production Classification categories; never, current, or former. Never/Current/Former Classification Terminology C70543 C78738 Never/Current/Former Classification NEVER NEVER Not ever; at no time in the past. Never Production C25471 C78738 Never/Current/Former Classification CURRENT CURRENT Occurring in or belonging to the present time. (NCI) Current Production C25627 C78738 Never/Current/Former Classification FORMER FORMER Previous Occurring prior to something else. (NCI) Previous Production

Covance Page 100 of 100 Confidential Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD1 Yes Questionaire Test Code QSTESTCD CVD1 Questionaire Test Code BLV01 BLV01 CVD1 Questionaire Test Code BLV02 BLV02 CVD1 Questionaire Test Code BLV03 BLV03 CVD1 Questionaire Test Code BLV04 BLV04 CVD1 Questionaire Test Code BLV05 BLV05 CVD1 Questionaire Test Code BLV06 BLV06 CVD1 Questionaire Test Code BLV07 BLV07 CVD1 Questionaire Test Code BLV08 BLV08 CVD1 Questionaire Test Code BLV09 BLV09 CVD1 Questionaire Test Code BLV10 BLV10 CVD1 Questionaire Test Code BLV11 BLV11 CVD1 Questionaire Test Code BLV12 BLV12 CVD1 Questionaire Test Code BLV13 BLV13 CVD1 Questionaire Test Code BLV14 BLV14 CVD1 Questionaire Test Code BLV15 BLV15 CVD1 Questionaire Test Code BLV16 BLV16 Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD2 Yes Questionaire Test Name QSTEST CVD2 Questionaire Test Name ALERT-DROWSY BLV01 CVD2 Questionaire Test Name CALM-EXCITED BLV02 CVD2 Questionaire Test Name STRONG-FEEBLE BLV03 CVD2 Questionaire Test Name MUZZY-CLEAR HEADED BLV04 CVD2 Questionaire Test Name WELL CO-ORDINATED-CLUMSY BLV05 CVD2 Questionaire Test Name LETHARGIC-ENERGETIC BLV06 CVD2 Questionaire Test Name CONTENTED-DISCONTENTED BLV07 CVD2 Questionaire Test Name TROUBLED-TRANQUIL BLV08 CVD2 Questionaire Test Name MENTALLY SLOW-QUICK WITTED BLV09 CVD2 Questionaire Test Name TENSE-RELAXED BLV10 CVD2 Questionaire Test Name ATTENTIVE-DREAMY BLV11 CVD2 Questionaire Test Name INCOMPETENT-PROFICIENT BLV12 CVD2 Questionaire Test Name HAPPY-SAD BLV13 CVD2 Questionaire Test Name ANTAGONISTIC-FRIENDLY BLV14 CVD2 Questionaire Test Name INTERESTED-BORED BLV15 CVD2 Questionaire Test Name WITHDRAWN-SOCIABLE BLV16 Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD3 Yes Physical Exam Test Code PETESTCD CVD3 Physical Exam Test Code PEMNSTAT PEMNSTAT CVD3 Physical Exam Test Code PECRNVES PECRNVES CVD3 Physical Exam Test Code PEMSCTNE PEMSCTNE CVD3 Physical Exam Test Code PESTNSYM PESTNSYM CVD3 Physical Exam Test Code PERFLXES PERFLXES CVD3 Physical Exam Test Code PESNRSYS PESNRSYS CVD3 Physical Exam Test Code PEGAIT PEGAIT CVD3 Physical Exam Test Code PEFNGNSE PEFNGNSE CVD3 Physical Exam Test Code PEGENAPP PEGENAPP CVD3 Physical Exam Test Code PESKIN PESKIN CVD3 Physical Exam Test Code PELYMNDS PELYMNDS CVD3 Physical Exam Test Code PEHEENT PEHEENT CVD3 Physical Exam Test Code PENECK PENECK CVD3 Physical Exam Test Code PETHXLNG PETHXLNG CVD3 Physical Exam Test Code PECARDIO PECARDIO CVD3 Physical Exam Test Code PEABDMN PEABDMN CVD3 Physical Exam Test Code PEMSCKTL PEMSCKTL CVD3 Physical Exam Test Code PENEURO PENEURO CVD3 Physical Exam Test Code PEBREAST PEBREAST CVD3 Physical Exam Test Code PEURGNTL PEURGNTL Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD4 Yes Physical Exam Test Name PETEST CVD4 Physical Exam Test Name MENTAL STATUS PEMNSTAT CVD4 Physical Exam Test Name CRANIAL NERVES PECRNVES CVD4 Physical Exam Test Name MUSCLE TONE PEMSCTNE CVD4 Physical Exam Test Name MUSCLE STRENGTH/SYMMETRY PESTNSYM CVD4 Physical Exam Test Name REFLEXES PERFLXES CVD4 Physical Exam Test Name SENSORY SYSTEM PESNRSYS CVD4 Physical Exam Test Name GAIT PEGAIT CVD4 Physical Exam Test Name FINGER-TO-NOSE PEFNGNSE CVD4 Physical Exam Test Name GENERAL APPEARANCE PEGENAPP CVD4 Physical Exam Test Name SKIN PESKIN CVD4 Physical Exam Test Name LYMPH NODES PELYMNDS CVD4 Physical Exam Test Name HEENT PEHEENT CVD4 Physical Exam Test Name NECK PENECK CVD4 Physical Exam Test Name THORAX/LUNGS PETHXLNG CVD4 Physical Exam Test Name CARDIOVASCULAR PECARDIO CVD4 Physical Exam Test Name ABDOMEN PEABDMN CVD4 Physical Exam Test Name MUSCULOSKELETAL PEMSCKTL CVD4 Physical Exam Test Name NEUROLOGICAL PENEURO CVD4 Physical Exam Test Name BREASTS PEBREAST CVD4 Physical Exam Test Name UROGENITAL PEURGNTL Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD5 Yes Subject Characteristic Test SCTEST CVD5 Subject Characteristic Test Education Level EDLEVEL CVD5 Subject Characteristic Test Marital Status MARISTAT CVD5 Subject Characteristic Test Employee Job EMPJOB CVD5 Subject Characteristic Test Skin Classification SKINCLAS CVD5 Subject Characteristic Test Skin Type SKINTYP CVD5 Subject Characteristic Test Employee Job Class JOBCLAS CVD5 Subject Characteristic Test Employee Salary Type SALTYP Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD6 Yes Subject Characteristic Code SCTESTCD CVD6 Subject Characteristic Code EDLEVEL EDLEVEL CVD6 Subject Characteristic Code MARISTAT MARISTAT CVD6 Subject Characteristic Code EMPJOB EMPJOB CVD6 Subject Characteristic Code SKINCLAS SKINCLAS CVD6 Subject Characteristic Code SKINTYP SKINTYP CVD6 Subject Characteristic Code JOBCLAS JOBCLAS CVD6 Subject Characteristic Code SALTYP SALTYP Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD7 Yes Deviation Sub Category DVSCAT CVD7 Deviation Sub Category MAJOR MAJOR CVD7 Deviation Sub Category MINOR MINOR Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD8 Yes Deviation Category DVCAT CVD8 Deviation Category PROTOCOL EXCLUDED THERAPY PROTOCOL EXCLUDED THERAPY CVD8 Deviation Category VIOLATION OF INCLUSION/EXCLUSION CRITERIA VIOLATION OF INCLUSION/EXCLUSION CRITERIA CVD8 Deviation Category ASSESSMENT PERFORMED PRIOR TO INFORMED CONSENT ASSESSMENT PERFORMED PRIOR TO INFORMED CONSENT CVD8 Deviation Category STUDY DRUG NOT ADMINISTERED AS PER PROTOCOL STUDY DRUG NOT ADMINISTERED AS PER PROTOCOL CVD8 Deviation Category TREATMENT COMPLIANCE TREATMENT COMPLIANCE CVD8 Deviation Category ASSESSMENT OR PROCEDURE PERFORMED INCORRECTLY ASSESSMENT OR PROCEDURE PERFORMED INCORRECTLY CVD8 Deviation Category PROTOCOL ASSESSMENT NOT PERFORMED PROTOCOL ASSESSMENT NOT PERFORMED CVD8 Deviation Category PROTOCOL SAMPLING NOT PERFORMED PROTOCOL SAMPLING NOT PERFORMED CVD8 Deviation Category ASSESSMENT/SAMPLING OUTSIDE PRTOCOL VISIT WINDOW ASSESSMENT/SAMPLING OUTSIDE PRTOCOL VISIT WINDOW Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD9 Yes Physical Exam Sub Category PESCAT CVD9 Physical Exam Sub Category MOTOR SYSTEM MOTOR SYSTEM CVD9 Physical Exam Sub Category CEREBELLAR FUNCTION CEREBELLAR FUNCTION Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD10 Yes Physical Exam Category PECAT CVD10 Physical Exam Category NEUROLOGICAL NEUROLOGICAL CVD10 Physical Exam Category GENERAL GENERAL Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD11 Yes Pharmacokentic Parameters Test PPTEST CVD11 Pharmacokentic Parameters Test AUC 0-t AUC0_T CVD11 Pharmacokentic Parameters Test AUC 0-24 AUC0_24 CVD11 Pharmacokentic Parameters Test AUC 0-72 AUC0_72 CVD11 Pharmacokentic Parameters Test AUC 0-120 AUC0_120 CVD11 Pharmacokentic Parameters Test AUC all AUC_ALL CVD11 Pharmacokentic Parameters Test AUC Extrapolated AUC_EXTR CVD11 Pharmacokentic Parameters Test AUC 0-inf AUC_INF CVD11 Pharmacokentic Parameters Test AUC last AUC_LAST CVD11 Pharmacokentic Parameters Test AUCss AUC_SS CVD11 Pharmacokentic Parameters Test Caverage CAVG CVD11 Pharmacokentic Parameters Test Clearance CL CVD11 Pharmacokentic Parameters Test Oral clearance CL_F CVD11 Pharmacokentic Parameters Test CLast CLAST CVD11 Pharmacokentic Parameters Test Cmax CMAX CVD11 Pharmacokentic Parameters Test Cmin CMIN CVD11 Pharmacokentic Parameters Test Corr X Y CORRXY CVD11 Pharmacokentic Parameters Test CPET1 CPET1 CVD11 Pharmacokentic Parameters Test CPET2 CPET2 CVD11 Pharmacokentic Parameters Test CPET3 CPET3 CVD11 Pharmacokentic Parameters Test CPET4 CPET4 CVD11 Pharmacokentic Parameters Test Points for Lambda LAMBDA_P CVD11 Pharmacokentic Parameters Test Lambda Z LAMBDAZ CVD11 Pharmacokentic Parameters Test Metabolic Ratio MR CVD11 Pharmacokentic Parameters Test Mean Residence Time MRT CVD11 Pharmacokentic Parameters Test R-Squared RSQ CVD11 Pharmacokentic Parameters Test Adjusted R-Squared RSQ_ADJ CVD11 Pharmacokentic Parameters Test t1/2 THALF CVD11 Pharmacokentic Parameters Test t1/2,eff THALF_EF CVD11 Pharmacokentic Parameters Test tLag TLAG CVD11 Pharmacokentic Parameters Test tLast TLAST CVD11 Pharmacokentic Parameters Test tmax TMAX CVD11 Pharmacokentic Parameters Test Vss VSS CVD11 Pharmacokentic Parameters Test Vss/F VSS_F CVD11 Pharmacokentic Parameters Test Vz VZ CVD11 Pharmacokentic Parameters Test Vz/F VZ_F CVD11 Pharmacokentic Parameters Test Ae(0-72) AE_0_72 Code Codelist Codelist Codelist Name CDISC Submission Value CDISC Preferred Term Code Extensible (Yes/No) CVD12 Yes Pharmacokentic Parameters Test Code PPTESTCD CVD12 Pharmacokentic Parameters Test Code AUC0_T AUC0_T CVD12 Pharmacokentic Parameters Test Code AUC0_24 AUC0_24 CVD12 Pharmacokentic Parameters Test Code AUC0_72 AUC0_72 CVD12 Pharmacokentic Parameters Test Code AUC0_120 AUC0_120 CVD12 Pharmacokentic Parameters Test Code AUC_ALL AUC_ALL CVD12 Pharmacokentic Parameters Test Code AUC_EXTR AUC_EXTR CVD12 Pharmacokentic Parameters Test Code AUC_INF AUC_INF CVD12 Pharmacokentic Parameters Test Code AUC_LAST AUC_LAST CVD12 Pharmacokentic Parameters Test Code AUC_SS AUC_SS CVD12 Pharmacokentic Parameters Test Code CAVG CAVG CVD12 Pharmacokentic Parameters Test Code CL CL CVD12 Pharmacokentic Parameters Test Code CL_F CL_F CVD12 Pharmacokentic Parameters Test Code CLAST CLAST CVD12 Pharmacokentic Parameters Test Code CMAX CMAX CVD12 Pharmacokentic Parameters Test Code CMIN CMIN CVD12 Pharmacokentic Parameters Test Code CORRXY CORRXY CVD12 Pharmacokentic Parameters Test Code CPET1 CPET1 CVD12 Pharmacokentic Parameters Test Code CPET2 CPET2 CVD12 Pharmacokentic Parameters Test Code CPET3 CPET3 CVD12 Pharmacokentic Parameters Test Code CPET4 CPET4 CVD12 Pharmacokentic Parameters Test Code LAMBDA_P LAMBDA_P CVD12 Pharmacokentic Parameters Test Code LAMBDAZ LAMBDAZ CVD12 Pharmacokentic Parameters Test Code MR MR CVD12 Pharmacokentic Parameters Test Code MRT MRT CVD12 Pharmacokentic Parameters Test Code RSQ RSQ CVD12 Pharmacokentic Parameters Test Code RSQ_ADJ RSQ_ADJ CVD12 Pharmacokentic Parameters Test Code THALF THALF CVD12 Pharmacokentic Parameters Test Code THALF_EF THALF_EF CVD12 Pharmacokentic Parameters Test Code TLAG TLAG CVD12 Pharmacokentic Parameters Test Code TLAST TLAST CVD12 Pharmacokentic Parameters Test Code TMAX TMAX CVD12 Pharmacokentic Parameters Test Code VSS VSS CVD12 Pharmacokentic Parameters Test Code VSS_F VSS_F CVD12 Pharmacokentic Parameters Test Code VZ VZ CVD12 Pharmacokentic Parameters Test Code VZ_F VZ_F CVD12 Pharmacokentic Parameters Test Code AE_0_72 AE_0_72 DOMAIN RDOMAIN QNAM QLABEL QVAL QORIG Comments and Rationales SUPPEX EX EXINFCNC Concentration of CRF IV dosing infusion concentration Infusate SUPPEX EX EXINFCNU Concentration of CRF IV dosing infusion concentration Infusate Units units SUPPEX EX EXINFRT Infusion Rate CRF IV dosing infusion rate SUPPEX EX EXINFRTU Infusion Rate Units CRF IV dosing infusion rate units SUPPEX EX EXVINF Volume infused CRF IV dosing volume infused SUPPEX EX EXVINFU Volume infused Units CRF IV dosing volume infused units