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Common Terminology Criteria for Adverse Events

Version 3.0

Index

Cancer Therapy Evaluation Program

NATIONAL INSTITUTES OF HEALTH National Cancer Institute

http://ctep.cancer.gov/

10/22/2003 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- A -- abdomen ENDOCRINE HEPATOBILIARY/PANCREAS Adrenal insufficiency 17 Liver dysfunction/failure (clinical) 34 GASTROINTESTINAL Pancreatitis 34 Colitis 19 Distension/bloating, abdominal 20 Pain --Select 55 Enteritis ( of the small bowel) 21 VASCULAR Fistula, GI --Select 22 Portal flow 70 Typhlitis (cecal inflammation) 27 HEMORRHAGE/BLEEDING abducens Hemorrhage, GI --Select 31 See: CN VI HEPATOBILIARY/PANCREAS abnormal Pancreatitis 34 BLOOD/BONE MARROW INFECTION Myelodysplasia 4 Colitis, infectious (e.g., Clostridium difficile) 35 CONSTITUTIONAL SYMPTOMS Infection (documented clinically or microbiologically) with 35 Odor (patient odor) 11 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 ENDOCRINE Select Neuroendocrine: 17 Infection with unknown ANC --Select 36 ADH secretion abnormality (e.g., SIADH or low ADH) Neuroendocrine: 17 MUSCULOSKELETAL/SOFT TISSUE gonadotropin secretion abnormality Soft tissue necrosis --Select 46 Neuroendocrine: 17 PAIN growth hormone secretion abnormality Neuroendocrine: 17 Pain --Select 55 prolactin hormone secretion abnormality SURGERY/INTRA-OPERATIVE INJURY GASTROINTESTINAL Intra-operative injury --Select 66 Fistula, GI --Select 22 abdominal pain GROWTH AND DEVELOPMENT GASTROINTESTINAL Bone age (alteration in bone age) 29 Ascites (non-malignant) 19 INFECTION Colitis 19 Viral hepatitis 36 Gastritis (including bile reflux gastritis) 22 MUSCULOSKELETAL/SOFT TISSUE Heartburn/dyspepsia 22 Typhlitis (cecal inflammation) 27 Extremity-lower (gait/walking) 43 , GI --Select 28 NEUROLOGY

abdomen - abnormal

2 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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accentuation Pyramidal tract dysfunction (e.g., increased tone, 51 GROWTH AND DEVELOPMENT hyperreflexia, positive Babinski, decreased fine motor Bone growth: 29 coordination) spine kyphosis/lordosis OCULAR/VISUAL access-related Keratitis (corneal inflammation/corneal ulceration) 52 PULMONARY/UPPER RESPIRATORY PULMONARY/UPPER RESPIRATORY Pulmonary 59 Fistula, pulmonary/upper respiratory --Select 57 VASCULAR RENAL/GENITOURINARY /embolism (vascular access-related) 70 Fistula, GU --Select 60 SEXUAL/REPRODUCTIVE FUNCTION accessory nerve See: CN XI Breast function/lactation 64 Orgasmic dysfunction 65 achalasia abrasion GASTROINTESTINAL /SKIN Dysphagia (difficulty swallowing) 21 Esophagitis 21 : dermatitis associated with radiation --Select 15 acid METABOLIC/LABORATORY GASTROINTESTINAL Uric acid, -high (hyperuricemia) 42 Colitis 19 Fistula, GI --Select 22 SYNDROMES Proctitis 26 "Retinoic acid syndrome" 69 HEPATOBILIARY/PANCREAS acidemia Pancreatitis 34 See: acidosis INFECTION Infection (documented clinically or microbiologically) with 35 acidosis Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Febrile neutropenia (fever of unknown origin without 35 Select clinically or microbiologically documented infection)(ANC Infection with unknown ANC --Select 36 <1.0 x 10e9/L, fever >=38.5 degrees C) Infection (documented clinically or microbiologically) with 35 absorption Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select HEPATOBILIARY/PANCREAS Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Pancreas, exocrine enzyme deficiency 34 Select Infection with unknown ANC --Select 36 Opportunistic infection associated with >=Grade 2 36 abrasion - acidosis

3 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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acute vascular leak syndrome Lymphopenia VASCULAR METABOLIC/LABORATORY Acute vascular leak syndrome 70 Acidosis (metabolic or respiratory) 40 Adams-Stokes Glucose, serum-high (hyperglycemia) 41 See: atrioventricular rhythm RENAL/GENITOURINARY Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 ADD tubular acidosis) NEUROLOGY SYNDROMES ADD (Attention Deficit Disorder) 47 Fanconi's syndrome 68 Cognitive disturbance 47 Renal tubular acidosis 68 48 /acneiform adenoviral DERMATOLOGY/ Rash: acne/acneiform 15 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select acrocyanosis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select COAGULATION Infection with unknown ANC --Select 36 DIC (disseminated intravascular coagulation) 10 Opportunistic infection associated with >=Grade 2 36 Lymphopenia ACTH Viral hepatitis 36 ENDOCRINE Neuroendocrine: 17 ADH ACTH deficiency ENDOCRINE actinic Neuroendocrine: 17 ADH secretion abnormality (e.g., SIADH or low ADH) OCULAR/VISUAL Keratitis (corneal inflammation/corneal ulceration) 52 ADHD See: ADD acuity See: visual acuity adhesions GASTROINTESTINAL acute infusion reaction Colitis 19 DERMATOLOGY/SKIN Enteritis (inflammation of the small bowel) 21 Injection site reaction/extravasation changes 14 Fistula, GI --Select 22 SYNDROMES adolescents Cytokine release syndrome/acute infusion reaction 68

acne/acneiform - adolescents

4 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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AUDITORY/EAR NEUROLOGY : patients with/without baseline audiogram and 2 Cognitive disturbance 47 enrolled in a monitoring program Confusion 48 Hearing: patients without baseline audiogram and not 2 (children <3 years of age) 48 enrolled in a monitoring program Mood alteration --Select 49 adrenal Personality/behavioral 50 (/) 50 ENDOCRINE Adrenal insufficiency 17 aguesia Masculinization of female 17 GASTROINTESTINAL METABOLIC/LABORATORY alteration () 27 Sodium, serum-low (hyponatremia) 42 airway SURGERY/INTRA-OPERATIVE INJURY ALLERGY/IMMUNOLOGY Intra-operative injury --Select 66 Allergic rhinitis (including sneezing, nasal stuffiness, 1 adrenocortical dysfunction postnasal drip) ENDOCRINE INFECTION Masculinization of female 17 Infection (documented clinically or microbiologically) with 35 Neuroendocrine: 17 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select ACTH deficiency Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select aerodigestive Infection with unknown ANC --Select 36 GASTROINTESTINAL PULMONARY/UPPER RESPIRATORY Mucositis/stomatitis (functional/symptomatic) --Select 24 Atelectasis 56 INFECTION Bronchospasm, wheezing 56 Infection (documented clinically or microbiologically) with 35 , larynx 57 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Fistula, pulmonary/upper respiratory --Select 57 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Obstruction/ of airway --Select 58 Select Prolonged intubation after pulmonary resection (>24 hrs 59 Infection with unknown ANC --Select 36 after surgery) SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

AGC albumin See: ANC INFECTION Viral hepatitis 36 agitation

adrenal - albumin

5 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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METABOLIC/LABORATORY Alkalosis (metabolic or respiratory) 40 Albumin, serum-low () 40 alkalosis Calcium, serum-low (hypocalcemia) 40 See: alkaline albuminuria allergic METABOLIC/LABORATORY ALLERGY/IMMUNOLOGY Proteinuria 42 Allergic reaction/hypersensitivity (including drug fever) 1 alcohol Allergic rhinitis (including sneezing, nasal stuffiness, 1 METABOLIC/LABORATORY postnasal drip) Autoimmune reaction 1 GGT (gamma-Glutamyl transpeptidase) 41 Serum sickness 1 SYNDROMES 1 Alcohol intolerance syndrome (antabuse-like syndrome) 68 PULMONARY/UPPER RESPIRATORY aldosterone Bronchospasm, wheezing 56 Edema, larynx 57 ENDOCRINE Obstruction/stenosis of airway --Select 58 Adrenal insufficiency 17 SYNDROMES alimentary tract Cytokine release syndrome/acute infusion reaction 68 GASTROINTESTINAL Dry mouth/salivary gland (xerostomia) 21 alopecia Malabsorption 23 See: hair Mucositis/stomatitis (functional/symptomatic) --Select 24 DERMATOLOGY/SKIN Necrosis, GI --Select 25 Hair loss/alopecia (scalp or body)

LYMPHATICS ALT Edema: 38 INFECTION viscera Opportunistic infection associated with >=Grade 2 36 MUSCULOSKELETAL/SOFT TISSUE Lymphopenia Trismus (difficulty, restriction or pain when opening mouth) 46 Viral hepatitis 36 PULMONARY/UPPER RESPIRATORY METABOLIC/LABORATORY Aspiration 56 ALT, SGPT (serum glutamic pyruvic transaminase) 40 alkaline alveolitis METABOLIC/LABORATORY PULMONARY/UPPER RESPIRATORY Alkaline phosphatase 40 Pneumonitis/pulmonary infiltrates 58

albuminuria - amblyopia

6 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- A -- amblyopia OCULAR/VISUAL Wound complication, non-infectious 16 Vision-blurred vision 54 GASTROINTESTINAL Dental: 20 ambulation teeth MUSCULOSKELETAL/SOFT TISSUE LYMPHATICS Arthritis (non-septic) 43 Edema: 38 Extremity-lower (gait/walking) 43 limb Joint-function 44 Muscle weakness, generalized or specific area (not due to 45 MUSCULOSKELETAL/SOFT TISSUE neuropathy) --Select Fibrosis-deep connective tissue 44 Fracture 44 amenorrhea VASCULAR ENDOCRINE Peripheral arterial ischemia 70 Neuroendocrine: 17 prolactin hormone secretion abnormality amylase SEXUAL/REPRODUCTIVE FUNCTION HEPATOBILIARY/PANCREAS Irregular menses (change from baseline) 64 Liver dysfunction/failure (clinical) 34 Pancreatitis 34 aminotransferase See: AST, ALT METABOLIC/LABORATORY METABOLIC/LABORATORY Amylase 40 ALT, SGPT (serum glutamic pyruvic transaminase) anal AST, SGOT(serum glutamic oxaloacetic transaminase) See: anus AML/MDS GASTROINTESTINAL SECONDARY MALIGNANCY Fistula, GI --Select Secondary Malignancy - possibly related to cancer treatment 63 Incontinence, anal (Specify, __) Stricture/stenosis (including anastomotic), GI --Select Ulcer, GI --Select HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, GI --Select Memory impairment 49 INFECTION amputation Infection (documented clinically or microbiologically) with ALLERGY/IMMUNOLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- Vasculitis 1 Select DERMATOLOGY/SKIN Infection with unknown ANC --Select

amblyopia - anal

7 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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See: anus BLOOD/BONE MARROW PAIN Neutrophils/granulocytes (ANC/AGC) 4 Pain --Select CONSTITUTIONAL SYMPTOMS SURGERY/INTRA-OPERATIVE INJURY Fever (in the absence of neutropenia, where neutropenia is 11 Intra-operative injury --Select defined as ANC <1.0 x 10e9/L) INFECTION anal/perianal Febrile neutropenia (fever of unknown origin without 35 See: anus clinically or microbiologically documented infection)(ANC INFECTION <1.0 x 10e9/L, fever >=38.5 degrees C) Infection (documented clinically or microbiologically) with Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select Infection with unknown ANC --Select 36 Opportunistic infection associated with >=Grade 2 36 anaphylaxis Lymphopenia ALLERGY/IMMUNOLOGY Viral hepatitis 36 Allergic reaction/hypersensitivity (including drug fever) 1 anejaculation SYNDROMES SEXUAL/REPRODUCTIVE FUNCTION Cytokine release syndrome/acute infusion reaction 68 Ejaculatory dysfunction 64 anastomosis anemia GASTROINTESTINAL ALLERGY/IMMUNOLOGY Dysphagia (difficulty swallowing) 21 Autoimmune reaction 1 Leak (including anastomotic), GI --Select 23 BLOOD/BONE MARROW Prolapse of stoma, GI 26 Stricture/stenosis (including anastomotic), GI --Select 27 4 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 HEPATOBILIARY/PANCREAS hemolysis) Biliary tree damage 34 COAGULATION Stricture (biliary tree, hepatic or pancreatic) 34 Thrombotic (e.g., thrombotic 10 RENAL/GENITOURINARY [TTP] or hemolytic uremic Leak (including anastomotic), GU --Select 60 syndrome [HUS]) Prolapse of stoma, GU 61 HEMORRHAGE/BLEEDING Stricture/stenosis (including anastomotic), GU --Select 62 Hemorrhage, CNS 30 Hemorrhage, GI --Select 31 ANC

anal/perianal - anemia

8 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Hemorrhage, GU --Select 32 Weight loss 12 Hemorrhage, pulmonary/upper respiratory --Select 32 ENDOCRINE Hemorrhage/bleeding associated with surgery, intra- 30 Adrenal insufficiency 17 operative or postoperative Petechiae/purpura (hemorrhage/bleeding into skin or 32 GASTROINTESTINAL mucosa) Anorexia 19 Nausea 24 angiitis ALLERGY/IMMUNOLOGY Vasculitis 1 NEUROLOGY VASCULAR Neuropathy: cranial --Select 50 Vessel injury- --Select 70 antabuse Vessel injury-vein --Select 71 SYNDROMES angina Alcohol intolerance syndrome (antabuse-like syndrome) 68 CARDIAC GENERAL anti-androgens Cardiac ischemia/infarction 7 Cardiac troponin I (cTnI) 7 SYNDROMES Cardiac troponin T (cTnT) 7 Alcohol intolerance syndrome (antabuse-like syndrome) 68 8 anti-estrogens/androgens PAIN SYNDROMES Pain --Select 55 Tumor flare 69 angioedema anti-osteoporotic ALLERGY/IMMUNOLOGY See: osteoporosis Allergic reaction/hypersensitivity (including drug fever) 1 anticoagulation ankylosed/fused COAGULATION MUSCULOSKELETAL/SOFT TISSUE Fibrinogen 10 Cervical spine-range of motion 43 INR (International Normalized Ratio of prothrombin time) 10 Lumbar spine-range of motion 44 PTT (Partial Thromboplastin Time) 10

Ano-rectal VASCULAR See: anus (including superficial thrombosis) 70 Thrombosis/embolism (vascular access-related) 70 anorexia Thrombosis/thrombus/embolism 70 CONSTITUTIONAL SYMPTOMS

angiitis - antiglobulin

9 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- A -- antiglobulin BLOOD/BONE MARROW NEUROLOGY Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Confusion 48 hemolysis) Irritability (children <3 years of age) 48 Memory impairment 49 antitussive Mood alteration --Select 49 PULMONARY/UPPER RESPIRATORY Personality/behavioral 50 Cough 56 Psychosis (hallucinations/delusions) 50 anuria aorta RENAL/GENITOURINARY SURGERY/INTRA-OPERATIVE INJURY Renal failure 61 Intra-operative injury --Select 66 Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 tubular acidosis) VASCULAR Vessel injury-artery --Select 70 anus GASTROINTESTINAL aphasia Fistula, GI --Select 22 NEUROLOGY Incontinence, anal 23 Aphasia, receptive and/or expressive 47 Mucositis/stomatitis (clinical exam) --Select 24 Dysphasia, receptive and/or expressive 48 Mucositis/stomatitis (functional/symptomatic) --Select 24 Speech impairment (e.g., dysphasia or aphasia) 51 Necrosis, GI --Select 25 aphonic Stricture/stenosis (including anastomotic), GI --Select 27 Ulcer, GI --Select 28 PULMONARY/UPPER RESPIRATORY Voice changes/dysarthria (e.g., hoarseness, loss or 59 HEMORRHAGE/BLEEDING alteration in voice, laryngitis) Hemorrhage, GI --Select 31 INFECTION aplasia BLOOD/BONE MARROW Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Bone marrow cellularity 4 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select apnea Infection with unknown ANC --Select 36 NEUROLOGY PAIN Apnea 47 Pain --Select 55 PULMONARY/UPPER RESPIRATORY SURGERY/INTRA-OPERATIVE INJURY Hypoxia 57 Intra-operative injury --Select 66 appendix

antiglobulin - appendix

10 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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GASTROINTESTINAL CARDIAC Fistula, GI --Select 22 Conduction abnormality/atrioventricular heart block --Select 5 Necrosis, GI --Select 25 Palpitations 5 Perforation, GI --Select 26 Prolonged QTc interval 5 INFECTION Supraventricular and nodal arrhythmia --Select 5 Vasovagal episode 6 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Ventricular arrhythmia --Select 6 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 CARDIAC GENERAL Select Cardiac ischemia/infarction 7 Infection with unknown ANC --Select 36 Left ventricular diastolic dysfunction 8 SURGERY/INTRA-OPERATIVE INJURY Left ventricular systolic dysfunction 8 Intra-operative injury --Select 66 Restrictive cardiomyopathy 8 Right ventricular dysfunction (cor pulmonale) 9 appetite GASTROINTESTINAL arsenic trioxide Anorexia 19 SYNDROMES Nausea 24 "Retinoic acid syndrome" 69 arachnoiditis artery NEUROLOGY CARDIAC GENERAL Arachnoiditis/meningismus/radiculitis 47 Cardiac ischemia/infarction 7 INFECTION arcuate deficit Infection (documented clinically or microbiologically) with 35 OCULAR/VISUAL Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Glaucoma 52 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select ARDS Infection with unknown ANC --Select 36 PULMONARY/UPPER RESPIRATORY SURGERY/INTRA-OPERATIVE INJURY Adult Respiratory Distress Syndrome (ARDS) 56 Intra-operative injury --Select 66 Pneumonitis/pulmonary infiltrates 58 Pulmonary fibrosis (radiographic changes) 59 VASCULAR Peripheral arterial ischemia 70 areola Vessel injury-artery --Select 70 SEXUAL/REPRODUCTIVE FUNCTION Visceral arterial ischemia (non-myocardial) 71 Breast nipple/areolar deformity 64 arthralgia arrhythmia MUSCULOSKELETAL/SOFT TISSUE

appetite - arthralgia

11 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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AST Arthritis (non-septic) 43 HEPATOBILIARY/PANCREAS PAIN Liver dysfunction/failure (clinical) 34 Pain --Select 55 INFECTION SYNDROMES Viral hepatitis 36 Cytokine release syndrome/acute infusion reaction 68 METABOLIC/LABORATORY AST, SGOT(serum glutamic oxaloacetic transaminase) 40 arthritis INFECTION asterixis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 HEPATOBILIARY/PANCREAS Select Liver dysfunction/failure (clinical) 34 MUSCULOSKELETAL/SOFT TISSUE Arthritis (non-septic) 43 asthenia CONSTITUTIONAL SYMPTOMS arthrodesis Fatigue (asthenia, lethargy, malaise) 11 MUSCULOSKELETAL/SOFT TISSUE SYNDROMES Joint-function 44 Cytokine release syndrome/acute infusion reaction 68 artificial tears asystole OCULAR/VISUAL See: atrioventricular rhythm Dry eye syndrome 52 ataxia ascites MUSCULOSKELETAL/SOFT TISSUE GASTROINTESTINAL Extremity-lower (gait/walking) 43 Ascites (non-malignant) 19 NEUROLOGY INFECTION Ataxia (incoordination) 47 Viral hepatitis 36 atelectasis aspiration PULMONARY/UPPER RESPIRATORY HEMORRHAGE/BLEEDING Atelectasis 56 Hematoma 30 atonia MUSCULOSKELETAL/SOFT TISSUE GASTROINTESTINAL Seroma 46 Colitis 19 PULMONARY/UPPER RESPIRATORY MUSCULOSKELETAL/SOFT TISSUE Aspiration 56 Muscle weakness, generalized or specific area (not due to 45

arthritis - atonia

12 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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neuropathy) --Select Hearing: patients without baseline audiogram and not 2 enrolled in a monitoring program atony RENAL/GENITOURINARY aura Urinary retention (including neurogenic bladder) 62 NEUROLOGY Seizure 51 atresia SEXUAL/REPRODUCTIVE FUNCTION autoimmune Vaginal stenosis/length 65 ALLERGY/IMMUNOLOGY Autoimmune reaction 1 atrioventricular rhythm CARDIAC ARRHYTHMIA AV block Conduction abnormality/atrioventricular heart block --Select 5 CARDIAC ARRHYTHMIA Supraventricular and nodal arrhythmia --Select 5 Conduction abnormality/atrioventricular heart block --Select 5

ENDOCRINE AV node Thyroid function, low (hypothyroidism) 18 See: atrioventricular rhythm avascular DERMATOLOGY/SKIN GASTROINTESTINAL Atrophy, skin 14 Dental: 20 Atrophy, subcutaneous 14 periodontal disease GROWTH AND DEVELOPMENT attention Bone growth: 29 NEUROLOGY femoral head; slipped capital femoral epiphysis ADD (Attention Deficit Disorder) 47 MUSCULOSKELETAL/SOFT TISSUE Cognitive disturbance 47 Osteonecrosis (avascular necrosis) 45 Confusion 48 Irritability (children <3 years of age) 48 attenuation NEUROLOGY Leukoencephalopathy (radiographic findings) 49 audiogram AUDITORY/EAR Hearing: patients with/without baseline audiogram and 2 enrolled in a monitoring program

atony - avascular

13 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- B --

Babinski NEUROLOGY See: biliary Myelitis 49 biliary Pyramidal tract dysfunction (e.g., increased tone, 51 hyperreflexia, positive Babinski, decreased fine motor GASTROINTESTINAL coordination) Fistula, GI --Select 22 Gastritis (including bile reflux gastritis) 22 balance Leak (including anastomotic), GI --Select 23 See: CN VIII Perforation, GI --Select 26 MUSCULOSKELETAL/SOFT TISSUE Stricture/stenosis (including anastomotic), GI --Select 27 Extremity-lower (gait/walking) 43 HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, GI --Select 31 Neuropathy: cranial --Select 50 HEPATOBILIARY/PANCREAS baldness Liver dysfunction/failure (clinical) 34 DERMATOLOGY/SKIN INFECTION Hair loss/alopecia (scalp or body) 14 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select banding Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 GASTROINTESTINAL Select Infection with unknown ANC --Select 36 22 SURGERY/INTRA-OPERATIVE INJURY behavior Intra-operative injury --Select 66 NEUROLOGY Confusion 48 bilirubin Irritability (children <3 years of age) 48 HEPATOBILIARY/PANCREAS Mood alteration --Select 49 Liver dysfunction/failure (clinical) 34 Personality/behavioral 50 METABOLIC/LABORATORY bicarbonate Bilirubin (hyperbilirubinemia) 40 METABOLIC/LABORATORY RENAL/GENITOURINARY Bicarbonate, serum-low 40 color change 62 bigeminy bladder CARDIAC ARRHYTHMIA HEMORRHAGE/BLEEDING Ventricular arrhythmia --Select 6 Hemorrhage, GU --Select 32 INFECTION bile

Babinski - bladder

14 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Infection (documented clinically or microbiologically) with 35 Ulcer, GI --Select 28 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select HEMORRHAGE/BLEEDING Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Hemorrhage, GI --Select 31 Infection with unknown ANC --Select 36 Hemorrhage, GU --Select 32 Hemorrhage, pulmonary/upper respiratory --Select 32 PAIN Hemorrhage/bleeding associated with surgery, intra- 30 Pain --Select 55 operative or postoperative RENAL/GENITOURINARY Petechiae/purpura (hemorrhage/bleeding into skin or 32 Bladder spasms 60 mucosa) Cystitis 60 INFECTION Fistula, GU --Select 60 Colitis, infectious (e.g., Clostridium difficile) 35 Leak (including anastomotic), GU --Select 60 RENAL/GENITOURINARY Obstruction, GU --Select 61 Cystitis 60 Perforation, GU --Select 61 Stricture/stenosis (including anastomotic), GU --Select 62 SEXUAL/REPRODUCTIVE FUNCTION Urinary retention (including neurogenic bladder) 62 Vaginal mucositis 65

SURGERY/INTRA-OPERATIVE INJURY blepharitis Intra-operative injury --Select 66 OCULAR/VISUAL bleeding Eyelid dysfunction 52 COAGULATION blindness DIC (disseminated intravascular coagulation) 10 OCULAR/VISUAL Thrombotic microangiopathy (e.g., thrombotic 10 Cataract 52 thrombocytopenic purpura [TTP] or hemolytic uremic Glaucoma 52 syndrome [HUS]) Keratitis (corneal inflammation/corneal ulceration) 52 DERMATOLOGY/SKIN Night blindness (nyctalopia) 52 Rash: dermatitis associated with radiation --Select 15 Optic disc edema 53 Rash: hand-foot skin reaction 15 Retinal detachment 53 GASTROINTESTINAL Retinopathy 53 Colitis 19 Scleral necrosis/melt 54 Dental: 20 Uveitis 54 periodontal disease Enteritis (inflammation of the small bowel) 21 Mucositis/stomatitis (clinical exam) --Select 24 DERMATOLOGY/SKIN Stricture/stenosis (including anastomotic), GI --Select 27 Photosensitivity 15 Typhlitis (cecal inflammation) 27 Rash/desquamation 15 bleeding - blisters

15 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Rash: hand-foot skin reaction 15 GROWTH AND DEVELOPMENT Bone age (alteration in bone age) 29 bloating Bone growth: 29 GASTROINTESTINAL limb length discrepancy Constipation 19 Bone growth: 29 Heartburn/dyspepsia 22 spine kyphosis/lordosis Bone growth: 29 Block-heart block femoral head; slipped capital femoral epiphysis See: atrioventricular rhythm INFECTION Infection (documented clinically or microbiologically) with 35 blurred Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select OCULAR/VISUAL Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Vision-blurred vision 54 Select Infection with unknown ANC --Select 36 blush MUSCULOSKELETAL/SOFT TISSUE DERMATOLOGY/SKIN Bone: spine-scoliosis 43 Flushing 14 Exostosis 43 BM Fracture 44 See: constipation Osteonecrosis (avascular necrosis) 45 Osteoporosis 46 BMD PAIN MUSCULOSKELETAL/SOFT TISSUE Pain --Select 55 Osteoporosis 46 SURGERY/INTRA-OPERATIVE INJURY BMI Intra-operative injury --Select 66 CONSTITUTIONAL SYMPTOMS bowel Obesity 11 GASTROINTESTINAL bone Colitis 19 BLOOD/BONE MARROW Constipation 19 Diarrhea 20 Bone marrow cellularity 4 Enteritis (inflammation of the small bowel) 21 ENDOCRINE Fistula, GI --Select 22 Thyroid function, low (hypothyroidism) 18 Ileus, GI (functional obstruction of bowel, i.e., 23 GASTROINTESTINAL neuroconstipation) Incontinence, anal 23 Dental: 20 periodontal disease Leak (including anastomotic), GI --Select 23

bloating - bowel

16 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Mucositis/stomatitis (clinical exam) --Select 24 See: atrioventricular rhythm Mucositis/stomatitis (functional/symptomatic) --Select 24 bradypnea Necrosis, GI --Select 25 Obstruction, GI --Select 25 HEPATOBILIARY/PANCREAS Perforation, GI --Select 26 Liver dysfunction/failure (clinical) 34 Stricture/stenosis (including anastomotic), GI --Select 27 NEUROLOGY Typhlitis (cecal inflammation) 27 Apnea 47 Ulcer, GI --Select 28 HEMORRHAGE/BLEEDING brain Hemorrhage, GI --Select 31 INFECTION Infection (documented clinically or microbiologically) with 35 INFECTION Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection (documented clinically or microbiologically) with 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with unknown ANC --Select 36 Select Infection with unknown ANC --Select 36 NEUROLOGY Arachnoiditis/meningismus/radiculitis 47 SURGERY/INTRA-OPERATIVE INJURY Encephalopathy 48 Intra-operative injury --Select 66 Seizure 51 BP Speech impairment (e.g., dysphasia or aphasia) 51 CARDIAC ARRHYTHMIA SURGERY/INTRA-OPERATIVE INJURY Vasovagal episode 6 Intra-operative injury --Select 66

CARDIAC GENERAL breast 7 ENDOCRINE Hypotension 8 Feminization of male 17 NEUROLOGY GROWTH AND DEVELOPMENT (fainting) 51 Puberty (precocious) 29 brachial PAIN NEUROLOGY Pain --Select 55 Brachial plexopathy 47 SEXUAL/REPRODUCTIVE FUNCTION SURGERY/INTRA-OPERATIVE INJURY Breast function/lactation 64 Intra-operative injury --Select 66 Breast nipple/areolar deformity 64 Breast volume/hypoplasia 64 bradycardia Gynecomastia 64

BP - breast

17 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- B --

SURGERY/INTRA-OPERATIVE INJURY DERMATOLOGY/SKIN Intra-operative injury --Select 66 Bruising (in absence of Grade 3 or 4 thrombocytopenia) 14 bronchial buffalo hump HEMORRHAGE/BLEEDING ENDOCRINE Hemorrhage, pulmonary/upper respiratory --Select 32 Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) INFECTION Infection (documented clinically or microbiologically) with 35 bullae Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select DERMATOLOGY/SKIN Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Rash/desquamation 15 Infection with unknown ANC --Select 36 burn PULMONARY/UPPER RESPIRATORY DERMATOLOGY/SKIN Atelectasis 56 Burn 14 Fistula, pulmonary/upper respiratory --Select 57 Obstruction/stenosis of airway --Select 58 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 bronchospasm ALLERGY/IMMUNOLOGY Allergic reaction/hypersensitivity (including drug fever) 1 BLOOD/BONE MARROW Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hemolysis) PULMONARY/UPPER RESPIRATORY Bronchospasm, wheezing 56 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 bruising COAGULATION Fibrinogen 10 INR (International Normalized Ratio of prothrombin time) 10 PTT (Partial Thromboplastin Time) 10

bronchial - burn

18 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- C --

C-spine MUSCULOSKELETAL/SOFT TISSUE Cardiac troponin I (cTnI) 7 Cervical spine-range of motion 43 Cardiac troponin T (cTnT) 7 calcium cardiomyopathy ENDOCRINE CARDIAC GENERAL Parathyroid function, low (hypoparathyroidism) 18 Restrictive cardiomyopathy 8

METABOLIC/LABORATORY cardiopathy Calcium, serum-high (hypercalcemia) 41 BLOOD/BONE MARROW Calcium, serum-low (hypocalcemia) 40 Iron overload 4 calciuria cardiopulmonary arrest RENAL/GENITOURINARY CARDIAC GENERAL Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 Cardiopulmonary arrest, cause unknown (non-fatal) 7 tubular acidosis) caries canalicular stenosis GASTROINTESTINAL OCULAR/VISUAL Dental: 20 Eyelid dysfunction 52 teeth leak syndrome carotid VASCULAR SURGERY/INTRA-OPERATIVE INJURY Acute vascular leak syndrome 70 Intra-operative injury --Select 66 Carbon monoxide diffusion capacity VASCULAR (DLco)PULMONARY/UPPER RESPIRATORY Vessel injury-artery --Select 70 Carbon monoxide diffusion capacity (DL(co)) 56 cataract OCULAR/VISUAL See: cardiopulmonary arrest Cataract 52 cardiac ischemia catarrhal symptoms CARDIAC GENERAL SYNDROMES Cardiac ischemia/infarction 7 Flu-like syndrome 68 Cardiac troponin I (cTnI) 7 catheter cardiac troponin INFECTION CARDIAC GENERAL Infection (documented clinically or microbiologically) with 35

C-spine - catheter

19 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- C --

Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection (documented clinically or microbiologically) with 35 Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with unknown ANC --Select 36 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 MUSCULOSKELETAL/SOFT TISSUE Select Infection with unknown ANC --Select 36 Local complication -device/prosthesis-related 44 SURGERY/INTRA-OPERATIVE INJURY RENAL/GENITOURINARY Intra-operative injury --Select 66 Urinary frequency/urgency 62 Urinary retention (including neurogenic bladder) 62 INFECTION cauterization Infection (documented clinically or microbiologically) with 35 HEMORRHAGE/BLEEDING Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Hemorrhage, GI --Select 31 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select CD4 Infection with unknown ANC --Select 36 BLOOD/BONE MARROW MUSCULOSKELETAL/SOFT TISSUE CD4 count 4 Soft tissue necrosis --Select 46 Lymphopenia 4 INFECTION centripetal obesity Opportunistic infection associated with >=Grade 2 36 ENDOCRINE Lymphopenia Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) cecitis GASTROINTESTINAL cerebral Typhlitis (cecal inflammation) 27 LYMPHATICS Edema: 38 cecum head and neck GASTROINTESTINAL NEUROLOGY Obstruction, GI --Select 25 CNS cerebrovascular ischemia 47 Perforation, GI --Select 26 Leukoencephalopathy (radiographic findings) 49 Stricture/stenosis (including anastomotic), GI --Select 27 Typhlitis (cecal inflammation) 27 cerebrospinal fluid Ulcer, GI --Select 28 See: CSF HEMORRHAGE/BLEEDING cerebrovascular Hemorrhage, GI --Select 31 CARDIAC GENERAL

cauterization - cerebrovascular

20 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- C --

CNS ischemia 7 Prolonged QTc interval 5 NEUROLOGY Supraventricular and nodal arrhythmia --Select 5 Ventricular arrhythmia --Select 6 CNS cerebrovascular ischemia 47 CARDIAC GENERAL cerumen Left ventricular diastolic dysfunction 8 AUDITORY/EAR Left ventricular systolic dysfunction 8 Otitis, external ear (non-infectious) 2 Myocarditis 8 Restrictive cardiomyopathy 8 cervical spine PULMONARY/UPPER RESPIRATORY MUSCULOSKELETAL/SOFT TISSUE Dyspnea () 57 Cervical spine-range of motion 43 chills cervix CONSTITUTIONAL SYMPTOMS INFECTION Fever (in the absence of neutropenia, where neutropenia is 11 Infection (documented clinically or microbiologically) with 35 defined as ANC <1.0 x 10e9/L) Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Rigors/chills 11 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select INFECTION Infection with unknown ANC --Select 36 Febrile neutropenia (fever of unknown origin without 35 SURGERY/INTRA-OPERATIVE INJURY clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) Intra-operative injury --Select 66 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select chelitis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 DERMATOLOGY/SKIN Select Chelitis 14 Infection with unknown ANC --Select 36 chemoradiation NEUROLOGY DERMATOLOGY/SKIN Arachnoiditis/meningismus/radiculitis 47 Rash: dermatitis associated with radiation --Select 15 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 chemosis OCULAR/VISUAL choking Ocular surface disease 53 PULMONARY/UPPER RESPIRATORY Aspiration 56 CHF CARDIAC ARRHYTHMIA cholangitis Conduction abnormality/atrioventricular heart block --Select 5 HEPATOBILIARY/PANCREAS

cerumen - cholangitis

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chylothorax Cholecystitis 34 LYMPHATICS Chyle or lymph leakage 38 cholecystitis PULMONARY/UPPER RESPIRATORY HEPATOBILIARY/PANCREAS Chylothorax 56 Cholecystitis 34 INFECTION chylous ascites Infection (documented clinically or microbiologically) with 35 See: ascites Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 cirrhosis Select HEPATOBILIARY/PANCREAS Infection with unknown ANC --Select 36 Liver dysfunction/failure (clinical) 34 METABOLIC/LABORATORY INFECTION Bilirubin (hyperbilirubinemia) 40 Viral hepatitis 36 METABOLIC/LABORATORY METABOLIC/LABORATORY ALT, SGPT (serum glutamic pyruvic transaminase) 40 Cholesterol, serum-high (hypercholestremia) 41 AST, SGOT(serum glutamic oxaloacetic transaminase) 40 Sodium, serum-low (hyponatremia) 42 chondrosarcoma claudication MUSCULOSKELETAL/SOFT TISSUE SURGERY/INTRA-OPERATIVE INJURY Exostosis 43 Intra-operative injury --Select 66 chorea VASCULAR NEUROLOGY Vessel injury-artery --Select 70 Extrapyramidal/involuntary movement/restlessness 48 Vessel injury-vein --Select 71 chromaturia clostridium difficile RENAL/GENITOURINARY INFECTION Urine color change 62 Colitis, infectious (e.g., Clostridium difficile) 35

Chvostek's sign clotting METABOLIC/LABORATORY COAGULATION Calcium, serum-low (hypocalcemia) 40 INR (International Normalized Ratio of prothrombin time) 10 PTT (Partial Thromboplastin Time) 10 chyle LYMPHATICS VASCULAR Chyle or lymph leakage 38 Phlebitis (including superficial thrombosis) 70

cholecystitis - clotting

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-- C --

Thrombosis/embolism (vascular access-related) 70 NEUROLOGY Thrombosis/thrombus/embolism 70 Neuropathy: cranial --Select 50 clumsy SURGERY/INTRA-OPERATIVE INJURY NEUROLOGY Intra-operative injury --Select 66 Ataxia (incoordination) 47 CN III cluster headache INFECTION PAIN Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Pain --Select 55 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select CN Infection with unknown ANC --Select 36 NEUROLOGY NEUROLOGY Neuropathy: cranial --Select 50 Taste alteration (CN VII, IX) 51 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

CN I CN IV INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36 NEUROLOGY NEUROLOGY Neuropathy: cranial --Select 50 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

CN II CN IX INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36 clumsy - CN IX

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NEUROLOGY NEUROLOGY Neuropathy: cranial --Select 50 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

CN V CN VIII INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36 NEUROLOGY NEUROLOGY Neuropathy: cranial --Select 50 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

CN VI CN X INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36 NEUROLOGY NEUROLOGY Neuropathy: cranial --Select 50 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66

CN VII CN XI INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36

CN V - CN XI

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NEUROLOGY Platelets 4 Neuropathy: cranial --Select 50 COAGULATION SURGERY/INTRA-OPERATIVE INJURY DIC (disseminated intravascular coagulation) 10 Intra-operative injury --Select 66 Fibrinogen 10 INR (International Normalized Ratio of prothrombin time) 10 CN XII PTT (Partial Thromboplastin Time) 10 INFECTION Thrombotic microangiopathy (e.g., thrombotic 10 Infection (documented clinically or microbiologically) with 35 thrombocytopenic purpura [TTP] or hemolytic uremic Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select syndrome [HUS]) Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 HEPATOBILIARY/PANCREAS Select Liver dysfunction/failure (clinical) 34 Infection with unknown ANC --Select 36 INFECTION NEUROLOGY Viral hepatitis 36 Neuropathy: cranial --Select 50 SURGERY/INTRA-OPERATIVE INJURY cochlear implant Intra-operative injury --Select 66 AUDITORY/EAR Hearing: patients with/without baseline audiogram and 2 CNS enrolled in a monitoring program CARDIAC GENERAL cognitive CNS ischemia 7 NEUROLOGY COAGULATION Cognitive disturbance 47 DIC (disseminated intravascular coagulation) 10 Encephalopathy 48 Thrombotic microangiopathy (e.g., thrombotic 10 Speech impairment (e.g., dysphasia or aphasia) 51 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) coitus HEMORRHAGE/BLEEDING PAIN Hemorrhage, CNS 30 Pain --Select 55 NEUROLOGY SEXUAL/REPRODUCTIVE FUNCTION CNS cerebrovascular ischemia 47 Vaginal dryness 65 CNS hemorrhage/bleeding 47 Vaginal stenosis/length 65 CNS necrosis/cystic progression 47 Speech impairment (e.g., dysphasia or aphasia) 51 colectomy GASTROINTESTINAL coagulation Necrosis, GI --Select 25 BLOOD/BONE MARROW Obstruction, GI --Select 25

CN XII - colectomy

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-- C --

Stricture/stenosis (including anastomotic), GI --Select 27 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select colitis Infection with unknown ANC --Select 36 ALLERGY/IMMUNOLOGY SURGERY/INTRA-OPERATIVE INJURY Autoimmune reaction 1 Intra-operative injury --Select 66 GASTROINTESTINAL coma Colitis 19 COAGULATION INFECTION Thrombotic microangiopathy (e.g., thrombotic 10 Colitis, infectious (e.g., Clostridium difficile) 35 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) CONSTITUTIONAL SYMPTOMS ALLERGY/IMMUNOLOGY Hypothermia 11 Autoimmune reaction 1 ENDOCRINE collapsed lung Neuroendocrine: 17 PULMONARY/UPPER RESPIRATORY ADH secretion abnormality (e.g., SIADH or low ADH) Pneumothorax 58 Pancreatic endocrine: 18 glucose intolerance SURGERY/INTRA-OPERATIVE INJURY Thyroid function, low (hypothyroidism) 18 Intra-operative injury --Select 66 HEMORRHAGE/BLEEDING colon Hemorrhage, CNS 30 GASTROINTESTINAL HEPATOBILIARY/PANCREAS Diarrhea 20 Liver dysfunction/failure (clinical) 34 Fistula, GI --Select 22 INFECTION Ileus, GI (functional obstruction of bowel, i.e., 23 Viral hepatitis 36 neuroconstipation) Obstruction, GI --Select 25 NEUROLOGY Perforation, GI --Select 26 Arachnoiditis/meningismus/radiculitis 47 Stricture/stenosis (including anastomotic), GI --Select 27 Somnolence/depressed level of consciousness 51 Ulcer, GI --Select 28 communicate HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, GI --Select 31 Speech impairment (e.g., dysphasia or aphasia) 51 INFECTION Infection (documented clinically or microbiologically) with 35 Complete block Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select See: atrioventricular rhythm

colitis - concentration

26 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- C -- concentration NEUROLOGY INFECTION Confusion 48 Infection (documented clinically or microbiologically) with 35 Irritability (children <3 years of age) 48 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Mood alteration --Select 49 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Conduction abnormality Infection with unknown ANC --Select 36 See: atrioventricular rhythm OCULAR/VISUAL Dry eye syndrome 52 conduit Eyelid dysfunction 52 GASTROINTESTINAL Ocular surface disease 53 Leak (including anastomotic), GI --Select 23 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66 constipation confluent ENDOCRINE DERMATOLOGY/SKIN Adrenal insufficiency 17 16 GASTROINTESTINAL GASTROINTESTINAL Constipation 19 Mucositis/stomatitis (clinical exam) --Select 24 Ileus, GI (functional obstruction of bowel, i.e., 23 SEXUAL/REPRODUCTIVE FUNCTION neuroconstipation) Vaginal mucositis 65 confusion COAGULATION METABOLIC/LABORATORY DIC (disseminated intravascular coagulation) 10 Glucose, serum-high (hyperglycemia) 41 ENDOCRINE NEUROLOGY Neuroendocrine: 17 ADH secretion abnormality (e.g., SIADH or low ADH) Confusion 48 Encephalopathy 48 METABOLIC/LABORATORY Memory impairment 49 Magnesium, serum-low (hypomagnesemia) 41 Somnolence/depressed level of consciousness 51 Phosphate, serum-low (hypophosphatemia) 41 NEUROLOGY congestive heart failure Seizure 51 CARDIAC GENERAL Left ventricular systolic dysfunction 8 Coombs' BLOOD/BONE MARROW conjunctiva

concentration - Coombs'

27 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Neuroendocrine: 17 hemolysis) prolactin hormone secretion abnormality coordination corticotrophin NEUROLOGY ENDOCRINE Pyramidal tract dysfunction (e.g., increased tone, 51 Neuroendocrine: 17 hyperreflexia, positive Babinski, decreased fine motor ACTH deficiency coordination) cortisol cor pulmonale ENDOCRINE CARDIAC GENERAL Adrenal insufficiency 17 Right ventricular dysfunction (cor pulmonale) 9 coryza cording ALLERGY/IMMUNOLOGY LYMPHATICS Allergic rhinitis (including sneezing, nasal stuffiness, 1 Phlebolymphatic cording 39 postnasal drip) cornea cosmesis INFECTION MUSCULOSKELETAL/SOFT TISSUE Infection (documented clinically or microbiologically) with 35 Fibrosis-cosmesis 43 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 cough Select CARDIAC GENERAL Infection with unknown ANC --Select 36 Left ventricular systolic dysfunction 8 OCULAR/VISUAL Right ventricular dysfunction (cor pulmonale) 9 Dry eye syndrome 52 PULMONARY/UPPER RESPIRATORY Keratitis (corneal inflammation/corneal ulceration) 52 Aspiration 56 SURGERY/INTRA-OPERATIVE INJURY Atelectasis 56 Intra-operative injury --Select 66 Cough 56 Pneumothorax 58 coronary Pulmonary fibrosis (radiographic changes) 59 CARDIAC GENERAL SYNDROMES Cardiac ischemia/infarction 7 Cytokine release syndrome/acute infusion reaction 68 Cardiac troponin I (cTnI) 7 Flu-like syndrome 68 corpus luteum CPAP ENDOCRINE PULMONARY/UPPER RESPIRATORY

coordination - CPAP

28 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Hypoxia 57 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 CPK CARDIAC GENERAL creatine Cardiac ischemia/infarction 7 METABOLIC/LABORATORY Cardiac troponin I (cTnI) 7 CPK (creatine phosphokinase) 41 METABOLIC/LABORATORY creatinine CPK (creatine phosphokinase) 41 COAGULATION MUSCULOSKELETAL/SOFT TISSUE Thrombotic microangiopathy (e.g., thrombotic 10 Myositis (inflammation/damage of muscle) 45 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) CPR METABOLIC/LABORATORY See: cardiopulmonary arrest Creatinine 41 cramps Glomerular filtration rate 41 ENDOCRINE Uric acid, serum-high (hyperuricemia) 42 Parathyroid function, low (hypoparathyroidism) 18 RENAL/GENITOURINARY GASTROINTESTINAL Renal failure 61 Abdominal pain or cramping 19 Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 tubular acidosis) Diarrhea 20 Malabsorption 23 SYNDROMES Tumor flare 69 METABOLIC/LABORATORY Tumor lysis syndrome 69 Calcium, serum-low (hypocalcemia) 40 PAIN Cretinism Pain --Select 55 ENDOCRINE Thyroid function, low (hypothyroidism) 18 cranial nerve INFECTION cricothyroid Infection (documented clinically or microbiologically) with 35 NEUROLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Laryngeal nerve dysfunction 48 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select crisis Infection with unknown ANC --Select 36 CARDIAC GENERAL NEUROLOGY Hypertension 7 Neuropathy: cranial --Select 50

CPK - Crohn's diesease

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Crohn's diesease GASTROINTESTINAL Thrombotic microangiopathy (e.g., thrombotic 10 Colitis 19 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) crown HEMORRHAGE/BLEEDING GASTROINTESTINAL Hemorrhage, CNS 30 Dental: 20 NEUROLOGY teeth development Dental: 19 CNS cerebrovascular ischemia 47 dentures or prosthesis Syncope (fainting) 51 crying cyanosis NEUROLOGY PULMONARY/UPPER RESPIRATORY Irritability (children <3 years of age) 48 Adult Respiratory Distress Syndrome (ARDS) 56 Mood alteration --Select 49 Cough 56 Dyspnea (shortness of breath) 57 OCULAR/VISUAL Obstruction/stenosis of airway --Select 58 Watery eye (epiphora, tearing) 54 cyst CSF LYMPHATICS NEUROLOGY Lymphocele 39 Arachnoiditis/meningismus/radiculitis 47 Leak, cerebrospinal fluid (CSF) 49 cystectomy RENAL/GENITOURINARY cTnI See: cardiac troponin Bladder spasms 60 Incontinence, urinary 60 cTnT See: cardiac troponin cystitis RENAL/GENITOURINARY Cushingoid Bladder spasms 60 CONSTITUTIONAL SYMPTOMS Cystitis 60 Weight gain 12 cytogenetics ENDOCRINE BLOOD/BONE MARROW Cushingoid appearance (e.g., moon face, buffalo hump, 17 Myelodysplasia 4 centripetal obesity, cutaneous striae)

CVA cytokine release syndrome COAGULATION SYNDROMES Cytokine release syndrome/acute infusion reaction 68 Crohn's diesease - cytokine release syndrome

30 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- D --

D-dimer COAGULATION HEMORRHAGE/BLEEDING DIC (disseminated intravascular coagulation) 10 Hemorrhage, CNS 30 NEUROLOGY DAT CNS cerebrovascular ischemia 47 BLOOD/BONE MARROW Cognitive disturbance 47 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Confusion 48 hemolysis) Hydrocephalus 48 deafness OCULAR/VISUAL AUDITORY/EAR Glaucoma 52 Hearing: patients with/without baseline audiogram and 2 VASCULAR enrolled in a monitoring program Hearing: patients without baseline audiogram and not 2 Peripheral arterial ischemia 70 enrolled in a monitoring program Visceral arterial ischemia (non-myocardial) 71 death deformity DEATH GROWTH AND DEVELOPMENT Death not associated with CTCAE term --Select 13 Bone growth: 29 femoral head; slipped capital femoral epiphysis debridement MUSCULOSKELETAL/SOFT TISSUE DERMATOLOGY/SKIN Muscular/skeletal hypoplasia 45 Burn 14 SEXUAL/REPRODUCTIVE FUNCTION Skin breakdown/decubitus ulcer 16 Ulceration 16 Breast nipple/areolar deformity 64 MUSCULOSKELETAL/SOFT TISSUE dehiscence Soft tissue necrosis --Select 46 DERMATOLOGY/SKIN Wound complication, non-infectious 16 decubitus DERMATOLOGY/SKIN Skin breakdown/decubitus ulcer 16 CONSTITUTIONAL SYMPTOMS Weight loss 12 deep tendon reflexes METABOLIC/LABORATORY GASTROINTESTINAL Calcium, serum-low (hypocalcemia) 40 Dehydration 19 Magnesium, serum-high (hypermagnesemia) 41 Diarrhea 20 Dysphagia (difficulty swallowing) 21 deficit Ileus, GI (functional obstruction of bowel, i.e., 23 neuroconstipation) D-dimer - dehydration

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Nausea 24 Dental: 20 Vomiting 28 teeth METABOLIC/LABORATORY INFECTION Acidosis (metabolic or respiratory) 40 Infection (documented clinically or microbiologically) with 35 Calcium, serum-high (hypercalcemia) 41 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 NEUROLOGY Confusion 48 PAIN Pain --Select 55 delusions See: hallucinations NEUROLOGY dementia Mood alteration --Select 49 NEUROLOGY Confusion 48 dermatitis DERMATOLOGY/SKIN density Rash/desquamation 15 DERMATOLOGY/SKIN Rash: dermatitis associated with radiation --Select 15 Induration/fibrosis (skin and subcutaneous tissue) 14 Rash: hand-foot skin reaction 15 LYMPHATICS dermatomyositis Lymphedema-related fibrosis 39 ALLERGY/IMMUNOLOGY MUSCULOSKELETAL/SOFT TISSUE Autoimmune reaction 1 Fibrosis-deep connective tissue 44 Osteoporosis 46 despair PULMONARY/UPPER RESPIRATORY NEUROLOGY Pulmonary fibrosis (radiographic changes) 59 Mood alteration --Select 49 dental desquamation GASTROINTESTINAL AUDITORY/EAR Dental: 20 Otitis, external ear (non-infectious) 2 teeth development DERMATOLOGY/SKIN Dental: 19 Photosensitivity 15 dentures or prosthesis Rash/desquamation 15 Dental: 20 periodontal disease Rash: acne/acneiform 15

delirium - desquamation

32 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- D --

dialysis Rash: dermatitis associated with radiation --Select 15 COAGULATION SYNDROMES Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic Cytokine release syndrome/acute infusion reaction 68 syndrome [HUS]) development METABOLIC/LABORATORY GASTROINTESTINAL Glomerular filtration rate 41 Dental: 20 Magnesium, serum-high (hypermagnesemia) 41 teeth development RENAL/GENITOURINARY GROWTH AND DEVELOPMENT Renal failure 61 Bone age (alteration in bone age) 29 Puberty (delayed) 29 diaphoresis CONSTITUTIONAL SYMPTOMS NEUROLOGY Sweating (diaphoresis) 12 Cognitive disturbance 47 ENDOCRINE device Cushingoid appearance (e.g., moon face, buffalo hump, 17 CARDIAC ARRHYTHMIA centripetal obesity, cutaneous striae) Conduction abnormality/atrioventricular heart block --Select 5 Hot flashes/flushes 17 Supraventricular and nodal arrhythmia --Select 5 METABOLIC/LABORATORY Ventricular arrhythmia --Select 6 Glucose, serum-high (hyperglycemia) 41 CARDIAC GENERAL Glucose, serum-low (hypoglycemia) 41 Left ventricular diastolic dysfunction 8 SYNDROMES Left ventricular systolic dysfunction 8 Cytokine release syndrome/acute infusion reaction 68 Restrictive cardiomyopathy 8 Right ventricular dysfunction (cor pulmonale) 9 diaphragmatic plication MUSCULOSKELETAL/SOFT TISSUE NEUROLOGY Local complication -device/prosthesis-related 44 Phrenic nerve dysfunction 50 diabetes diarrhea METABOLIC/LABORATORY ENDOCRINE Acidosis (metabolic or respiratory) 40 Adrenal insufficiency 17 Glucose, serum-high (hyperglycemia) 41 GASTROINTESTINAL Glucose, serum-low (hypoglycemia) 41 Dehydration 19 Potassium, serum-low (hypokalemia) 42 Diarrhea 20 OCULAR/VISUAL Fistula, GI --Select 22 Cataract 52 Malabsorption 23 development - diarrhea

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-- D --

Obstruction, GI --Select 25 Obstruction/stenosis of airway --Select 58 Stricture/stenosis (including anastomotic), GI --Select 27 RENAL/GENITOURINARY diastolic Obstruction, GU --Select 61 Stricture/stenosis (including anastomotic), GU --Select 62 CARDIAC GENERAL Hypertension 7 diplopia Left ventricular diastolic dysfunction 8 OCULAR/VISUAL DIC Ophthalmoplegia/diplopia (double vision) 53 COAGULATION disc DIC (disseminated intravascular coagulation) 10 See: optic disc Fibrinogen 10 INR (International Normalized Ratio of prothrombin time) 10 discharge PTT (Partial Thromboplastin Time) 10 AUDITORY/EAR Otitis, external ear (non-infectious) 2 difficile Otitis, middle ear (non-infectious) 2 See: clostridium difficile SEXUAL/REPRODUCTIVE FUNCTION INFECTION Vaginal discharge (non-infectious) 65 Colitis, infectious (e.g., Clostridium difficile) discoloration diffusion HEMORRHAGE/BLEEDING PULMONARY/UPPER RESPIRATORY Petechiae/purpura (hemorrhage/bleeding into skin or 32 Carbon monoxide diffusion capacity (DL(co)) 56 mucosa) digestion LYMPHATICS HEPATOBILIARY/PANCREAS Dermal change lymphedema, phlebolymphedema 38 Pancreatitis 34 discouragement METABOLIC/LABORATORY NEUROLOGY Lipase 41 Mood alteration --Select 49 dilation disease GASTROINTESTINAL DEATH Dysphagia (difficulty swallowing) 21 Death not associated with CTCAE term --Select 13 Obstruction, GI --Select 25 Stricture/stenosis (including anastomotic), GI --Select 27 OCULAR/VISUAL Ocular surface disease 53 PULMONARY/UPPER RESPIRATORY

diastolic - disequilibrium

34 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- D -- disequilibrium NEUROLOGY Eyelid dysfunction 52 48 Optic disc edema 53 Scleral necrosis/melt 54 disfigurement SEXUAL/REPRODUCTIVE FUNCTION DERMATOLOGY/SKIN Ejaculatory dysfunction 64 Rash: acne/acneiform 15 MUSCULOSKELETAL/SOFT TISSUE disorientation Fibrosis-cosmesis 43 NEUROLOGY Confusion 48 disorder ALLERGY/IMMUNOLOGY disseminated Autoimmune reaction 1 See: DIC BLOOD/BONE MARROW distention Splenic function 4 GASTROINTESTINAL DERMATOLOGY/SKIN Ascites (non-malignant) 19 changes 15 Distension/bloating, abdominal 20 Flatulence 22 GASTROINTESTINAL Obstruction, GI --Select 25 Dental: 20 teeth development RENAL/GENITOURINARY Dental: 20 Bladder spasms 60 periodontal disease Obstruction, GU --Select 61 Dental: 20 Urinary frequency/urgency 62 teeth Urinary retention (including neurogenic bladder) 62 Salivary gland changes/saliva 26 MUSCULOSKELETAL/SOFT TISSUE diuresis Joint-function 44 ENDOCRINE Muscle weakness, generalized or specific area (not due to 45 Neuroendocrine: 17 neuropathy) --Select ADH secretion abnormality (e.g., SIADH or low ADH)

NEUROLOGY dizziness Cognitive disturbance 47 CARDIAC ARRHYTHMIA Extrapyramidal/involuntary movement/restlessness 48 Conduction abnormality/atrioventricular heart block --Select 5 Neuropathy: cranial --Select 50 Prolonged QTc interval 5 Seizure 51 Supraventricular and nodal arrhythmia --Select 5 Speech impairment (e.g., dysphasia or aphasia) 51 Vasovagal episode 6 OCULAR/VISUAL

disequilibrium - dizziness

35 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- D --

CARDIAC GENERAL SYNDROMES Hypotension 8 Cytokine release syndrome/acute infusion reaction 68 NEUROLOGY dry eye syndrome Dizziness 48 OCULAR/VISUAL Encephalopathy 48 Dry eye syndrome 52 Syncope (fainting) 51 SYNDROMES duodenum Cytokine release syndrome/acute infusion reaction 68 GASTROINTESTINAL Fistula, GI --Select 22 DKA Necrosis, GI --Select 25 METABOLIC/LABORATORY Obstruction, GI --Select 25 Glucose, serum-high (hyperglycemia) 41 Perforation, GI --Select 26 Stricture/stenosis (including anastomotic), GI --Select 27 DLco Ulcer, GI --Select 28 PULMONARY/UPPER RESPIRATORY HEMORRHAGE/BLEEDING Carbon monoxide diffusion capacity (DL(co)) 56 Hemorrhage, GI --Select 31 DM INFECTION METABOLIC/LABORATORY Infection (documented clinically or microbiologically) with 35 Glucose, serum-high (hyperglycemia) 41 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Glucose, serum-low (hypoglycemia) 41 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select dribbling Infection with unknown ANC --Select 36 RENAL/GENITOURINARY SURGERY/INTRA-OPERATIVE INJURY Incontinence, urinary 60 Intra-operative injury --Select 66 Urinary retention (including neurogenic bladder) 62 dura drowsiness NEUROLOGY METABOLIC/LABORATORY Arachnoiditis/meningismus/radiculitis 47 Sodium, serum-low (hyponatremia) 42 DVT NEUROLOGY See: thrombosis Somnolence/depressed level of consciousness 51 dwarfism drug fever ENDOCRINE ALLERGY/IMMUNOLOGY Neuroendocrine: 17 Allergic reaction/hypersensitivity (including drug fever) 1

DKA - dwarfism

36 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- D --

growth hormone secretion abnormality Neuropathy: cranial --Select 50 dysarthria dysphasia NEUROLOGY NEUROLOGY Laryngeal nerve dysfunction 48 Neuropathy: cranial --Select 50 Speech impairment (e.g., dysphasia or aphasia) 51 Speech impairment (e.g., dysphasia or aphasia) 51 PULMONARY/UPPER RESPIRATORY dyspnea Voice changes/dysarthria (e.g., hoarseness, loss or 59 ALLERGY/IMMUNOLOGY alteration in voice, laryngitis) Allergic reaction/hypersensitivity (including drug fever) 1 dysgeusia PULMONARY/UPPER RESPIRATORY See: CN IX, CN VII Atelectasis 56 GASTROINTESTINAL Dyspnea (shortness of breath) 57 Salivary gland changes/saliva 26 SYNDROMES Taste alteration (dysgeusia) 27 Cytokine release syndrome/acute infusion reaction 68 dysmenorrhea dysuria SEXUAL/REPRODUCTIVE FUNCTION PAIN Dysmenorrhea 64 Pain --Select 55 dyspareunia RENAL/GENITOURINARY SEXUAL/REPRODUCTIVE FUNCTION Cystitis 60 Vaginal dryness 65 Vaginal mucositis 65 dyspepsia GASTROINTESTINAL Heartburn/dyspepsia 22 dysphagia GASTROINTESTINAL Dysphagia (difficulty swallowing) 21 Esophagitis 21 Obstruction, GI --Select 25 Salivary gland changes/saliva 26 Stricture/stenosis (including anastomotic), GI --Select 27 NEUROLOGY dysarthria - dysuria

37 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- E -- ear See: CN IX CARDIAC ARRHYTHMIA AUDITORY/EAR Conduction abnormality/atrioventricular heart block --Select 5 Hearing: patients with/without baseline audiogram and 2 Prolonged QTc interval 5 enrolled in a monitoring program Supraventricular and nodal arrhythmia --Select 5 Hearing: patients without baseline audiogram and not 2 Vasovagal episode 6 enrolled in a monitoring program Ventricular arrhythmia --Select 6 Otitis, external ear (non-infectious) 2 Otitis, middle ear (non-infectious) 2 CARDIAC GENERAL Tinnitus 3 Cardiac ischemia/infarction 7 Cardiopulmonary arrest, cause unknown (non-fatal) 7 INFECTION Myocarditis 8 Infection (documented clinically or microbiologically) with 35 Pericarditis 8 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Restrictive cardiomyopathy 8 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select METABOLIC/LABORATORY Infection with unknown ANC --Select 36 Potassium, serum-high (hyperkalemia) 41 NEUROLOGY Potassium, serum-low (hypokalemia) 42 Neuropathy: cranial --Select 50 ectropion PAIN OCULAR/VISUAL Pain --Select 55 Eyelid dysfunction 52 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 eczema ALLERGY/IMMUNOLOGY earache Allergic reaction/hypersensitivity (including drug fever) 1 PAIN DERMATOLOGY/SKIN Pain --Select 55 Dry skin 14 ecchymosis edema COAGULATION ALLERGY/IMMUNOLOGY DIC (disseminated intravascular coagulation) 10 Allergic reaction/hypersensitivity (including drug fever) 1 DERMATOLOGY/SKIN Serum sickness 1 Bruising (in absence of Grade 3 or 4 thrombocytopenia) 14 AUDITORY/EAR ENDOCRINE Otitis, external ear (non-infectious) 2 Cushingoid appearance (e.g., moon face, buffalo hump, 17 CARDIAC GENERAL centripetal obesity, cutaneous striae) Left ventricular systolic dysfunction 8 ECG ear - edema

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-- E --

CONSTITUTIONAL SYMPTOMS VASCULAR Hypothermia 11 Acute vascular leak syndrome 70 Weight gain 12 EEG DERMATOLOGY/SKIN NEUROLOGY Rash: dermatitis associated with radiation --Select 15 Leukoencephalopathy (radiographic findings) 49 Rash: hand-foot skin reaction 15 ENDOCRINE EF Neuroendocrine: 17 CARDIAC GENERAL ADH secretion abnormality (e.g., SIADH or low ADH) Left ventricular systolic dysfunction 8 Thyroid function, low (hypothyroidism) 18 GASTROINTESTINAL effusion Ascites (non-malignant) 19 CARDIAC GENERAL Myocarditis 8 LYMPHATICS Pericardial effusion (non-malignant) 8 Dermal change lymphedema, phlebolymphedema 38 Edema: 38 MUSCULOSKELETAL/SOFT TISSUE head and neck Joint-effusion 44 Edema: 38 PULMONARY/UPPER RESPIRATORY limb Pleural effusion (non-malignant) 58 Edema: 38 trunk/genital SYNDROMES Edema: 38 "Retinoic acid syndrome" 69 viscera Lymphedema-related fibrosis 39 EIOP METABOLIC/LABORATORY OCULAR/VISUAL Proteinuria 42 Glaucoma 52 OCULAR/VISUAL ejaculation Optic disc edema 53 SEXUAL/REPRODUCTIVE FUNCTION PULMONARY/UPPER RESPIRATORY Ejaculatory dysfunction 64 Edema, larynx 57 Nasal cavity/paranasal sinus reactions 58 ejection Voice changes/dysarthria (e.g., hoarseness, loss or 59 See: EF alteration in voice, laryngitis) EKG RENAL/GENITOURINARY See: ECG Renal failure 61

EEG - electrocardiogram

39 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- E -- electrocardiogram See: ECG Mood alteration --Select 49 electrolyte empyema GASTROINTESTINAL INFECTION Dehydration 19 Infection (documented clinically or microbiologically) with 35 METABOLIC/LABORATORY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Bicarbonate, serum-low 40 Select Calcium, serum-high (hypercalcemia) 41 Infection with unknown ANC --Select 36 Calcium, serum-low (hypocalcemia) 40 Potassium, serum-high (hyperkalemia) 41 encephalitis Potassium, serum-low (hypokalemia) 42 INFECTION Sodium, serum-high (hypernatremia) 42 Infection (documented clinically or microbiologically) with 35 Sodium, serum-low (hyponatremia) 42 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select RENAL/GENITOURINARY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 Infection with unknown ANC --Select 36 tubular acidosis) SYNDROMES encephalopathy Tumor flare 69 COAGULATION Thrombotic microangiopathy (e.g., thrombotic 10 embolism thrombocytopenic purpura [TTP] or hemolytic uremic COAGULATION syndrome [HUS]) Thrombotic microangiopathy (e.g., thrombotic 10 HEPATOBILIARY/PANCREAS thrombocytopenic purpura [TTP] or hemolytic uremic Liver dysfunction/failure (clinical) 34 syndrome [HUS]) INFECTION PULMONARY/UPPER RESPIRATORY Viral hepatitis 36 59 NEUROLOGY VASCULAR Encephalopathy 48 Thrombosis/embolism (vascular access-related) 70 Leukoencephalopathy (radiographic findings) 49 Thrombosis/thrombus/embolism 70 endocarditis emesis CARDIAC GENERAL GASTROINTESTINAL Valvular heart disease 9 Vomiting 28 INFECTION Infection (documented clinically or microbiologically) with 35 NEUROLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select electrocardiogram - endocarditis

40 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- E --

enophthalmos Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 OCULAR/VISUAL Select Proptosis/enophthalmos 53 Infection with unknown ANC --Select 36 enteritis endocrinopathy GASTROINTESTINAL BLOOD/BONE MARROW Enteritis (inflammation of the small bowel) 21 Iron overload 4 Necrosis, GI --Select 25 endoscopy entropion GASTROINTESTINAL OCULAR/VISUAL Esophagitis 21 Eyelid dysfunction 52 Gastritis (including bile reflux gastritis) 22 Hemorrhoids 22 enucleation Leak (including anastomotic), GI --Select 23 OCULAR/VISUAL Necrosis, GI --Select 25 Glaucoma 52 Ulcer, GI --Select 28 Scleral necrosis/melt 54 HEMORRHAGE/BLEEDING enuresis Hemorrhage, GI --Select 31 Hemorrhage, GU --Select 32 RENAL/GENITOURINARY Hemorrhage, pulmonary/upper respiratory --Select 32 Urinary frequency/urgency 62 Hemorrhage/bleeding associated with surgery, intra- 30 enzymes operative or postoperative GASTROINTESTINAL HEPATOBILIARY/PANCREAS Malabsorption 23 Cholecystitis 34 HEPATOBILIARY/PANCREAS PULMONARY/UPPER RESPIRATORY Pancreas, exocrine enzyme deficiency 34 Fistula, pulmonary/upper respiratory --Select 57 Pancreatitis 34 Obstruction/stenosis of airway --Select 58 METABOLIC/LABORATORY RENAL/GENITOURINARY ALT, SGPT (serum glutamic pyruvic transaminase) 40 Leak (including anastomotic), GU --Select 60 AST, SGOT(serum glutamic oxaloacetic transaminase) 40 Obstruction, GU --Select 61 GGT (gamma-Glutamyl transpeptidase) 41 Stricture/stenosis (including anastomotic), GU --Select 62 Lipase 41 enema epidermal necrolysis GASTROINTESTINAL DERMATOLOGY/SKIN Constipation 19 Rash: multiforme (e.g., Stevens-Johnson 15

endocrinopathy - epidermal necrolysis

41 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- E --

syndrome, toxic epidermal necrolysis) Photosensitivity 15 Rash/desquamation 15 epilation Rash: dermatitis associated with radiation --Select 15 OCULAR/VISUAL Rash: (e.g., Stevens-Johnson 15 Eyelid dysfunction 52 syndrome, toxic epidermal necrolysis) Rash: hand-foot skin reaction 15 epilepsy GASTROINTESTINAL See: seizure Mucositis/stomatitis (clinical exam) --Select 24 epiphora Mucositis/stomatitis (functional/symptomatic) --Select 24 OCULAR/VISUAL MUSCULOSKELETAL/SOFT TISSUE Watery eye (epiphora, tearing) 54 Arthritis (non-septic) 43 OCULAR/VISUAL epiphysiodesis GROWTH AND DEVELOPMENT Eyelid dysfunction 52 Bone growth: 29 SEXUAL/REPRODUCTIVE FUNCTION limb length discrepancy Vaginal mucositis 65 epiphysis VASCULAR GROWTH AND DEVELOPMENT Phlebitis (including superficial thrombosis) 70 Bone growth: 29 erythroderma femoral head; slipped capital femoral epiphysis DERMATOLOGY/SKIN epistaxis Rash/desquamation 15 HEMORRHAGE/BLEEDING Rash: erythema multiforme (e.g., Stevens-Johnson 15 Hemorrhage, pulmonary/upper respiratory --Select 32 syndrome, toxic epidermal necrolysis) Rash: hand-foot skin reaction 15 erections INFECTION SEXUAL/REPRODUCTIVE FUNCTION Infection (documented clinically or microbiologically) with 35 Erectile dysfunction 64 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Libido 65 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select erythema Infection with unknown ANC --Select 36 AUDITORY/EAR MUSCULOSKELETAL/SOFT TISSUE Otitis, external ear (non-infectious) 2 Arthritis (non-septic) 43 DERMATOLOGY/SKIN VASCULAR Injection site reaction/extravasation changes 14 Phlebitis (including superficial thrombosis) 70

epilation -

42 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- E -- esophageal varices estrogen HEMORRHAGE/BLEEDING ENDOCRINE Hemorrhage, GI --Select 31 Neuroendocrine: 17 prolactin hormone secretion abnormality esophagitis SEXUAL/REPRODUCTIVE FUNCTION GASTROINTESTINAL Gynecomastia 64 Dysphagia (difficulty swallowing) 21 Esophagitis 21 euphoria Heartburn/dyspepsia 22 NEUROLOGY Mucositis/stomatitis (functional/symptomatic) --Select 24 Mood alteration --Select 49 esophagus evacuation GASTROINTESTINAL GASTROINTESTINAL Fistula, GI --Select 22 Constipation 19 Leak (including anastomotic), GI --Select 23 HEMORRHAGE/BLEEDING Mucositis/stomatitis (clinical exam) --Select 24 Hematoma 30 Mucositis/stomatitis (functional/symptomatic) --Select 24 Necrosis, GI --Select 25 evisceration Obstruction, GI --Select 25 DERMATOLOGY/SKIN Perforation, GI --Select 26 Wound complication, non-infectious 16 Stricture/stenosis (including anastomotic), GI --Select 27 Ulcer, GI --Select 28 INFECTION HEMORRHAGE/BLEEDING Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Hemorrhage, GI --Select 31 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 INFECTION Select Infection (documented clinically or microbiologically) with 35 Infection with unknown ANC --Select 36 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 excitability Select METABOLIC/LABORATORY Infection with unknown ANC --Select 36 Calcium, serum-high (hypercalcemia) 41 PAIN NEUROLOGY Pain --Select 55 Irritability (children <3 years of age) 48 PULMONARY/UPPER RESPIRATORY exfoliative Fistula, pulmonary/upper respiratory --Select 57 See: dermatitis SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 exocrine

esophageal varices - exocrine

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-- E --

eye HEPATOBILIARY/PANCREAS See: CN VI, CN IV Pancreas, exocrine enzyme deficiency 34 INFECTION Infection (documented clinically or microbiologically) with 35 exostosis Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select MUSCULOSKELETAL/SOFT TISSUE Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Exostosis 43 Select Infection with unknown ANC --Select 36 expressive dysphasia NEUROLOGY See: dysphasia Neuropathy: cranial --Select 50 external OCULAR/VISUAL See: ear Dry eye syndrome 52 Eyelid dysfunction 52 extraocular Scleral necrosis/melt 54 See: CN III Watery eye (epiphora, tearing) 54 MUSCULOSKELETAL/SOFT TISSUE PAIN Muscle weakness, generalized or specific area (not due to 45 neuropathy) --Select Pain --Select 55 SURGERY/INTRA-OPERATIVE INJURY extrapyramidal/involuntary Intra-operative injury --Select 66 movementNEUROLOGY Extrapyramidal/involuntary movement/restlessness 48 eyelid See: CN III extrasystoles OCULAR/VISUAL CARDIAC ARRHYTHMIA Eyelid dysfunction 52 Conduction abnormality/atrioventricular heart block --Select 5 Supraventricular and nodal arrhythmia --Select 5 Ventricular arrhythmia --Select 6 extravasation DERMATOLOGY/SKIN Injection site reaction/extravasation changes 14 HEMORRHAGE/BLEEDING Hematoma 30 SYNDROMES Cytokine release syndrome/acute infusion reaction 68

exostosis - eyelid

44 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F -- face ENDOCRINE Ataxia (incoordination) 47 Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) fallopian tube Masculinization of female 17 HEMORRHAGE/BLEEDING LYMPHATICS Hemorrhage, GU --Select 32 Edema: 38 INFECTION head and neck Infection (documented clinically or microbiologically) with 35 MUSCULOSKELETAL/SOFT TISSUE Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Muscle weakness, generalized or specific area (not due to 45 Select neuropathy) --Select Infection with unknown ANC --Select 36 NEUROLOGY RENAL/GENITOURINARY Neuropathy: cranial --Select 50 Leak (including anastomotic), GU --Select 60 PAIN Obstruction, GU --Select 61 Pain --Select 55 Perforation, GU --Select 61 SURGERY/INTRA-OPERATIVE INJURY Stricture/stenosis (including anastomotic), GU --Select 62 Intra-operative injury --Select 66 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 facial nerve See: CN VII Fanconi's syndrome METABOLIC/LABORATORY fainting Phosphate, serum-low (hypophosphatemia) 41 CARDIAC ARRHYTHMIA Syncope 5 RENAL/GENITOURINARY Vasovagal episode 6 Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 tubular acidosis) ENDOCRINE Adrenal insufficiency 17 fascia METABOLIC/LABORATORY DERMATOLOGY/SKIN Glucose, serum-low (hypoglycemia) 41 Wound complication, non-infectious 16 NEUROLOGY INFECTION Dizziness 48 Infection (documented clinically or microbiologically) with 35 Syncope (fainting) 51 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 falling Select Infection with unknown ANC --Select 36 NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY face - fascia

45 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F --

Intra-operative injury --Select 66 Mood alteration --Select 49 fascitis feminization See: fascia ENDOCRINE Feminization of male 17 fatigue CONSTITUTIONAL SYMPTOMS femoral head Fatigue (asthenia, lethargy, malaise) 11 GROWTH AND DEVELOPMENT MUSCULOSKELETAL/SOFT TISSUE Bone growth: 29 Muscle weakness, generalized or specific area (not due to 45 femoral head; slipped capital femoral epiphysis neuropathy) --Select fertility SYNDROMES SEXUAL/REPRODUCTIVE FUNCTION Cytokine release syndrome/acute infusion reaction 68 Infertility/sterility 64 FEV1 NEUROLOGY PULMONARY/UPPER RESPIRATORY Mood alteration --Select 49 FEV(1) 57 febrile neutropenia fever BLOOD/BONE MARROW ALLERGY/IMMUNOLOGY Neutrophils/granulocytes (ANC/AGC) 4 Allergic reaction/hypersensitivity (including drug fever) 1 INFECTION Autoimmune reaction 1 Febrile neutropenia (fever of unknown origin without 35 Serum sickness 1 clinically or microbiologically documented infection)(ANC CONSTITUTIONAL SYMPTOMS <1.0 x 10e9/L, fever >=38.5 degrees C) Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Fever (in the absence of neutropenia, where neutropenia is 11 Select defined as ANC <1.0 x 10e9/L) Infection with unknown ANC --Select 36 Rigors/chills 11 GASTROINTESTINAL feces Colitis 19 GASTROINTESTINAL Enteritis (inflammation of the small bowel) 21 Constipation 19 Typhlitis (cecal inflammation) 27 Diarrhea 20 HEPATOBILIARY/PANCREAS Incontinence, anal 23 Pancreatitis 34 feelings INFECTION NEUROLOGY Febrile neutropenia (fever of unknown origin without 35

fascitis - fever

46 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F --

clinically or microbiologically documented infection)(ANC Petechiae/purpura (hemorrhage/bleeding into skin or 32 <1.0 x 10e9/L, fever >=38.5 degrees C) mucosa) Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select fibrosis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 DERMATOLOGY/SKIN Select Atrophy, subcutaneous fat 14 Infection with unknown ANC --Select 36 Induration/fibrosis (skin and subcutaneous tissue) 14 NEUROLOGY INFECTION Arachnoiditis/meningismus/radiculitis 47 Viral hepatitis 36 SYNDROMES LYMPHATICS "Retinoic acid syndrome" 69 Lymphedema-related fibrosis 39 Cytokine release syndrome/acute infusion reaction 68 Flu-like syndrome 68 MUSCULOSKELETAL/SOFT TISSUE Fibrosis-cosmesis 43 fibrillation Fibrosis-deep connective tissue 44 CARDIAC ARRHYTHMIA PULMONARY/UPPER RESPIRATORY Supraventricular and nodal arrhythmia --Select 5 Pulmonary fibrosis (radiographic changes) 59 Ventricular arrhythmia --Select 6 CONSTITUTIONAL SYMPTOMS First degree block See: atrioventricular rhythm Hypothermia 11 fissure fibrin GASTROINTESTINAL COAGULATION Proctitis 26 DIC (disseminated intravascular coagulation) 10 fistula fibrinogen GASTROINTESTINAL COAGULATION Fistula, GI --Select 22 Fibrinogen 10 Prolapse of stoma, GI 26 HEMORRHAGE/BLEEDING Stricture/stenosis (including anastomotic), GI --Select 27 Hematoma 30 PULMONARY/UPPER RESPIRATORY Hemorrhage, CNS 30 Fistula, pulmonary/upper respiratory --Select 57 Hemorrhage, GI --Select 31 Hemorrhage, GU --Select 32 RENAL/GENITOURINARY Hemorrhage, pulmonary/upper respiratory --Select 32 Fistula, GU --Select 60 Hemorrhage/bleeding associated with surgery, intra- 30 Prolapse of stoma, GU 61 operative or postoperative SURGERY/INTRA-OPERATIVE INJURY fibrillation - fistula

47 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F --

flexion Intra-operative injury --Select 66 MUSCULOSKELETAL/SOFT TISSUE Bone: spine-scoliosis 43 fixation Cervical spine-range of motion 43 DERMATOLOGY/SKIN Lumbar spine-range of motion 44 Induration/fibrosis (skin and subcutaneous tissue) 14 floaters GROWTH AND DEVELOPMENT OCULAR/VISUAL Bone growth: 29 femoral head; slipped capital femoral epiphysis Vision-flashing lights/floaters 54

MUSCULOSKELETAL/SOFT TISSUE flu-like Fibrosis-deep connective tissue 44 See: syndrome flank fluids PAIN CARDIAC GENERAL Pain --Select 55 Hypotension 8 flap GASTROINTESTINAL DERMATOLOGY/SKIN Anorexia 19 Skin breakdown/decubitus ulcer 16 Ascites (non-malignant) 19 Ulceration 16 Dehydration 19 Wound complication, non-infectious 16 Dysphagia (difficulty swallowing) 21 Esophagitis 21 MUSCULOSKELETAL/SOFT TISSUE Fistula, GI --Select 22 Soft tissue necrosis --Select 46 Gastritis (including bile reflux gastritis) 22 Nausea 24 flare Obstruction, GI --Select 25 SYNDROMES Stricture/stenosis (including anastomotic), GI --Select 27 Tumor flare 69 Ulcer, GI --Select 28 flashes NEUROLOGY ENDOCRINE Leak, cerebrospinal fluid (CSF) 49 Hot flashes/flushes 17 SYNDROMES OCULAR/VISUAL "Retinoic acid syndrome" 69 Vision-flashing lights/floaters 54 VASCULAR Acute vascular leak syndrome 70 flatulence GASTROINTESTINAL flushing Flatulence 22 fixation - flushing

48 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F --

forgetful ALLERGY/IMMUNOLOGY NEUROLOGY Allergic reaction/hypersensitivity (including drug fever) 1 Memory impairment 49 CONSTITUTIONAL SYMPTOMS fracture Sweating (diaphoresis) 12 ENDOCRINE DERMATOLOGY/SKIN Neuroendocrine: 17 Flushing 14 gonadotropin secretion abnormality ENDOCRINE GASTROINTESTINAL Hot flashes/flushes 17 Dental: 20 teeth flutter MUSCULOSKELETAL/SOFT TISSUE CARDIAC ARRHYTHMIA Fracture 44 Supraventricular and nodal arrhythmia --Select 5 Osteoporosis 46 Ventricular arrhythmia --Select 6 frequency focal RENAL/GENITOURINARY DERMATOLOGY/SKIN Cystitis 60 Telangiectasia 16 Urinary frequency/urgency 62 NEUROLOGY function Leukoencephalopathy (radiographic findings) 49 ALLERGY/IMMUNOLOGY Seizure 51 Autoimmune reaction 1 Folstein Mini-Mental Exam BLOOD/BONE MARROW NEUROLOGY Splenic function 4 Mental status 49 ENDOCRINE forced expiratory volume Parathyroid function, low (hypoparathyroidism) 18 See: FEV1 Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 Thyroid function, low (hypothyroidism) 18 foreign body GASTROINTESTINAL INFECTION Mucositis/stomatitis (functional/symptomatic) --Select 24 Infection (documented clinically or microbiologically) with 35 Splenic function 26 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 MUSCULOSKELETAL/SOFT TISSUE Select Arthritis (non-septic) 43 Infection with unknown ANC --Select 36 Bone: spine-scoliosis 43 Extremity-lower (gait/walking) 43

flutter - function

49 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- F --

Extremity-upper (function) 43 Joint-function 44 NEUROLOGY Memory impairment 49 Neuropathy: motor 50 Neuropathy: sensory 50 SEXUAL/REPRODUCTIVE FUNCTION Breast function/lactation 64 Erectile dysfunction 64 Vaginal stenosis/length 65 fuse MUSCULOSKELETAL/SOFT TISSUE Cervical spine-range of motion 43 Lumbar spine-range of motion 44

fuse - fuse

50 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- G -- gait GROWTH AND DEVELOPMENT SURGERY/INTRA-OPERATIVE INJURY Bone growth: 29 Intra-operative injury --Select 66 limb length discrepancy Bone growth: 29 gallstones spine kyphosis/lordosis HEPATOBILIARY/PANCREAS MUSCULOSKELETAL/SOFT TISSUE Cholecystitis 34 Extremity-lower (gait/walking) 43 gamma-glutamyl NEUROLOGY See: GGT Ataxia (incoordination) 47 Dizziness 48 gas See: flatulence galactorrhea ENDOCRINE gastrectomy Feminization of male 17 GASTROINTESTINAL Neuroendocrine: 17 Gastritis (including bile reflux gastritis) 22 prolactin hormone secretion abnormality SURGERY/INTRA-OPERATIVE INJURY SEXUAL/REPRODUCTIVE FUNCTION Intra-operative injury --Select 66 Gynecomastia 64 gastric gallbladder GASTROINTESTINAL GASTROINTESTINAL Gastritis (including bile reflux gastritis) 22 Fistula, GI --Select 22 Ileus, GI (functional obstruction of bowel, i.e., 23 Necrosis, GI --Select 25 neuroconstipation) Obstruction, GI --Select 25 Necrosis, GI --Select 25 Perforation, GI --Select 26 Perforation, GI --Select 26 HEPATOBILIARY/PANCREAS Stricture/stenosis (including anastomotic), GI --Select 27 Ulcer, GI --Select 28 Cholecystitis 34 HEMORRHAGE/BLEEDING INFECTION Hemorrhage, GI --Select 31 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select gastritis Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 See: gastric Select Infection with unknown ANC --Select 36 gastroesophageal reflux PAIN GASTROINTESTINAL Pain --Select 55 Esophagitis 21

gait - gastroesophageal reflux

51 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- G --

Gastritis (including bile reflux gastritis) 22 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Heartburn/dyspepsia 22 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select gender-appropriate Infection with unknown ANC --Select 36 CARDIAC GENERAL PAIN Hypertension 7 Pain --Select 55 GROWTH AND DEVELOPMENT SURGERY/INTRA-OPERATIVE INJURY Short stature 29 Intra-operative injury --Select 66 genital Glasgow coma scale INFECTION NEUROLOGY Infection (documented clinically or microbiologically) with 35 Somnolence/depressed level of consciousness 51 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 glaucoma Select OCULAR/VISUAL Infection with unknown ANC --Select 36 Glaucoma 52 RENAL/GENITOURINARY Fistula, GU --Select 60 glomerular filtration See: GFR SEXUAL/REPRODUCTIVE FUNCTION Erectile dysfunction 64 METABOLIC/LABORATORY Glomerular filtration rate GFR METABOLIC/LABORATORY glossopharyngeal See: CN IX Glomerular filtration rate 41 glucose GGT ENDOCRINE METABOLIC/LABORATORY Cushingoid appearance (e.g., moon face, buffalo hump, 17 GGT (gamma-Glutamyl transpeptidase) 41 centripetal obesity, cutaneous striae) Neuroendocrine: 17 gingiva growth hormone secretion abnormality GASTROINTESTINAL Pancreatic endocrine: 18 Dental: 20 glucose intolerance periodontal disease METABOLIC/LABORATORY Necrosis, GI --Select 25 Glucose, serum-high (hyperglycemia) 41 INFECTION Glucose, serum-low (hypoglycemia) 41 Infection (documented clinically or microbiologically) with 35

gender-appropriate - glyceride

52 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- G -- glyceride growth METABOLIC/LABORATORY ENDOCRINE Cholesterol, serum-high (hypercholestremia) 41 Neuroendocrine: 17 growth hormone secretion abnormality glycosuria GROWTH AND DEVELOPMENT ENDOCRINE Bone growth: 29 Pancreatic endocrine: 18 limb length discrepancy glucose intolerance Bone growth: 29 METABOLIC/LABORATORY spine kyphosis/lordosis Glucose, serum-high (hyperglycemia) 41 Bone growth: 29 femoral head; slipped capital femoral epiphysis RENAL/GENITOURINARY Growth velocity (reduction in growth velocity) 29 Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 Short stature 29 tubular acidosis) guiac gonadotropin HEMORRHAGE/BLEEDING ENDOCRINE Hemorrhage, GI --Select 31 Neuroendocrine: 17 gonadotropin secretion abnormality gums GASTROINTESTINAL graft Mucositis/stomatitis (clinical exam) --Select 24 DERMATOLOGY/SKIN Mucositis/stomatitis (functional/symptomatic) --Select 24 Skin breakdown/decubitus ulcer 16 Ulceration 16 INFECTION Wound complication, non-infectious 16 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection (documented clinically or microbiologically) with 35 Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with unknown ANC --Select 36 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 PAIN Select Infection with unknown ANC --Select 36 Pain --Select 55

MUSCULOSKELETAL/SOFT TISSUE gustatory Soft tissue necrosis --Select 46 GASTROINTESTINAL grand mall Taste alteration (dysgeusia) 27 See: seizure GVHD granulocytes DERMATOLOGY/SKIN See: ANC Rash/desquamation 15

glyceride - GVHD

53 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- G --

GASTROINTESTINAL Diarrhea 20 Mucositis/stomatitis (functional/symptomatic) --Select 24 HEPATOBILIARY/PANCREAS Liver dysfunction/failure (clinical) 34 gynecomastia SEXUAL/REPRODUCTIVE FUNCTION Gynecomastia 64

gynecomastia - gynecomastia

54 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H -- hair hearing DERMATOLOGY/SKIN See: CN VIII Hair loss/alopecia (scalp or body) 14 AUDITORY/EAR Hearing: patients with/without baseline audiogram and 2 hallucinations enrolled in a monitoring program NEUROLOGY Hearing: patients without baseline audiogram and not 2 Confusion 48 enrolled in a monitoring program Encephalopathy 48 NEUROLOGY Psychosis (hallucinations/delusions) 50 Neuropathy: cranial --Select 50 hand-foot heart DERMATOLOGY/SKIN CARDIAC ARRHYTHMIA Rash: hand-foot skin reaction 15 Conduction abnormality/atrioventricular heart block --Select 5 haptoglobin CARDIAC GENERAL ALLERGY/IMMUNOLOGY Cardiac ischemia/infarction 7 Cardiac troponin I (cTnI) 7 Autoimmune reaction 1 Left ventricular diastolic dysfunction 8 BLOOD/BONE MARROW Left ventricular systolic dysfunction 8 Haptoglobin 4 Myocarditis 8 Hemoglobin 4 Restrictive cardiomyopathy 8 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Right ventricular dysfunction (cor pulmonale) 9 hemolysis) Valvular heart disease 9 METABOLIC/LABORATORY INFECTION Bilirubin (hyperbilirubinemia) 40 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select hardware Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 See: device Select Infection with unknown ANC --Select 36 headache NEUROLOGY METABOLIC/LABORATORY Leak, cerebrospinal fluid (CSF) 49 Triglyceride, serum-high (hypertriglyceridemia) 42 PAIN SURGERY/INTRA-OPERATIVE INJURY Pain --Select 55 Intra-operative injury --Select 66 SYNDROMES heartburn "Retinoic acid syndrome" 69 See: dyspepsia Cytokine release syndrome/acute infusion reaction 68 Flu-like syndrome 68 height

hair - height

55 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

GROWTH AND DEVELOPMENT GASTROINTESTINAL Short stature 29 Colitis 19 MUSCULOSKELETAL/SOFT TISSUE HEMORRHAGE/BLEEDING Osteoporosis 46 Hemorrhage, GI --Select 31 helicobacter pylorii hematoma GASTROINTESTINAL HEMORRHAGE/BLEEDING Ulcer, GI --Select 28 Hematoma 30 helmet cells hematuria ALLERGY/IMMUNOLOGY HEMORRHAGE/BLEEDING Autoimmune reaction 1 Hemorrhage, GU --Select 32 BLOOD/BONE MARROW RENAL/GENITOURINARY Haptoglobin 4 Cystitis 60 Hemoglobin 4 Urine color change 62 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hemolysis) hemodialysis COAGULATION RENAL/GENITOURINARY Thrombotic microangiopathy (e.g., thrombotic 10 Renal failure 61 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) hemoglobin ALLERGY/IMMUNOLOGY METABOLIC/LABORATORY Autoimmune reaction 1 Bilirubin (hyperbilirubinemia) 40 BLOOD/BONE MARROW hematemesis Hemoglobin 4 COAGULATION Hemolysis (e.g., immune hemolytic anemia, drug-related 4 DIC (disseminated intravascular coagulation) 10 hemolysis) GASTROINTESTINAL METABOLIC/LABORATORY Gastritis (including bile reflux gastritis) 22 Hemoglobinuria 41

HEMORRHAGE/BLEEDING hemoglobinuria Hemorrhage, GI --Select 31 METABOLIC/LABORATORY hematochezia Hemoglobinuria 41 CONSTITUTIONAL SYMPTOMS hemolysis Weight loss 12 ALLERGY/IMMUNOLOGY helicobacter pylorii - hemolysis

56 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

Autoimmune reaction 1 COAGULATION BLOOD/BONE MARROW DIC (disseminated intravascular coagulation) 10 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 INR (International Normalized Ratio of prothrombin time) 10 hemolysis) Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic METABOLIC/LABORATORY syndrome [HUS]) Phosphate, serum-low (hypophosphatemia) 41 HEMORRHAGE/BLEEDING hemolytic anemia Hemorrhage, CNS 30 BLOOD/BONE MARROW Hemorrhage, GI --Select 31 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Hemorrhage, GU --Select 32 hemolysis) Hemorrhage, pulmonary/upper respiratory --Select 32 Hemorrhage/bleeding associated with surgery, intra- 30 COAGULATION operative or postoperative Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic hepatic coma syndrome [HUS]) HEPATOBILIARY/PANCREAS hemolytic uremic syndrome Liver dysfunction/failure (clinical) 34 See: HUS METABOLIC/LABORATORY Alkaline phosphatase 40 hemoptysis ALT, SGPT (serum glutamic pyruvic transaminase) 40 HEMORRHAGE/BLEEDING AST, SGOT(serum glutamic oxaloacetic transaminase) 40 Hemorrhage, pulmonary/upper respiratory --Select 32 GGT (gamma-Glutamyl transpeptidase) 41 hemorrhage hepatic enzymes See: bleeding See: AST, ALT hemorrhoids hepatitis GASTROINTESTINAL HEPATOBILIARY/PANCREAS Hemorrhoids 22 Liver dysfunction/failure (clinical) 34 Proctitis 26 INFECTION HEMORRHAGE/BLEEDING Viral hepatitis 36 Hemorrhage, GI --Select 31 METABOLIC/LABORATORY PAIN Bilirubin (hyperbilirubinemia) 40 Pain --Select 55 hepatomegaly hemostasis HEPATOBILIARY/PANCREAS

hemolytic anemia - hepatomegaly

57 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

Hohman's sign Liver dysfunction/failure (clinical) 34 See: thrombosis

VASCULAR hormone Portal vein flow 70 ENDOCRINE hernia Neuroendocrine: 17 ACTH deficiency DERMATOLOGY/SKIN Neuroendocrine: 17 Wound complication, non-infectious 16 ADH secretion abnormality (e.g., SIADH or low ADH) Neuroendocrine: 17 hesitancy growth hormone secretion abnormality RENAL/GENITOURINARY Neuroendocrine: 17 Urinary retention (including neurogenic bladder) 62 prolactin hormone secretion abnormality Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 hiccoughs Thyroid function, low (hypothyroidism) 18 PULMONARY/UPPER RESPIRATORY GROWTH AND DEVELOPMENT Hiccoughs (hiccups, singultus) 57 Puberty (delayed) 29 Short stature 29 hirsutism See: masculinization of female hot flashes See: flushing ALLERGY/IMMUNOLOGY Howell-Jolly bodies Allergic reaction/hypersensitivity (including drug fever) 1 BLOOD/BONE MARROW DERMATOLOGY/SKIN Splenic function 4 Rash: erythema multiforme (e.g., Stevens-Johnson 15 hump syndrome, toxic epidermal necrolysis) Urticaria (hives, welts, wheals) 16 See: Cushingoid SYNDROMES hunger Cytokine release syndrome/acute infusion reaction 68 METABOLIC/LABORATORY Glucose, serum-low (hypoglycemia) 41 hoarseness NEUROLOGY HUS Speech impairment (e.g., dysphasia or aphasia) 51 COAGULATION PULMONARY/UPPER RESPIRATORY Thrombotic microangiopathy (e.g., thrombotic 10 Voice changes/dysarthria (e.g., hoarseness, loss or 59 thrombocytopenic purpura [TTP] or hemolytic uremic alteration in voice, laryngitis) syndrome [HUS]) hydrocephalus

hernia - hydrocephalus

58 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

hyperchloremic NEUROLOGY METABOLIC/LABORATORY Hydrocephalus 48 Acidosis (metabolic or respiratory) 40 hydronephrosis hypercholestremia RENAL/GENITOURINARY METABOLIC/LABORATORY Obstruction, GU --Select 61 Cholesterol, serum-high (hypercholestremia) 41 Stricture/stenosis (including anastomotic), GU --Select 62 hyperemesis hyperammonemia GASTROINTESTINAL METABOLIC/LABORATORY Nausea 24 Uric acid, serum-high (hyperuricemia) 42 hyperglycemia hyperbaric oxygen ENDOCRINE DERMATOLOGY/SKIN Cushingoid appearance (e.g., moon face, buffalo hump, 17 Skin breakdown/decubitus ulcer 16 centripetal obesity, cutaneous striae) Ulceration 16 HEPATOBILIARY/PANCREAS Wound complication, non-infectious 16 Pancreatitis 34 MUSCULOSKELETAL/SOFT TISSUE METABOLIC/LABORATORY Osteonecrosis (avascular necrosis) 45 Glucose, serum-high (hyperglycemia) 41 Soft tissue necrosis --Select 46 hyperintensities NEUROLOGY NEUROLOGY CNS necrosis/cystic progression 47 Leukoencephalopathy (radiographic findings) 49 hyperbilirubinemia hyperkalemia METABOLIC/LABORATORY METABOLIC/LABORATORY Bilirubin (hyperbilirubinemia) 40 Potassium, serum-high (hyperkalemia) 41 hypercalcemia Uric acid, serum-high (hyperuricemia) 42 METABOLIC/LABORATORY SYNDROMES Calcium, serum-high (hypercalcemia) 41 Tumor lysis syndrome 69 SYNDROMES hyperkinetic Tumor flare 69 NEUROLOGY hypercapneic Cognitive disturbance 47 METABOLIC/LABORATORY hyperlipoproteinemia Acidosis (metabolic or respiratory) 40

hydronephrosis - hyperlipoproteinemia

59 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

METABOLIC/LABORATORY DERMATOLOGY/SKIN Triglyceride, serum-high (hypertriglyceridemia) 42 Injection site reaction/extravasation changes 14 Rash/desquamation 15 hypermagnesemia Urticaria (hives, welts, wheals) 16 METABOLIC/LABORATORY SYNDROMES Magnesium, serum-high (hypermagnesemia) 41 Cytokine release syndrome/acute infusion reaction 68 hypermetabolic hypertension ENDOCRINE CARDIAC GENERAL Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 Hypertension 7 hypernatremia 8 METABOLIC/LABORATORY ENDOCRINE Sodium, serum-high (hypernatremia) 42 Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) hyperosmolar METABOLIC/LABORATORY ENDOCRINE Sodium, serum-high (hypernatremia) 42 Pancreatic endocrine: 18 NEUROLOGY glucose intolerance Hydrocephalus 48 SYNDROMES DERMATOLOGY/SKIN Cytokine release syndrome/acute infusion reaction 68 Hyperpigmentation 14 VASCULAR ENDOCRINE Portal vein flow 70 Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) hypertensive crisis See: hypertension hyperreflexia NEUROLOGY hyperthyroidism Arachnoiditis/meningismus/radiculitis 47 ENDOCRINE Pyramidal tract dysfunction (e.g., increased tone, 51 Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 hyperreflexia, positive Babinski, decreased fine motor coordination) hypertriglyceridemia hypersensitivity METABOLIC/LABORATORY ALLERGY/IMMUNOLOGY Triglyceride, serum-high (hypertriglyceridemia) 42 Allergic reaction/hypersensitivity (including drug fever) 1 hypertrophy

hypermagnesemia - hypertrophy

60 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H --

MUSCULOSKELETAL/SOFT TISSUE Cushingoid appearance (e.g., moon face, buffalo hump, 17 Exostosis 43 centripetal obesity, cutaneous striae) hyperuricemia hypogeusia METABOLIC/LABORATORY GASTROINTESTINAL Uric acid, serum-high (hyperuricemia) 42 Taste alteration (dysgeusia) 27 hypnesthesia hypoglossal See: CN XII NEUROLOGY Brachial plexopathy 47 hypoglycemia Somnolence/depressed level of consciousness 51 METABOLIC/LABORATORY hypoalbuminemia Glucose, serum-low (hypoglycemia) 41 INFECTION hypokalemia Viral hepatitis 36 ENDOCRINE METABOLIC/LABORATORY Cushingoid appearance (e.g., moon face, buffalo hump, 17 Albumin, serum-low (hypoalbuminemia) 40 centripetal obesity, cutaneous striae) Calcium, serum-low (hypocalcemia) 40 METABOLIC/LABORATORY Alkalosis (metabolic or respiratory) 40 hypocalcemia Potassium, serum-low (hypokalemia) 42 METABOLIC/LABORATORY Calcium, serum-low (hypocalcemia) 40 hypomagnesemia RENAL/GENITOURINARY METABOLIC/LABORATORY Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 Magnesium, serum-low (hypomagnesemia) 41 tubular acidosis) hyponatremia hypocellular ENDOCRINE BLOOD/BONE MARROW Neuroendocrine: 17 Bone marrow cellularity 4 ADH secretion abnormality (e.g., SIADH or low ADH) METABOLIC/LABORATORY hypochloremic Sodium, serum-low (hyponatremia) 42 METABOLIC/LABORATORY Alkalosis (metabolic or respiratory) 40 hypoparathyroidism ENDOCRINE hypocortisolism Parathyroid function, low (hypoparathyroidism) 18 ENDOCRINE

hyperuricemia - hypophosphatemia

61 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H -- hypophosphatemia METABOLIC/LABORATORY CARDIAC GENERAL Phosphate, serum-low (hypophosphatemia) 41 Hypotension 8 RENAL/GENITOURINARY CONSTITUTIONAL SYMPTOMS Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 Hypothermia 11 tubular acidosis) ENDOCRINE hypopigmentation Adrenal insufficiency 17 DERMATOLOGY/SKIN Neuroendocrine: 17 ACTH deficiency Hypopigmentation 14 INFECTION hypoplasia Febrile neutropenia (fever of unknown origin without 35 GASTROINTESTINAL clinically or microbiologically documented infection)(ANC Dental: 20 <1.0 x 10e9/L, fever >=38.5 degrees C) teeth development Infection (documented clinically or microbiologically) with 35 Dental: 20 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select periodontal disease Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select MUSCULOSKELETAL/SOFT TISSUE Infection with unknown ANC --Select 36 Muscular/skeletal hypoplasia 45 Opportunistic infection associated with >=Grade 2 36 SEXUAL/REPRODUCTIVE FUNCTION Lymphopenia Breast volume/hypoplasia 64 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 hyposalivation GASTROINTESTINAL hypothalmic Dry mouth/salivary gland (xerostomia) 21 ENDOCRINE Thyroid function, low (hypothyroidism) 18 hypotension ALLERGY/IMMUNOLOGY hypothermia Allergic reaction/hypersensitivity (including drug fever) 1 CONSTITUTIONAL SYMPTOMS BLOOD/BONE MARROW Hypothermia 11 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hypothyroidism hemolysis) ALLERGY/IMMUNOLOGY CARDIAC ARRHYTHMIA Autoimmune reaction 1 Conduction abnormality/atrioventricular heart block --Select 5 ENDOCRINE Prolonged QTc interval 5 Supraventricular and nodal arrhythmia --Select 5 Adrenal insufficiency 17 Ventricular arrhythmia --Select 6 Thyroid function, low (hypothyroidism) 18 hypophosphatemia - hypovolemic

62 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- H -- hypovolemic shock CARDIAC GENERAL Hypotension 8 HEMORRHAGE/BLEEDING Hemorrhage, CNS 30 Hemorrhage, GI --Select 31 Hemorrhage, GU --Select 32 Hemorrhage, pulmonary/upper respiratory --Select 32 Hemorrhage/bleeding associated with surgery, intra- 30 operative or postoperative hypoxia PULMONARY/UPPER RESPIRATORY Adult Respiratory Distress Syndrome (ARDS) 56 Hypoxia 57

hypovolemic shock - hypoxia

63 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- I --

ICP imbalance HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, CNS 30 Dizziness 48 NEUROLOGY immune Arachnoiditis/meningismus/radiculitis 47 BLOOD/BONE MARROW idioventricular Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hemolysis) CARDIAC ARRHYTHMIA Ventricular arrhythmia --Select 6 INFECTION Opportunistic infection associated with >=Grade 2 36 ileus Lymphopenia GASTROINTESTINAL Viral hepatitis 36 Colitis 19 SYNDROMES Enteritis (inflammation of the small bowel) 21 Cytokine release syndrome/acute infusion reaction 68 Ileus, GI (functional obstruction of bowel, i.e., 23 neuroconstipation) impaction Necrosis, GI --Select 25 GASTROINTESTINAL Obstruction, GI --Select 25 Constipation 19 Perforation, GI --Select 26 Ileus, GI (functional obstruction of bowel, i.e., 23 Stricture/stenosis (including anastomotic), GI --Select 27 neuroconstipation) Typhlitis (cecal inflammation) 27 Ulcer, GI --Select 28 implant AUDITORY/EAR HEMORRHAGE/BLEEDING Hearing: patients with/without baseline audiogram and 2 Hemorrhage, GI --Select 31 enrolled in a monitoring program INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Select Infection with unknown ANC --Select 36 Infection with unknown ANC --Select 36 SURGERY/INTRA-OPERATIVE INJURY OCULAR/VISUAL Intra-operative injury --Select 66 Cataract 52 impotency NEUROLOGY SEXUAL/REPRODUCTIVE FUNCTION Psychosis (hallucinations/delusions) 50 Erectile dysfunction 64

ICP - impulsive

64 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- I -- impulsive NEUROLOGY <1.0 x 10e9/L, fever >=38.5 degrees C) Cognitive disturbance 47 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select incoherence Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 NEUROLOGY Select Infection with unknown ANC --Select 36 Psychosis (hallucinations/delusions) 50 Opportunistic infection associated with >=Grade 2 36 incontinence Lymphopenia Viral hepatitis 36 GASTROINTESTINAL Diarrhea 20 NEUROLOGY Incontinence, anal 23 Arachnoiditis/meningismus/radiculitis 47 Mucositis/stomatitis (functional/symptomatic) --Select 24 SEXUAL/REPRODUCTIVE FUNCTION Proctitis 26 Vaginitis (not due to infection) 65 RENAL/GENITOURINARY infertile Bladder spasms 60 ENDOCRINE Incontinence, urinary 60 Neuroendocrine: 17 incoordination gonadotropin secretion abnormality NEUROLOGY SEXUAL/REPRODUCTIVE FUNCTION Ataxia (incoordination) 47 Infertility/sterility 64 induration infiltrates DERMATOLOGY/SKIN PULMONARY/UPPER RESPIRATORY Atrophy, skin 14 Pneumonitis/pulmonary infiltrates 58 Atrophy, subcutaneous fat 14 Induration/fibrosis (skin and subcutaneous tissue) 14 inflammation DERMATOLOGY/SKIN MUSCULOSKELETAL/SOFT TISSUE Injection site reaction/extravasation changes 14 Fibrosis-deep connective tissue 44 GASTROINTESTINAL infarction Colitis 19 See: cardiac ischemia Enteritis (inflammation of the small bowel) 21 Gastritis (including bile reflux gastritis) 22 infection Mucositis/stomatitis (clinical exam) --Select 24 INFECTION Mucositis/stomatitis (functional/symptomatic) --Select 24 Colitis, infectious (e.g., Clostridium difficile) 35 Proctitis 26 Febrile neutropenia (fever of unknown origin without 35 Typhlitis (cecal inflammation) 27 clinically or microbiologically documented infection)(ANC impulsive - inflammation

65 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- I --

Ulcer, GI --Select 28 Hemorrhage/bleeding associated with surgery, intra- 30 operative or postoperative HEPATOBILIARY/PANCREAS Petechiae/purpura (hemorrhage/bleeding into skin or 32 Cholecystitis 34 mucosa) INFECTION insomnia Colitis, infectious (e.g., Clostridium difficile) 35 CONSTITUTIONAL SYMPTOMS LYMPHATICS Insomnia 11 Lymphedema-related fibrosis 39 NEUROLOGY MUSCULOSKELETAL/SOFT TISSUE Mood alteration --Select 49 Arthritis (non-septic) 43 Myositis (inflammation/damage of muscle) 45 insufficiency NEUROLOGY COAGULATION Arachnoiditis/meningismus/radiculitis 47 Thrombotic microangiopathy (e.g., thrombotic 10 Myelitis 49 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) OCULAR/VISUAL ENDOCRINE Keratitis (corneal inflammation/corneal ulceration) 52 Adrenal insufficiency 17 SYNDROMES MUSCULOSKELETAL/SOFT TISSUE Tumor flare 69 Fracture 44 influenza-like insulin SYNDROMES ENDOCRINE Flu-like syndrome 68 Pancreatic endocrine: 18 infusion reaction glucose intolerance See: cytokine release syndrome METABOLIC/LABORATORY Glucose, serum-high (hyperglycemia) 41 INR Glucose, serum-low (hypoglycemia) 41 COAGULATION INR (International Normalized Ratio of prothrombin time) 10 intercourse SEXUAL/REPRODUCTIVE FUNCTION HEMORRHAGE/BLEEDING Ejaculatory dysfunction 64 Hematoma 30 Erectile dysfunction 64 Hemorrhage, CNS 30 Orgasmic dysfunction 65 Hemorrhage, GI --Select 31 Vaginal mucositis 65 Hemorrhage, GU --Select 32 Hemorrhage, pulmonary/upper respiratory --Select 32 intercranial pressure influenza-like - intercranial pressure

66 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- I --

intraocular pressure NEUROLOGY OCULAR/VISUAL Arachnoiditis/meningismus/radiculitis 47 Glaucoma 52 Hydrocephalus 48 intubation intestine NEUROLOGY GASTROINTESTINAL Apnea 47 Enteritis (inflammation of the small bowel) 21 PULMONARY/UPPER RESPIRATORY Ileus, GI (functional obstruction of bowel, i.e., 23 Adult Respiratory Distress Syndrome (ARDS) 56 neuroconstipation) Leak (including anastomotic), GI --Select 23 Dyspnea (shortness of breath) 57 Malabsorption 23 Edema, larynx 57 Obstruction, GI --Select 25 Hypoxia 57 Perforation, GI --Select 26 Obstruction/stenosis of airway --Select 58 Prolapse of stoma, GI 26 Prolonged intubation after pulmonary resection (>24 hrs 59 after surgery) Stricture/stenosis (including anastomotic), GI --Select 27 Ulcer, GI --Select 28 inversion HEMORRHAGE/BLEEDING OCULAR/VISUAL Hemorrhage, GI --Select 31 Eyelid dysfunction 52

PAIN involuntary movements Pain --Select 55 NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY Ataxia (incoordination) 47 Intra-operative injury --Select 66 Encephalopathy 48 Extrapyramidal/involuntary movement/restlessness 48 intra-operative Seizure 51 HEMORRHAGE/BLEEDING Tremor 51 Hemorrhage/bleeding associated with surgery, intra- 30 OCULAR/VISUAL operative or postoperative Nystagmus 53 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 ionized calcium See: calcium intracranial pressure HEMORRHAGE/BLEEDING iron Hemorrhage, CNS 30 BLOOD/BONE MARROW NEUROLOGY Iron overload 4 Hydrocephalus 48 HEMORRHAGE/BLEEDING

intestine - iron

67 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- I --

Hemorrhage, GI --Select 31 Peripheral arterial ischemia 70 Visceral arterial ischemia (non-myocardial) 71 irrigation HEMORRHAGE/BLEEDING isoenzyme Hemorrhage, GU --Select 32 See: CPK RENAL/GENITOURINARY itching Cystitis 60 See: pruritus irritability IVC NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY Irritability (children <3 years of age) 48 Intra-operative injury --Select 66 irritation VASCULAR OCULAR/VISUAL Vessel injury-vein --Select 71 Keratitis (corneal inflammation/corneal ulceration) 52 Ocular surface disease 53 SEXUAL/REPRODUCTIVE FUNCTION Vaginitis (not due to infection) 65 ischemia ALLERGY/IMMUNOLOGY Vasculitis 1 CARDIAC GENERAL Cardiac ischemia/infarction 7 GASTROINTESTINAL Colitis 19 Enteritis (inflammation of the small bowel) 21 Typhlitis (cecal inflammation) 27 INFECTION Colitis, infectious (e.g., Clostridium difficile) 35 NEUROLOGY CNS cerebrovascular ischemia 47 Syncope (fainting) 51 VASCULAR

irrigation - IVC

68 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- J --

Jacksonian seizure NEUROLOGY Select Seizure 51 Infection with unknown ANC --Select 36 SURGERY/INTRA-OPERATIVE INJURY jaundice Intra-operative injury --Select 66 BLOOD/BONE MARROW Hemolysis (e.g., immune hemolytic anemia, drug-related 4 joint hemolysis) INFECTION HEPATOBILIARY/PANCREAS Infection (documented clinically or microbiologically) with 35 Cholecystitis 34 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Liver dysfunction/failure (clinical) 34 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Pancreatitis 34 Select Infection with unknown ANC --Select 36 METABOLIC/LABORATORY MUSCULOSKELETAL/SOFT TISSUE Bilirubin (hyperbilirubinemia) 40 Arthritis (non-septic) 43 jaw Joint-effusion 44 See: CN V Joint-function 44 MUSCULOSKELETAL/SOFT TISSUE PAIN Trismus (difficulty, restriction or pain when opening mouth) 46 Pain --Select 55 NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY Neuropathy: cranial --Select 50 Intra-operative injury --Select 66 jejunum SYNDROMES GASTROINTESTINAL Cytokine release syndrome/acute infusion reaction 68 Fistula, GI --Select 22 jugular Necrosis, GI --Select 25 SURGERY/INTRA-OPERATIVE INJURY Obstruction, GI --Select 25 Intra-operative injury --Select 66 Perforation, GI --Select 26 Stricture/stenosis (including anastomotic), GI --Select 27 VASCULAR Ulcer, GI --Select 28 Vessel injury-vein --Select 71

HEMORRHAGE/BLEEDING junctional Hemorrhage, GI --Select 31 See: nodal INFECTION Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35

Jacksonian seizure - junctional

69 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- K --

K+ See: potassium METABOLIC/LABORATORY Calcium, serum-high (hypercalcemia) 41 keratitis Magnesium, serum-high (hypermagnesemia) 41 OCULAR/VISUAL Potassium, serum-high (hyperkalemia) 41 Dry eye syndrome 52 Sodium, serum-low (hyponatremia) 42 Keratitis (corneal inflammation/corneal ulceration) 52 PAIN Ocular surface disease 53 Pain --Select 55 keratoconjunctivitis RENAL/GENITOURINARY OCULAR/VISUAL Fistula, GU --Select 60 Dry eye syndrome 52 Leak (including anastomotic), GU --Select 60 Ocular surface disease 53 Perforation, GU --Select 61 Renal failure 61 keratopathy OCULAR/VISUAL SURGERY/INTRA-OPERATIVE INJURY Keratitis (corneal inflammation/corneal ulceration) 52 Intra-operative injury --Select 66

Kernig's sign koilonychias NEUROLOGY DERMATOLOGY/SKIN Arachnoiditis/meningismus/radiculitis 47 Nail changes 15 ketoacidosis kyphosis ENDOCRINE GROWTH AND DEVELOPMENT Pancreatic endocrine: 18 Bone growth: 29 glucose intolerance spine kyphosis/lordosis METABOLIC/LABORATORY Glucose, serum-high (hyperglycemia) 41 kidney HEMORRHAGE/BLEEDING Hemorrhage, GU --Select 32 INFECTION Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36

K+ - kyphosis

70 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- L --

L-spine MUSCULOSKELETAL/SOFT TISSUE Pain --Select 55 Lumbar spine-range of motion 44 PULMONARY/UPPER RESPIRATORY Edema, larynx 57 lacrimation Obstruction/stenosis of airway --Select 58 OCULAR/VISUAL Recurrent laryngeal nerve dysfunction 59 Dry eye syndrome 52 Voice changes/dysarthria (e.g., hoarseness, loss or 59 Watery eye (epiphora, tearing) 54 alteration in voice, laryngitis) lactation SURGERY/INTRA-OPERATIVE INJURY ENDOCRINE Intra-operative injury --Select 66 Neuroendocrine: 17 laryngectomy prolactin hormone secretion abnormality PULMONARY/UPPER RESPIRATORY SEXUAL/REPRODUCTIVE FUNCTION Edema, larynx 57 Breast function/lactation 64 Voice changes/dysarthria (e.g., hoarseness, loss or 59 alteration in voice, laryngitis) lactic acid METABOLIC/LABORATORY laryngismus Acidosis (metabolic or respiratory) 40 PULMONARY/UPPER RESPIRATORY Obstruction/stenosis of airway --Select 58 lacunas NEUROLOGY laryngitis Leukoencephalopathy (radiographic findings) 49 See: dysarthria language laryngospasm AUDITORY/EAR ALLERGY/IMMUNOLOGY Hearing: patients with/without baseline audiogram and 2 Allergic reaction/hypersensitivity (including drug fever) 1 enrolled in a monitoring program PULMONARY/UPPER RESPIRATORY NEUROLOGY Voice changes/dysarthria (e.g., hoarseness, loss or 59 Speech impairment (e.g., dysphasia or aphasia) 51 alteration in voice, laryngitis) laryngeal larynx NEUROLOGY See: CN X Laryngeal nerve dysfunction 48 GASTROINTESTINAL Neuropathy: motor 50 Mucositis/stomatitis (clinical exam) --Select 24 Speech impairment (e.g., dysphasia or aphasia) 51 Mucositis/stomatitis (functional/symptomatic) --Select 24 PAIN HEMORRHAGE/BLEEDING

L-spine - larynx

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-- L --

See: CN X Leak, cerebrospinal fluid (CSF) 49 Hemorrhage, pulmonary/upper respiratory --Select 32 PULMONARY/UPPER RESPIRATORY INFECTION Prolonged chest tube drainage or air leak after pulmonary 58 Infection (documented clinically or microbiologically) with 35 resection Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select RENAL/GENITOURINARY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Leak (including anastomotic), GU --Select 60 Select Infection with unknown ANC --Select 36 SYNDROMES NEUROLOGY Acute vascular leak syndrome 68 Neuropathy: cranial --Select 50 VASCULAR PAIN Acute vascular leak syndrome 70 Pain --Select 55 learning problems PULMONARY/UPPER RESPIRATORY NEUROLOGY Edema, larynx 57 Cognitive disturbance 47 Fistula, pulmonary/upper respiratory --Select 57 Obstruction/stenosis of airway --Select 58 lens SURGERY/INTRA-OPERATIVE INJURY INFECTION Intra-operative injury --Select 66 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select laxatives Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select GASTROINTESTINAL Infection with unknown ANC --Select 36 Constipation 19 OCULAR/VISUAL Incontinence, anal 23 Cataract 52 leak SURGERY/INTRA-OPERATIVE INJURY GASTROINTESTINAL Intra-operative injury --Select 66 Fistula, GI --Select 22 Gastritis (including bile reflux gastritis) 22 leptomeningitis Leak (including anastomotic), GI --Select 23 NEUROLOGY Perforation, GI --Select 26 Arachnoiditis/meningismus/radiculitis 47 Prolapse of stoma, GI 26 LYMPHATICS DERMATOLOGY/SKIN Chyle or lymph leakage 38 Rash/desquamation 15 NEUROLOGY GASTROINTESTINAL

laxatives - lesions

72 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- L --

Ulcer, GI --Select 28 SYNDROMES HEMORRHAGE/BLEEDING "Retinoic acid syndrome" 69 Petechiae/purpura (hemorrhage/bleeding into skin or 32 leukoencephalopathy mucosa) NEUROLOGY lethargy Leukoencephalopathy (radiographic findings) 49 CONSTITUTIONAL SYMPTOMS Fatigue (asthenia, lethargy, malaise) 11 leukopenia ALLERGY/IMMUNOLOGY HEPATOBILIARY/PANCREAS Autoimmune reaction 1 Liver dysfunction/failure (clinical) 34 METABOLIC/LABORATORY level of consciousness Magnesium, serum-low (hypomagnesemia) 41 COAGULATION MUSCULOSKELETAL/SOFT TISSUE Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic Muscle weakness, generalized or specific area (not due to 45 syndrome [HUS]) neuropathy) --Select NEUROLOGY NEUROLOGY Arachnoiditis/meningismus/radiculitis 47 Hydrocephalus 48 Mental status 49 Mental status 49 Seizure 51 SYNDROMES Somnolence/depressed level of consciousness 51 Cytokine release syndrome/acute infusion reaction 68 Lhermitte sign leukemia NEUROLOGY SECONDARY MALIGNANCY Myelitis 49 Secondary Malignancy - possibly related to cancer treatment 63 (Specify, __) libido SEXUAL/REPRODUCTIVE FUNCTION leukocytes Libido 65 BLOOD/BONE MARROW Leukocytes (total WBC) 4 lid INFECTION See: eyelid Infection (documented clinically or microbiologically) with 35 light sensitivity Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select OCULAR/VISUAL Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Vision-photophobia 54 Infection with unknown ANC --Select 36

lethargy -

73 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- L -- lightheadedness CARDIAC ARRHYTHMIA Lipase 41 Conduction abnormality/atrioventricular heart block --Select 5 lipids Palpitations 5 Vasovagal episode 6 METABOLIC/LABORATORY Cholesterol, serum-high (hypercholestremia) 41 CARDIAC GENERAL Lipase 41 Hypotension 8 NEUROLOGY lips Dizziness 48 DERMATOLOGY/SKIN Syncope (fainting) 51 Chelitis 14 GASTROINTESTINAL limb Dry mouth/salivary gland (xerostomia) 21 GROWTH AND DEVELOPMENT Bone growth: 29 INFECTION limb length discrepancy Infection (documented clinically or microbiologically) with 35 LYMPHATICS Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Edema: 38 Select limb Infection with unknown ANC --Select 36 MUSCULOSKELETAL/SOFT TISSUE PAIN Extremity-lower (gait/walking) 43 Pain --Select 55 Extremity-upper (function) 43 Fibrosis-deep connective tissue 44 SURGERY/INTRA-OPERATIVE INJURY Local complication -device/prosthesis-related 44 Intra-operative injury --Select 66 PAIN SYNDROMES Pain --Select 55 "Retinoic acid syndrome" 69

VASCULAR liver Peripheral arterial ischemia 70 GASTROINTESTINAL Vessel injury-artery --Select 70 Fistula, GI --Select 22 limp Leak (including anastomotic), GI --Select 23 See: limb Necrosis, GI --Select 25 Perforation, GI --Select 26 lipase Stricture/stenosis (including anastomotic), GI --Select 27 HEPATOBILIARY/PANCREAS HEMORRHAGE/BLEEDING Pancreatitis 34 Hemorrhage, GI --Select 31 METABOLIC/LABORATORY lightheadedness - liver

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lordosis HEPATOBILIARY/PANCREAS GROWTH AND DEVELOPMENT Liver dysfunction/failure (clinical) 34 Bone growth: 29 spine kyphosis/lordosis INFECTION Infection (documented clinically or microbiologically) with 35 lymphangiosarcoma Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select LYMPHATICS Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Edema: 38 Infection with unknown ANC --Select 36 limb Edema: 38 Viral hepatitis 36 trunk/genital METABOLIC/LABORATORY lymphatic AST, SGOT(serum glutamic oxaloacetic transaminase) 40 Bilirubin (hyperbilirubinemia) 40 CONSTITUTIONAL SYMPTOMS Weight gain 12 PAIN Pain --Select 55 INFECTION Infection (documented clinically or microbiologically) with 35 SURGERY/INTRA-OPERATIVE INJURY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Intra-operative injury --Select 66 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select liver enzymes Infection with unknown ANC --Select 36 See: AST, ALT LYMPHATICS LOC Chyle or lymph leakage 38 HEMORRHAGE/BLEEDING Dermal change lymphedema, phlebolymphedema 38 Hemorrhage, CNS 30 Edema: 38 head and neck NEUROLOGY Edema: 38 Arachnoiditis/meningismus/radiculitis 47 limb Seizure 51 Edema: 38 Somnolence/depressed level of consciousness 51 trunk/genital Edema: 38 lockjaw viscera MUSCULOSKELETAL/SOFT TISSUE Lymphedema-related fibrosis 39 Lymphocele 39 Trismus (difficulty, restriction or pain when opening mouth) 46 Phlebolymphatic cording 39 loneliness PAIN NEUROLOGY Pain --Select 55 Mood alteration --Select 49 lymphedema

liver enzymes - lymphedema

75 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- L --

See: lymphatic lymphocele LYMPHATICS Lymphocele 39 lymphocytes BLOOD/BONE MARROW CD4 count 4 Lymphopenia 4 INFECTION Opportunistic infection associated with >=Grade 2 36 Lymphopenia lymphoedema See: lymphatic lymphoma SECONDARY MALIGNANCY Secondary Malignancy - possibly related to cancer treatment 63 (Specify, __) lymphopenia See: lymphocytes lymphorrhea See: lymphatic lysis METABOLIC/LABORATORY Uric acid, serum-high (hyperuricemia) 42 SYNDROMES Tumor flare 69 Tumor lysis syndrome 69 VASCULAR Thrombosis/embolism (vascular access-related) 70 Thrombosis/thrombus/embolism 70

lymphocele - lysis

76 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- M -- macular malnutrition DERMATOLOGY/SKIN GASTROINTESTINAL Rash/desquamation 15 Anorexia 19 OCULAR/VISUAL Malabsorption 23 Nausea 24 Optic disc edema 53 Vomiting 28 Retinal detachment 53 Retinopathy 53 mammary gland madarosis SEXUAL/REPRODUCTIVE FUNCTION OCULAR/VISUAL Breast function/lactation 64 Gynecomastia 64 Eyelid dysfunction 52 masculinization of female magnesium ENDOCRINE METABOLIC/LABORATORY Cushingoid appearance (e.g., moon face, buffalo hump, 17 Magnesium, serum-high (hypermagnesemia) 41 centripetal obesity, cutaneous striae) Magnesium, serum-low (hypomagnesemia) 41 Masculinization of female 17 malabsorption mastoiditis ENDOCRINE AUDITORY/EAR Pancreatic endocrine: 18 Otitis, external ear (non-infectious) 2 glucose intolerance Otitis, middle ear (non-infectious) 2 GASTROINTESTINAL Malabsorption 23 maxilla HEPATOBILIARY/PANCREAS GASTROINTESTINAL Pancreas, exocrine enzyme deficiency 34 Dental: 20 periodontal disease malaise MDS CONSTITUTIONAL SYMPTOMS SECONDARY MALIGNANCY Fatigue (asthenia, lethargy, malaise) 11 Secondary Malignancy - possibly related to cancer treatment 63 MUSCULOSKELETAL/SOFT TISSUE (Specify, __) Muscle weakness, generalized or specific area (not due to 45 neuropathy) --Select mediastinal HEMORRHAGE/BLEEDING SYNDROMES Hemorrhage, pulmonary/upper respiratory --Select 32 Cytokine release syndrome/acute infusion reaction 68 Flu-like syndrome 68 INFECTION Infection (documented clinically or microbiologically) with 35

macular - mediastinal

77 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- M --

Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with unknown ANC --Select 36 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 NEUROLOGY Select Infection with unknown ANC --Select 36 Arachnoiditis/meningismus/radiculitis 47 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66 megacolon meningismus See: arachnoiditis GASTROINTESTINAL Colitis 19 meningitis Constipation 19 See: meninges INFECTION INFECTION Colitis, infectious (e.g., Clostridium difficile) 35 Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select melena Infection with normal ANC or Grade 1 or 2 neutrophils -- ALLERGY/IMMUNOLOGY Select Infection with unknown ANC --Select Autoimmune reaction 1 NEUROLOGY CONSTITUTIONAL SYMPTOMS Arachnoiditis/meningismus/radiculitis 47 Weight loss 12 GASTROINTESTINAL menometrorrhagia Colitis 19 HEMORRHAGE/BLEEDING HEMORRHAGE/BLEEDING Hemorrhage, GU --Select 32 Hemorrhage, GI --Select 31 menopause memory ENDOCRINE NEUROLOGY Hot flashes/flushes 17 Confusion 48 SEXUAL/REPRODUCTIVE FUNCTION Memory impairment 49 Irregular menses (change from baseline) 64 meninges menorrhagia INFECTION ENDOCRINE Infection (documented clinically or microbiologically) with 35 Thyroid function, low (hypothyroidism) 18 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select HEMORRHAGE/BLEEDING Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Hemorrhage, GU --Select 32

megacolon - menses

78 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- M -- menses SEXUAL/REPRODUCTIVE FUNCTION Pain --Select 55 Irregular menses (change from baseline) 64 Mini-Mental menstruation See: Folstein Mini-Mental Exam See: menses NEUROLOGY Mental status metabolic ENDOCRINE MMSE Neuroendocrine: 17 See: Folstein Mini-Mental Exam growth hormone secretion abnormality Thyroid function, low (hypothyroidism) 18 Mobitz See: atrioventricular rhythm METABOLIC/LABORATORY Acidosis (metabolic or respiratory) 40 mood Alkalosis (metabolic or respiratory) 40 NEUROLOGY metallic taste Encephalopathy 48 Mood alteration --Select 49 GASTROINTESTINAL Salivary gland changes/saliva 26 moon face ENDOCRINE MI Cushingoid appearance (e.g., moon face, buffalo hump, 17 CARDIAC GENERAL centripetal obesity, cutaneous striae) Cardiac ischemia/infarction 7 Cardiac troponin I (cTnI) 7 motion sickness METABOLIC/LABORATORY GASTROINTESTINAL CPK (creatine phosphokinase) 41 Nausea 24 VASCULAR NEUROLOGY Vessel injury-artery --Select 70 Neuropathy: cranial --Select 50 microangiopathy motor COAGULATION NEUROLOGY Thrombotic microangiopathy (e.g., thrombotic 10 Neuropathy: cranial --Select 50 thrombocytopenic purpura [TTP] or hemolytic uremic Neuropathy: motor 50 syndrome [HUS]) Pyramidal tract dysfunction (e.g., increased tone, 51 hyperreflexia, positive Babinski, decreased fine motor migrane coordination) PAIN Seizure 51

menses - motor

79 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- M --

SURGERY/INTRA-OPERATIVE INJURY DEATH Intra-operative injury --Select 66 Death not associated with CTCAE term --Select 13 mucosa muscle GASTROINTESTINAL INFECTION Dehydration 19 Infection (documented clinically or microbiologically) with 35 Mucositis/stomatitis (clinical exam) --Select 24 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Mucositis/stomatitis (functional/symptomatic) --Select 24 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Salivary gland changes/saliva 26 Select Infection with unknown ANC --Select 36 HEMORRHAGE/BLEEDING MUSCULOSKELETAL/SOFT TISSUE Petechiae/purpura (hemorrhage/bleeding into skin or 32 mucosa) Extremity-lower (gait/walking) 43 Extremity-upper (function) 43 INFECTION Fibrosis-deep connective tissue 44 Infection (documented clinically or microbiologically) with 35 Muscle weakness, generalized or specific area (not due to 45 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select neuropathy) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Muscular/skeletal hypoplasia 45 Select Myositis (inflammation/damage of muscle) 45 Infection with unknown ANC --Select 36 NEUROLOGY PULMONARY/UPPER RESPIRATORY Brachial plexopathy 47 Nasal cavity/paranasal sinus reactions 58 Neuropathy: cranial --Select 50 SEXUAL/REPRODUCTIVE FUNCTION OCULAR/VISUAL Vaginal mucositis 65 Ocular muscle weakness 52 mucus PAIN GASTROINTESTINAL Pain --Select 55 Colitis 19 SURGERY/INTRA-OPERATIVE INJURY Enteritis (inflammation of the small bowel) 21 Intra-operative injury --Select 66 Typhlitis (cecal inflammation) 27 SYNDROMES INFECTION Cytokine release syndrome/acute infusion reaction 68 Colitis, infectious (e.g., Clostridium difficile) 35 musculoskeletal MUGA See: muscle CARDIAC GENERAL Left ventricular systolic dysfunction 8 myalgia PAIN multi-organ failure mucosa - myalgia

80 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- M --

Pain --Select 55 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select SYNDROMES Infection with unknown ANC --Select 36 Cytokine release syndrome/acute infusion reaction 68 Flu-like syndrome 68 MUSCULOSKELETAL/SOFT TISSUE Myositis (inflammation/damage of muscle) 45 myelitis INFECTION myxedema Infection (documented clinically or microbiologically) with 35 ENDOCRINE Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Thyroid function, low (hypothyroidism) 18 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 NEUROLOGY Myelitis 49 myelodysplasia BLOOD/BONE MARROW Myelodysplasia 4 myocardial See: cardiac ischemia myocardial infarction CARDIAC GENERAL Cardiac ischemia/infarction 7 Cardiac troponin I (cTnI) 7 METABOLIC/LABORATORY CPK (creatine phosphokinase) 41 myocarditis CARDIAC GENERAL Myocarditis 8 myositis INFECTION Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select myelitis - myxedema

81 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- N --

Na+ See: sodium Ileus, GI (functional obstruction of bowel, i.e., 23 neuroconstipation) nails Nausea 24 DERMATOLOGY/SKIN Obstruction, GI --Select 25 Nail changes 15 Ulcer, GI --Select 28 INFECTION Vomiting 28 Infection (documented clinically or microbiologically) with 35 HEPATOBILIARY/PANCREAS Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Pancreatitis 34 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 METABOLIC/LABORATORY Select Infection with unknown ANC --Select 36 Magnesium, serum-low (hypomagnesemia) 41 SURGERY/INTRA-OPERATIVE INJURY NEUROLOGY Intra-operative injury --Select 66 Arachnoiditis/meningismus/radiculitis 47 Dizziness 48 narrowing SYNDROMES CARDIAC GENERAL Cytokine release syndrome/acute infusion reaction 68 Cardiac ischemia/infarction 7 GASTROINTESTINAL neck Stricture/stenosis (including anastomotic), GI --Select 27 INFECTION Infection (documented clinically or microbiologically) with 35 RENAL/GENITOURINARY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Stricture/stenosis (including anastomotic), GU --Select 62 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 SEXUAL/REPRODUCTIVE FUNCTION Select Infection with unknown ANC --Select 36 Vaginal stenosis/length 65 LYMPHATICS nasal Edema: 38 ALLERGY/IMMUNOLOGY head and neck Allergic rhinitis (including sneezing, nasal stuffiness, 1 MUSCULOSKELETAL/SOFT TISSUE postnasal drip) Cervical spine-range of motion 43 PULMONARY/UPPER RESPIRATORY Soft tissue necrosis --Select 46 Nasal cavity/paranasal sinus reactions 58 PAIN SURGERY/INTRA-OPERATIVE INJURY Pain --Select 55 Intra-operative injury --Select 66 SURGERY/INTRA-OPERATIVE INJURY nausea Intra-operative injury --Select 66 GASTROINTESTINAL necrolysis Na+ - necrolysis

82 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- N --

DERMATOLOGY/SKIN Osteonecrosis (avascular necrosis) 45 Rash: erythema multiforme (e.g., Stevens-Johnson 15 Soft tissue necrosis --Select 46 syndrome, toxic epidermal necrolysis) NEUROLOGY necrosis Leukoencephalopathy (radiographic findings) 49 AUDITORY/EAR OCULAR/VISUAL Otitis, external ear (non-infectious) 2 Scleral necrosis/melt 54 Otitis, middle ear (non-infectious) 2 PULMONARY/UPPER RESPIRATORY DERMATOLOGY/SKIN Nasal cavity/paranasal sinus reactions 58 Injection site reaction/extravasation changes 14 SEXUAL/REPRODUCTIVE FUNCTION Rash: dermatitis associated with radiation --Select 15 Vaginal mucositis 65 GASTROINTESTINAL Colitis 19 necrotizing fascitis Dental: 20 DERMATOLOGY/SKIN periodontal disease Wound complication, non-infectious 16 Enteritis (inflammation of the small bowel) 21 INFECTION Mucositis/stomatitis (clinical exam) --Select 24 Infection (documented clinically or microbiologically) with 35 Necrosis, GI --Select 25 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Salivary gland changes/saliva 26 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Typhlitis (cecal inflammation) 27 Select GROWTH AND DEVELOPMENT Infection with unknown ANC --Select 36 Bone growth: 29 nerve femoral head; slipped capital femoral epiphysis INFECTION INFECTION Infection (documented clinically or microbiologically) with 35 Colitis, infectious (e.g., Clostridium difficile) 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Febrile neutropenia (fever of unknown origin without 35 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 clinically or microbiologically documented infection)(ANC Select <1.0 x 10e9/L, fever >=38.5 degrees C) Infection with unknown ANC --Select 36 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select NEUROLOGY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Laryngeal nerve dysfunction 48 Select Neuropathy: cranial --Select 50 Infection with unknown ANC --Select 36 Neuropathy: motor 50 Opportunistic infection associated with >=Grade 2 36 Neuropathy: sensory 50 Lymphopenia Phrenic nerve dysfunction 50 MUSCULOSKELETAL/SOFT TISSUE Speech impairment (e.g., dysphasia or aphasia) 51

necrosis - nerve

83 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- N --

PAIN GROWTH AND DEVELOPMENT Pain --Select 55 Short stature 29 PULMONARY/UPPER RESPIRATORY neurogenic bladder Voice changes/dysarthria (e.g., hoarseness, loss or 59 RENAL/GENITOURINARY alteration in voice, laryngitis) Urinary retention (including neurogenic bladder) 62 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 neurologic GASTROINTESTINAL neuralgia Dysphagia (difficulty swallowing) 21 PAIN HEMORRHAGE/BLEEDING Pain --Select 55 Hemorrhage, CNS 30 neuritis NEUROLOGY NEUROLOGY CNS cerebrovascular ischemia 47 Brachial plexopathy 47 Hydrocephalus 48 Neuropathy: motor 50 Syncope (fainting) 51 neuroconstipation neuropathy GASTROINTESTINAL MUSCULOSKELETAL/SOFT TISSUE Constipation 19 Fibrosis-deep connective tissue 44 Distension/bloating, abdominal 20 Muscle weakness, generalized or specific area (not due to 45 Ileus, GI (functional obstruction of bowel, i.e., 23 neuropathy) --Select neuroconstipation) NEUROLOGY Typhlitis (cecal inflammation) 27 Neuropathy: cranial --Select 50 neuroendocrine Neuropathy: motor 50 ENDOCRINE Neuropathy: sensory 50 Neuroendocrine: 17 Speech impairment (e.g., dysphasia or aphasia) 51 ACTH deficiency OCULAR/VISUAL Neuroendocrine: 17 Eyelid dysfunction 52 ADH secretion abnormality (e.g., SIADH or low ADH) Ocular muscle weakness 52 Neuroendocrine: 17 gonadotropin secretion abnormality neutropenia Neuroendocrine: 17 growth hormone secretion abnormality INFECTION Neuroendocrine: 17 Febrile neutropenia (fever of unknown origin without 35 prolactin hormone secretion abnormality clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) neuralgia - neutropenia

84 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- N --

non-essential organ Infection (documented clinically or microbiologically) with 35 ALLERGY/IMMUNOLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Autoimmune reaction 1 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select nose Infection with unknown ANC --Select 36 HEMORRHAGE/BLEEDING neutrophils Hemorrhage, pulmonary/upper respiratory --Select 32 BLOOD/BONE MARROW INFECTION Neutrophils/granulocytes (ANC/AGC) 4 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Febrile neutropenia (fever of unknown origin without 35 Select clinically or microbiologically documented infection)(ANC Infection with unknown ANC --Select 36 <1.0 x 10e9/L, fever >=38.5 degrees C) Infection (documented clinically or microbiologically) with 35 SURGERY/INTRA-OPERATIVE INJURY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Intra-operative injury --Select 66 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select NSAIDS Infection with unknown ANC --Select 36 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 night blindness OCULAR/VISUAL nuccal rigidity Night blindness (nyctalopia) 52 NEUROLOGY Arachnoiditis/meningismus/radiculitis 47 nipple SEXUAL/REPRODUCTIVE FUNCTION numbness Breast nipple/areolar deformity 64 NEUROLOGY Neuropathy: sensory 50 nocturia RENAL/GENITOURINARY nyctalopia Urinary frequency/urgency 62 OCULAR/VISUAL Night blindness (nyctalopia) 52 nodal See: supraventricular and nodal arrhythmia nystagmus NEUROLOGY non-autologous HEMORRHAGE/BLEEDING Dizziness 48 Hemorrhage/bleeding associated with surgery, intra- 30 OCULAR/VISUAL operative or postoperative Nystagmus 53

neutrophils - nystagmus

85 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- O -- obesity CONSTITUTIONAL SYMPTOMS Obstruction/stenosis of airway --Select 58 Obesity 11 RENAL/GENITOURINARY Weight gain 12 Obstruction, GU --Select 61 ENDOCRINE Prolapse of stoma, GU 61 Cushingoid appearance (e.g., moon face, buffalo hump, 17 centripetal obesity, cutaneous striae) obtundation NEUROLOGY obstipation Somnolence/depressed level of consciousness 51 GASTROINTESTINAL Colitis 19 ocular Constipation 19 INFECTION Ileus, GI (functional obstruction of bowel, i.e., 23 Infection (documented clinically or microbiologically) with 35 neuroconstipation) Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select INFECTION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Colitis, infectious (e.g., Clostridium difficile) 35 Infection with unknown ANC --Select 36 obstruction MUSCULOSKELETAL/SOFT TISSUE ALLERGY/IMMUNOLOGY Muscle weakness, generalized or specific area (not due to 45 Allergic rhinitis (including sneezing, nasal stuffiness, 1 neuropathy) --Select postnasal drip) NEUROLOGY GASTROINTESTINAL Neuropathy: cranial --Select 50 Constipation 19 OCULAR/VISUAL Distension/bloating, abdominal 20 Glaucoma 52 Dysphagia (difficulty swallowing) 21 Ocular muscle weakness 52 Ileus, GI (functional obstruction of bowel, i.e., 23 Ocular surface disease 53 neuroconstipation) Vitreous hemorrhage 54 Obstruction, GI --Select 25 Prolapse of stoma, GI 26 PAIN Typhlitis (cecal inflammation) 27 Pain --Select 55 LYMPHATICS SURGERY/INTRA-OPERATIVE INJURY Dermal change lymphedema, phlebolymphedema 38 Intra-operative injury --Select 66

NEUROLOGY oculomotor Hydrocephalus 48 See: CN III PULMONARY/UPPER RESPIRATORY odor Nasal cavity/paranasal sinus reactions 58

obesity - odor

86 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- O --

opportunistic infection CONSTITUTIONAL SYMPTOMS INFECTION Odor (patient odor) 11 Opportunistic infection associated with >=Grade 2 36 Lymphopenia NEUROLOGY Neuropathy: cranial --Select 50 optic disc NEUROLOGY odynophagia Neuropathy: cranial --Select 50 GASTROINTESTINAL Dysphagia (difficulty swallowing) 21 OCULAR/VISUAL Optic disc edema 53 olfactory SURGERY/INTRA-OPERATIVE INJURY See: CN I Intra-operative injury --Select 66 oligospermia optic nerve SEXUAL/REPRODUCTIVE FUNCTION See: CN II Infertility/sterility 64 orgasm oliguria SEXUAL/REPRODUCTIVE FUNCTION COAGULATION Orgasmic dysfunction 65 DIC (disseminated intravascular coagulation) 10 GASTROINTESTINAL See: hypotension Dehydration 19 RENAL/GENITOURINARY osteoarthritis Renal failure 61 See: arthritis ophthalmologic changes osteochondroma OCULAR/VISUAL MUSCULOSKELETAL/SOFT TISSUE Cataract 52 Exostosis 43 Glaucoma 52 osteomalacia Keratitis (corneal inflammation/corneal ulceration) 52 Ocular surface disease 53 METABOLIC/LABORATORY Optic disc edema 53 Phosphate, serum-low (hypophosphatemia) 41 Retinal detachment 53 osteomyelitis Retinopathy 53 AUDITORY/EAR Scleral necrosis/melt 54 Uveitis 54 Otitis, external ear (non-infectious) 2 Vitreous hemorrhage 54 INFECTION

odynophagia - osteomyelitis

87 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- O --

otalgia Infection (documented clinically or microbiologically) with 35 AUDITORY/EAR Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Earache (otalgia) 2 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select otitis Infection with unknown ANC --Select 36 AUDITORY/EAR osteonecrosis Otitis, external ear (non-infectious) 2 GASTROINTESTINAL Otitis, middle ear (non-infectious) 2 Dental: 20 INFECTION periodontal disease Infection (documented clinically or microbiologically) with 35 MUSCULOSKELETAL/SOFT TISSUE Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Osteonecrosis (avascular necrosis) 45 Select Infection with unknown ANC --Select 36 osteopenia ENDOCRINE ototoxicity Neuroendocrine: 17 AUDITORY/EAR gonadotropin secretion abnormality Hearing: patients with/without baseline audiogram and 2 MUSCULOSKELETAL/SOFT TISSUE enrolled in a monitoring program Osteoporosis 46 ovary osteophytosis HEMORRHAGE/BLEEDING MUSCULOSKELETAL/SOFT TISSUE Hemorrhage, GU --Select 32 Exostosis 43 RENAL/GENITOURINARY Perforation, GU --Select 61 osteoporosis MUSCULOSKELETAL/SOFT TISSUE SURGERY/INTRA-OPERATIVE INJURY Osteoporosis 46 Intra-operative injury --Select 66 ostomy ovulation GASTROINTESTINAL ENDOCRINE Diarrhea 20 Neuroendocrine: 17 Prolapse of stoma, GI 26 prolactin hormone secretion abnormality PAIN RENAL/GENITOURINARY Pain --Select 55 Prolapse of stoma, GU 61 SEXUAL/REPRODUCTIVE FUNCTION SURGERY/INTRA-OPERATIVE INJURY Infertility/sterility 64 Intra-operative injury --Select 66

osteonecrosis - ovulation

88 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P -- pacemaker See: atrioventricular rhythm Hemorrhage, GI --Select 31 palate HEPATOBILIARY/PANCREAS See: CN X Pancreas, exocrine enzyme deficiency 34 NEUROLOGY Pancreatitis 34 Neuropathy: cranial --Select 50 INFECTION Infection (documented clinically or microbiologically) with 35 paleness Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select DERMATOLOGY/SKIN Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Hypopigmentation 14 Select Infection with unknown ANC --Select 36 palpitations METABOLIC/LABORATORY CARDIAC ARRHYTHMIA Amylase 40 Palpitations 5 Lipase 41 Supraventricular and nodal arrhythmia --Select 5 SURGERY/INTRA-OPERATIVE INJURY METABOLIC/LABORATORY Intra-operative injury --Select 66 Calcium, serum-low (hypocalcemia) 40 pancreatitis palsy HEPATOBILIARY/PANCREAS NEUROLOGY Pancreatitis 34 Tremor 51 METABOLIC/LABORATORY pan-uveitis Amylase 40 OCULAR/VISUAL Lipase 41 Uveitis 54 papillary formation pancreas LYMPHATICS ENDOCRINE Dermal change lymphedema, phlebolymphedema 38 Pancreatic endocrine: 18 papilloma glucose intolerance PULMONARY/UPPER RESPIRATORY GASTROINTESTINAL Voice changes/dysarthria (e.g., hoarseness, loss or 59 Fistula, GI --Select 22 alteration in voice, laryngitis) Leak (including anastomotic), GI --Select 23 Necrosis, GI --Select 25 papular Stricture/stenosis (including anastomotic), GI --Select 27 DERMATOLOGY/SKIN HEMORRHAGE/BLEEDING Rash/desquamation 15

pacemaker - paracentesis

89 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P -- paracentesis GASTROINTESTINAL METABOLIC/LABORATORY Ascites (non-malignant) 19 Calcium, serum-low (hypocalcemia) 40 NEUROLOGY paralysis Brachial plexopathy 47 HEMORRHAGE/BLEEDING Neuropathy: sensory 50 Hemorrhage, CNS 30 NEUROLOGY parotid CNS cerebrovascular ischemia 47 SURGERY/INTRA-OPERATIVE INJURY Neuropathy: motor 50 Intra-operative injury --Select 66 Phrenic nerve dysfunction 50 Pyramidal tract dysfunction (e.g., increased tone, 51 PD hyperreflexia, positive Babinski, decreased fine motor See: progressive disease coordination) PE paranasal PULMONARY/UPPER RESPIRATORY INFECTION Dyspnea (shortness of breath) 57 Infection (documented clinically or microbiologically) with 35 VASCULAR Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Thrombosis/embolism (vascular access-related) 70 Select Thrombosis/thrombus/embolism 70 Infection with unknown ANC --Select 36 pediatric PULMONARY/UPPER RESPIRATORY AUDITORY/EAR Nasal cavity/paranasal sinus reactions 58 Hearing: patients with/without baseline audiogram and 2 enrolled in a monitoring program parasthesia Hearing: patients without baseline audiogram and not 2 See: paresthesia enrolled in a monitoring program parathyroid CARDIAC GENERAL ENDOCRINE Hypertension 7 Parathyroid function, low (hypoparathyroidism) 18 HEMORRHAGE/BLEEDING METABOLIC/LABORATORY Hemorrhage/bleeding associated with surgery, intra- 30 Magnesium, serum-low (hypomagnesemia) 41 operative or postoperative METABOLIC/LABORATORY SURGERY/INTRA-OPERATIVE INJURY Creatinine 41 Intra-operative injury --Select 66 peeling paresthesia DERMATOLOGY/SKIN

paracentesis - peeling

90 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

Photosensitivity 15 PAIN Rash: hand-foot skin reaction 15 Pain --Select 55 peliosis SEXUAL/REPRODUCTIVE FUNCTION HEMORRHAGE/BLEEDING Ejaculatory dysfunction 64 Erectile dysfunction 64 Petechiae/purpura (hemorrhage/bleeding into skin or 32 mucosa) SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 pelvic See: pelvis perforation AUDITORY/EAR pelvis INFECTION Otitis, external ear (non-infectious) 2 Infection (documented clinically or microbiologically) with 35 GASTROINTESTINAL Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Colitis 19 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Dysphagia (difficulty swallowing) 21 Select Enteritis (inflammation of the small bowel) 21 Infection with unknown ANC --Select 36 Perforation, GI --Select 26 MUSCULOSKELETAL/SOFT TISSUE Proctitis 26 Fracture 44 Typhlitis (cecal inflammation) 27 Muscle weakness, generalized or specific area (not due to 45 HEPATOBILIARY/PANCREAS neuropathy) --Select Cholecystitis 34 Soft tissue necrosis --Select 46 INFECTION PAIN Colitis, infectious (e.g., Clostridium difficile) 35 Pain --Select 55 OCULAR/VISUAL RENAL/GENITOURINARY Keratitis (corneal inflammation/corneal ulceration) 52 Fistula, GU --Select 60 RENAL/GENITOURINARY SURGERY/INTRA-OPERATIVE INJURY Perforation, GU --Select 61 Intra-operative injury --Select 66 periarteritis nodosa penis ALLERGY/IMMUNOLOGY INFECTION Autoimmune reaction 1 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select pericardial effusion Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select CARDIAC GENERAL Infection with unknown ANC --Select 36 Pericardial effusion (non-malignant) 8

peliosis - perineum

91 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P -- perineum PAIN Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Pain --Select 55 Select Infection with unknown ANC --Select 36 periodontal PAIN GASTROINTESTINAL Pain --Select 55 Dental: 20 SURGERY/INTRA-OPERATIVE INJURY periodontal disease Intra-operative injury --Select 66 perirectal PAIN peritonitis Pain --Select 55 PAIN Pain --Select 55 peristomal GASTROINTESTINAL personality Prolapse of stoma, GI 26 NEUROLOGY Personality/behavioral 50 INFECTION Infection (documented clinically or microbiologically) with 35 petechiae Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select COAGULATION Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Thrombotic microangiopathy (e.g., thrombotic 10 Select thrombocytopenic purpura [TTP] or hemolytic uremic Infection with unknown ANC --Select 36 syndrome [HUS]) RENAL/GENITOURINARY HEMORRHAGE/BLEEDING Prolapse of stoma, GU 61 Petechiae/purpura (hemorrhage/bleeding into skin or 32 mucosa) peritoneum GASTROINTESTINAL petit mal Ascites (non-malignant) 19 See: seizure Colitis 19 Enteritis (inflammation of the small bowel) 21 pH Necrosis, GI --Select 25 METABOLIC/LABORATORY Typhlitis (cecal inflammation) 27 Acidosis (metabolic or respiratory) 40 Alkalosis (metabolic or respiratory) 40 HEMORRHAGE/BLEEDING Hemorrhage, GI --Select 31 phantom limb pain INFECTION PAIN Infection (documented clinically or microbiologically) with 35 Pain --Select 55 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select

perineum - pharynx

92 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P -- pharynx See: CN IX, CN X LYMPHATICS GASTROINTESTINAL Phlebolymphatic cording 39 Fistula, GI --Select 22 Leak (including anastomotic), GI --Select 23 phlebolymphedema Mucositis/stomatitis (clinical exam) --Select 24 LYMPHATICS Mucositis/stomatitis (functional/symptomatic) --Select 24 Dermal change lymphedema, phlebolymphedema 38 Necrosis, GI --Select 25 phosphate Stricture/stenosis (including anastomotic), GI --Select 27 METABOLIC/LABORATORY HEMORRHAGE/BLEEDING Phosphate, serum-low (hypophosphatemia) 41 Hemorrhage, pulmonary/upper respiratory --Select 32 INFECTION photophobia Infection (documented clinically or microbiologically) with 35 NEUROLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Arachnoiditis/meningismus/radiculitis 47 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 OCULAR/VISUAL Select Infection with unknown ANC --Select 36 Vision-photophobia 54

NEUROLOGY photopsia Neuropathy: cranial --Select 50 OCULAR/VISUAL PAIN Vision-flashing lights/floaters 54 Pain --Select 55 photosensitivity PULMONARY/UPPER RESPIRATORY DERMATOLOGY/SKIN Fistula, pulmonary/upper respiratory --Select 57 Photosensitivity 15 Obstruction/stenosis of airway --Select 58 NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY Arachnoiditis/meningismus/radiculitis 47 Intra-operative injury --Select 66 OCULAR/VISUAL phlebitis Vision-photophobia 54 DERMATOLOGY/SKIN phrenic nerve dysfunction Injection site reaction/extravasation changes 14 NEUROLOGY VASCULAR Phrenic nerve dysfunction 50 Phlebitis (including superficial thrombosis) 70 Thrombosis/embolism (vascular access-related) 70 pigmentation DERMATOLOGY/SKIN phlebolymphatic cording Hyperpigmentation 14

pharynx - pigmentation

93 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

Hypopigmentation 14 prolactin hormone secretion abnormality ENDOCRINE Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 Adrenal insufficiency 17 GROWTH AND DEVELOPMENT HEMORRHAGE/BLEEDING Short stature 29 Petechiae/purpura (hemorrhage/bleeding into skin or 32 SURGERY/INTRA-OPERATIVE INJURY mucosa) Intra-operative injury --Select 66 piles PJC GASTROINTESTINAL CARDIAC ARRHYTHMIA Hemorrhoids 22 Supraventricular and nodal arrhythmia --Select 5 pink eye platelets OCULAR/VISUAL BLOOD/BONE MARROW Ocular surface disease 53 Platelets 4 pinna HEMORRHAGE/BLEEDING SURGERY/INTRA-OPERATIVE INJURY Hematoma 30 Intra-operative injury --Select 66 Hemorrhage, CNS 30 Hemorrhage, GI --Select 31 pitting Hemorrhage, GU --Select 32 DERMATOLOGY/SKIN Hemorrhage, pulmonary/upper respiratory --Select 32 Nail changes 15 Hemorrhage/bleeding associated with surgery, intra- 30 operative or postoperative LYMPHATICS Petechiae/purpura (hemorrhage/bleeding into skin or 32 Edema: 38 mucosa) limb Edema: 38 pleura trunk/genital CONSTITUTIONAL SYMPTOMS Weight gain 12 pituitary ENDOCRINE HEMORRHAGE/BLEEDING Neuroendocrine: 17 Hemorrhage, pulmonary/upper respiratory --Select 32 ADH secretion abnormality (e.g., SIADH or low ADH) INFECTION Neuroendocrine: 17 Infection (documented clinically or microbiologically) with 35 gonadotropin secretion abnormality Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Neuroendocrine: 17 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 growth hormone secretion abnormality Select Neuroendocrine: 17 Infection with unknown ANC --Select 36

piles - pleura

94 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

PAIN Pneumonitis/pulmonary infiltrates 58 Pain --Select 55 Pneumothorax 58

PULMONARY/UPPER RESPIRATORY pneumonitis Dyspnea (shortness of breath) 57 PULMONARY/UPPER RESPIRATORY Fistula, pulmonary/upper respiratory --Select 57 Aspiration 56 Pleural effusion (non-malignant) 58 Pneumonitis/pulmonary infiltrates 58 SURGERY/INTRA-OPERATIVE INJURY Pulmonary fibrosis (radiographic changes) 59 Intra-operative injury --Select 66 pneumothorax pleural effusion PULMONARY/UPPER RESPIRATORY See: pleura Pneumothorax 58 pleurodesis pollakiuria PULMONARY/UPPER RESPIRATORY RENAL/GENITOURINARY Pleural effusion (non-malignant) 58 Urinary frequency/urgency 62 plexopathy polyarthritis NEUROLOGY MUSCULOSKELETAL/SOFT TISSUE Brachial plexopathy 47 Arthritis (non-septic) 43 plication PAIN See: diaphragmatic plication Pain --Select 55

PNC porokeratosis CARDIAC ARRHYTHMIA DERMATOLOGY/SKIN Supraventricular and nodal arrhythmia --Select 5 Rash/desquamation 15 pneumonia poroma INFECTION MUSCULOSKELETAL/SOFT TISSUE Infection (documented clinically or microbiologically) with 35 Exostosis 43 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 portal vein Select SURGERY/INTRA-OPERATIVE INJURY Infection with unknown ANC --Select 36 Intra-operative injury --Select 66 PULMONARY/UPPER RESPIRATORY VASCULAR Aspiration 56 Portal vein flow 70 Dyspnea (shortness of breath) 57 pleural effusion - post-infectious neuralgia

95 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P -- post-infectious neuralgia PAIN operative or postoperative Pain --Select 55 precocious postictal GROWTH AND DEVELOPMENT See: seizure Puberty (precocious) 29 postmenopausal premature MUSCULOSKELETAL/SOFT TISSUE CARDIAC ARRHYTHMIA Osteoporosis 46 Supraventricular and nodal arrhythmia --Select 5 Ventricular arrhythmia --Select 6 postnasal drip ALLERGY/IMMUNOLOGY pressure Allergic rhinitis (including sneezing, nasal stuffiness, 1 DERMATOLOGY/SKIN postnasal drip) Skin breakdown/decubitus ulcer 16 postural imbalance OCULAR/VISUAL NEUROLOGY Glaucoma 52 Ataxia (incoordination) 47 PAIN Pain --Select 55 potassium ENDOCRINE proctalgia Adrenal insufficiency 17 GASTROINTESTINAL Cushingoid appearance (e.g., moon face, buffalo hump, 17 Proctitis 26 centripetal obesity, cutaneous striae) PAIN METABOLIC/LABORATORY Pain --Select 55 Potassium, serum-high (hyperkalemia) 41 Potassium, serum-low (hypokalemia) 42 proctitis Uric acid, serum-high (hyperuricemia) 42 GASTROINTESTINAL pRBC Proctitis 26 HEMORRHAGE/BLEEDING progesterone Hematoma 30 ENDOCRINE Hemorrhage, CNS 30 Neuroendocrine: 17 Hemorrhage, GI --Select 31 prolactin hormone secretion abnormality Hemorrhage, GU --Select 32 Hemorrhage, pulmonary/upper respiratory --Select 32 progressive disease Hemorrhage/bleeding associated with surgery, intra- 30 DEATH

post-infectious neuralgia - progressive disease

96 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

Death not associated with CTCAE term --Select 13 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 prolactin ENDOCRINE prosthesis Neuroendocrine: 17 GASTROINTESTINAL prolactin hormone secretion abnormality Dental: 19 dentures or prosthesis prolapse INFECTION GASTROINTESTINAL Infection (documented clinically or microbiologically) with 35 Prolapse of stoma, GI 26 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select RENAL/GENITOURINARY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Prolapse of stoma, GU 61 Select Infection with unknown ANC --Select 36 promyelocytic MUSCULOSKELETAL/SOFT TISSUE SYNDROMES Local complication -device/prosthesis-related 44 "Retinoic acid syndrome" 69 Muscular/skeletal hypoplasia 45 proptosis SEXUAL/REPRODUCTIVE FUNCTION OCULAR/VISUAL Erectile dysfunction 64 Proptosis/enophthalmos 53 prostration prostate SYNDROMES HEMORRHAGE/BLEEDING Flu-like syndrome 68 Hemorrhage, GU --Select 32 protein INFECTION METABOLIC/LABORATORY Infection (documented clinically or microbiologically) with 35 Magnesium, serum-low (hypomagnesemia) 41 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Proteinuria 42 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select proteinuria Infection with unknown ANC --Select 36 METABOLIC/LABORATORY PAIN Proteinuria 42 Pain --Select 55 prothrombin time RENAL/GENITOURINARY COAGULATION Obstruction, GU --Select 61 Perforation, GU --Select 61 INR (International Normalized Ratio of prothrombin time) 10 Stricture/stenosis (including anastomotic), GU --Select 62 pruritis prolactin - pruritis

97 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

See: pruritus Psychosis (hallucinations/delusions) 50 pruritus PT ALLERGY/IMMUNOLOGY See: INR Allergic reaction/hypersensitivity (including drug fever) 1 PTT DERMATOLOGY/SKIN COAGULATION Injection site reaction/extravasation changes 14 PTT (Partial Thromboplastin Time) 10 Pruritus/itching 15 Rash/desquamation 15 HEMORRHAGE/BLEEDING Rash: acne/acneiform 15 Hematoma 30 Rash: dermatitis associated with radiation --Select 15 Hemorrhage, CNS 30 Rash: erythema multiforme (e.g., Stevens-Johnson 15 Hemorrhage, GI --Select 31 syndrome, toxic epidermal necrolysis) Hemorrhage, GU --Select 32 Rash: hand-foot skin reaction 15 Hemorrhage, pulmonary/upper respiratory --Select 32 METABOLIC/LABORATORY Hemorrhage/bleeding associated with surgery, intra- 30 operative or postoperative Bilirubin (hyperbilirubinemia) 40 Petechiae/purpura (hemorrhage/bleeding into skin or 32 SEXUAL/REPRODUCTIVE FUNCTION mucosa) Vaginitis (not due to infection) 65 puberty SYNDROMES GROWTH AND DEVELOPMENT Cytokine release syndrome/acute infusion reaction 68 Puberty (delayed) 29 Puberty (precocious) 29 pseudocysts HEPATOBILIARY/PANCREAS pulmonale Pancreatitis 34 CARDIAC GENERAL Right ventricular dysfunction (cor pulmonale) 9 pseudohypoparathyroidism ENDOCRINE Parathyroid function, low (hypoparathyroidism) 18 CARDIAC GENERAL Pulmonary hypertension 8 pseudomembranes Restrictive cardiomyopathy 8 GASTROINTESTINAL Right ventricular dysfunction (cor pulmonale) 9 Mucositis/stomatitis (clinical exam) --Select 24 PULMONARY/UPPER RESPIRATORY psychosis Dyspnea (shortness of breath) 57 NEUROLOGY VASCULAR Encephalopathy 48

pruritus - pulmonary edema

98 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- P --

Acute vascular leak syndrome 70 defined as ANC <1.0 x 10e9/L) INFECTION pupil See: CN III Febrile neutropenia (fever of unknown origin without 35 clinically or microbiologically documented infection)(ANC NEUROLOGY <1.0 x 10e9/L, fever >=38.5 degrees C) Neuropathy: cranial --Select 50 pyrosis purpura GASTROINTESTINAL ALLERGY/IMMUNOLOGY Heartburn/dyspepsia 22 Autoimmune reaction 1 COAGULATION DIC (disseminated intravascular coagulation) 10 Fibrinogen 10 INR (International Normalized Ratio of prothrombin time) 10 PTT (Partial Thromboplastin Time) 10 Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) DERMATOLOGY/SKIN Bruising (in absence of Grade 3 or 4 thrombocytopenia) 14 HEMORRHAGE/BLEEDING Petechiae/purpura (hemorrhage/bleeding into skin or 32 mucosa)

PVCs CARDIAC ARRHYTHMIA Ventricular arrhythmia --Select 6 pyramidal tract dysfunction NEUROLOGY Pyramidal tract dysfunction (e.g., increased tone, 51 hyperreflexia, positive Babinski, decreased fine motor coordination) pyrexia CONSTITUTIONAL SYMPTOMS Fever (in the absence of neutropenia, where neutropenia is 11 pupil - pyrosis

99 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- Q --

QTc CARDIAC ARRHYTHMIA Prolonged QTc interval 5 queasy GASTROINTESTINAL Nausea 24

QTc - queasy

100 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- R -- rachioscoliosis MUSCULOSKELETAL/SOFT TISSUE Lumbar spine-range of motion 44 Bone: spine-scoliosis 43 Trismus (difficulty, restriction or pain when opening mouth) 46 radiation rapid eye movements DERMATOLOGY/SKIN OCULAR/VISUAL Burn 14 Nystagmus 53 Rash: dermatitis associated with radiation --Select 15 rash GASTROINTESTINAL ALLERGY/IMMUNOLOGY Mucositis/stomatitis (clinical exam) --Select 24 Allergic reaction/hypersensitivity (including drug fever) 1 Mucositis/stomatitis (functional/symptomatic) --Select 24 Proctitis 26 DERMATOLOGY/SKIN Rash/desquamation 15 HEMORRHAGE/BLEEDING Rash: acne/acneiform 15 Hemorrhage, GI --Select 31 Rash: dermatitis associated with radiation --Select 15 Hemorrhage, GU --Select 32 Rash: erythema multiforme (e.g., Stevens-Johnson 15 Hemorrhage, pulmonary/upper respiratory --Select 32 syndrome, toxic epidermal necrolysis) LYMPHATICS Rash: hand-foot skin reaction 15 Dermal change lymphedema, phlebolymphedema 38 SYNDROMES MUSCULOSKELETAL/SOFT TISSUE Cytokine release syndrome/acute infusion reaction 68 Trismus (difficulty, restriction or pain when opening mouth) 46 RBC PULMONARY/UPPER RESPIRATORY BLOOD/BONE MARROW Pulmonary fibrosis (radiographic changes) 59 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hemolysis) radiculitis See: arachnoiditis COAGULATION Thrombotic microangiopathy (e.g., thrombotic 10 RAEB thrombocytopenic purpura [TTP] or hemolytic uremic BLOOD/BONE MARROW syndrome [HUS]) Myelodysplasia 4 HEMORRHAGE/BLEEDING Hematoma 30 range of motion Hemorrhage, CNS 30 LYMPHATICS Hemorrhage, GI --Select 31 Phlebolymphatic cording 39 Hemorrhage, GU --Select 32 MUSCULOSKELETAL/SOFT TISSUE Hemorrhage, pulmonary/upper respiratory --Select 32 Hemorrhage/bleeding associated with surgery, intra- 30 Cervical spine-range of motion 43 operative or postoperative Joint-function 44 rachioscoliosis - RBC

101 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- R --

Petechiae/purpura (hemorrhage/bleeding into skin or 32 INFECTION mucosa) Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select receptive dysphasia Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 NEUROLOGY Select Speech impairment (e.g., dysphasia or aphasia) 51 Infection with unknown ANC --Select 36 PAIN reconstruction Pain --Select 55 DERMATOLOGY/SKIN Burn 14 SURGERY/INTRA-OPERATIVE INJURY Skin breakdown/decubitus ulcer 16 Intra-operative injury --Select 66 Ulceration 16 reflexes Wound complication, non-infectious 16 NEUROLOGY MUSCULOSKELETAL/SOFT TISSUE Neuropathy: sensory 50 Local complication -device/prosthesis-related 44 Soft tissue necrosis --Select 46 reflux SURGERY/INTRA-OPERATIVE INJURY GASTROINTESTINAL Intra-operative injury --Select 66 Esophagitis 21 Gastritis (including bile reflux gastritis) 22 rectitis Heartburn/dyspepsia 22 See: proctitis regional ileitis rectum GASTROINTESTINAL GASTROINTESTINAL Colitis 19 Fistula, GI --Select 22 INFECTION Leak (including anastomotic), GI --Select 23 Colitis, infectious (e.g., Clostridium difficile) 35 Mucositis/stomatitis (clinical exam) --Select 24 Mucositis/stomatitis (functional/symptomatic) --Select 24 regurgitation Necrosis, GI --Select 25 CARDIAC GENERAL Obstruction, GI --Select 25 Valvular heart disease 9 Perforation, GI --Select 26 Proctitis 26 GASTROINTESTINAL Stricture/stenosis (including anastomotic), GI --Select 27 Heartburn/dyspepsia 22 Ulcer, GI --Select 28 Vomiting 28 HEMORRHAGE/BLEEDING renal Hemorrhage, GI --Select 31 BLOOD/BONE MARROW

receptive dysphasia - renal

102 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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Hemolysis (e.g., immune hemolytic anemia, drug-related 4 SURGERY/INTRA-OPERATIVE INJURY hemolysis) Intra-operative injury --Select 66 COAGULATION VASCULAR Thrombotic microangiopathy (e.g., thrombotic 10 Vessel injury-artery --Select 70 thrombocytopenic purpura [TTP] or hemolytic uremic Vessel injury-vein --Select 71 syndrome [HUS]) HEMORRHAGE/BLEEDING resection Hemorrhage, GU --Select 32 DERMATOLOGY/SKIN METABOLIC/LABORATORY Ulceration 16 Creatinine 41 Wound complication, non-infectious 16 Glomerular filtration rate 41 GASTROINTESTINAL Phosphate, serum-low (hypophosphatemia) 41 Gastritis (including bile reflux gastritis) 22 Sodium, serum-low (hyponatremia) 42 Necrosis, GI --Select 25 Uric acid, serum-high (hyperuricemia) 42 Obstruction, GI --Select 25 PAIN Stricture/stenosis (including anastomotic), GI --Select 27 Pain --Select 55 INFECTION RENAL/GENITOURINARY Colitis, infectious (e.g., Clostridium difficile) 35 Fistula, GU --Select 60 PULMONARY/UPPER RESPIRATORY Obstruction, GU --Select 61 Prolonged chest tube drainage or air leak after pulmonary 58 Perforation, GU --Select 61 resection Renal failure 61 Prolonged intubation after pulmonary resection (>24 hrs 59 Stricture/stenosis (including anastomotic), GU --Select 62 after surgery) Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 RENAL/GENITOURINARY tubular acidosis) Fistula, GU --Select 60 SYNDROMES Obstruction, GU --Select 61 Cytokine release syndrome/acute infusion reaction 68 Perforation, GU --Select 61 Stricture/stenosis (including anastomotic), GU --Select 62 repair Urinary retention (including neurogenic bladder) 62 GASTROINTESTINAL SURGERY/INTRA-OPERATIVE INJURY Dental: 20 Intra-operative injury --Select 66 teeth RENAL/GENITOURINARY residual urine Obstruction, GU --Select 61 RENAL/GENITOURINARY Stricture/stenosis (including anastomotic), GU --Select 62 Urinary retention (including neurogenic bladder) 62

repair - respiration

103 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- R -- respiration CARDIAC GENERAL Extrapyramidal/involuntary movement/restlessness 48 Left ventricular diastolic dysfunction 8 Irritability (children <3 years of age) 48 Left ventricular systolic dysfunction 8 restriction GASTROINTESTINAL GASTROINTESTINAL Mucositis/stomatitis (functional/symptomatic) --Select 24 Dental: 19 HEMORRHAGE/BLEEDING dentures or prosthesis Hemorrhage, pulmonary/upper respiratory --Select 32 MUSCULOSKELETAL/SOFT TISSUE HEPATOBILIARY/PANCREAS Cervical spine-range of motion 43 Liver dysfunction/failure (clinical) 34 Trismus (difficulty, restriction or pain when opening mouth) 46 METABOLIC/LABORATORY SYNDROMES Acidosis (metabolic or respiratory) 40 "Retinoic acid syndrome" 69 Alkalosis (metabolic or respiratory) 40 restrictive cardiomyopathy Magnesium, serum-high (hypermagnesemia) 41 CARDIAC GENERAL NEUROLOGY Restrictive cardiomyopathy 8 Apnea 47 Phrenic nerve dysfunction 50 resuscitation PULMONARY/UPPER RESPIRATORY CARDIAC GENERAL Adult Respiratory Distress Syndrome (ARDS) 56 Cardiopulmonary arrest, cause unknown (non-fatal) 7 Atelectasis 56 retention Edema, larynx 57 Fistula, pulmonary/upper respiratory --Select 57 RENAL/GENITOURINARY Hypoxia 57 Urinary retention (including neurogenic bladder) 62 Obstruction/stenosis of airway --Select 58 SYNDROMES Pleural effusion (non-malignant) 58 "Retinoic acid syndrome" 69 Pneumonitis/pulmonary infiltrates 58 Pneumothorax 58 retina SYNDROMES OCULAR/VISUAL "Retinoic acid syndrome" 69 Glaucoma 52 Retinal detachment 53 VASCULAR SURGERY/INTRA-OPERATIVE INJURY Acute vascular leak syndrome 70 Intra-operative injury --Select 66 restlessness Retinoic acid syndrome NEUROLOGY SYNDROMES

respiration - Retinoic acid syndrome

104 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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"Retinoic acid syndrome" 69 postnasal drip) retinopathy rhonchi OCULAR/VISUAL PULMONARY/UPPER RESPIRATORY Retinopathy 53 Adult Respiratory Distress Syndrome (ARDS) 56 Cough 56 retrograde ejaculation Voice changes/dysarthria (e.g., hoarseness, loss or 59 SEXUAL/REPRODUCTIVE FUNCTION alteration in voice, laryngitis) Ejaculatory dysfunction 64 rickets retroperitoneum See: phosphate HEMORRHAGE/BLEEDING ridging Hemorrhage, GU --Select 32 DERMATOLOGY/SKIN PAIN Nail changes 15 Pain --Select 55 rigors rhegmatogenous CONSTITUTIONAL SYMPTOMS OCULAR/VISUAL Rigors/chills 11 Retinal detachment 53 SYNDROMES rheumatism Cytokine release syndrome/acute infusion reaction 68 See: arthritis ringing in ears rhinitis See: tinnitus ALLERGY/IMMUNOLOGY ROM Allergic rhinitis (including sneezing, nasal stuffiness, 1 MUSCULOSKELETAL/SOFT TISSUE postnasal drip) Joint-function 44 INFECTION Infection (documented clinically or microbiologically) with 35 RTA Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select METABOLIC/LABORATORY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Phosphate, serum-low (hypophosphatemia) 41 Select Infection with unknown ANC --Select 36 RENAL/GENITOURINARY Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 rhinorrhea tubular acidosis) ALLERGY/IMMUNOLOGY Allergic rhinitis (including sneezing, nasal stuffiness, 1 rub

retinopathy - rub

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CARDIAC GENERAL Pericardial effusion (non-malignant) 8 Pericarditis 8 runny nose See: rhinitis rupture RENAL/GENITOURINARY Urinary retention (including neurogenic bladder) 62

runny nose - rupture

106 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- S -- sacral plexus SURGERY/INTRA-OPERATIVE INJURY PAIN Intra-operative injury --Select 66 Pain --Select 55 sadness schistocytes NEUROLOGY BLOOD/BONE MARROW Mood alteration --Select 49 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 hemolysis) saliva COAGULATION GASTROINTESTINAL Thrombotic microangiopathy (e.g., thrombotic 10 Dry mouth/salivary gland (xerostomia) 21 thrombocytopenic purpura [TTP] or hemolytic uremic Salivary gland changes/saliva 26 syndrome [HUS]) METABOLIC/LABORATORY salivary gland Bilirubin (hyperbilirubinemia) 40 GASTROINTESTINAL Dry mouth/salivary gland (xerostomia) 21 schizophrenia Fistula, GI --Select 22 NEUROLOGY Salivary gland changes/saliva 26 Psychosis (hallucinations/delusions) 50 INFECTION Infection (documented clinically or microbiologically) with 35 Schwartz-Bartter Syndrome Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select ENDOCRINE Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Neuroendocrine: 17 Select ADH secretion abnormality (e.g., SIADH or low ADH) Infection with unknown ANC --Select 36 scleral necrosis SURGERY/INTRA-OPERATIVE INJURY OCULAR/VISUAL Intra-operative injury --Select 66 Scleral necrosis/melt 54 salt craving sclero derma ENDOCRINE ALLERGY/IMMUNOLOGY Adrenal insufficiency 17 Autoimmune reaction 1 SAS sclerosis NEUROLOGY PULMONARY/UPPER RESPIRATORY Leukoencephalopathy (radiographic findings) 49 Pneumothorax 58 scalp Prolonged chest tube drainage or air leak after pulmonary 58 DERMATOLOGY/SKIN resection Hair loss/alopecia (scalp or body) 14 sacral plexus - scoliosis

107 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- S -- scoliosis MUSCULOSKELETAL/SOFT TISSUE HEPATOBILIARY/PANCREAS Bone: spine-scoliosis 43 Liver dysfunction/failure (clinical) 34 METABOLIC/LABORATORY scrotum Sodium, serum-high (hypernatremia) 42 INFECTION Infection (documented clinically or microbiologically) with 35 NEUROLOGY Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Arachnoiditis/meningismus/radiculitis 47 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 CNS cerebrovascular ischemia 47 Select Seizure 51 Infection with unknown ANC --Select 36 PAIN self-esteem Pain --Select 55 NEUROLOGY Confusion 48 SURGERY/INTRA-OPERATIVE INJURY Mood alteration --Select 49 Intra-operative injury --Select 66 Personality/behavioral 50 Psychosis (hallucinations/delusions) 50 OCULAR/VISUAL senility Keratitis (corneal inflammation/corneal ulceration) 52 NEUROLOGY Second degree block Confusion 48 See: atrioventricular rhythm Memory impairment 49

Second Malignancy sensory SECONDARY MALIGNANCY NEUROLOGY Secondary Malignancy - possibly related to cancer treatment 63 Myelitis 49 (Specify, __) Neuropathy: cranial --Select 50 Neuropathy: sensory 50 seizure SURGERY/INTRA-OPERATIVE INJURY COAGULATION Intra-operative injury --Select 66 Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) HEPATOBILIARY/PANCREAS ENDOCRINE Cholecystitis 34 Neuroendocrine: 17 Pancreatitis 34 ADH secretion abnormality (e.g., SIADH or low ADH) INFECTION HEMORRHAGE/BLEEDING Febrile neutropenia (fever of unknown origin without 35 Hemorrhage, CNS 30 scoliosis - sepsis

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clinically or microbiologically documented infection)(ANC SEXUAL/REPRODUCTIVE FUNCTION <1.0 x 10e9/L, fever >=38.5 degrees C) Ejaculatory dysfunction 64 Infection (documented clinically or microbiologically) with 35 Erectile dysfunction 64 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infertility/sterility 64 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Libido 65 Infection with unknown ANC --Select 36 Orgasmic dysfunction 65 Opportunistic infection associated with >=Grade 2 36 Vaginal dryness 65 Lymphopenia Vaginal mucositis 65 RENAL/GENITOURINARY SF Obstruction, GU --Select 61 CARDIAC GENERAL Stricture/stenosis (including anastomotic), GU --Select 62 Left ventricular systolic dysfunction 8 septic shock SGOT See: sepsis METABOLIC/LABORATORY sequestrectomy AST, SGOT(serum glutamic oxaloacetic transaminase) 40 MUSCULOSKELETAL/SOFT TISSUE SGPT Osteonecrosis (avascular necrosis) 45 METABOLIC/LABORATORY serologic ALT, SGPT (serum glutamic pyruvic transaminase) 40 ALLERGY/IMMUNOLOGY shaking Autoimmune reaction 1 CONSTITUTIONAL SYMPTOMS seroma Rigors/chills 11 MUSCULOSKELETAL/SOFT TISSUE NEUROLOGY Seroma 46 Pyramidal tract dysfunction (e.g., increased tone, 51 hyperreflexia, positive Babinski, decreased fine motor serum sickness coordination) ALLERGY/IMMUNOLOGY Tremor 51 Serum sickness 1 shock sex CARDIAC ARRHYTHMIA GROWTH AND DEVELOPMENT Conduction abnormality/atrioventricular heart block --Select 5 Puberty (delayed) 29 Prolonged QTc interval 5 PAIN Supraventricular and nodal arrhythmia --Select 5 Ventricular arrhythmia --Select 6 Pain --Select 55

septic shock - shock

109 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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SIADH CARDIAC GENERAL ENDOCRINE Hypotension 8 Neuroendocrine: 17 ADH secretion abnormality (e.g., SIADH or low ADH) INFECTION Febrile neutropenia (fever of unknown origin without 35 sicca clinically or microbiologically documented infection)(ANC OCULAR/VISUAL <1.0 x 10e9/L, fever >=38.5 degrees C) 53 Infection (documented clinically or microbiologically) with 35 Ocular surface disease Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Sick Sinus Syndrome Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select See: atrioventricular rhythm Infection with unknown ANC --Select 36 sight Opportunistic infection associated with >=Grade 2 36 Lymphopenia OCULAR/VISUAL Cataract 52 short stature Glaucoma 52 GROWTH AND DEVELOPMENT Vision-blurred vision 54 Short stature 29 Vision-flashing lights/floaters 54 Vision-photophobia 54 shortening fraction See: SF silent aspiration PULMONARY/UPPER RESPIRATORY shortness of breath Aspiration 56 CARDIAC ARRHYTHMIA Palpitations 5 singultus CARDIAC GENERAL PULMONARY/UPPER RESPIRATORY Left ventricular diastolic dysfunction 8 Hiccoughs (hiccups, singultus) 57 Left ventricular systolic dysfunction 8 sinus PULMONARY/UPPER RESPIRATORY CARDIAC ARRHYTHMIA Adult Respiratory Distress Syndrome (ARDS) 56 Conduction abnormality/atrioventricular heart block --Select 5 Dyspnea (shortness of breath) 57 Supraventricular and nodal arrhythmia --Select 5 Hypoxia 57 INFECTION Pneumothorax 58 Pulmonary fibrosis (radiographic changes) 59 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select shoulder Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select NEUROLOGY Infection with unknown ANC --Select 36 Brachial plexopathy 47

short stature - sinus

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PAIN ALLERGY/IMMUNOLOGY Pain --Select 55 Allergic rhinitis (including sneezing, nasal stuffiness, 1 postnasal drip) PULMONARY/UPPER RESPIRATORY Nasal cavity/paranasal sinus reactions 58 RENAL/GENITOURINARY Incontinence, urinary 60 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 sodium METABOLIC/LABORATORY sinusitis Sodium, serum-high (hypernatremia) 42 ALLERGY/IMMUNOLOGY Sodium, serum-low (hyponatremia) 42 Allergic reaction/hypersensitivity (including drug fever) 1 Allergic rhinitis (including sneezing, nasal stuffiness, 1 soft tissue postnasal drip) INFECTION sleep Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select CONSTITUTIONAL SYMPTOMS Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Insomnia 11 Select NEUROLOGY Infection with unknown ANC --Select 36 Mood alteration --Select 49 LYMPHATICS PULMONARY/UPPER RESPIRATORY Lymphedema-related fibrosis 39 Cough 56 MUSCULOSKELETAL/SOFT TISSUE Hiccoughs (hiccups, singultus) 57 Soft tissue necrosis --Select 46 slipped capital femoral epiphysis PULMONARY/UPPER RESPIRATORY GROWTH AND DEVELOPMENT Nasal cavity/paranasal sinus reactions 58 Bone growth: 29 somatotropin femoral head; slipped capital femoral epiphysis ENDOCRINE smell Neuroendocrine: 17 See: CN I growth hormone secretion abnormality CONSTITUTIONAL SYMPTOMS GROWTH AND DEVELOPMENT Odor (patient odor) 11 Short stature 29 NEUROLOGY somnolence Neuropathy: cranial --Select 50 ENDOCRINE sneezing Thyroid function, low (hypothyroidism) 18

sinusitis - somnolence

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sphincter NEUROLOGY GASTROINTESTINAL Encephalopathy 48 Incontinence, anal 23 Somnolence/depressed level of consciousness 51 SURGERY/INTRA-OPERATIVE INJURY spasms Intra-operative injury --Select 66 ENDOCRINE spinal accessory Thyroid function, low (hypothyroidism) 18 See: CN XI NEUROLOGY spinal cord Extrapyramidal/involuntary movement/restlessness 48 INFECTION PULMONARY/UPPER RESPIRATORY Infection (documented clinically or microbiologically) with 35 Cough 56 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select RENAL/GENITOURINARY Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Bladder spasms 60 Infection with unknown ANC --Select 36 speech NEUROLOGY AUDITORY/EAR Arachnoiditis/meningismus/radiculitis 47 Hearing: patients with/without baseline audiogram and 2 Ataxia (incoordination) 47 enrolled in a monitoring program Myelitis 49 NEUROLOGY SURGERY/INTRA-OPERATIVE INJURY Speech impairment (e.g., dysphasia or aphasia) 51 Intra-operative injury --Select 66 PULMONARY/UPPER RESPIRATORY spine Voice changes/dysarthria (e.g., hoarseness, loss or 59 alteration in voice, laryngitis) GROWTH AND DEVELOPMENT Bone growth: 29 sperm spine kyphosis/lordosis HEMORRHAGE/BLEEDING MUSCULOSKELETAL/SOFT TISSUE Hemorrhage, GU --Select 32 Bone: spine-scoliosis 43 RENAL/GENITOURINARY Cervical spine-range of motion 43 Leak (including anastomotic), GU --Select 60 Lumbar spine-range of motion 44 Obstruction, GU --Select 61 spleen Perforation, GU --Select 61 BLOOD/BONE MARROW Stricture/stenosis (including anastomotic), GU --Select 62 Splenic function 4 SEXUAL/REPRODUCTIVE FUNCTION INFECTION Infertility/sterility 64 Infection (documented clinically or microbiologically) with 35 spasms - spleen

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steatorrhea Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select HEPATOBILIARY/PANCREAS Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Pancreas, exocrine enzyme deficiency 34 Select Pancreatitis 34 Infection with unknown ANC --Select 36 SURGERY/INTRA-OPERATIVE INJURY stenosis Intra-operative injury --Select 66 ALLERGY/IMMUNOLOGY Allergic rhinitis (including sneezing, nasal stuffiness, 1 splenectomy postnasal drip) BLOOD/BONE MARROW AUDITORY/EAR Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Otitis, external ear (non-infectious) 2 hemolysis) CARDIAC GENERAL SURGERY/INTRA-OPERATIVE INJURY Valvular heart disease 9 Intra-operative injury --Select 66 GASTROINTESTINAL splenomegaly Obstruction, GI --Select 25 ALLERGY/IMMUNOLOGY Prolapse of stoma, GI 26 Serum sickness 1 Stricture/stenosis (including anastomotic), GI --Select 27 VASCULAR OCULAR/VISUAL Portal vein flow 70 Eyelid dysfunction 52 PULMONARY/UPPER RESPIRATORY ST-wave Nasal cavity/paranasal sinus reactions 58 CARDIAC GENERAL Obstruction/stenosis of airway --Select 58 Cardiac ischemia/infarction 7 RENAL/GENITOURINARY stasis Prolapse of stoma, GU 61 LYMPHATICS Stricture/stenosis (including anastomotic), GU --Select 62 Dermal change lymphedema, phlebolymphedema 38 SEXUAL/REPRODUCTIVE FUNCTION Vaginal stenosis/length 65 stature GROWTH AND DEVELOPMENT stent Short stature 29 INFECTION Infection (documented clinically or microbiologically) with 35 status epilepticus Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select See: seizure Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select steapsin Infection with unknown ANC --Select 36 See: lipase

splenectomy - stent

113 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

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PULMONARY/UPPER RESPIRATORY Lumbar spine-range of motion 44 Atelectasis 56 Stokes-Adams Fistula, pulmonary/upper respiratory --Select 57 See: atrioventricular rhythm Obstruction/stenosis of airway --Select 58 RENAL/GENITOURINARY stoma Obstruction, GU --Select 61 GASTROINTESTINAL Stricture/stenosis (including anastomotic), GU --Select 62 Leak (including anastomotic), GI --Select 23 Necrosis, GI --Select 25 sterile Obstruction, GI --Select 25 SEXUAL/REPRODUCTIVE FUNCTION Prolapse of stoma, GI 26 Infertility/sterility 64 Stricture/stenosis (including anastomotic), GI --Select 27 Ulcer, GI --Select 28 sternomastoid See: CN XI HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, GI --Select 31 Hemorrhage, GU --Select 32 Neuropathy: cranial --Select 50 Hemorrhage, pulmonary/upper respiratory --Select 32 steroids RENAL/GENITOURINARY ALLERGY/IMMUNOLOGY Leak (including anastomotic), GU --Select 60 Vasculitis 1 Obstruction, GU --Select 61 BLOOD/BONE MARROW Perforation, GU --Select 61 Hemolysis (e.g., immune hemolytic anemia, drug-related 4 Prolapse of stoma, GU 61 hemolysis) Stricture/stenosis (including anastomotic), GU --Select 62 PULMONARY/UPPER RESPIRATORY SURGERY/INTRA-OPERATIVE INJURY Obstruction/stenosis of airway --Select 58 Intra-operative injury --Select 66

SYNDROMES stomach "Retinoic acid syndrome" 69 GASTROINTESTINAL Stevens-Johnson Syndrome Fistula, GI --Select 22 Leak (including anastomotic), GI --Select 23 DERMATOLOGY/SKIN Mucositis/stomatitis (clinical exam) --Select 24 Rash: erythema multiforme (e.g., Stevens-Johnson 15 Mucositis/stomatitis (functional/symptomatic) --Select 24 syndrome, toxic epidermal necrolysis) Nausea 24 stiffness Necrosis, GI --Select 25 MUSCULOSKELETAL/SOFT TISSUE Obstruction, GI --Select 25 Joint-function 44 Perforation, GI --Select 26 sterile - stomach

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Stricture/stenosis (including anastomotic), GI --Select 27 Pancreas, exocrine enzyme deficiency 34 Ulcer, GI --Select 28 INFECTION Vomiting 28 Colitis, infectious (e.g., Clostridium difficile) 35 HEMORRHAGE/BLEEDING Hemorrhage, GI --Select 31 storm See: thyroid storm INFECTION ENDOCRINE Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Thyroid function, high (hyperthyroidism, thyrotoxicosis) Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 strabismus Select Infection with unknown ANC --Select 36 NEUROLOGY Neuropathy: cranial --Select 50 PAIN Pain --Select 55 SURGERY/INTRA-OPERATIVE INJURY See: striae Intra-operative injury --Select 66 striae stomatitis DERMATOLOGY/SKIN DERMATOLOGY/SKIN Striae 16 Rash: erythema multiforme (e.g., Stevens-Johnson 15 ENDOCRINE syndrome, toxic epidermal necrolysis) Cushingoid appearance (e.g., moon face, buffalo hump, 17 GASTROINTESTINAL centripetal obesity, cutaneous striae) Mucositis/stomatitis (clinical exam) --Select 24 stricture Mucositis/stomatitis (functional/symptomatic) --Select 24 GASTROINTESTINAL Salivary gland changes/saliva 26 Obstruction, GI --Select 25 stool Stricture/stenosis (including anastomotic), GI --Select 27 GASTROINTESTINAL RENAL/GENITOURINARY Colitis 19 Stricture/stenosis (including anastomotic), GU --Select 62 Constipation 19 Diarrhea 20 stricture/stenosis (including Enteritis (inflammation of the small bowel) 21 anastomotic)GASTROINTESTINAL Incontinence, anal 23 Dysphagia (difficulty swallowing) 21 Proctitis 26 Obstruction, GI --Select 25 Typhlitis (cecal inflammation) 27 Prolapse of stoma, GI 26 HEPATOBILIARY/PANCREAS Stricture/stenosis (including anastomotic), GI --Select 27

stomatitis - stricture/stenosis (including anastomotic)

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stupor RENAL/GENITOURINARY HEPATOBILIARY/PANCREAS Prolapse of stoma, GU 61 Liver dysfunction/failure (clinical) 34 Stricture/stenosis (including anastomotic), GU --Select 62 NEUROLOGY Urinary retention (including neurogenic bladder) 62 Arachnoiditis/meningismus/radiculitis 47 stridor Somnolence/depressed level of consciousness 51 PULMONARY/UPPER RESPIRATORY subarachnoid Edema, larynx 57 HEMORRHAGE/BLEEDING Obstruction/stenosis of airway --Select 58 Hemorrhage, CNS 30 Voice changes/dysarthria (e.g., hoarseness, loss or 59 alteration in voice, laryngitis) NEUROLOGY Arachnoiditis/meningismus/radiculitis 47 stroke Leukoencephalopathy (radiographic findings) 49 COAGULATION Thrombotic microangiopathy (e.g., thrombotic 10 subdural thrombocytopenic purpura [TTP] or hemolytic uremic HEMORRHAGE/BLEEDING syndrome [HUS]) Hemorrhage, CNS 30 HEMORRHAGE/BLEEDING Hemorrhage, CNS 30 sublingual GASTROINTESTINAL NEUROLOGY Salivary gland changes/saliva 26 CNS cerebrovascular ischemia 47 Syncope (fainting) 51 substernal pain VASCULAR CARDIAC GENERAL Vessel injury-artery --Select 70 Cardiac ischemia/infarction 7 GASTROINTESTINAL stuffiness Heartburn/dyspepsia 22 ALLERGY/IMMUNOLOGY Allergic rhinitis (including sneezing, nasal stuffiness, 1 PAIN postnasal drip) Pain --Select 55 stumbling sudden death MUSCULOSKELETAL/SOFT TISSUE DEATH Extremity-lower (gait/walking) 43 Death not associated with CTCAE term --Select 13 NEUROLOGY sufficient Ataxia (incoordination) 47 AUDITORY/EAR

stridor - sufficient

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Hearing: patients with/without baseline audiogram and 2 Hot flashes/flushes 17 enrolled in a monitoring program SYNDROMES Cytokine release syndrome/acute infusion reaction 68 NEUROLOGY swelling Mood alteration --Select 49 DERMATOLOGY/SKIN sunburn Injection site reaction/extravasation changes 14 DERMATOLOGY/SKIN GASTROINTESTINAL Photosensitivity 15 Distension/bloating, abdominal 20 supraventricular and nodal LYMPHATICS arrhythmiaCARDIAC ARRHYTHMIA Dermal change lymphedema, phlebolymphedema 38 Edema: 38 Supraventricular and nodal arrhythmia --Select 5 limb SVC Edema: 38 trunk/genital VASCULAR Edema: 38 Vessel injury-vein --Select 71 viscera Lymphocele 39 SVT MUSCULOSKELETAL/SOFT TISSUE See: supraventricular and nodal arrhythmia Arthritis (non-septic) 43 swallowing symblepharon GASTROINTESTINAL OCULAR/VISUAL Dysphagia (difficulty swallowing) 21 Esophagitis 21 Eyelid dysfunction 52 Mucositis/stomatitis (functional/symptomatic) --Select 24 syncope NEUROLOGY ALLERGY/IMMUNOLOGY Neuropathy: cranial --Select 50 Autoimmune reaction 1 PULMONARY/UPPER RESPIRATORY CARDIAC ARRHYTHMIA Aspiration 56 Conduction abnormality/atrioventricular heart block --Select 5 Prolonged QTc interval 5 sweating Supraventricular and nodal arrhythmia --Select 5 CONSTITUTIONAL SYMPTOMS Vasovagal episode 6 Sweating (diaphoresis) 12 Ventricular arrhythmia --Select 6 ENDOCRINE ENDOCRINE

suicidal ideation - syncope

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-- S --

Adrenal insufficiency 17 Flu-like syndrome 68 HEMORRHAGE/BLEEDING Thrombotic microangiopathy 69 Tumor flare 69 Hemorrhage, CNS 30 Tumor lysis syndrome 69 NEUROLOGY CNS cerebrovascular ischemia 47 systolic Dizziness 48 CARDIAC GENERAL Syncope (fainting) 51 Left ventricular systolic dysfunction 8 syndrome CARDIAC ARRHYTHMIA Conduction abnormality/atrioventricular heart block --Select 5 COAGULATION Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) DERMATOLOGY/SKIN Rash: erythema multiforme (e.g., Stevens-Johnson 15 syndrome, toxic epidermal necrolysis) ENDOCRINE Neuroendocrine: 17 ADH secretion abnormality (e.g., SIADH or low ADH) METABOLIC/LABORATORY Proteinuria 42 OCULAR/VISUAL Dry eye syndrome 52 PULMONARY/UPPER RESPIRATORY Adult Respiratory Distress Syndrome (ARDS) 56 RENAL/GENITOURINARY Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 tubular acidosis) SYNDROMES "Retinoic acid syndrome" 69 Alcohol intolerance syndrome (antabuse-like syndrome) 68 Cytokine release syndrome/acute infusion reaction 68 syndrome - systolic

118 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- T -- t-score MUSCULOSKELETAL/SOFT TISSUE Puberty (delayed) 29 Osteoporosis 46 taste T-wave See: CN VI, CN IX CARDIAC GENERAL GASTROINTESTINAL Cardiac ischemia/infarction 7 Salivary gland changes/saliva 26 Taste alteration (dysgeusia) 27 METABOLIC/LABORATORY Potassium, serum-high (hyperkalemia) 41 NEUROLOGY Neuropathy: cranial --Select 50 tachycardia SURGERY/INTRA-OPERATIVE INJURY CARDIAC ARRHYTHMIA Intra-operative injury --Select 66 Supraventricular and nodal arrhythmia --Select 5 Ventricular arrhythmia --Select 6 tearing SYNDROMES OCULAR/VISUAL Cytokine release syndrome/acute infusion reaction 68 Watery eye (epiphora, tearing) 54 tachypnea teeth CARDIAC GENERAL GASTROINTESTINAL Left ventricular diastolic dysfunction 8 Dental: 20 Left ventricular systolic dysfunction 8 teeth development Dental: 20 PULMONARY/UPPER RESPIRATORY teeth Adult Respiratory Distress Syndrome (ARDS) 56 PAIN Cough 56 Pain --Select 55 Pneumothorax 58 Pulmonary fibrosis (radiographic changes) 59 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 talk NEUROLOGY telangiectasia Speech impairment (e.g., dysphasia or aphasia) 51 DERMATOLOGY/SKIN Telangiectasia 16 tamponade OCULAR/VISUAL CARDIAC GENERAL Eyelid dysfunction 52 Pericardial effusion (non-malignant) 8 temperature Tanner Stage CONSTITUTIONAL SYMPTOMS GROWTH AND DEVELOPMENT

t-score - temperature

119 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- T --

Fever (in the absence of neutropenia, where neutropenia is 11 RENAL/GENITOURINARY defined as ANC <1.0 x 10e9/L) Renal failure 61 INFECTION Febrile neutropenia (fever of unknown origin without 35 tethering clinically or microbiologically documented infection)(ANC LYMPHATICS <1.0 x 10e9/L, fever >=38.5 degrees C) Lymphedema-related fibrosis 39

TEN MUSCULOSKELETAL/SOFT TISSUE See: Stevens-Johnson Syndrome Fibrosis-deep connective tissue 44 tenesmus Third degree block GASTROINTESTINAL See: atrioventricular rhythm Proctitis 26 thirst testes GASTROINTESTINAL GROWTH AND DEVELOPMENT Dehydration 19 Puberty (delayed) 29 Dry mouth/salivary gland (xerostomia) 21 HEMORRHAGE/BLEEDING thombolysis Hemorrhage, GU --Select 32 HEMORRHAGE/BLEEDING PAIN Hemorrhage, CNS 30 Pain --Select 55 thoracentesis RENAL/GENITOURINARY PULMONARY/UPPER RESPIRATORY Obstruction, GU --Select 61 Chylothorax 56 Perforation, GU --Select 61 Pleural effusion (non-malignant) 58 Stricture/stenosis (including anastomotic), GU --Select 62 thoracostomy tetany PULMONARY/UPPER RESPIRATORY ENDOCRINE Fistula, pulmonary/upper respiratory --Select 57 Parathyroid function, low (hypoparathyroidism) 18 Prolonged chest tube drainage or air leak after pulmonary 58 METABOLIC/LABORATORY resection Calcium, serum-low (hypocalcemia) 40 thought processes Magnesium, serum-low (hypomagnesemia) 41 NEUROLOGY Phosphate, serum-low (hypophosphatemia) 41 Mood alteration --Select 49 MUSCULOSKELETAL/SOFT TISSUE Trismus (difficulty, restriction or pain when opening mouth) 46 threshold shift

TEN - threshold shift

120 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- T --

AUDITORY/EAR Intra-operative injury --Select 66 Hearing: patients with/without baseline audiogram and 2 enrolled in a monitoring program thyroid storm ENDOCRINE thrombocytopenia Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 BLOOD/BONE MARROW Platelets 4 thyroplasty NEUROLOGY COAGULATION Laryngeal nerve dysfunction 48 Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic thyrotoxicosis syndrome [HUS]) ENDOCRINE DERMATOLOGY/SKIN Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 Bruising (in absence of Grade 3 or 4 thrombocytopenia) 14 thyroxin thromboplastin ENDOCRINE COAGULATION Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 PTT (Partial Thromboplastin Time) 10 TIA thrombosis NEUROLOGY COAGULATION CNS cerebrovascular ischemia 47 Thrombotic microangiopathy (e.g., thrombotic 10 Syncope (fainting) 51 thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) tidal volume VASCULAR See: FEV1 Phlebitis (including superficial thrombosis) 70 Thrombosis/embolism (vascular access-related) 70 tingling Thrombosis/thrombus/embolism 70 NEUROLOGY Neuropathy: cranial --Select 50 thyroid Neuropathy: sensory 50 ALLERGY/IMMUNOLOGY Autoimmune reaction 1 tinnitus AUDITORY/EAR ENDOCRINE Tinnitus 3 Adrenal insufficiency 17 Thyroid function, high (hyperthyroidism, thyrotoxicosis) 18 NEUROLOGY Thyroid function, low (hypothyroidism) 18 Dizziness 48 SURGERY/INTRA-OPERATIVE INJURY

thrombocytopenia - tired

121 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- T -- tired torticollis CONSTITUTIONAL SYMPTOMS NEUROLOGY Fatigue (asthenia, lethargy, malaise) 11 Extrapyramidal/involuntary movement/restlessness 48

TMJ trachea PAIN GASTROINTESTINAL Pain --Select 55 Mucositis/stomatitis (clinical exam) --Select 24 Mucositis/stomatitis (functional/symptomatic) --Select 24 Todd's paralysis HEMORRHAGE/BLEEDING NEUROLOGY Hemorrhage, pulmonary/upper respiratory --Select 32 Seizure 51 INFECTION toenails Infection (documented clinically or microbiologically) with 35 DERMATOLOGY/SKIN Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Nail changes 15 Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 See: CN IX, CN XII PULMONARY/UPPER RESPIRATORY NEUROLOGY Fistula, pulmonary/upper respiratory --Select 57 Neuropathy: cranial --Select 50 Obstruction/stenosis of airway --Select 58 SURGERY/INTRA-OPERATIVE INJURY SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 Intra-operative injury --Select 66 tonic tracheo-esophageal See: seizure GASTROINTESTINAL Fistula, GI --Select 22 tooth See: teeth PULMONARY/UPPER RESPIRATORY Fistula, pulmonary/upper respiratory --Select 57 toothache PAIN tracheotomy Pain --Select 55 LYMPHATICS Edema: 38 Torsade de pointes head and neck CARDIAC ARRHYTHMIA NEUROLOGY Prolonged QTc interval 5 Laryngeal nerve dysfunction 48 Ventricular arrhythmia --Select 6 PULMONARY/UPPER RESPIRATORY

tired - tracheotomy

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-- T --

Edema, larynx 57 METABOLIC/LABORATORY Obstruction/stenosis of airway --Select 58 Glomerular filtration rate 41 Prolonged intubation after pulmonary resection (>24 hrs 59 RENAL/GENITOURINARY after surgery) Renal failure 61 transaminase See: ALT, AST transudate METABOLIC/LABORATORY PULMONARY/UPPER RESPIRATORY ALT, SGPT (serum glutamic pyruvic transaminase) Pleural effusion (non-malignant) 58 AST, SGOT(serum glutamic oxaloacetic transaminase) trapezius transfusion See: CN XI BLOOD/BONE MARROW tremor Hemolysis (e.g., immune hemolytic anemia, drug-related 4 METABOLIC/LABORATORY hemolysis) Magnesium, serum-low (hypomagnesemia) 41 HEMORRHAGE/BLEEDING NEUROLOGY Hematoma 30 Hemorrhage, CNS 30 Extrapyramidal/involuntary movement/restlessness 48 Hemorrhage, GI --Select 31 Pyramidal tract dysfunction (e.g., increased tone, 51 hyperreflexia, positive Babinski, decreased fine motor Hemorrhage, GU --Select 32 coordination) Hemorrhage, pulmonary/upper respiratory --Select 32 Tremor 51 Hemorrhage/bleeding associated with surgery, intra- 30 operative or postoperative tresis Petechiae/purpura (hemorrhage/bleeding into skin or 32 GASTROINTESTINAL mucosa) Perforation, GI --Select 26 RENAL/GENITOURINARY Cystitis 60 trichiasis OCULAR/VISUAL transient Eyelid dysfunction 52 See: TIA trichoma transplant See: trichiasis CARDIAC GENERAL Left ventricular diastolic dysfunction 8 trigeminal Left ventricular systolic dysfunction 8 See: CN V Restrictive cardiomyopathy 8 Right ventricular dysfunction (cor pulmonale) 9 trigeminy

transaminase - trigeminy

123 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- T --

CARDIAC ARRHYTHMIA (Specify, __) Ventricular arrhythmia --Select 6 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 triglyceride Tumor flare 69 METABOLIC/LABORATORY Tumor lysis syndrome 69 Lipase 41 Triglyceride, serum-high (hypertriglyceridemia) 42 turgor GASTROINTESTINAL trismus Dehydration 19 METABOLIC/LABORATORY Calcium, serum-low (hypocalcemia) 40 LYMPHATICS Dermal change lymphedema, phlebolymphedema 38 MUSCULOSKELETAL/SOFT TISSUE Lymphedema-related fibrosis 39 Trismus (difficulty, restriction or pain when opening mouth) 46 TURP trochlear RENAL/GENITOURINARY See: CN IV Urinary retention (including neurogenic bladder) 62 troponin tympanic membrane See: cardiac troponin AUDITORY/EAR TSH Otitis, external ear (non-infectious) 2 ENDOCRINE tympanostomy Thyroid function, low (hypothyroidism) 18 AUDITORY/EAR TTP Otitis, external ear (non-infectious) 2 COAGULATION tympany Thrombotic microangiopathy (e.g., thrombotic 10 thrombocytopenic purpura [TTP] or hemolytic uremic GASTROINTESTINAL syndrome [HUS]) Distension/bloating, abdominal 20 SYNDROMES typhlitis Thrombotic microangiopathy 69 GASTROINTESTINAL tumor Typhlitis (cecal inflammation) 27 PAIN Pain --Select 55 SECONDARY MALIGNANCY Secondary Malignancy - possibly related to cancer treatment 63 triglyceride - typhlitis

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-- U -- ulcer DERMATOLOGY/SKIN Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Skin breakdown/decubitus ulcer 16 Select Infection with unknown ANC --Select 36 GASTROINTESTINAL Distension/bloating, abdominal 20 uremic Gastritis (including bile reflux gastritis) 22 COAGULATION Mucositis/stomatitis (clinical exam) --Select 24 Thrombotic microangiopathy (e.g., thrombotic 10 Mucositis/stomatitis (functional/symptomatic) --Select 24 thrombocytopenic purpura [TTP] or hemolytic uremic Ulcer, GI --Select 28 syndrome [HUS]) RENAL/GENITOURINARY ulceration Renal failure 61 DERMATOLOGY/SKIN Injection site reaction/extravasation changes 14 uremic frost Rash: acne/acneiform 15 RENAL/GENITOURINARY Rash: dermatitis associated with radiation --Select 15 Renal failure 61 Rash: erythema multiforme (e.g., Stevens-Johnson 15 syndrome, toxic epidermal necrolysis) urgency Ulceration 16 GASTROINTESTINAL GASTROINTESTINAL Diarrhea 20 Dysphagia (difficulty swallowing) 21 RENAL/GENITOURINARY Mucositis/stomatitis (clinical exam) --Select 24 Urinary frequency/urgency 62 Ulcer, GI --Select 28 LYMPHATICS uric acid Dermal change lymphedema, phlebolymphedema 38 METABOLIC/LABORATORY Edema: 38 Uric acid, serum-high (hyperuricemia) 42 head and neck urinary OCULAR/VISUAL HEMORRHAGE/BLEEDING Keratitis (corneal inflammation/corneal ulceration) 52 Hemorrhage, GU --Select 32 SEXUAL/REPRODUCTIVE FUNCTION INFECTION Vaginal mucositis 65 Vaginitis (not due to infection) 65 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select ungual Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select INFECTION Infection with unknown ANC --Select 36 Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select PAIN

ulcer - urinary

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-- U --

Pain --Select 55 Perforation, GU --Select 61 RENAL/GENITOURINARY Stricture/stenosis (including anastomotic), GU --Select 62 Fistula, GU --Select 60 SURGERY/INTRA-OPERATIVE INJURY Incontinence, urinary 60 Intra-operative injury --Select 66 Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 62 tubular acidosis) uveitis Urinary frequency/urgency 62 OCULAR/VISUAL Urinary retention (including neurogenic bladder) 62 Uveitis 54 Urine color change 62 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 urticaria ALLERGY/IMMUNOLOGY Allergic reaction/hypersensitivity (including drug fever) 1 DERMATOLOGY/SKIN Urticaria (hives, welts, wheals) 16 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 uterus HEMORRHAGE/BLEEDING Hemorrhage, GU --Select 32 INFECTION Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 PAIN Pain --Select 55 RENAL/GENITOURINARY Fistula, GU --Select 60 Leak (including anastomotic), GU --Select 60 Obstruction, GU --Select 61 urticaria - uveitis

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-- V -- vagina HEMORRHAGE/BLEEDING GASTROINTESTINAL Hemorrhage, GU --Select 32 Hemorrhoids 22 INFECTION HEMORRHAGE/BLEEDING Infection (documented clinically or microbiologically) with 35 Hemorrhage, GI --Select 31 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 vas deferens Select HEMORRHAGE/BLEEDING Infection with unknown ANC --Select 36 Hemorrhage, GU --Select 32 PAIN RENAL/GENITOURINARY Pain --Select 55 Leak (including anastomotic), GU --Select 60 RENAL/GENITOURINARY Obstruction, GU --Select 61 Fistula, GU --Select 60 Perforation, GU --Select 61 Leak (including anastomotic), GU --Select 60 Stricture/stenosis (including anastomotic), GU --Select 62 Obstruction, GU --Select 61 Perforation, GU --Select 61 vasculitis Stricture/stenosis (including anastomotic), GU --Select 62 ALLERGY/IMMUNOLOGY Vasculitis 1 SEXUAL/REPRODUCTIVE FUNCTION Vaginal discharge (non-infectious) 65 DERMATOLOGY/SKIN Vaginal dryness 65 Rash: hand-foot skin reaction 15 Vaginal mucositis 65 vasomotor Vaginal stenosis/length 65 Vaginitis (not due to infection) 65 ENDOCRINE Hot flashes/flushes 17 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66 vasopressin ENDOCRINE vaginitis See: vagina Neuroendocrine: 17 ADH secretion abnormality (e.g., SIADH or low ADH) Vagus vasovagal See: CN X CARDIAC ARRHYTHMIA valve Vasovagal episode 6 CARDIAC GENERAL vein Valvular heart disease 9 INFECTION varices Infection (documented clinically or microbiologically) with 35

vagina - vein

127 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- V --

Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select See: dizziness Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select vesicular Infection with unknown ANC --Select 36 DERMATOLOGY/SKIN LYMPHATICS Rash/desquamation 15 Phlebolymphatic cording 39 vestibulocochlear SURGERY/INTRA-OPERATIVE INJURY See: CN VIII Intra-operative injury --Select 66 viral hepatitis VASCULAR INFECTION Portal vein flow 70 Viral hepatitis 36 Thrombosis/embolism (vascular access-related) 70 Thrombosis/thrombus/embolism 70 virilism Vessel injury to a vein intra-operatively 71 ENDOCRINE ventilation Masculinization of female 17 NEUROLOGY viscera Phrenic nerve dysfunction 50 LYMPHATICS PULMONARY/UPPER RESPIRATORY Edema: 38 Chylothorax 56 viscera FEV(1) 57 SURGERY/INTRA-OPERATIVE INJURY Hypoxia 57 Intra-operative injury --Select 66 Pleural effusion (non-malignant) 58 VASCULAR Pneumonitis/pulmonary infiltrates 58 Vessel injury-artery --Select 70 Pneumothorax 58 Vessel injury-vein --Select 71 SYNDROMES Visceral arterial ischemia (non-myocardial) 71 "Retinoic acid syndrome" 69 Cytokine release syndrome/acute infusion reaction 68 vision See: CN II VASCULAR NEUROLOGY Acute vascular leak syndrome 70 Neuropathy: cranial --Select 50 ventriculostomy OCULAR/VISUAL HEMORRHAGE/BLEEDING Cataract 52 Hemorrhage, CNS 30 Dry eye syndrome 52 Eyelid dysfunction 52

ventilation - vision

128 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- V --

vocal cord See: CN II NEUROLOGY Glaucoma 52 Laryngeal nerve dysfunction 48 Keratitis (corneal inflammation/corneal ulceration) 52 Night blindness (nyctalopia) 52 VOD Nystagmus 53 CONSTITUTIONAL SYMPTOMS Ocular surface disease 53 Weight gain 12 Ophthalmoplegia/diplopia (double vision) 53 VASCULAR Optic disc edema 53 Portal vein flow 70 Proptosis/enophthalmos 53 Retinal detachment 53 voice Retinopathy 53 NEUROLOGY Scleral necrosis/melt 54 Speech impairment (e.g., dysphasia or aphasia) 51 Uveitis 54 Vision-blurred vision 54 PULMONARY/UPPER RESPIRATORY Vision-flashing lights/floaters 54 Voice changes/dysarthria (e.g., hoarseness, loss or 59 Vision-photophobia 54 alteration in voice, laryngitis) Vitreous hemorrhage 54 vomiting Watery eye (epiphora, tearing) 54 ENDOCRINE vital Adrenal insufficiency 17 PULMONARY/UPPER RESPIRATORY GASTROINTESTINAL Vital capacity 59 Dehydration 19 Ileus, GI (functional obstruction of bowel, i.e., 23 neuroconstipation) DERMATOLOGY/SKIN Nausea 24 Hypopigmentation 14 Obstruction, GI --Select 25 Stricture/stenosis (including anastomotic), GI --Select 27 ENDOCRINE Ulcer, GI --Select 28 Adrenal insufficiency 17 Vomiting 28 vitrectomy NEUROLOGY OCULAR/VISUAL Arachnoiditis/meningismus/radiculitis 47 Vitreous hemorrhage 54 SYNDROMES Cytokine release syndrome/acute infusion reaction 68 vitreous OCULAR/VISUAL vulva Vitreous hemorrhage 54 INFECTION

vital - vulva

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-- V --

Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 SURGERY/INTRA-OPERATIVE INJURY Intra-operative injury --Select 66

vital - vulva

130 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- W -- wakefulness weight CONSTITUTIONAL SYMPTOMS CONSTITUTIONAL SYMPTOMS Insomnia 11 Obesity 11 Weight gain 12 walk Weight loss 12 MUSCULOSKELETAL/SOFT TISSUE ENDOCRINE Extremity-lower (gait/walking) 43 Adrenal insufficiency 17 NEUROLOGY Thyroid function, low (hypothyroidism) 18 Neuropathy: motor 50 GASTROINTESTINAL watery eye Anorexia 19 OCULAR/VISUAL Malabsorption 23 Nausea 24 Watery eye (epiphora, tearing) 54 Vomiting 28 WBC HEPATOBILIARY/PANCREAS BLOOD/BONE MARROW Pancreas, exocrine enzyme deficiency 34 Leukocytes (total WBC) 4 SYNDROMES weakness "Retinoic acid syndrome" 69 ENDOCRINE welts Adrenal insufficiency 17 DERMATOLOGY/SKIN GASTROINTESTINAL Urticaria (hives, welts, wheals) 16 Malabsorption 23 SYNDROMES METABOLIC/LABORATORY Cytokine release syndrome/acute infusion reaction 68 Sodium, serum-low (hyponatremia) 42 Wenckebach MUSCULOSKELETAL/SOFT TISSUE CARDIAC ARRHYTHMIA Extremity-lower (gait/walking) 43 Conduction abnormality/atrioventricular heart block --Select 5 Muscle weakness, generalized or specific area (not due to 45 neuropathy) --Select wheals NEUROLOGY DERMATOLOGY/SKIN Laryngeal nerve dysfunction 48 Urticaria (hives, welts, wheals) 16 Myelitis 49 SYNDROMES Neuropathy: motor 50 Neuropathy: sensory 50 Cytokine release syndrome/acute infusion reaction 68 Phrenic nerve dysfunction 50 wheezing

wakefulness - wheezing

131 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- W --

ALLERGY/IMMUNOLOGY Allergic reaction/hypersensitivity (including drug fever) 1 PULMONARY/UPPER RESPIRATORY Bronchospasm, wheezing 56

WNL CARDIAC GENERAL Hypertension 7

Wolff-Parkinson-White See: atrioventricular rhythm wound DERMATOLOGY/SKIN Skin breakdown/decubitus ulcer 16 Ulceration 16 Wound complication, non-infectious 16 HEMORRHAGE/BLEEDING Hematoma 30 INFECTION Infection (documented clinically or microbiologically) with 35 Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) --Select Infection with normal ANC or Grade 1 or 2 neutrophils -- 35 Select Infection with unknown ANC --Select 36 MUSCULOSKELETAL/SOFT TISSUE Fracture 44 Local complication -device/prosthesis-related 44 Soft tissue necrosis --Select 46

WPW CARDIAC ARRHYTHMIA Conduction abnormality/atrioventricular heart block --Select 5

WNL - WPW

132 of 133 Public Health Service Cancer Therapy Evaluation Program National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) - Index Terms Report Bethesda, Maryland 20892

-- X -- xerostomia GASTROINTESTINAL Dry mouth/salivary gland (xerostomia) 21 Salivary gland changes/saliva 26

xerostomia - xerostomia

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