Supplemental Appendix A. List of Assessed Hepatic Events and Relevant ICD-9 Codes Or Procedure

Supplemental Appendix A. List of assessed hepatic events and relevant ICD-9 codes or procedure codes used to identify these events from medical claims. Outcomes Codes Descriptions 1. All Fatalities in Patients with and without Pre-existing Hepatic Conditions or Baseline Hepatic Risks, Provided that the Underlying or any of the Contributory Causes of Death in the Death Certificate was a Hepatic Event, or in the Absence of a Death Certificate, that there is Clear Evidence of a Hepatic Event in Relation to the Death ICD-9, Vol. 1=798.xx Sudden death, cause unknown Patstat (patient status)=20, 21, 22, Death All deaths in 23, 24, 25, 26, 27, 28, 29, 40, 41, conjunction with codes 42) for all hepatic events

2. All Cases of Potential Acute Hepatic Failure Defined by the Following Conditions when no Other Explicit Etiology is Specified ICD-9, Vol. 1=570.xx Acute and subacute necrosis of live ICD-9, Vol. 1=572.2x Hepatic coma Hepatic failure Hepatic ICD-9, Vol. 1=572.2x Hepatic coma encephalopathy ICD-9, Vol. 1=070.0x Viral hepatitis A with hepatic coma ICD-9, Vol. 1=070.2x Viral hepatitis B with hepatic coma ICD-9, Vol. 1=070.4x Other specified viral hepatitis with hepatic coma ICD-9, Vol. 1=070.6x Unspecified viral hepatitis with hepatic coma

ICD-9, Vol. 1=070.71 Unspecified viral hepatitis C with hepatic coma Hepatic coma ICD-9, Vol. 1=572.2x Hepatic coma ICD-9, Vol. 1= V42.7 Liver replaced by transplant ICD-9, Vol. 3= 50.5x Liver transplant Liver transplant CPT=47133-47147 Liver transplantation

Ingenix i3 Drug Safety 1 Supplemental Appendix A. Continued Outcomes Codes Descriptions 3. All Cases of Potential Severe Hepatic Injury as Defined by the Following Conditions Hepatic necrosis ICD-9, Vol. 1=570.xx Acute and subacute necrosis of liver ICD-9, Vol. 1=571.0x Alcoholic fatty liver Toxic liver disease ICD-9, Vol. 1=571.2x Alcoholic cirrhosis of liver ICD-9, Vol. 1=573.3x Hepatitis, unspecified Toxic hepatitis ICD-9, Vol. 1=571.1x Acute alcoholic hepatitis ICD-9, Vol. 1=571.1x Acute alcoholic hepatitis ICD-9, Vol. 1=070.20 Viral hepatitis B with hepatic coma: acute or unspecified, without mention of hepatitis delta ICD-9, Vol. 1=070.30 Viral hepatitis B without mention of hepatic coma: acute or unspecified, without mention of hepatitis delta ICD-9, Vol. 1=070.31 Viral hepatitis B without mention of hepatic coma: acute or unspecified, with hepatitis delta ICD-9, Vol. 1=070.41 Other specified viral hepatitis with hepatic coma: Acute hepatitis C with hepatic coma

ICD-9, Vol. 1=070.51 Other specified viral hepatitis without mention of hepatic coma: Acute hepatitis C without Acute hepatitis mention of hepatic coma Jaundice/icterus ICD-9, Vol. 1=782.4x Jaundice, unspecified, not of newborn Ascites ICD-9, Vol. 1=789.5x Ascites CPT*=47120 Hepatectomy, resection of liver; partial lobectomy

CPT=47122 Hepatectomy, resection of liver; trisegmentectomy

CPT=47125 Hepatectomy, resection of liver; total left lobectomy

CPT=47130 Hepatectomy, resection of liver; total right lobectomy

ICD-9, Vol. 3=50.2x Local excision or destruction of liver tissue or Hepatectomy lesion CPT=47765 Anastomosis, of intrahepatic ducts and gastrointestinal tract ICD-9, Vol. 3=50.xx except 50.5x Operations on liver except liver transplant and hepatectomy and 50.2x Other liver operations

Supplemental Appendix A. Continued

Ingenix i3 Drug Safety 2 Outcomes Codes Descriptions 4. All Cases with Billing Codes that in Combination with Potential Hepatic Concerns Indicate, or are Found upon Chart Review to Contain Lab Values that are Highly Suggestive of Severe Hepatic Injury a. Potential hepatic concerns: Hypoprothrombinemia, ICD-9, Vol. 1=286.7x Acquired coagulation factor deficiency acquired Abnormal coagulation ICD-9, Vol. 1=790.92 Abnormal coagulation profile profile Drug-induced ICD-9, Vol. 1=286.7x and ICD-9, Acquired coagulation factor deficiency and coagulation factor Vol. 1=E962.0x assault by poisoning (drugs and medicinal deficiencies substances) b. Abnormal hepatic enzyme levels and other lab values: CPT=84450 and ICD-9, Vol. Test of Transferase; aspartate amino (AST) 1=790.4 (SGOT) and Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase [LDH] CPT=84460 and ICD-9, Vol. Test of Transferase; alanine amino (ALT) 1=790.4 (SGPT) and Nonspecific elevation of levels of Abnormal AST or ALT transaminase or lactic acid dehydrogenase level [LDH] Abnormal bilirubin CPT=82247 and ICD-9, Vol. Test of Bilirubin; total and Disorders of bilirubin level 1=277.4x excretion * CPT=Current Procedural Terminology codes

Ingenix i3 Drug Safety 3