Table 2 Hepatic outcome definitions

Hepatic-related death

Fatality where the underlying or any of the contributory causes of death in the death certificate was a hepatic event based on linkage to the National Death Index (NDI), or in the absence of a death certificate, where there is evidence of an underlying hepatic event on the basis of health insurance claims in relation to the death

Liver failure (non-fatal), in the absence of explicit identification of an alternative etiology

Liver failure, not resulting in death, defined by the following conditions

 ● Hepatic failure

 ● Fulminant hepatitis (non-infectious)

 ● Hepatic encephalopathy

 ● Hepatic coma

 ● Liver transplant or renal and liver transplant

 ● When explicitly associated with acute liver disease:

 ● Acquired coagulation factor V deficiency due to liver disease (factor V level <30 %)

 ● Acquired hypoprothrombinemia

 ● International normalized ratio (INR) >1.5, prothrombin time >16 s

Other clinically significant hepatic injury, in the absence of explicit identification of an alternative etiology

Hepatic injury, defined by any of the following:

 ● ALT > 500 IU/ml or ≥10x ULN, with any of the following: incident toxic hepatitis; incident acute hepatitis; incident hepatic necrosis; incident toxic liver disease; or incident toxic hepatitis

 ● ALT > 250 IU/mL or > 5x ULN with any of the following: nausea/vomiting; abdominal pain; weakness; or fatigue

 ● ALT > 3x ULN with any of the following: jaundice/icterus when alkaline phosphatase <2x ULN; ascites; or a combination of total bilirubin >2x ULN (Hy’s rule) and alkaline phosphatase <2x ULN

Non-serious hepatic enzyme elevation, in the absence of explicit identification of an alternative etiology

Presence of the combination of all the following, provided the patient is asymptomatic:

 ● 5x ULN < ALT <10x ULN

 ● T bilirubin <2x ULN

 ● Any ICD-9 hepatic code, validated by medical record review, when no symptoms associated with it and in absence of any codes for hepatic failure or serious hepatic injury (hepatic coma, jaundice, ascites, etc.)