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Table 2 Hepatic outcome definitions

From: Hepatic outcomes among adults taking duloxetine: a retrospective cohort study in a US health care claims database

Hepatic outcome Definition
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.)