Table 4.

Liver-related adverse events coded as MedDRA terms in Vigibase were classified into 6 prime categories of important liver endpoints.

General	Liver disorder, hepatotoxicity, liver injury, hepatotoxic effect, hepatic pain
Liver function biomarkers	Alanine aminotransferase abnormal, alanine aminotransferase increased, aspartate aminotransferase, aspartate aminotransferase abnormal, aspartate aminotransferase increased, bilirubinaemia, bilirubin increased, blood bilirubin abnormal, blood bilirubin increased, hepatic enzyme increased, hepatic enzymes increased, hyperbilirubinemia, liver function test abnormal, liver function tests abnormal nos*
Medical diagnoses	Hepatic failure, hepatitis granulomatous, acute hepatic failure, hepatitis fulminant, hepatic disease, hepatitis nos, autoimmune hepatitis, hepatitis acute, hepatomegaly, hepatitis chronic active, hepatosplenomegaly, hepatitis cholestatic, jaundice, hepatitis cholestatic, jaundice cholestatic, hepatitis, jaundice nos, ocular icterus, yellow skin, hepatic encephalopathy, hepatic infarction, hepatitis A, hepatitis A antibody positive, hepatitis B antibody
Biliary tract disorder	Biliary cirrhosis, bile duct stone, bile duct stricture, bile duct carcinoma, portal hypertension, hepatorenal syndrome, hypertension portal, gallbladder disorder, cholecystitis, cholecystitis chronic, cholelithiasis, cholestasis intrahepatic, cholestasis, cholangitis, portal vein thrombosis, hepatic cirrhosis, cryptogenic cirrhosis
Histological changes	Biopsy liver abnormal, hepatic necrosis, hepatic steatosis, hepatocellular damage, fatty liver
Liver malignancies	Hepatic neoplasm, hepatic neoplasm malignant, hepatic metastases

*nos not otherwise specified.