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