Table 1.

Hepatic SMQs and laboratory criteria used in the definition of possible severe DILI (see accompanying text for full definition)

Hepatic SMQs	Laboratory criteria
• Cholestasis and jaundice of hepatic origin • Hepatic failure, fibrosis and cirrhosis, and other liver damage-related conditions • Hepatitis, noninfectious • Liver-related investigations, signs, and symptoms • Liver-related coagulation and bleeding disturbances	• ALT or AST >8 × ULN • ALT or AST >5 × ULN for >2 weeks • ALT or AST >3 × ULN and total bilirubin >2 × ULN or INR >1.5 (total bilirubin measurement can be within 30 days of the ALT elevation) • ALT or AST >3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%)

INR, international normalized ratio.