Category	Severity	Description
1	Mild	Elevated ALT/ALP concentration reaching clinical chemistry criteria for drug‐induced liver injury, but bilirubin concentration < 2 × ULN
2	Moderate	Elevated ALT/ALP concentration reaching criteria for drug‐induced liver injury, and bilirubin concentration ≥ 2 × ULN, or symptomatic hepatitis
3	Severe	Elevated ALT/ALP concentration reaching criteria for drug‐induced liver injury, bilirubin concentration ≥ 2 × ULN, and 1 of the following. International normalized ratio ≥ 1.5 Ascites and/or encephalopathy, disease duration < 26 weeks, and absence of underlying cirrhosis Other organ failure considered to be due to drug‐induced liver injury
4	Fatal or transplantation	Death or transplantation due to drug‐induced liver injury