Table 1.

Grading assessment of immune-mediated hepatitis according to the Common Terminology Criteria of Adverse Events (CTCAE) and Drug-Induced Liver Injury Network (DILIN) criteria.

DILIN	CTCAE	Grade
Elevated serum ALT and/or ALP; TBil < 2.5 mg/dL; INR < 1.5; with or without symptoms (fatigue, weakness, nausea, anorexia, right upper abdominal pain, jaundice, pruritus, rash, or weight loss)	ALT/AST < 3× ULN; ALP/GGT > 1–2.5× ULN; TBili < 1.5× ULN	1
Elevated serum ALT and/or ALP; TBil ≥ 2.5 mg/dL or INR ≥ 1.5 without elevated TBil; symptoms may be aggravated	AST/ALT 3–5× ULN; ALP/GGT > 2.5–5× ULN; TBili 2–3× ULN	2
Elevated serum ALT and/or ALP; TBil ≥ 5 mg/dL with or without INR ≥ 1.5; symptoms are further aggravated; indication for hospitalization or prolonged hospitalization	AST/ALT 5–20× ULN; ALP/GGT > 5–20× ULN; TBili > 3× ULN	3
Elevated serum ALT and/or ALP; TBil ≥ 10 mg/dL or daily elevation ≥ 1.0 mg/dL; INR ≥ 1.5 with ascites, encephalopathy, or other organ dysfunction	AST/ALT > 20× ULN; ALP/GGT > 20× ULN; TBili > 10× ULN	4
Death	Death due to hepatoto×icity	5

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase; TBil, total bilirubin; INR, international normalized ratio; ULN, upper limit of normal.