Table 1.

National Cancer Institute hepatic impairment classification criteria

Liver function assessment	Normal	Mild [Link]	Moderate	Severe
Total bilirubin	≤ULN	B1: ≤ULN B2: 1–1.5 × ULN	1.5–3 × ULN	>3 × ULN
Aspartate aminotransferase	≤ULN	B1: >ULN B2: Any[Link]	Any	Any

Mild liver dysfunction may be defined according to either of the two criteria (B1 and B2), so patients in the mild hepatic impairment cohort may come from either of these groups and are combined for all analyses.

‘Any’ denotes no specific limit of aspartate aminotransferase for a mild, moderate or severe classification assuming that total bilirubin requirements have been met.

ULN, upper limit of normal.