. 2019 Mar 2;38(1):99–110. doi: 10.1007/s10637-019-00745-z

Table 4.

Summary of TEAE hepatotoxicity laboratory assessment

Worst value during active treatment period	Cohort 1^a n = 3 n (%)	Cohort 2^b n = 8 n (%)	Total N = 11 n (%)
AST/ALT >3 × ULN and ≤ 5 × ULN	1 (33)	1 (13)	2 (18)
AST/ALT >5 × ULN	1 (33)	1 (13)	2 (18)
Total bilirubin >2 × ULN	1 (33)	1 (13)	2 (18)
AST/ALT >3 × ULN and concurrent total bilirubin >2 × ULN	1 (33)	0	1 (9)

ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal

^aCohort 1: 600 mg/d (200 mg in the morning and 400 mg in the evening)

^bCohort 2: 1000 mg/d (400 mg in the morning and 600 mg in the evening) for the first 2 weeks. Thereafter, the dose was reduced to 800 mg/d (400 mg in the morning and 400 mg in the evening)