Table 4.
Worst value during active treatment period | Cohort 1a n = 3 n (%) |
Cohort 2b 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)