Nintedanib (n = 332) | Placebo (n = 331) | |
---|---|---|
Hepatic adverse eventa | 87 (26.2) | 24 (7.3) |
Elevations in ALT and/or AST | ||
≥ 3 × ULN | 47 (14.2) | 6 (1.8) |
≥ 5 × ULN | 14 (4.2) | 1 (0.3) |
≥ 8 × ULN | 3 (0.9) | 1 (0.3) |
Elevations in ALT and/or AST ≥ 3 × ULN and bilirubin ≥ 2 × ULNb | 0 (0) | 1 (0.3) |
Elevation in total bilirubin | ||
≥ 1.5 × ULN | 3 (0.9) | 6 (1.8) |
≥ 2 × ULN | 1 (0.3) | 1 (0.3) |
Elevation in alkaline phosphatase | ||
≥ 1.5 × ULN | 17 (5.1) | 6 (1.8) |
≥ 2 × ULN | 8 (2.4) | 3 (0.9) |