Table 6.
Hepatic adverse events and elevations in liver enzymes and bilirubin in the INBUILD trial
| 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) |
Data are n (%) of patients with elevations reported between first trial drug intake and 28 days after last trial drug intake. Median exposure to trial drug was 17.4 months in both groups. Liver enzyme and bilirubin elevations are based on central laboratory data
ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
aBased on the standardized MedDRA query ‘liver related investigations, signs and symptoms’ (broad definition) which included preferred terms such as “ALT increased”, “AST increased” and “gamma-glutamyltransferase increased”
bOne patient in the nintedanib group had elevations in ALT and/or AST ≥ 3 × ULN and bilirubin ≥ 2 × ULN based on local laboratory data. One patient in each group met criteria for Hy’s Law