Hepatic adverse events and elevations in hepatic enzymes and bilirubin in the SENSCIS trial
| Nintedanib (n=288) | Placebo (n=288) | |
| Hepatic adverse event * | 40 (13.9) | 9 (3.1) |
| Elevation in ALT and/or AST | ||
| ≥3× ULN | 14 (4.9) | 2 (0.7) |
| ≥5× ULN | 3 (1.0) | 1 (0.3) |
| ≥8× ULN | 0 | 1 (0.3) |
| Elevation in ALT and/or AST≥3× ULN and in bilirubin ≥2× ULN | 0 | 0 |
| Elevation in total bilirubin | ||
| ≥1.5× ULN | 1 (0.3) | 0 |
| ≥2× ULN | 1 (0.3) | 0 |
| Elevation in alkaline phosphatase | ||
| ≥1.5× ULN | 10 (3.5) | 3 (1.0) |
| ≥2× ULN | 3 (1.0) | 0 |
Data are n (%) of patients with ≥1 such event reported over 52 weeks (or until 28 days after last trial drug intake for patients who discontinued trial drug before week 52).
*Based on the standardised MedDRA query ‘liver related investigations, signs and symptoms’ (broad definition).
ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; ULN, upper limit of normal.