Adverse events (AEs)
| Placebo# | Nintedanib 50 mg twice daily¶ | Nintedanib 100 mg twice daily+ | Nintedanib 150 mg twice daily§ | |||||
|---|---|---|---|---|---|---|---|---|
| Alone | Added to ongoing pirfenidone | Alone | Added to ongoing pirfenidone | Alone | Added to ongoing pirfenidone | Alone | Added to ongoing pirfenidone | |
| Subjects n | 7 | 5 | 2 | 4 | 4 | 4 | 11 | 13 |
| Any AE | 2 (28.6) | 2 (40.0) | 0 | 0 | 3 (75.0) | 1 (25.0) | 6 (54.5) | 9 (69.2) |
| Serious AEs | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 |
| Investigator-defined drug-related AEs | 1 (14.3) | 1 (20.0) | 0 | 0 | 1 (25.0) | 0 | 3 (27.3) | 7 (53.8) |
| Most common AEsƒ | ||||||||
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (38.5) |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 4 (30.8) |
| Diarrhoea | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 2 (15.4) |
| Nasopharyngitis | 0 | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 2 (15.4) |
| Abdominal discomfort | 0 | 1 (20.0) | 0 | 0 | 0 | 0 | 1 (9.1) | 0 |
| Stomatitis | 0 | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (7.7) |
| Alanine aminotransferase increased## | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 0 |
| Aspartate aminotransferase increased## | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 0 |
| AEs leading to discontinuation of study drug | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 2 (15.4) |
| Transaminases increased | 0 | 0 | 0 | 0 | 0 | 0 | 2 (18.2) | 1 (7.7) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7.7) |