Phase Ic study in patients with idiopathic pulmonary fibrosis: summary of adverse events (AEs)
| Placebo | BI 1015550 18 mg twice daily | Total on treatment | |
| Patients treated | 5 (100.0) | 10 (100.0) | 15 (100.0) |
| Any AE | 5 (100.0) | 10 (100.0) | 15 (100.0) |
| Severe AEs | 0 (0.0) | 1 (10.0) | 1 (6.7) |
| Investigator-defined drug-related AE | 3 (60.0) | 9 (90.0) | 12 (80.0) |
| AE leading to discontinuation of study drug | 0 (0.0) | 1 (10.0) | 1 (6.7) |
| Patients with AESI# | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Patients with other significant AEs according to ICH E3 | 0 (0.0) | 1 (10.0) | 1 (6.7) |
| Patients with SAEs | 0 (0.0) | 1 (10.0) | 1 (6.7) |
| Patients requiring or prolonging hospitalisation | 0 (0.0) | 1 (10.0) | 1 (6.7) |
Data are presented as n (%). AESI: adverse event of special interest; ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; SAE: serious adverse event. #: hepatic injury was defined as an AESI.