Adverse events of particular interest in the pooled population treated with nintedanib and in the INPULSIS trials
| Pooled population treated with nintedanib (n=1126) | INPULSIS | |||||
| Nintedanib (n=638) | Placebo (n=423) | |||||
| Events, n | Event rate (per 100 patient exposure-years) | Events, n | Event rate (per 100 patient exposure-years) | Events, n | Event rate (per 100 patient exposure-years) | |
| Hepatic enzyme elevation | 330 | 12.1 | 132 | 22.2 | 14 | 3.4 |
| Bleeding | 253 | 9.3 | 94 | 15.8 | 42 | 10.2 |
| MACE | 101 | 3.7 | 26 | 4.4 | 11 | 2.7 |
| Myocardial infarction | 30 | 1.1 | 11 | 1.8 | 2 | 0.5 |
MACE, major adverse cardiovascular events.