Risk or rate ratio of acute investigator-reported exacerbation and of adjudicated exacerbation for the two INPULSIS trials comparing nintedanib with placebo
| Nintedanib | Placebo | Risk or rate ratio (95% CI) | p-value | |
| INPULSIS-1 | ||||
| Patients n | 309 | 204 | ||
| Patients with at least one investigator-reported acute exacerbation | 19 (6.1) | 11 (5.4) | 1.14 (0.55–2.35) | 0.72 |
| Investigator-reported acute exacerbations# | 20 (6.5) | 13 (6.4) | 1.02 (0.52–2.00) | 0.96 |
| Confirmed or suspected acute exacerbations# | 7 (2.3) | 8 (3.9) | 0.58 (0.21–1.57) | 0.28 |
| “False” acute exacerbations# | 12 (3.9) | 5 (2.5) | ||
| INPULSIS-2 | ||||
| Patients n | 329 | 219 | ||
| Patients with at least one investigator-reported acute exacerbation | 12 (3.6) | 21 (9.6) | 0.38 (0.19–0.76) | 0.006 |
| Investigator-reported acute exacerbations# | 13 (3.9) | 24 (10.9) | 0.36 (0.19–0.69) | 0.002 |
| Confirmed or suspected acute exacerbations# | 5 (1.5) | 16 (7.3) | 0.21 (0.08–0.56) | 0.002 |
| “False” acute exacerbations# | 7 (2.1) | 7 (3.2) |
Data are presented as n (%), unless otherwise stated. #: the numbers of patients were not provided in the paper for the breakdown of patients with confirmed exacerbation, so the number of events was also used. A total of three investigator-reported exacerbations did not have sufficient data for adjudication.