Risk and risk ratio of acute investigator-reported exacerbation and of adjudicated exacerbation in the INPULSIS trials comparing nintedanib with placebo
| Number (%) | Nintedanib | Placebo | Risk ratio (95% CI) | p Value |
|---|---|---|---|---|
| Patients | 638 | 423 | ||
| Patients with at least one investigator-reported acute exacerbation | 31 (4.9) | 32 (7.6) | 0.64 (0.40 to 1.04) | 0.07 |
| Patients with a confirmed/suspected acute exacerbation* | 12 (1.9) | 20 (4.7) | 0.40 (0.20 to 0.81) | 0.01 |
| Patients with a ‘false’ acute exacerbation | 19 (3.0) | 12 (2.8) |
*The numbers of patients were not provided in the paper and were estimated from the corresponding rates of confirmed/reported acute exacerbations among all exacerbations.