Mortality following acute exacerbation
| Mortality rate¶ | Patients with investigator-reported acute exacerbations | Patients with events adjudicated as confirmed or suspected acute exacerbations# | Patients with all events adjudicated as not acute exacerbations# | |||
| Nintedanib (n=34) | Placebo (n=35) | Nintedanib (n=14) | Placebo (n=25) | Nintedanib (n=23) | Placebo (n=13) | |
| 30-day | 7 (20.6) | 14 (40.0) | 3 (21.4) | 9 (36.0) | 4 (17.4) | 5 (38.5) |
| 90-day | 10 (29.4) | 15 (42.9) | 5 (35.7) | 12 (48.0) | 6 (26.1) | 7 (53.9) |
| 180-day | 12 (35.3) | 20 (57.1) | 6 (42.9) | 15 (60.0) | 7 (30.4) | 7 (53.9) |
#: analyses based on patients who had one or more adjudicated confirmed or suspected acute exacerbation or who had one or more event that was adjudicated and all events were adjudicated as not acute exacerbations; ¶: calculated as the number (%) of patients who died within 30, 90 or 180 days of onset of a first exacerbation event. The three categories of patient shown in this table are not mutually exclusive.