Proportions of patients with disease progression over 52 weeks and HR for time to first event by subgroup
| FVC >90% predicted | FVC ≤90% predicted | |||
|---|---|---|---|---|
| Nintedanib (n=166) | Placebo (n=108) | Nintedanib (n=472) | Placebo (n=315) | |
| Absolute decline in FVC ≥10% predicted or death, n (%) | 44 (26.5) | 44 (40.7) | 129 (27.3) | 131 (41.6) |
| HR (95% CI) | 0.59 (0.38 to 0.89) | 0.61 (0.48 to 0.78) | ||
| Treatment-by-subgroup interaction | p=0.8304 | |||
| Criterion reached first, n (%) | ||||
| Absolute decline in FVC ≥10% predicted | 42 (25.3) | 43 (39.8) | 106 (22.5) | 110 (34.9) |
| Death | 2 (1.2) | 1 (0.9) | 23 (4.9) | 21 (6.7) |
| Absolute decline in FVC ≥5% predicted or death, n (%) | 100 (60.2) | 84 (77.8) | 230 (48.7) | 219 (69.5) |
| HR (95% CI) | 0.67 (0.50 to 0.90) | 0.59 (0.49 to 0.71) | ||
| Treatment-by-subgroup interaction | p=0.4862 | |||
| Criterion reached first, n (%) | ||||
| Absolute decline in FVC ≥5% predicted | 99 (59.6) | 83 (76.9) | 218 (46.2) | 209 (66.3) |
| Death | 1 (0.6) | 1 (0.9) | 12 (2.5) | 10 (3.2) |