GAP stage I | Hazard ratio (95% CI) | GAP stage II/III | Hazard ratio (95% CI) | Treatment-by-subgroup interaction p-value | |||
Nintedanib | Placebo | Nintedanib | Placebo | ||||
Subjects n | 304 | 196 | 334 | 226 | |||
Absolute decline in FVC ≥10% predicted or death | 75 (24.7) | 78 (39.8) | 0.59 (0.43–0.81) | 98 (29.3) | 97 (42.9) | 0.60 (0.45–0.79) | 0.84 |
Criterion reached first | |||||||
Absolute decline in FVC ≥10% predicted | 69 (22.7) | 75 (38.3) | 79 (23.7) | 78 (34.5) | |||
Death | 6 (2.0) | 3 (1.5) | 19 (5.7) | 19 (8.4) | |||
Absolute decline in FVC ≥5% predicted or death | 156 (51.3) | 142 (72.4) | 0.58 (0.46–0.73) | 174 (52.1) | 160 (70.8) | 0.63 (0.51–0.78) | 0.55 |
Criterion reached first | |||||||
Absolute decline in FVC ≥5% predicted | 154 (50.7) | 141 (71.9) | 163 (48.8) | 150 (66.4) | |||
Death | 2 (0.7) | 1 (0.5) | 11 (3.3) | 10 (4.4) |
Data are presented as n or n (%), unless otherwise stated. FVC: forced vital capacity.