Baseline characteristics by subgroup (mean±SD or n (%))
| FVC >90% predicted | FVC ≤90% predicted | |||
|---|---|---|---|---|
| Nintedanib (n=166) | Placebo (n=108) | Nintedanib (n=472) | Placebo (n=315) | |
| Age, years | 68.2±8.0 | 67.5±7.6 | 66.1±8.1 | 66.8±8.0 |
| Male | 121 (72.9) | 75 (69.4) | 386 (81.8) | 259 (82.2) |
| Race | ||||
| White | 87 (52.4) | 61 (56.5) | 273 (57.8) | 187 (59.4) |
| Asian | 54 (32.5) | 37 (34.3) | 140 (29.7) | 91 (28.9) |
| Black | 0 (0.0) | 0 (0.0) | 2 (0.4) | 0 (0.0) |
| Missing* | 25 (15.1) | 10 (9.3) | 57 (12.1) | 37 (11.7) |
| Smoking status | ||||
| Never smoked | 45 (27.1) | 33 (30.6) | 129 (27.3) | 89 (28.3) |
| Ex-smoker | 110 (66.3) | 66 (61.1) | 325 (68.9) | 217 (68.9) |
| Current smoker | 11 (6.6) | 9 (8.3) | 18 (3.8) | 9 (2.9) |
| Time since diagnosis, years | 1.4±1.2 | 1.3±1.3 | 1.7±1.4 | 1.7±1.3 |
| Centrilobular emphysema | 77 (46.4) | 53 (49.1) | 177 (37.5) | 113 (35.9) |
| FVC, mL | 3306±821 | 3420±945 | 2505±610 | 2491±598 |
| FVC, % predicted | 103.1±11.0 | 103.9±12.4 | 71.5±10.7 | 70.8±10.6 |
| FEV1/FVC ratio, % | 79.2±6.0 | 78.7±5.6 | 82.5±5.5 | 82.7±5.8 |
| Diffusion capacity of the lung for carbon monoxide, % predicted† | 52.8±13.3 | 52.3±12.6 | 45.5±13.1 | 45.1±13.2 |
| St George's Respiratory Questionnaire total score‡ | 32.2±18.5 | 31.3±15.2 | 42.0±18.7 | 42.4±18.7 |
| Composite physiologic index§ | 37.3±9.8 | 37.2±9.2 | 49.0±9.5 | 49.5±9.7 |
*In France, regulation did not permit the collection of data on race.
†n=314 for placebo in FVC ≤90% predicted subgroup.
‡n=160 for nintedanib and n=106 for placebo in FVC >90% predicted subgroup and n=464 for nintedanib and n=313 for placebo in FVC ≤90% predicted subgroup.
§n=314 for placebo in FVC ≤90% predicted subgroup.