TABLE 1.
Baseline characteristics stratified by baseline GAP (gender, age, physiology) stage
| GAP stage I | GAP stage II/III | |||
| Nintedanib | Placebo | Nintedanib | Placebo | |
| Subjects | 304 | 196 | 334 | 226 |
| Age years | 62.9±8.1 | 63.1±8.3 | 70.0±6.6 | 70.3±5.8 |
| Male | 208 (68.4) | 132 (67.3) | 299 (89.5) | 202 (89.4) |
| Race | ||||
| White | 173 (56.9) | 110 (56.1) | 187 (56.0) | 137 (60.6) |
| Asian | 94 (30.9) | 60 (30.6) | 100 (29.9) | 68 (30.1) |
| Black | 0 (0.0) | 0 (0.0) | 2 (0.6) | 0 (0.0) |
| Missing# | 37 (12.2) | 26 (13.3) | 45 (13.5) | 21 (9.3) |
| Former or current smoker | 209 (68.8) | 130 (66.3) | 255 (76.3) | 171 (75.7) |
| FVC mL | 2883±823 | 2957±911 | 2559±656 | 2537±645 |
| FVC % predicted | 85.8±17.3 | 87.4±18.9 | 74.2±16.0 | 72.3±14.2 |
| FEV1/FVC ratio | 81.4±5.6 | 81.1±6.1 | 81.9±6.1 | 82.2±5.8 |
| DLCO % predicted | 54.0±13.8 | 53.5±14.1 | 41.4±10.0 | 41.3±9.7 |
| SGRQ total score¶ | 36.2±19.7 | 38.2±19.3 | 42.6±18.2 | 40.7±17.8 |
Data are presented as n, mean±sd or n (%). FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; DLCO: diffusing capacity of the lung for carbon monoxide; SGRQ: St George's Respiratory Questionnaire. #: in France, regulations did not permit the collection of data on race; ¶: n=299 for nintedanib and n=194 for placebo in GAP stage I subgroup; n=325 for nintedanib and n=224 for placebo in GAP stage II/III subgroup.