Baseline characteristics
Pooled population treated with nintedanib (n=1126) | Pooled population treated with placebo (n=565) | INPULSIS trials | ||
Nintedanib (n=638) | Placebo (n=423) | |||
Age, years, mean (SD) | 66.9 (8.1) | 66.6 (8.2) | 66.6 (8.1) | 67.0 (7.9) |
Male, n (%) | 882 (78.3) | 434 (76.8) | 507 (79.5) | 334 (79.0) |
Race, n (%) | ||||
White | 695 (61.7) | 367 (65.0) | 360 (56.4) | 248 (58.6) |
Asian | 316 (28.1) | 151 (26.7) | 194 (30.4) | 128 (30.3) |
Black | 2 (0.2) | 0 (0.0) | 2 (0.3) | 0 (0.0) |
Missing* | 113 (10.0) | 47 (8.3) | 82 (12.9) | 47 (11.1) |
Body mass index, kg/m2, mean (SD) | 27.9 (4.6) | 27.9 (4.6) | 28.1 (4.6) | 27.6 (4.6) |
Smoking history, n (%) | ||||
Former smoker | 768 (68.2) | 374 (66.2) | 435 (68.2) | 283 (66.9) |
Never smoker | 313 (27.8) | 167 (29.6) | 174 (27.3) | 122 (28.8) |
Current smoker | 45 (4.0) | 24 (4.2) | 29 (4.5) | 18 (4.3) |
FVC, % predicted, mean (SD) | 78.7 (18.4) | 79.5 (18.3) | 79.7 (17.6) | 79.3 (18.2) |
FEV1/FVC, %, mean (SD) | 81.6 (6.4) | 81.7 (5.9) | 81.7 (5.8) | 81.7 (6.0) |
DLco, % predicted, mean (SD) | 48.2 (13.5)† | 47.7 (13.5) | 47.4 (13.5) | 47.0 (13.4) |
*In France, regulation did not permit the collection of data on race.
†n=821 (DLco was not collected at the start of the open-label extensions of TOMORROW and INPULSIS-ON).
DLco, diffusing capacity of the lung for carbon monoxide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity.