TABLE 1

Baseline characteristics stratified by baseline GAP (gender, age, physiology) stage

GAP stage IGAP stage II/III
NintedanibPlaceboNintedanibPlacebo
Subjects304196334226
Age years62.9±8.163.1±8.370.0±6.670.3±5.8
Male208 (68.4)132 (67.3)299 (89.5)202 (89.4)
Race
 White173 (56.9)110 (56.1)187 (56.0)137 (60.6)
 Asian94 (30.9)60 (30.6)100 (29.9)68 (30.1)
 Black0 (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 smoker209 (68.8)130 (66.3)255 (76.3)171 (75.7)
FVC mL2883±8232957±9112559±6562537±645
FVC % predicted85.8±17.387.4±18.974.2±16.072.3±14.2
FEV1/FVC ratio81.4±5.681.1±6.181.9±6.182.2±5.8
DLCO % predicted54.0±13.853.5±14.141.4±10.041.3±9.7
SGRQ total score36.2±19.738.2±19.342.6±18.240.7±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.