TABLE 2

Proportions of patients with disease progression over 52 weeks and hazard ratio for time to first event by baseline GAP (gender, age, physiology) stage

GAP stage IHazard ratio (95% CI)GAP stage II/IIIHazard ratio (95% CI)Treatment-by-subgroup interaction p-value
NintedanibPlaceboNintedanibPlacebo
Subjects n304196334226
Absolute decline in FVC ≥10% predicted or death75 (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% predicted69 (22.7)75 (38.3)79 (23.7)78 (34.5)
   Death6 (2.0)3 (1.5)19 (5.7)19 (8.4)
Absolute decline in FVC ≥5% predicted or death156 (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%    predicted154 (50.7)141 (71.9)163 (48.8)150 (66.4)
   Death2 (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.