Table 1 Baseline demographics and clinical characteristics in the INPULSIS® trials
From: Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis
Nintedanib | Placebo | |
|---|---|---|
(n = 638) | (n = 423) | |
Male, n (%) | 507 (79.5) | 334 (79.0) |
Age, years, mean (SD) | 66.6 (8.1) | 67.0 (7.9) |
Weight, kg, mean (SD) | 79.2 (16.6) | 78.6 (16.5) |
Race, n (%) | ||
White | 360 (56.4) | 248 (58.6) |
Asian | 194 (30.4) | 128 (30.3) |
Black | 2 (0.3) | 0 (0.0) |
Missinga | 82 (12.9) | 47 (11.1) |
Smoking status, n (%) | ||
Never smoked | 174 (27.3) | 122 (28.8) |
Ex-smoker | 435 (68.2) | 283 (66.9) |
Current smoker | 29 (4.5) | 18 (4.3) |
Time since diagnosis of IPF, years, mean (SD)b | 1.7 (1.4) | 1.6 (1.3) |
FVC, mL, mean (SD) | 2714 (757) | 2728 (810) |
FVC, % predicted, mean (SD) | 79.7 (17.6) | 79.3 (18.2) |
FEV1/FVC ratio, %, mean (SD) | 81.7 (5.8) | 81.7 (6.0) |
DLCO, % predicted, mean (SD) | 47.4 (13.5) | 47.0 (13.4) |
SpO2, %, mean (SD) | 95.9 (2.3) | 95.8 (2.0) |
SGRQ total score, mean (SD)c | 39.5 (19.2) | 39.6 (18.5) |