Table 1.
INPULSIS and present study baseline characteristics
| Characteristics | Pooled data of INPULSIS 1 and 2 | Present study | |
|---|---|---|---|
| Placebo | Nintedanib 150 mg bid | Both treatment arms (pooled) | |
| Number of patients | 423 (100.0) | 638 (100.0) | 1014 (100.0) |
| Age (years) | 67.0 ± 7.9 | 66.6 ± 8.1 | 66.7 ± 8.0 |
| Sex | |||
| Male | 334 (79.0) | 507 (79.5) | 805 (79.4) |
| Female | 89 (21.0) | 131 (20.5) | 209 (20.6) |
| Weight (kg) | 78.64 ± 16.54 | 79.23 ± 16.57 | 79.24 ± 26.52 |
| Height (cm) | 168.2 ± 9.1 | 167.5 ± 9.3 | 169.94 ± 9.21 |
| Smoking history | |||
| Never smoked | 122 (28.8) | 174 (27.3) | 282 (27.8) |
| Ex-smoker | 283 (66.9) | 435 (68.2) | 689 (67.9) |
| Currently smokes | 18 (4.3) | 29 (4.5) | 43 (4.2) |
| Time since diagnosis (years) | |||
| Mean ± SD | 1.57 ± 1.31 | 1.65 ± 1.36 | 1.61 ± 1.33 |
| Minimum | 0.0 | 0.0 | 0.0 |
| Median | 1.17 | 1.26 | 1.2 |
| Maximum | 5.0 | 5.20 | 5.0 |
| FVC (ml) | 2727.7 ± 810.2 | 2713.5 ± 757.0 | 2734.59 ± 772.93 |
| FVC%pred | 79.27 ± 18.22 | 79.74 ± 17.57 | 78.3 ± 18.2a |
Data are presented as N (%) or mean ± SD
bid twice daily, FVC force vital capacity, FVC%pred force vital capacity percent predicted, SD standard deviation
aThe value reflects the FVC%pred at the beginning of any of the available 3-month intervals (3774)