Table 1.
Demographics and baseline characteristics.
| Tezacaftor/ivacaftor (n = 50) | Placebo (n = 47) | |
|---|---|---|
| Age, mean (SD), years | 34.3 (8.7) | 33.3 (10.0) |
| ≥18 years of age at screening, n (%) | 50 (100.0) | 46 (97.9) |
| Female, n (%) | 31 (62.0) | 30 (63.8) |
| ppFEV1, mean (SD), % | 44.6 (16.1) | 48.0 (18.1) |
| ppFEV1 category at baseline, n (%) | ||
| < 40% | 27 (54.0) | 21 (44.7) |
| ≥40% and < 70% | 19 (38.0) | 17 (36.2) |
| ≥70% | 4 (8.0) | 9 (19.1) |
| Country of enrollment, n (%) | ||
| United States | 24 (48.0) | 24 (51.1) |
| Germany | 18 (36.0) | 19 (40.4) |
| France | 8 (16.0) | 4 (8.5) |
| Use of inhaled bronchodilator, n (%)a | ||
| Yes | 48 (96.0) | 46 (97.9) |
| No | 2 (4.0) | 1 (2.1) |
ppFEV1, percent predicted forced expiratory volume in 1 s.
a
Included medications started before the first dose of study drug.