Demographics and baseline characteristics
| Phase 3 trials‡ | |||
|---|---|---|---|
| Characteristic*† | Integrated population (N=1299) | Pirfenidone (N=623) | Placebo (N=624) |
| Age, years | 68 (42–88) | 68 (45–80) | 68 (40–80) |
| Men, n (%) | 968 (74.5) | 463 (74.3) | 465 (74.5) |
| Caucasian, n (%) | 1229 (94.6) | 592 (95.0) | 590 (94.6) |
| FVC, % predicted | 69.1 (22–127) | 71.1 (46–123) | 69.8 (47–138) |
| <50% predicted, n (%) | 97 (7.5) | 13 (2.1) | 8 (1.3) |
| DLCO, % predicted | 43.3 (10–81) | 44.0 (25–81) | 44.3 (21–170) |
| <35% predicted, n (%) | 210 (16.2) | 92 (14.8) | 90 (14.4) |
| <30% predicted, n (%) | 79 (6.1) | 19 (3.0) | 16 (2.6) |
| Diagnosis, n (%) | |||
| IPF | 1297 (99.8) | 623 (100) | 624 (100) |
| Secondary pulmonary fibrosis§ | 2 (0.2) | 0 | 0 |
| Supplemental oxygen, n (%) | 375 (28.9) | 155 (24.9) | 150 (24.0) |
| Time since IPF diagnosis, years | 1.9 (>0–10) | 1.1 (>0–5) | 1.1 (>0–4) |
*Values are expressed as the median (range) unless otherwise indicated.
†Measured at the time of first dose of study drug.
‡CAPACITY (studies 004 and 006) and ASCEND (study 016).
§Study 002.
DLCO, carbon monoxide diffusing capacity; FVC, forced vital capacity; IPF, idiopathic pulmonary fibrosis.