Baseline demographics and clinical characteristics (based on actual dose), modified intention-to-treat population
| Characteristics* | Pirfenidone | Placebo | ||||
| Total (n=623) | DI≤90% (n=199) | DI>90% (n=424) | Total (n=624) | DI≤90% (n=65) | DI>90% (n=559) | |
| Age | 68.0 (45–80) | 68.0 (46–80) | 68.0 (45–80) | 68.0 (40–80) | 68 (48–79) | 68.0 (40–80) |
| Male, n (%) | 463 (74.3) | 131 (65.8) | 332 (78.3) | 465 (74.5) | 45 (69.2) | 420 (75.1) |
| White, n (%) | 592 (95.0) | 188 (94.5) | 404 (95.3) | 590 (94.6) | 57 (87.7) | 533 (95.3) |
| Weight, kg | 86.5 (40–168) | 82.0 (40–157) | 87.7 (44–168) | 85.7 (40–147) | 84.4 (54–138) | 86.0 (40–147) |
| BMI, kg/m2 | 29.6 (19–47) | 29.4 (19–42) | 29.7 (19–47) | 29.3 (15–48) | 29.0 (23–42) | 29.3 (15–48) |
| Men | 29.5 (19–44) | 29.6 (19–42) | 29.4 (20–44) | 29.3 (20–48) | 29.3 (23–42) | 29.3 (20–48) |
| Women | 29.8 (19–47) | 28.9 (19–42) | 30.9 (19–47) | 29.3 (15–44) | 26.9 (23–39) | 29.4 (15–44) |
| FVC, % predicted | 71.1 (48–124) | 72.8 (48–120) | 70.3 (48–124) | 70.3 (48–136) | 69.3 (50–112) | 70.6 (48–136) |
| 6MWD, m | 400.0 (112–731) | 391.0 (112–619) | 405.0 (145–731) | 413.5 (163–716) | 398.5 (168–573) | 416.0 (163–716) |
*Values expressed as median (range), unless otherwise stated.
6MWD, 6 min walk distance; BMI, body mass index; DI, dose intensity; FVC, forced vital capacity.