Analysis of %FVC and 6MWD at month 12 (with imputation by the sum of squared differences) by dose intensity (based on actual dose)
| Change from baseline category, n (%) | DI>90% | Relative difference, % | P values* | DI≤90% | Relative difference, % | P values* | ||
| Pirfenidone (n=424) | Placebo (n=559) | Pirfenidone (n=199) | Placebo (n=65) | |||||
| Decline ≥10% in %FVC or death | 49 (11.6) | 143 (25.6) | −54.8 | <0.0001 | 43 (21.6) | 21 (32.3) | −33.1 | 0.0805 |
| Decline ≥50 m in 6MWD or death | 103 (24.4) | 184 (33.4) | −26.9 | 0.0023 | 50 (25.6) | 30 (46.9) | −45.3 | 0.0014 |
Relative difference=100 × (% pirfenidone − % placebo)/%placebo.
*For χ2 test, the categories ‘No decline and decline <10% to 0%’ and ‘No decline and decline <50 m to 0 m’, respectively, were combined.
6MWD, 6 min walk distance; %FVC, per cent predicted forced vital capacity; DI, dose intensity.