Outcomes after 6 months of continued treatment following an initial decline in per cent predicted FVC ≥10%*
| Pirfenidone (N=34) | Placebo (N=68) | Relative difference (%) | p Value† | |
|---|---|---|---|---|
| ≥10% decline in FVC or death | 2 (5.9%) | 19 (27.9%) | −78.9 | 0.009 |
| No further decline in FVC‡ | 20 (58.8%) | 26 (38.2%) | 53.8 | 0.059 |
| Death | 1 (2.9%) | 14 (20.6%) | −85.7 | 0.018 |
*Initial decline in per cent predicted FVC ≥10% occurring during the first 3 months or 6 months of study treatment.
†Fisher's exact test.
‡Either no decline or increase in FVC.