Outcomes during the 6-month period following an initial ≥10% relative decline in %FVC during the first 6 months of treatment
| Initial ≥10% Relative%FVC Decline | ||||
|---|---|---|---|---|
| Outcome in subsequent 6 months, n (%) | Pirfenidone (N = 80) | Placebo (N = 140) | Relative Difference,% | P-value |
| ≥10% relative decline in FVC or death | 17 (21.3) | 50 (35.7) | –40.5 | 0.033 |
| Death | 5 (6.3) | 16 (11.4) | –45.3 | 0.242 |
| No further decline in FVC | 41 (51.3) | 50 (35.7) | 43.5 | 0.033 |
FVC, forced vital capacity.