Subgroup analysis of safety outcomes at 1 year
| Pirfenidone 2403 mg·day−1 | Placebo | |||||||||
| Subjects n | Grade 3 AE | Grade 4 AE | Serious AE | AE leading to treatment DC | Subjects n | Grade 3 AE | Grade 4 AE | Serious AE | AE leading to treatment DC | |
| Time since diagnosis years | ||||||||||
| <1 | 281 | 23.5 | 3.2 | 19.9 | 8.5 | 282 | 22.7 | 4.6 | 19.9 | 8.5 |
| 1–≤2 | 173 | 24.3 | 4.0 | 20.8 | 16.2 | 164 | 20.1 | 6.1 | 22.0 | 8.5 |
| >2 | 169 | 26.6 | 3.6 | 21.3 | 13.6 | 177 | 29.9 | 6.2 | 26.6 | 9.0 |
| FVC % pred | ||||||||||
| <65 | 205 | 25.4 | 5.4 | 23.9 | 15.1 | 224 | 29.0 | 6.3 | 27.7 | 11.2 |
| 65–≤80 | 272 | 25.4 | 2.6 | 19.1 | 12.5 | 230 | 24.3 | 5.2 | 21.7 | 8.3 |
| >80 | 146 | 21.9 | 2.7 | 18.5 | 6.8 | 170 | 17.1 | 4.7 | 15.9 | 5.9 |
| DLCO % pred | ||||||||||
| <40 | 207 | 28.5 | 3.4 | 23.7 | 14.0 | 211 | 32.2 | 9.5 | 33.6 | 12.8 |
| 40–<50 | 229 | 25.3 | 5.2 | 23.1 | 12.7 | 230 | 22.6 | 4.8 | 20.4 | 8.3 |
| ≥50 | 187 | 19.3 | 1.6 | 13.9 | 9.1 | 181 | 16.6 | 1.7 | 11.6 | 4.4 |
| 6MWD m | ||||||||||
| <350 | 168 | 33.3 | 5.4 | 26.8 | 13.7 | 141 | 33.3 | 11.3 | 34.8 | 14.9 |
| 350–<450 | 255 | 22.0 | 2.7 | 20.0 | 11.8 | 269 | 21.6 | 4.5 | 19.3 | 8.9 |
| ≥450 | 194 | 20.1 | 3.1 | 16.0 | 10.8 | 205 | 20.0 | 2.4 | 17.1 | 4.4 |
| Supplemental O2 use | ||||||||||
| Yes | 155 | 29.0 | 5.2 | 25.8 | 11.0 | 150 | 36.0 | 9.3 | 34.0 | 12.0 |
| No | 468 | 23.1 | 3.0 | 18.8 | 12.4 | 474 | 20.3 | 4.2 | 18.6 | 7.6 |
Data are presented as % of patients in each stratum based on events occurring between the first dose and 28 days after the last dose of study drug, unless otherwise stated. AE: adverse event; DC: discontinuation; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; 6MWD: 6-min walk distance.