Patients with TEAEs of interest by dose intensity (based on actual dose), modified intention-to-treat population
| TEAEs (all-grade, grouped), n (%) | Pirfenidone (n=623) | Placebo (n=624) | ||
| DI≤90% (n=199) | DI>90% (n=424) | DI≤90% (n=65) | DI>90% (n=559) | |
| Any TEAE, n (%) | 166 (83.4) | 275 (64.9) | 37 (56.9) | 219 (39.2) |
| Nausea | 97 (48.7) | 128 (30.2) | 19 (29.2) | 79 (14.1) |
| Rash | 83 (41.7) | 140 (33.0) | 13 (20.0) | 72 (12.9) |
| Diarrhoea | 49 (24.6) | 112 (26.4) | 18 (27.7) | 109 (19.5) |
| Vomiting | 39 (19.6) | 45 (10.6) | 7 (10.8) | 33 (5.9) |
| Photosensitivity | 21 (10.6) | 37 (8.7) | 2 (3.1) | 5 (0.9) |
DI, dose intensity; TEAE, treatment-emergent adverse event.