Pirfenidone dose reductions and interruptions during 12 months of treatment (based on actual dose)
| Pirfenidone (n=623) | Placebo (n=624) | |
| Daily dose, mean (SD), mg | 2054.0 (425.05) | – |
| Patients with any dose reduction, n (%)* | 479 (76.9) | 449 (72.0) |
| Patients with temporary dose reductions, including permanent dose reductions, n (%) | 372 (59.7) | 375 (60.1) |
| Patients with only temporary dose reductions, excluding permanent dose reductions, n (%) | 283 (45.4) | 319 (51.1) |
| Patients with permanent dose reductions, including temporary dose reductions, n (%) | 196 (31.5) | 130 (20.8) |
| Patients with only permanent dose reductions, excluding temporary dose reductions, n (%) | 107 (17.2) | 74 (11.9) |
| Cumulative days of dose reduction, median (IQR) | 38.0 (9–103) | 29.0 (7–95) |
| Patients with any dose interruption, n (%)† | 290 (46.5) | 194 (31.1) |
| Patients with temporary dose interruptions, n (%) | 244 (39.2) | 145 (23.2) |
| Patients with permanent dose interruptions (discontinuation), n (%)‡ | 95 (15.2) | 79 (12.7) |
| Cumulative days of dose interruption, median (IQR)* | 14.0 (3–29) | 4.0 (1–13) |
*Not including patients who discontinued.
†Dose interruption was defined as the patient receiving a zero dose after having previously received a higher dose.
‡Permanent dose interruption was defined as the patient stopping study treatment prematurely.
IQR, interquartile range; SD, standard deviation.