Table 2.
Adverse events according to pirfenidone dose.
| Total (n = 142) | Low-dose (n = 79) | High-dose (n = 63) | P value | |
|---|---|---|---|---|
| Dyspepsia | 55 (38.7%) | 38 (48.1%) | 17 (27.0%) | 0.017 |
| Anorexia | 36 (25.4%) | 28 (35.4%) | 8 (12.7%) | 0.004 |
| Rash | 36 (25.4%) | 23 (29.1%) | 13 (20.6%) | 0.337 |
| Fatigue | 23(16.2%) | 11 (13.9%) | 12 (19.0%) | 0.552 |
| Photosensitivity | 16 (11.3%) | 8 (10.1%) | 8 (12.7%) | 0.830 |
| Nausea | 15 (10.6%) | 14 (17.7%) | 1 (1.6%) | 0.005 |
| Dizziness | 10 (7.0%) | 7 (8.9%) | 3 (4.8%) | 0.536 |
| Weight loss | 8 (5.6%) | 5 (6.3%) | 3 (4.8%) | 0.971 |
| GERD | 8 (5.6%) | 4 (5.1%) | 4 (6.3%) | 1.000 |
| Liver enzyme elevation | 8 (5.6%) | 5 (6.3%) | 3 (4.8%) | 0.971 |
| Diarrhea | 5 (3.5%) | 1 (1.3%) | 4 (6.3%) | 0.240 |
| Insomnia | 7 (4.9%) | 6 (7.6%) | 1 (1.6%) | 0.210 |
| Headache | 4 (2.8%) | 2 (2.5%) | 2 (3.2%) | 1.000 |
| Constipation | 1(0.7%) | 0 (0.0%) | 1 (1.6%) | 0.909 |
Values are expressed as number (%).
GERD gastroesophageal reflux disease.