TEAE reported in ≥ 10% of patients from both treatment groups overall. Values are n (%).
| TEAE | Pirfenidone, 2403 mg/day | |||||
|---|---|---|---|---|---|---|
| 2-week Titration Group, n = 32 | 4-week Titration Group, n = 31 | |||||
| Mild | Moderate | Severe | Mild | Moderate | Severe | |
| Nausea | 13 (40.6) | 2 (6.3) | 1 (3.1) | 12 (38.7) | 2 (6.5) | 1 (3.2) |
| Headache | 12 (37.5) | 2 (6.3) | 0 | 12 (38.7) | 2 (6.5) | 0 |
| Fatigue | 6 (18.8) | 5 (15.6) | 2 (6.3) | 8 (25.8) | 1 (3.2) | 1 (3.2) |
| Diarrhea | 7 (21.9) | 0 | 2 (6.3) | 8 (25.8) | 2 (6.5) | 0 |
| Vomiting | 5 (15.6) | 3 (9.4) | 1 (3.1) | 7 (22.6) | 2 (6.5) | 0 |
| Cough* | 8 (25.0) | 2 (6.3) | 0 | 3 (9.7) | 1 (3.2) | 0 |
| GERD, including worsening GERD | 3 (9.4) | 3 (9.4) | 0 | 5 (16.1) | 1 (3.2) | 1 (3.2) |
| Rash | 6 (18.8) | 2 (6.3) | 0 | 3 (9.7) | 2 (6.5) | 0 |
| Dizziness | 3 (9.4) | 2 (6.3) | 0 | 3 (9.7) | 2 (6.5) | 0 |
| Arthralgia | 3 (9.4) | 2 (6.3) | 0 | 2 (6.5) | 2 (6.5) | 0 |
| Anorexia | 3 (9.4) | 2 (6.3) | 0 | 1 (3.2) | 1 (3.2) | 0 |
| Back pain | 4 (12.5) | 1 (3.1) | 0 | 1 (3.2) | 2 (6.5) | 0 |
| Dyspepsia | 1 (3.1) | 2 (6.3) | 1 (3.1) | 3 (9.7) | 1 (3.2) | 0 |
| Pruritus | 2 (6.3) | 2 (6.3) | 0 | 4 (12.9) | 0 | 0 |
| Asthenia* | 0 | 1 (3.1) | 1 (3.1) | 3 (9.7) | 2 (6.5) | 0 |
| Dyspnea | 2 (6.3) | 1 (3.1) | 0 | 3 (9.7) | 1 (3.2) | 0 |
| Insomnia* | 0 | 2 (6.3) | 0 | 5 (16.1) | 0 | 0 |
| Stomach discomfort | 3 (9.4) | 0 | 0 | 3 (9.7) | 1 (3.2) | 0 |
| Constipation | 5 (15.6) | 0 | 0 | 1 (3.2) | 0 | 0 |
↵* Events with treatment differences ≥ 10%; p values by the Fisher’s exact test all > 0.1. TEAE: treatment-emergent adverse event; GERD: gastroesophageal reflux disease.