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.