Tolerability and safety of pirfenidone (n = 30)
| Tolerability, n (%) | |
| Tolerated recommended dose (2403 mg/day) | 19 (63.3) |
| Tolerated less than recommended dose | 9 (30.0) |
| Unable to tolerate drug | 2 (6.7) |
| AEs, n (%) | |
| Fatigue | 25 (83.3) |
| Nausea | 18 (60.0) |
| Weight loss | 11 (36.7) |
| Gastroesophageal reflux disorder | 11 (36.7) |
| Loss of appetite | 9 (30.0) |
| Diarrhea | 6 (20.0) |
| Ocular photosensitivity | 6 (20.0) |
| Vomiting | 6 (20.0) |
| Dry eyes | 4 (13.3) |
| Myalgias | 3 (10.0) |
| Change in taste | 4 (13.3) |
| LFT abnormalities | 3 (10.0) |
| Rash | 1 (3.3) |
| SAEs | |
| Total SAEs, n | 23 |
| Participants with an SAE, n (%) | 12 (40.0) |
| Infection-related SAEs, n (% of all SAEs) | 20 (87.0) |
| Drug-related SAEs, n (% of all SAEs) | 1 (4.3) |
| Deaths, n (%) | 4 (13.3) |
| Tolerability, n (%) | |
| Tolerated recommended dose (2403 mg/day) | 19 (63.3) |
| Tolerated less than recommended dose | 9 (30.0) |
| Unable to tolerate drug | 2 (6.7) |
| AEs, n (%) | |
| Fatigue | 25 (83.3) |
| Nausea | 18 (60.0) |
| Weight loss | 11 (36.7) |
| Gastroesophageal reflux disorder | 11 (36.7) |
| Loss of appetite | 9 (30.0) |
| Diarrhea | 6 (20.0) |
| Ocular photosensitivity | 6 (20.0) |
| Vomiting | 6 (20.0) |
| Dry eyes | 4 (13.3) |
| Myalgias | 3 (10.0) |
| Change in taste | 4 (13.3) |
| LFT abnormalities | 3 (10.0) |
| Rash | 1 (3.3) |
| SAEs | |
| Total SAEs, n | 23 |
| Participants with an SAE, n (%) | 12 (40.0) |
| Infection-related SAEs, n (% of all SAEs) | 20 (87.0) |
| Drug-related SAEs, n (% of all SAEs) | 1 (4.3) |
| Deaths, n (%) | 4 (13.3) |