Summary of most commonly occurring treatment-emergent adverse events (incidence ≥10% in either group)
| Baseline FVC ≥80% | Baseline FVC <80% | Baseline GAP stage I | Baseline GAP stage II–III | |||||
| Pirfenidone | Placebo | Pirfenidone | Placebo | Pirfenidone | Placebo | Pirfenidone | Placebo | |
| Patients | 146 | 170 | 477 | 454 | 247 | 235 | 376 | 387 |
| Nausea | 53 (36.3) | 26 (15.3) | 168 (35.2) | 69 (15.2) | 92 (37.2) | 39 (16.6) | 129 (34.3) | 56 (14.5) |
| Cough | 31 (21.2) | 39 (22.9) | 113 (23.7) | 112 (24.7) | 62 (25.1) | 55 (23.4) | 82 (21.8) | 95 (24.5) |
| Diarrhoea | 37 (25.3) | 30 (17.6) | 116 (24.3) | 87 (19.2) | 61 (24.7) | 46 (19.6) | 92 (24.5) | 71 (18.3) |
| Upper respiratory tract infection | 40 (27.4) | 41 (24.1) | 102 (21.4) | 85 (18.7) | 61 (24.7) | 48 (20.4) | 81 (21.5) | 76 (19.6) |
| Fatigue | 32 (21.9) | 28 (16.5) | 111 (23.3) | 78 (17.2) | 57 (23.1) | 43 (18.3) | 86 (22.9) | 63 (16.3) |
| Headache | 22 (15.1) | 34 (20.0) | 106 (22.2) | 79 (17.4) | 55 (22.3) | 51 (21.7) | 73 (19.4) | 62 (16.0) |
| Rash | 46 (31.5) | 17 (10.0) | 136 (28.5) | 39 (8.6) | 75 (30.4) | 23 (9.8) | 107 (28.5) | 32 (8.3) |
| Nasopharyngitis | 22 (15.1) | 29 (17.1) | 72 (15.1) | 70 (15.4) | 38 (15.4) | 51 (21.7) | 56 (14.9) | 48 (12.4) |
| Dyspnoea | 16 (11.0) | 21 (12.4) | 66 (13.8) | 80 (17.6) | 31 (12.6) | 30 (12.8) | 51 (13.6) | 70 (18.1) |
| Dizziness | 20 (13.7) | 18 (10.6) | 84 (17.6) | 45 (9.9) | 44 (17.8) | 21 (8.9) | 60 (16.0) | 42 (10.9) |
| Dyspepsia | 27 (18.5) | 10 (5.9) | 84 (17.6) | 32 (7.0) | 40 (16.2) | 15 (6.4) | 71 (18.9) | 27 (7.0) |
| Bronchitis | 12 (8.2) | 12 (7.1) | 58 (12.2) | 70 (15.4) | 34 (13.8) | 51 (21.7) | 56 (14.9) | 48 (12.4) |
| Idiopathic pulmonary fibrosis | 12 (8.2) | 11 (6.5) | 41 (8.6) | 80 (17.6) | 31 (12.6) | 30 (12.8) | 51 (13.6) | 70 (18.1) |
| Constipation | 17 (11.6) | 19 (11.2) | 42 (8.8) | 44 (9.7) | 23 (9.3) | 16 (6.8) | 36 (9.6) | 47 (12.1) |
| Vomiting | 15 (10.3) | 11 (6.5) | 64 (13.4) | 27 (5.9) | 28 (11.3) | 10 (4.3) | 51 (13.6) | 28 (7.2) |
| Anorexia | 11 (7.5) | 2 (1.2) | 66 (13.8) | 25 (5.5) | 20 (8.1) | 3 (1.3) | 57 (15.2) | 24 (6.2) |
| Gastro-oesophageal reflux disease | 14 (9.6) | 8 (4.7) | 50 (10.5) | 27 (5.9) | 29 (11.7) | 14 (6.0) | 35 (9.3) | 21 (5.4) |
Data are presented as n or n (%). FVC: forced vital capacity; GAP: gender, age and physiology index.