Treatment-emergent adverse events*
| Phase 3 multinational trials‡ | |||
|---|---|---|---|
| Integrated population (N=1299)† | Pirfenidone (N=623) | Placebo (N=624) | |
| Duration of exposure, median (range), years | 1.7 (>0, 9.9) | 1.0 (>0, 2.3) | 1.0 (>0, 2.3) |
| Treatment-emergent adverse event, % | |||
| Nausea | 37.6 | 36.1 | 15.5 |
| Cough | 35.1 | 27.8 | 29.2 |
| Dyspnoea | 30.9 | 16.9 | 20.2 |
| Upper respiratory tract infection | 30.6 | 26.8 | 25.3 |
| Idiopathic pulmonary fibrosis | 29.3 | 13.0 | 19.9 |
| Fatigue | 28.2 | 26.0 | 19.1 |
| Diarrhoea | 28.1 | 25.8 | 20.4 |
| Rash | 25.0 | 30.3 | 10.3 |
| Bronchitis | 23.8 | 14.1 | 15.4 |
| Headache | 21.6 | 22.0 | 19.2 |
| Nasopharyngitis | 21.3 | 16.7 | 17.9 |
| Dizziness | 21.2 | 18.0 | 11.4 |
| Dyspepsia | 18.4 | 18.5 | 6.9 |
| Vomiting | 15.9 | 13.3 | 6.3 |
| Weight decreased | 15.6 | 10.1 | 5.4 |
| Back pain | 15.4 | 10.4 | 10.4 |
| Anorexia | 15.2 | 13.0 | 5.0 |
*Occurring in ≥15% of patients in the cumulative clinical database.
†Includes two patients in study 002 with a diagnosis of “pulmonary fibrosis.”
‡CAPACITY (studies 004 and 006) and ASCEND (study 016).