Summary of adverse events occurring during and up to 1 day after the end of study treatment
| Adverse event, n (%) | Placebo (n=90) | Bosentan (n=96) |
|---|---|---|
| All patients with ≥1 adverse event | 76 (84.4) | 83 (86.5) |
| Peripheral oedema | 4 (4.4) | 18 (18.8) |
| Elevated aminotransferases* | 2 (2.2) | 12 (12.5) |
| Arthralgia | 6 (6.7) | 10 (10.4) |
| Headache | 11 (12.2) | 9 (9.4) |
| Infected skin ulcer | 6 (6.7) | 9 (9.4) |
| Upper respiratory tract infection | 7 (7.8) | 8 (8.3) |
| Diarrhoea | 8 (8.9) | 6 (6.3) |
| Pain in extremity | 4 (4.4) | 6 (6.3) |
| Nausea | 11 (12.2) | 5 (5.2) |
| Skin ulcer/disease progression | 7 (7.8) | 5 (5.2) |
| Urinary tract infection | 3 (3.3) | 5 (5.2) |
| Dermatitis | 2 (2.2) | 5 (5.2) |
| Other† | 70 (77.8) | 78 (81.3) |
| All patients with ≥1 serious adverse event | 15 (16.7) | 9 (9.4) |