Adverse events reported by at least 10% of patients in either group
| Symptom | Ropinirole (n = 146) | Placebo (n = 138) |
|---|---|---|
| Values are n (%). | ||
| *Despite reports of somnolence as an adverse event, the overall level of daytime somnolence measured by the medical outcomes study sleep scale showed significant improvement related to ropinirole treatment over the duration of the trial. | ||
| †Severe adverse events were defined as those that prevented normal everyday activities. Only nausea occurred in more than five patients in either group (ropinirole 7; placebo 0). | ||
| Nausea | 55 (37.7) | 9 (6.5) |
| Headache | 29 (19.9) | 23 (16.7) |
| Vomiting | 19 (13.0) | 2 (1.4) |
| Abdominal pain | 18 (12.3) | 12 (8.7) |
| Somnolence* | 18 (12.3) | 10 (7.2) |
| Upper respiratory tract infection | 14 (9.6) | 15 (10.9) |
| Patients reporting at least one adverse event | 120 (82.2) | 103 (74.6) |
| Patients reporting at least one severe adverse event† | 34 (23.3) | 21 (15.2) |