Occurrence of adverse events (AEs)/treatment group
| pramipexole (n=44) | placebo (n=40) | p Value | |
|---|---|---|---|
| Values are number of patients (%) with at least one AE; common treatment emergent adverse events, occurring in at least 10% of patients in either treatment group; and serious adverse events; p values (Fisher's exact test) for the differences between treatment groups | |||
| Any AE | 41 (93.2) | 31 (77.5) | 0.06 |
| Fatigue | 10 (22.7) | 4 (10) | 0.15 |
| Dizziness | 8 (18.2) | 6 (15) | 0.78 |
| Insomnia | 9 (20.5) | 3 (7.5) | 0.12 |
| Nausea | 7 (15.9) | 3 (7.5) | 0.32 |
| Aggravation of parkinsonism | 4 (9.1) | 4 (10) | 1.00 |
| Abdominal pain | 6 (13.6) | 1 (2.5) | 0.11 |
| Tremor | 2 (4.5) | 5 (12.5) | 0.25 |
| Headache | 6 (13.6) | 1 (2.5) | 0.11 |
| Serious AE | 2 (4.5) | 2 (5) | 1.00 |
| Assessed as drug related | 1 (2.3) | 0 | 1.00 |