Characteristic | Placebo (n = 65) | Rasagiline 1 mg (n = 65) |
---|---|---|
Patients with TEAEs | 30 (46.2) | 27 (41.5) |
SAEs | 4 (6.2) | 0 (0) |
TEAEs leading to withdrawal | 5 (7.7) | 3 (4.6) |
Nervous system disorder | 10 (15.4) | 13 (20.0) |
Bradykinesia | 0 (0) | 1 (1.5) |
Dizziness | 3 (4.6) | 3 (4.6) |
Headache | 0 (0) | 2 (3.1) |
Parkinson’s diseasea | 4 (6.2) | 5 (7.7) |
Poor quality sleep | 0 (0) | 1 (1.5) |
Somnolence | 0 (0) | 2 (3.1) |
Speech disorder | 1 (1.5) | 0 (0) |
Tremor | 3 (4.6) | 3 (4.6) |
Gastrointestinal disorders | 7 (10.8) | 5 (7.7) |
Abdominal discomfort | 2 (3.1) | 0 (0) |
Constipation | 0 (0) | 1 (1.5) |
Diarrhea | 1 (1.5) | 2 (3.1) |
Dry mouth | 1 (1.5) | 1 (1.5) |
Gastric dilation | 1 (1.5) | 0 (0) |
Nausea | 1 (1.5) | 0 (0) |
Psychiatric disorders | 2 (3.1) | 2 (3.1) |
Hallucination | 0 (0) | 1 (1.5) |
Insomnia | 1 (1.5) | 1 (1.5) |
Major depression | 1 (1.5) | 0 (0) |
Eye disorders | 1 (1.5) | 2 (3.1) |