Table 3.
Adverse events and adverse drug reactions occurring in ≥0.5% of patients
| Adverse Events* n = 510 | Adverse Drug Reactions* n = 510 | |
|---|---|---|
| 125 (24.5%) | 116 (22.7%) | |
| Somnolence | 48 (9.4%) | 48 (9.4%) |
| Weight increased | 18 (3.5%) | 17 (3.3%) |
| Headache | 8 (1.6%) | 6 (1.2%) |
| Nausea | 7 (1.4%) | 7 (1.4%) |
| Increased appetite | 6 (1.2%) | 6 (1.2%) |
| Obesity | 5 (1.0%) | 5 (1.0%) |
| Insomnia | 4 (0.8%) | 3 (0.6%) |
| Tic disorders | 4 (0.8%) | 4 (0.8%) |
| Akathisia | 4 (0.8%) | 4 (0.8%) |
| Constipation | 4 (0.8%) | 4 (0.8%) |
| Malaise | 4 (0.8%) | 4 (0.8%) |
| Irritability | 3 (0.6%) | 3 (0.6%) |
| Dizziness | 3 (0.6%) | 3 (0.6%) |
| Vomiting | 3 (0.6%) | 3 (0.6%) |
*: MedDRA/J version (22.1)