Table 3 Incidence of treatment-emergent adverse events (≥2% in any group; safety set)
Adverse event,n(%) | Quetiapine XR + Lithium (n= 173) | Quetiapine XR + Placebo (n= 183) |
|---|---|---|
Tremor | 27 (15.6) | 9 (4.9) |
Somnolence | 22 (12.7) | 10 (5.5) |
Constipation | 16 (9.2) | 16 (8.7) |
Dry mouth | 14 (8.1) | 14 (7.7) |
Dizziness | 11 (6.4) | 8 (4.4) |
Insomnia | 11 (6.4) | 12 (6.6) |
Headache | 9 (5.2) | 11 (6.0) |
Pyrexia | 10 (5.8) | 9 (4.9) |
Diarrhea | 8 (4.6) | 2 (1.1) |
Vomiting | 8 (4.6) | 0 |
Sedation | 5 (2.9) | 3 (1.6) |
Dysarthria | 4 (2.3) | 2 (1.1) |
Nausea | 5 (2.9) | 3 (1.6) |
Weight increased | 2 (1.2) | 5 (2.7) |
Increased appetite | 4 (2.3) | 1 (0.5) |