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) |
Patients with multiple events falling under the same category are counted only once in that category.