Table 4. Treatment-Emergent AEs, n (%).
| AE | RLAI (n=329) | Quetiapine (n=337) |
|---|---|---|
| Any AE | 225 (68.4) | 235 (69.7) |
| Serious AE | 63 (19.1) | 77 (22.8) |
| Common AEs | ||
| Psychiatric symptoms | 142 (43.2) | 145 (43.0) |
| Prolactin-related | 45 (13.7) | 11 (3.3) |
| Weight gain | 23 (7.0) | 21 (6.2) |
| Headache | 20 (6.1) | 17 (5.0) |
| Somnolence | 6 (1.8) | 38 (11.3) |
| Relationship to study drug | ||
| None/doubtful | 222 (67.5) | 186 (55.2) |
| Possible/probable/very likely | 107 (32.5) | 151 (44.8) |
| Extrapyramidal symptom AEs | ||
| Any | 34 (10.3) | 19 (5.6) |
| Tremor | 10 (3.0) | 2 (0.6) |
| Dystonia | 1 (0.3) | 2 (0.6) |
| Hyperkinesia | 13 (4.0) | 8 (2.4) |
| Parkinsonism | 15 (4.6) | 6 (1.8) |
| Dyskinesia | 1 (0.3) | 3 (0.9) |
Abbreviations: AE, adverse event; RLAI, risperidone long-acting injectable.