Table 3.
Adverse Events Reported by ≥ 5% of Patients in Either Double-Blind Treatment Group During Phase Ca,b
| Early Responders |
Early Nonresponders |
|||
| Adverse Event | Placebo (n = 47) | Aripiprazole (n = 110) | Placebo (n = 478) | Aripiprazole (n = 429) |
| Akathisia | 3 (6.4) | 30 (27.3) | 19 (4.0) | 92 (21.4) |
| Headache | 6 (12.8) | 9 (8.2) | 47 (9.8) | 33 (7.7) |
| Tremor | 5 (10.6) | 8 (7.3) | Not reported | Not reported |
| Restlessness | 2 (4.3) | 18 (16.4) | 11 (2.3) | 48 (11.2) |
| Insomnia | 1 (2.1) | 8 (7.3) | 15 (3.1) | 35 (8.2) |
| Abnormal dreams | 5 (10.6) | 1 (0.9) | Not reported | Not reported |
| Constipation | 2 (4.3) | 6 (5.5) | Not reported | Not reported |
| Dry mouth | 4 (8.5) | 6 (5.5) | Not reported | Not reported |
| Nausea | 5 (10.6) | 5 (4.5) | Not reported | Not reported |
| Diarrhea | 3 (6.4) | 3 (2.7) | 25 (5.2) | 18 (4.2) |
| Fatigue | 2 (4.3) | 13 (11.8) | 19 (4.0) | 33 (7.7) |
| Upper respiratory tract infection | 6 (12.8) | 9 (8.2) | 23 (4.8) | 25 (5.8) |
| Blurred vision | 1 (2.1) | 7 (6.4) | 6 (1.3) | 27 (6.3) |
| Somnolence | Not reported | Not reported | 12 (2.5) | 27 (6.3) |
a
Data are reported as n (%).
b
Patients may have had more than 1 adverse event but were counted in the overall total only once. Each patient was also counted, at most, once for a particular adverse event, even if the adverse event occurred more than once for the same patient.