Table 4.
Incidence of Treatment-Emergent Adverse Events (All Causalities) Occurring in ≥5% of Subjects
| |
RCT |
OLE |
|
|---|---|---|---|
| n | Ziprasidone 149 | Placebo 88 | Ziprasidone 162 |
| Adverse event, n (%) | |||
| Sedation | 49 (32.9) | 5 (5.7) | 43 (26.5) |
| Somnolence | 37 (24.8) | 7 (8.0) | 38 (23.5) |
| Headache | 33 (22.1) | 19 (21.6) | 36 (22.2) |
| Fatigue | 23 (15.4) | 6 (6.8) | 11 (6.8) |
| Nausea | 21 (14.1) | 6 (6.8) | 13 (8.0) |
| Dizziness | 19 (12.8) | 2 (2.3) | 12 (7.4) |
| Insomnia | 14 (9.4) | 3 (3.4) | 22 (13.6) |
| Vomiting | 12 (8.1) | 1 (1.1) | 12 (7.4) |
| Blurred vision | 9 (6.0) | 1 (1.1) | (<5) |
| Tremor | 9 (6.0) | 0 | (<5) |
| Restlessness | 8 (5.4) | 1 (1.1) | (<5) |
| Musculoskeletal stiffness | 8 (5.4) | 0 (0) | (<5) |
| Upper abdominal pain | 8 (5.4) | 3 (3.4) | 15 (9.3) |
| Upper respiratory tract infection | 8 (5.4) | 0 | (<5) |
| Akathisia | 8 (5.4) | 1 (1.1) | (<5) |
| Overdosea | 7 (4.7) | 5 (5.7) | (<5) |
| Abdominal discomfort | (<5) | (<5) | 11 (6.8) |
| Cough | (<5) | (<5) | 9 (5.6) |
| Nasal congestion | (<5) | (<5) | 12 (7.4) |
a
Overdose was recorded as an adverse event in 10 cases (6 ziprasidone, 4 placebo) because of investigator dosing errors. One further overdose in the ziprasidone group was recorded as a serious adverse event and another in the placebo group was graded as mild. None of these overdoses were associated with suicide attempts.
OLE, open-label extension; RCT, randomized controlled trial.