Table 3.
Summary of adverse events
| Placebo N = 235 | Lurasidone N = 247 | |
|---|---|---|
| Overall | ||
| Any AE | 120 (51.1) | 116 (47.0) |
| Serious AE | 4 (1.7) | 2 (0.8) |
| AE leading to discontinuation | 15 (6.4) | 14 (5.7) |
| AE of special interest | ||
| Any extrapyramidal AE | 12 (5.1) | 20 (8.1) |
| Hyperglycemia/new‐onset diabetes | 7 (3.0) | 11 (4.5) |
| Weight gain | 1 (0.4) | 4 (1.6) |
| ≥7% increase in weight | 2 (0.9) | 8 (3.3) |
| Hypersensitivity | 8 (3.4) | 11 (4.5) |
| Common adverse events† | ||
| Akathisia | 4 (1.7) | 10 (4.0) |
| Dizziness | 3 (1.3) | 7 (2.8) |
| Somnolence | 0 | 7 (2.8) |
| Abdominal discomfort | 0 | 5 (2.0) |
| Asthenia | 2 (0.9) | 5 (2.0) |
†
Treatment‐emergent adverse events reported in ≥2% on lurasidone and ≥ 2x placebo.
AE were classified using MedDRA Version 19.1.
Number (%) of patients is shown.
AE, treatment‐emergent adverse event.