Table 5.
Adverse Events
| Treatment | |||
|---|---|---|---|
| ALKS 3831 (n = 46), n (%) | OLZ (n = 45), n (%) | B‐OLZ (n = 48), n (%) | |
| Any AEs | 28 (60.9) | 23 (51.1) | 27 (56.3) |
| AEs by severity | |||
| Mild | 23 (50.0) | 20 (44.4) | 23 (47.9) |
| Moderate | 5 (10.9) | 3 (6.7) | 4 (8.3) |
| Severe | 0 | 0 | 0 |
| Drug‐related AEsa | 26 (56.5) | 20 (44.4) | 26 (54.2) |
| Serious AEs | 0 | 0 | 1 (2.1) |
| AEs leading to study discontinuation | 0 | 0 | 2 (4.2) |
| AEs reported by ≥5% of subjects, n (%) | |||
| Dizziness | 14 (30.4) | 11 (24.4) | 12 (25.0) |
| Somnolence | 9 (19.6) | 4 (8.9) | 9 (18.8) |
| Nausea | 7 (15.2) | 2 (4.4) | 3 (6.3) |
| Tachycardia | 6 (13.0) | 5 (11.1) | 6 (12.5) |
| Sedation | 5 (10.9) | 1 (2.2) | 2 (4.2) |
| Headache | 2 (4.3) | 2 (4.4) | 3 (6.3) |
| Blood CPK increased | 0 | 1 (2.2) | 3 (6.3) |
| Syncope | 0 | 0 | 3 (6.3) |
AE, adverse event; B‐OLZ, brand olanzapine; CPK, creatine phosphokinase; OLZ, olanzapine.
a
Related = definitely related, probably related, or possibly related.