Table 2.
Summary of adverse events.
| Parameter | Placebo (n = 12) | Olanzapine (n = 24) | OLZ/SAM (n = 24) |
|---|---|---|---|
| Subjects with any AE, n (%) | 9 (75.0) | 19 (79.2) | 21 (87.5) |
| AEs occurring in ≥10% of subjects,a n (%) | |||
| Increased alanine aminotransferase | 0 | 11 (45.8) | 6 (25.0) |
| Fatigue | 1 (8.3) | 7 (29.2) | 7 (29.2) |
| Somnolence | 0 | 2 (8.3) | 7 (29.2) |
| Constipation | 1 (8.3) | 0 | 7 (29.2) |
| Dry mouth | 0 | 0 | 8 (33.3) |
| Headache | 2 (16.7) | 1 (4.2) | 5 (20.8) |
| Dizziness | 2 (16.7) | 0 | 5 (20.8) |
| Increased aspartate aminotransferase | 0 | 2 (8.3) | 5 (20.8) |
AE adverse event, OLZ/SAM combination of olanzapine and samidorphan.
aIn the overall safety population.