AE-Preferred Term | Dose-Optimization Phase |
|---|
| Â | Males | Females |
|---|
| Â | (n = 98) | (n = 31) |
|---|
| Â | n (%) | n (%) |
|---|
Any AE | 83 (84.7) | 27 (87.1) |
Abdominal pain upper | 16 (16.3) | 4 (12.9) |
Affect lability | 11 (11.2) | 2 (6.5) |
Decreased appetite | 47 (48.0) | 14 (45.2) |
Headache | 18 (18.4) | 4 (12.9) |
Insomnia | 30 (30.6) | 5 (16.1) |
Irritability | 16 (16.3) | 5 (16.1) |
Nausea | 7 (7.1) | 4 (12.9) |
- For tables 6-9: TEAEs were assigned to either the open-label dose-optimization phase or the double-blind crossover phase of the study and were summarized separately. TEAEs that continued uninterrupted from the dose-optimization to the crossover phase without a change in severity were counted only in the dose-optimization phase category. TEAEs with a change in severity across phases or that resolved and then restarted in the crossover phase were counted both in the dose-optimization and crossover arms. TEAEs for which a missing or incomplete start date made it impossible to determine in which phase of the study they started were counted as starting in the dose-optimization phase.
