Table 3. Incidence of Treatment-Emergent Adverse Events, % (Safety Population; Incidence ≥3% and 2-Times Placebo).
| Placebo (N=111) | Dasotraline 4 mg/day (N=116) | Dasotraline 8 mg/day (N=111) | |
|---|---|---|---|
| Insomnia | 15.5 | 34.5 | 45.0 |
| Decreased appetite | 2.7 | 10.3 | 22.5 |
| Dry mouth | 2.7 | 7.8 | 17.1 |
| Anxiety | 1.8 | 9.5 | 9.0 |
| Nausea | 2.7 | 6.0 | 9.9 |
| Dizziness | 0.9 | 6.9 | 8.1 |
| Palpitations | 0 | 5.2 | 2.7 |
| Weight decreased | 0.9 | 2.6 | 5.4 |
| Tension headache | 0 | 5.2 | 0 |
| Panic attack | 0.9 | 0 | 3.6 |
| Any TEAE rated as ‘severe' | 2.7 | 6.0 | 13.5 |
Abbreviation: TEAE, treatment-emergent adverse event.