Table 3.
Summary of treatment-emergent adverse events and treatment-emergent adverse events occurring in ≥5% in either treatment group during the 1-week treatment period
| Vortioxetine, n (%) | Placebo, n (%) | |
|---|---|---|
| Number of treated patients | 39 | 41 |
| Patients with TEAEs | 21 (53.8) | 15 (36.6) |
| TEAEs occurring in ≥5% in either group | ||
| Nauseaa | 5 (12.8) | 7 (17.1) |
| Dizziness | 4 (10.3) | 3 (7.3) |
| Erythema | 4 (10.3) | 0 |
| Insomnia | 3 (7.7) | 1 (2.4) |
| Headache | 2 (5.1) | 1 (2.4) |
| Diarrhea | 2 (5.1) | 1 (2.4) |
| Anxiety | 2 (5.1) | 0 |
| Blood pressure increased | 2 (5.1) | 0 |
| Sedation | 1 (2.6) | 3 (7.3) |
| Somnolence | 1 (2.6) | 4 (9.8) |
No serious adverse events or deaths occurred during the study. No patients withdrew from the study due to adverse events.
TEAE, treatment-emergent adverse event.
a
One patient in the vortioxetine group reported vomiting.