Table 2. Adverse Event Information by Group.
| All Participants (n=67) | Randomization Group |
|||
|---|---|---|---|---|
| Placebo (n = 34) | Vortioxetine (n=33) | p-value | ||
| Any adverse event reported – n (%) | 37 (55.2%) | 17 (50.0%) | 20 (60.6%) | 0.53 |
| Number of visits per participant with AEs reported – n (%) | 0.43 | |||
| 0 | 30 (44.8%) | 17 (50.0%) | 13 (39.4%) | |
| 1 | 15 (22.4%) | 9 (26.5%) | 6 (18.2%) | |
| 2 | 12 (17.9%) | 5 (14.7%) | 7 (21.2%) | |
| 3 | 2 (3.0%) | 0 (0.0%) | 2 (6.1%) | |
| 4 | 5 (7.5%) | 3 (8.8%) | 2 (6.1%) | |
| 5 | 1 (1.5%) | 0 (0.0%) | 1 (3.0%) | |
| 6 | 2 (3.0%) | 0 (0.0%) | 2 (6.1%) | |
| Number of AEs reported (total across participants and visits) | 124 | 49 | 75 | N/A |
| Average number of AEs per participant (across all visits) | 3.4 | 2.9 | 3.8 | N/A |
| Description of most common AEs (> 3 reports) – n | N/A | |||
| Nausea | 28 | 9 | 19 | |
| Dry Mouth | 12 | 5 | 7 | |
| Headaches | 11 | 7 | 4 | |
| Dizziness | 10 | 5 | 5 | |
| Insomnia | 7 | 2 | 7 | |
| Vomiting | 5 | 2 | 3 | |
| Anxiety | 4 | 0 | 4 | |
| Gas/bloating | 4 | 3 | 1 | |
| Diarrhea | 4 | 0 | 4 | |
| Constipation | 4 | 3 | 1 | |