Table 3.
Treatment-emergent adverse events (TEAE).
| TEAE | N (%) | Onset of TEAE | Relation to dose escalation | Action taken | Outcome at last FU |
|---|---|---|---|---|---|
| Dizziness | 6 (28.6%) | Between week 2 and week 4 | Probably related | No action taken (3 cases) Dose reduced (2 cases) Drug withdrawn (1 case) |
Resolved Resolved Resolved |
| Somnolence | 1 (4.8%) | Week 4 | Probably related | Drug withdrawn | Resolved |
| Headache | 1 (4.8%) | Between week 4 and week 6 | Probably related | No action taken | Resolved |
| Blurred vision | 1 (4.8%) | Week 8 | Possibly related | No action taken | Resolved |
| Decreased libido | 1 (4.8%) | Week 8 | Possibly related | No action taken | Resolved (improved over several weeks of follow-up) |
| Weight gain | 1 (4.8%) | Week 8 | Probably related | No action taken | Resolved (improved over several weeks of FU) |
| Snoring | 1 (4.8%) | Week 8 | Possibly related | No action taken | Resolved (improved over several weeks of FU) |
| Diarrhea | 1 (4.8%) | Between week 4 and week 6 | Possibly related | No action taken | Resolved (improved over several weeks of FU) |
| Depressive symptoms | 3 (14.3%) | Week 4 | Probably related | No action taken | Resolved |
| Irritability | 2 (9.5%) | Week 4 | Probably related | No action taken | Resolved |
| Anxiety | 1 (4.8%) | Week 4 | Probably related | No action taken | Resolved |
| Agitation | 1 (4.8%) | Week 6 | Probably related | Dose reduced | Resolved |
| Aggression | 1 (4.8%) | Week 6 | Probably related | Dose reduced | Resolved |