Table 5.
Incidence of treatment emergent adverse events reported by ≥5% of patients (n)
| PREFERRED TERM | TCOAD (N=202) | PLACEBO (N=204) |
|---|---|---|
| Headache | 67 (33.2%) | 55 (27.0%) |
| Somnolence† | 63 (31.2%) | 32 (15.7%) |
| Dry mouth | 51 (25.2%) | 26 (12.7%) |
| Dizziness | 50 (24.8%) | 25 (12.3%) |
| Nausea | 42 (20.8%) | 26 (12.7%) |
| Sedation† | 34 (16.8%) | 7 (3.4%) |
| Fatigue | 30 (14.9%) | 17 (8.3%) |
| Diarrhea | 19 (9.4%) | 23 (11.3%) |
| Constipation | 16 (7.9%) | 4 (2.0%) |
| Back pain | 11 (5.4%) | 7 (3.4%) |
| Vision blurred | 11 (5.4%) | — |
†
Note: Sedation and somnolence were recorded as separate preferred terms. To ensure proper classification within each category, each reported case of somnolence and sedation was followed-up and confirmed by the investigator.
TCOAD=Trazodone Contramid OAD