Table 7.
Mean time to onset and median duration of treatment emergent adverse events reported by ≥5% of patients
| TIME TO ONSET, DAYS [MEAN (SD)] | DURATION, DAYS [MEDIAN (IQR)] | |||
|---|---|---|---|---|
| PREFERRED TERM | TCOAD (N=202) | PLACEBO (N=204) | TCOAD (N=202) | PLACEBO (N=204) |
| Headache | 9.8 (10.3) | 9.6 (9.4) | 4 (1, 14) | 3 (1, 15) |
| Somnolence | 7.6 (7.0) | 9.7 (10.5) | 9 (4, 22) | 4.5 (3, 11) |
| Dry mouth | 6.1 (6.0) | 9.8 (13.3) | 27 (12, 46) | 22.5 (5, 44) |
| Dizziness | 6.7 (5.6) | 11.2 (8.0) | 4 (2, 17) | 2 (1, 10) |
| Nausea | 9.6 (8.8) | 9.2 (8.1) | 3 (1, 7) | 2 (1, 7) |
| Sedation | 6.1 (5.9) | 5.9 (3.7) | 12.5 (6, 27) | 18 (3, 32) |
| Fatigue | 7.9 (7.5) | 13.3 (15.2) | 23 (10, 53) | 19 (8, 23) |
| Diarrhea | 16.5 (13.2) | 16.8 (14.1) | 3 (1, 7) | 3 (1, 5) |
| Constipation | 7.2 (7.0) | 17.3 (15.4) | 7 (3, 29.5) | 14.5 (6.5, 19) |
| Back pain | 26.0 (18.7) | 22.9 (22.0) | 4 (1, 14) | 3 (1, 4) |
| Vision blurred | 8.6 (5.1) | — | 20 (2, 23) | — |
TCOAD=Trazodone Contramid OAD