Table 3.
Spontaneously reported or observed adverse events with total relative frequency >3% and with probable or possible relation to trial drug and dropout rate due to adverse events (safety population). Values are numbers (percentages)
| Variable | Group
|
||
|---|---|---|---|
| Placebo (n=47) |
Hypericum extract (n=106) | Imipramine (n=110) |
|
| Patients with adverse events | 9 (19) | 23 (22) | 51 (46) |
| Dry mouth | 6 (13) | 7 (7) | 42 (38) |
| Nausea | 1 (2) | 8 (8) | 12 (11) |
| Constipation | 3 (6) | 4 (4) | 7 (6) |
| Headache | 1 (2) | 3 (3) | 6 (6) |
| Palpitation | 0 | 4 (4) | 6 (6) |
| Dizziness | 1 (2) | 1 (1) | 7 (6) |
| Dropout rate due to adverse events | 0 | 0 | 1 (1) |