Table 6.
Proportion of Participants Who Experienced at Least 1 Adverse Event by Treatment Group
| No. (%) |
||||
|---|---|---|---|---|
| SSRI | Venlafaxine | NoCBT | CBT | |
| Total No. of participants | 168 | 166 | 168 | 166 |
| ≥ 1 Serious adverse event | 18 (10.7) | 19 (11.4) | 14 (8.3) | 23 (13.9) |
| ≥ 1 Adverse event | 86 (51.2) | 78 (47.0) | 84 (50.0) | 80 (48.2) |
| Event/problem | ||||
| Harm-relateda | 31 (18.5) | 37 (22.3) | 32 (19.0) | 36 (21.7) |
| Suicide attempts | 6 (3.6) | 11 (6.6) | 7 (4.2) | 10 (6.0) |
| Sleep | 5 (3.0) | 12 (7.2) | 7 (4.2) | 10 (6.0) |
| Irritability | 8 (4.8) | 8 (4.8) | 6 (3.6) | 10 (6.0) |
| Flu-like | 31 (18.5) | 21 (12.7) | 26 (15.5) | 26 (15.7) |
| Aches | 24 (14.3) | 23 (13.9) | 23 (13.7) | 24 (14.5) |
| Accident/injury | 12 (7.1) | 7 (4.2) | 10 (6.0) | 9 (5.4) |
| Gastrointestinal | 9 (5.4) | 7 (4.2) | 7 (4.2) | 9 (5.4) |
| Skinb | 3 (1.8) | 13 (7.8) | 7 (4.2) | 9 (5.4) |
| Musculoskeletal | 6 (3.6) | 10 (6.0) | 5 (3.0) | 11 (6.6) |
Abbreviations: CBT, cognitive behavioral therapy; SSRI, selective serotonin reuptake inhibior.
a
Defined as suicidal ideation, suicide attempt, or self-injurious behavior.
b
By medication: , P = .01.