Table 3. Summary of Adverse Events by Treatment Group.
| No. (%) | ||
|---|---|---|
| Fluoxetine (n = 75) | Placebo (n = 71) | |
| Participants with at least 1 AEa | 34 (45) | 30 (42.3) |
| Total No. of AEs | ||
| Mean (SD) | 2.5 (1.6) | 2.6 (2.1) |
| 1 | 14 (41) | 13 (43) |
| 2 | 3 (9) | 6 (20) |
| 3 | 7 (21) | 3 (10) |
| 4 | 7 (21) | 3 (10) |
| 5 | 1 (3) | 1 (3) |
| 6 | 2 (6) | 2 (7) |
| 7 | 0 | 1 (3) |
| 9 | 0 | 1 (3) |
Abbreviation: AE, adverse event.
a
Adverse events, assessed at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 17, 18, 19, 20, and 22 weeks, were most commonly irritability, mood disturbance, nausea, vomiting, and sleep disorders.