TABLE 3.
Adverse event summary for the Safety Sample
| Atomoxetine (n=19) | Placebo (n=19) | Relative Risk {a} | ||||
|---|---|---|---|---|---|---|
| Adverse Event | Freq. | Percent | Freq. | Percent | Estimate | 95% CI |
| At least one AE | 19 | 100% | 16 | 84% | 1.19 | [0.98, 1.44] |
| Anxiety/depression | 3 | 16% | 2 | 11% | 1.50 | [0.28, 7.99] |
| Dizziness/lightheaded | 6 | 32% | 3 | 16% | 2.00 | [0.58, 6.85] |
| Drowsiness | 3 | 16% | 3 | 16% | 1.00 | [0.23, 4.34] |
| Dry mouth | 3 | 16% | 3 | 16% | 1.00 | [0.23, 4.34] |
| Gastrointestinal | 9 | 47% | 4 | 21% | 2.25 | [0.83, 6.06] |
| Headache | 7 | 37% | 5 | 26% | 1.40 | [0.54, 3.64] |
| Hot/cold flashes | 3 | 16% | 0 | 0% | -- | -- |
| Increased Urination | 0 | 0% | 2 | 11% | -- | -- |
| Insomnia | 0 | 0% | 4 | 21% | -- | -- |
| Irritability | 2 | 11% | 1 | 5% | 2.00 | [0.20, 20.24] |
| Musculoskeletal | 6 | 32% | 5 | 26% | 1.20 | [0.44, 3.27] |
| Respiratory | 0 | 0% | 1 | 5% | -- | -- |
| Sexual dysfunction | 5 | 26% | 0 | 0% | -- | -- |
| Sinus/allergies/flu-like symptoms | 7 | 37% | 9 | 47% | 0.78 | [0.37, 1.66] |
| Other | 5 | 26% | 3 | 16% | 1.67 | [0.46, 6.01] |
{a}
Relative risk, which is the ratio of the Atomoxetine percentage to the Placebo percentage, is not reported if one of the two percentages is zero.