Table 3.
Adverse event summary for the Modified Intention-to-Treat Sample
| Buspirone (n=23) | Placebo (n=27) | Relative Risk {a} | ||||
|---|---|---|---|---|---|---|
| Adverse Event | Freq. | Percent | Freq. | Percent | Estimate | 95% CI |
| At least one AE | 22 | 96% | 21 | 78% | 1.23 | [0.99, 1.53] |
| Anxiety/depression | 0 | 0% | 1 | 4% | -- | -- |
| Dizziness | 9 | 39% | 3 | 11% | 3.52 | [1.08, 11.49] |
| Drowsiness | 7 | 30% | 7 | 26% | 1.17 | [0.48, 2.85] |
| Dry mouth | 4 | 17% | 2 | 7% | 2.35 | [0.47, 11.67] |
| Flushing/sweating | 5 | 22% | 2 | 7% | 2.93 | [0.63, 13.73] |
| Gastrointestinal | 8 | 35% | 8 | 30% | 1.17 | [0.52, 2.63] |
| Headache | 9 | 39% | 9 | 33% | 1.17 | [0.56, 2.46] |
| Insomnia | 1 | 4% | 2 | 7% | 0.59 | [0.06, 6.06] |
| Lightheaded/shakiness | 4 | 17% | 3 | 11% | 1.57 | [0.39, 6.28] |
| Metallic taste | 1 | 4% | 0 | 0% | -- | -- |
| Musculoskeletal | 2 | 9% | 2 | 7% | 1.17 | [0.18, 7.69] |
| Sexual dysfunction | 1 | 4% | 1 | 4% | 1.17 | [0.08, 17.74] |
| Sinus/allergies/flu | 10 | 43% | 5 | 19% | 2.35 | [0.94, 5.88] |
| Tingling | 2 | 9% | 0 | 0% | -- | -- |
| Unusual dreams | 2 | 9% | 2 | 7% | 1.17 | [0.18, 7.69] |
| Other | 2 | 9% | 2 | 7% | 1.17 | [0.18, 7.69] |
{a}
Relative risk, which is the ratio of the Buspirone percentage to the Placebo percentage, is not reported if one of the two percentages is zero.