Table 3.
Adverse events reported by at least 5% of participants during open-label treatment.
| Adverse event | All | Men | Women | P-value | OR (CI) Male : female |
|---|---|---|---|---|---|
| Insomnia | 58% | 54% | 64% | 0.08 | 1.5 (0.9, 2.4) |
| Headache | 37% | 30% | 46% | 0.004 | 2.0 (1.2, 3.2) |
| Skin rash | 19% | 17% | 22% | 0.27 | 1.4 (0.8, 2.5) |
| Vivid dreams | 14% | 12% | 17% | 0.29 | 1.4 (0.7, 2.7) |
| Dry mouth | 13% | 15% | 10% | 0.20 | 0.6 (0.3, 1.3) |
| Anxiety | 13% | 11% | 16% | 0.19 | 1.6 (0.8, 3.1) |
| Nausea | 7% | 5% | 11% | 0.06 | 2.3 (0.9, 5.5) |
| Dizziness | 6% | 4% | 7% | 0.27 | 1.7 (0.6, 4.6) |
| Racing heart | 5% | 3% | 8% | 0.06 | 2.6 (0.9, 7.4) |
No adverse events were reported during extended treatment by as many as 5% of participants. CI: confidence inerval; OR: odds ratio.