Table 2.
Adverse events.
| Adverse event | Overall | Men | Women | ||||||
|---|---|---|---|---|---|---|---|---|---|
| TX | TX | TX | |||||||
| 30 mg (n = 43) | 90 mg (n = 37) | PBO (n = 40) | 30 mg (n = 22) | 90 mg (n = 20) | PBO (n = 20) | 30 mg (n = 21) | 90 mg (n = 17) | PBO (n = 20) | |
| Sedation | 60.5%a | 54.1%ab | 35.0%b | 59.1%a | 45.0%ab | 20.0%b | 61.9% | 64.7% | 50.0% |
| Dizziness | 30.2% | 18.9% | 15.0% | 22.7% | 10.0% | 15.0% | 38.1% | 29.4% | 15.0% |
| Itchiness/rash | 16.3%a | 0%b | 20.0%a | 13.6% | 0% | 10.0% | 19.1%ab | 0%a | 30.0%b |
| Tired/fatigue | 0% | 5.4% | 7.5% | 0% | 0% | 0% | 0% | 11.8% | 15.0% |
| Nausea | 16.3% | 8.1% | 10.0% | 18.2% | 5.0% | 5.0% | 14.3% | 11.8% | 15.0% |
| Constipation | 9.3% | 2.7% | 7.5% | 13.6% | 0% | 5.0% | 4.8% | 5.9% | 10.0% |
| Headache | 9.3% | 10.8% | 10.0% | 9.1% | 0% | 5.0% | 9.5% | 23.5% | 15.0% |
| At least one AE | 76.7% | 62.2% | 60.0% | 72.7%a | 50.0%ab | 35.0%b | 80.9% | 76.5% | 85.0% |
Note: percentages followed by the same superscripts are not pairwise statistically significantly different (p ≥ 0.05). No superscripts indicate no significant pairwise difference (p ≥ 0.05).