Table 3.
Moderate to severe adverse events experienced by patients randomized to placebo and VEN during the trial (N=103)
| PBO | VEN-XR | ||||
|---|---|---|---|---|---|
| (N=52) | (N=51) | p-valuea | |||
| Adverse Effect | n | % | n | % | |
| Anxiety | 1 | 1.9 | 6 | 11.8 | 0.060 |
| Diarrhea | 3 | 5.8 | 4 | 7.8 | 0.715 |
| Dizziness | 2 | 3.8 | 8 | 15.7 | 0.052 |
| Fatigue | 1 | 1.9 | 6 | 11.8 | 0.060 |
| GI Upset | 2 | 3.8 | 6 | 11.8 | 0.160 |
| Headache | 4 | 7.7 | 2 | 3.9 | 0.678 |
| Insomnia | 4 | 7.7 | 7 | 13.7 | 0.358 |
| Loss of Libido | 0 | 0 | 6 | 11.8 | 0.013 |
| Muscle Aches | 4 | 7.7 | 2 | 3.9 | 0.678 |
| Nausea | 4 | 7.7 | 6 | 11.8 | 0.526 |
| Syncopy or Light Headed | 4 | 7.7 | 2 | 3.9 | 0.678 |
a
P-values were obtained using Fisher exact test.
*
Side effects encountered exclusively in the VEN-XR group include constipation, depression, fever, gas, and loss of libido.