TABLE 7.
TEAEs (safety populations)
| ADVERSE EVENTS | OPEN-LABEL PERIOD | DOUBLE-BLIND PERIOD | |
|---|---|---|---|
| Levomilnacipran ER 40–120mg/d N=734, % | Placebo n=112, % | Levomilnacipran ER 40–120mg/d n=233, % | |
| Patients with ≥1 TEAEs | 85.0 | 59.8 | 63.1 |
| AEs leading to premature discontinuation | 10.9 | 2.7 | 3.4 |
| COMMON TEAEs (≥5% IN ANY TREATMENT GROUP) | |||
| Nausea | 21.8 | 4.5 | 5.6 |
| Headache | 19.2 | 9.8 | 13.3 |
| Constipation | 11.2 | 4.5 | 0.9 |
| Hyperhidrosis | 10.9 | 0.9 | 1.7 |
| Dizziness | 10.6 | 4.5 | 1.7 |
| Dry mouth | 10.6 | 0.9 | 1.3 |
| Erectile dysfunctiona | 8.7 | 2.0 | 1.1 |
| Insomnia | 8.6 | 4.5 | 2.1 |
| Heart rate increased | 7.4 | 0.9 | 1.3 |
| Upper respiratory tract infection | 6.9 | 8.9 | 7.3 |
| Nasopharyngitis | 3.4 | 8.0 | 8.6 |
a = percentage based on number of males in the open-label (n=309) or double-blind (placebo=51, levomilnacipran ER=94) treatment period.
TEAE: treatment-emergent adverse event; ER: extended-release