Summary of adverse events, safety population
| Group; no. (%) | |||
|---|---|---|---|
| Adverse event | Placebo, n = 186 | Levomilnacipran ER, 40 mg/day, n = 188 | Levomilnacipran ER, 80 mg/day, n = 188 |
| Double-blind treatment | |||
| Treatment-emergent adverse events | 103 (55.4) | 128 (68.1) | 149 (79.3) |
| Deaths | 0 | 0 | 0 |
| Serious adverse events | 1 (0.5) | 3 (1.6) | 0 |
| Double-blind down-taper | |||
| Treatment-emergent adverse events | 14 (7.5) | 6 (3.2) | 11 (5.9) |
| Deaths | 0 | 0 | 0 |
| Serious adverse events | 0 | 0 | 0 |
| Patients with any newly emergent adverse events* | 12 (6.5) | 6 (3.2) | 9 (4.8) |
ER = extended-release.
↵* A newly emergent adverse event was one that occurred during the double-blind down-taper period or within 30 d of the last dose of down-taper.
Note: One patient reported a serious adverse event (worsening depression) during the screening period and was discontinued before randomization.