Table 1

Patient populations and disposition characteristics, by treatment group

Group; no. (%)
VariablePlaceboLevomilnacipran ER, 40 mg/dayLevomilnacipran ER, 80 mg/day
Populations
 Randomized189190189
 Safety186188188
 Intent-to-treat185185187
Disposition*
 Completed study154 (82.8)145 (77.1)142 (75.5)
 Prematurely exited study32 (17.2)43 (22.9)46 (24.5)
  Adverse event3 (1.6)12 (6.4)‡19 (10.1)‡
  Insufficient therapeutic response3 (1.6)3 (1.6)3 (1.6)
  Protocol violation4 (2.2)10 (5.3)6 (3.2)
  Withdrawal of consent8 (4.3)10 (5.3)7 (3.7)
  Lost to follow-up14 (7.5)8 (4.3)11 (5.9)
 Entered double-blind down-taper period†147 (79.0)136 (72.3)141 (75.0)

  • ER = extended-release.

  • ↵* Safety population.

  • ↵† Patients who completed or prematurely exited the study were eligible to enter the down-taper period.

  • ↵‡ p < 0.05 compared with placebo; Fisher exact test.