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. 2014 Jan-Feb;11(1-2):10–22.

TABLE 5.

Relapse rates by baseline severity

OPEN-LABEL BASELINE MADRS TOTAL SCORE PLACEBO na (%) LEVOMILNACIPRAN ER 40–120MG/DAY na (%) HAZARD RATIO
Estimate (95% CI) P Value
≥26 16/82 (19.5) 25/170 (14.7) 0.724 (0.387, 1.357) 0.3137
≥28 14/70 (20.0) 19/132 (14.4) 0.672 (0.337, 1.340) 0.2588
≥30 13/53 (24.5) 16/95 (16.8) 0.627 (0.301, 1.303) 0.2108
≥32 10/39 (25.6) 11/73 (15.1) 0.496 (0.211, 1.170) 0.1093
≥34 6/25 (24.0) 5/44 (11.4) 0.392 (0.119, 1.286) 0.1223
≥36 5/13 (38.5) 3/25 (12.0) 0.216 (0.051, 0.910) 0.0368

na = number of patients who relapsed/number of patients with MADRS open-label baseline total score.

Hazard ratio, 95% CI, and P value are based on Cox proportional hazards model with treatment group as the explanatory variable.

MADRS: Montgomery-Åsberg Depression Rating Scale; ER: extended-release; CI; confidence Interval