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