Placebo run-in (n = 195) | SAM-760 (n = 91)a | Placebo (n = 94) | Placebo washout (n = 164) | |
---|---|---|---|---|
Number of AEs | 39 | 53 | 62 | 22 |
Number of subjects (%) | ||||
With AEs | 25 (12.8) | 38 (41.8) | 39 (41.5) | 19 (11.6) |
With serious AEs | 1 (0.5) | 2 (2.2) | 2 (2.1) | 4 (2.4) |
With severe AEs | 2 (1.0) | 0 | 0 | 2 (1.2) |
Discontinued due to AEs | 2 (1.0) | 2 (2.2) | 0 | 1 (0.6) |
Dose reduced or temporary discontinuation due to AEs | 1 (0.5) | 2 (2.2) | 1 (1.1) | 0 |