|
| Placebo/Edivoxetine | Edivoxetine/Edivoxetine | All Patients | |||
| Measure (Unit)/Criteria | N | n (%) | N | n (%) | N | n (%) |
| Elevated Any Time |
|
|
|
|
|
|
| SDP of ≥140 mm Hg and an increase of ≥20 mm Hg from baseline | 195 | 20 (10.3) | 92 | 4 (4.4) | 287 | 24 (8.4) |
| DBP of ≥90 mm Hg and an increase of ≥10 mm Hg from baseline | 195 | 54 (27.7) | 92 | 24 (26.1) | 287 | 78 (27.2) |
| Pulse > 100 beats per minute (bpm) and an increase of ≥15 bpm from baseline. | 195 | 109 (55.9) | 92 | 35 (38.0) | 287 | 144 (50.2) |
| Sustained Elevation at 3 Consecutive Visits |
|
|
|
|
|
|
| SDP of ≥140 mm Hg and an increase of ≥20 mm Hg from baseline | 185 | 2 (1.1) | 86 | 0 | 271 | 1 (0.7) |
| DBP of ≥90 mm Hg and an increase of ≥10 mm Hg from baseline | 185 | 22 (11.9) | 86 | 8 (9.3) | 271 | 30 (11.1) |
| Pulse >100 beats per minute (bpm) and an increase of ≥15 bpm from baseline | 185 | 46 (24.9) | 86 | 8 (9.3) | 271 | 54 (20.0) |
| Potentially Clinically Significant, Any Time |
|
|
|
|
|
|
| SDP of ≥180 mm Hg and an increase of ≥20 mm Hg from baseline | 195 | 0 | 92 | 0 | 287 | 0 |
| DBP of ≥105 mm Hg and an increase of ≥15 mm Hg from baseline | 195 | 6 (3.1) | 92 | 2 (2.2) | 287 | 2 (2.8) |