|
|
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) |