Table 4 Treatment-Emergent vital sign abnormalities
Older
p values
Younger
Treatment
by age
Placebo
PCS Weight
Duloxetine
Placebo
Duloxetine
group
interaction
N*
n (%)
N*
n (%)
N*
n (%)
N*
n (%)
92
3 (3.3)
102
0
153
0
128
1 (0.8)
gain
PCS Weight
--92
0
102
6 (5.9)
153
1 (0.7)
128
2 (1.6)
loss
Sustained
--84
2 (2.4)
95
1 (1.1)
140
2 (1.4)
121
3 (2.5)
.37
82
0
91
0
135
1 (0.4)
116
0
---
63
2 (3.2)
78
1 (1.3)
124
2 (1.6)
110
3 (2.7)
.34
82
8 (9.8)
98
13 (13.3)
150
8 (5.3)
128
13 (10.2)
.60
93
0
102
0
152
1 (0.7)
136
0
---
hypertension
Diastolic
hypertension
Systolic
hypertension
Orthostatic
hypotension
Orthostatic
tachycardia
Definitions: N*, number of patients at baseline who were at risk for abnormality. PCS (potentially clinically
significant) weight gain is ≥7% increase in body weight. PCS (potentially clinically significant) weight loss
is ≥5% decrease in body weight. Diastolic hypertension is sitting diastolic blood pressure ≥ 85 mm Hg and
increase from baseline of 10 mm Hg for at least 3 consecutive visits. Systolic hypertension is sitting
systolic blood pressure ≥ 140 mm Hg and an increase from baseline of 10 mm Hg for at least 3
consecutive visits. Sustained hypertension is having both diastolic and systolic hypertension for at least 3
consecutive visits. Orthostatic hypotension is a decrease of at least 10 mm Hg less than the supine
diastolic blood pressure or the standing systolic blood pressure at least 20 mm Hg less than the supine
systolic blood pressure. Orthostatic tachycardia is increase of ≥100 beats per minute upon standing.