| |
Placebo (n = 196)
|
Duloxetine (n = 194)
|
p Valuea
|
|---|
|
AEs
|
123 (62.8)
|
148 (76.3)
|
0.0042b
|
|
ADRs
|
70 (35.7)
|
125 (64.4)
|
<0.0001b
|
|
Serious AEs
|
1 (0.5)
|
1 (0.5)
|
1.000
|
|
Serious ADRs
|
0 (0.0)
|
1 (0.5)
|
0.4974
|
|
Discontinuations due to AEs
|
15 (7.7)
|
14 (7.2)
|
1.000
|
|
Discontinuations due to ADRs
|
10 (5.1)
|
14 (7.2)
|
0.4077
|
|
AEs by preferred term
| | | |
|
Somnolence
|
21 (10.7)
|
51 (26.3)
|
<0.0001b
|
|
Nausea
|
9 (4.6)
|
42 (21.6)
|
<0.0001b
|
|
Constipation
|
8 (4.1)
|
29 (14.9)
|
0.0002b
|
|
Nasopharyngitis
|
29 (14.8)
|
26 (13.4)
|
0.7715
|
|
Dry mouth
|
7 (3.6)
|
14 (7.2)
|
0.1218
|
|
Decreased appetite
|
1 (0.5)
|
13 (6.7)
|
0.0008b
|
|
Dizziness
|
2 (1.0)
|
11 (5.7)
|
0.0112b
|
|
Headache
|
6 (3.1)
|
9 (4.6)
|
0.4437
|
|
Fatigue
|
6 (3.1)
|
9 (4.6)
|
0.4437
|
|
Diarrhea
|
7 (3.6)
|
8 (4.1)
|
0.7990
|
-
ADR adverse drug reaction, AE adverse event
- Values are n (%)
-
aFisher’s exact test
-
bStatistically significant at a two-sided level of 0.05
