Table 5

TEAEs occurring in ≥ 5% of women randomized to duloxetine, or significantly more often with duloxetine than with placebo.


Duloxetine
Placebo
P

Values are expressed as n (%)
(N = 60)
(N = 61)

Total number of women with ≥ 1 TEAE
48 (80)
27 (44.3)
< .001
Constipation
10 (16.7)
0 (0.0)
.001
Dry mouth
10 (16.7)
2 (3.3)
.016
Nausea
9 (15.0)
0 (0.0)
.001
Somnolence
9 (15.0)
0 (0.0)
.001
Dizziness
8 (13.3)
6 (9.8)
.583
Fatigue
5 (8.3)
0 (0.0)
.027
Hyperhidrosis
5 (8.3)
0 (0.0)
.027
Cough
4 (6.7)
4 (6.6)
> .999
Decreased appetite
4 (6.7)
1 (1.6)
.207
Insomnia
4 (6.7)
2 (3.3)
.439
Asthenia
3 (5.0)
1 (1.6)
.365
Chest discomfort
3 (5.0)
3 (4.9)
> .999
Palpations
3 (5.0)
2 (3.3)
.680

Lin et al. BMC Urology 2008 8:2   doi:10.1186/1471-2490-8-2