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