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

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