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Table 3 Treatment-Emergent Adverse Eventsa Observed during the Extension Phase

From: Maintenance of effect of duloxetine in Chinese patients with pain due to osteoarthritis: 13-week open-label extension data

Adverse Event, n (%)

DLX_DLX

PLA_DLX

N = 166

N = 175

Patients with ≥1 TEAE

42 (25.3)

81 (46.3)

Dry mouth

3 (1.8)

15 (8.6)

Somnolence

4 (2.4)

10 (5.7)

Alanine aminotransferase increased

3 (1.8)

10 (5.7)

Nausea

5 (3.0)

8 (4.6)

Aspartate aminotransferase increased

1 (0.6)

8 (4.6)

Dizziness

3 (1.8)

7 (4.0)

Constipation

1 (0.6)

7 (4.0)

Weight decreased

0

4 (2.3)

  1. Abbreviations: DLX duloxetine, PLA placebo, TEAE treatment-emergent adverse event
  2. aTEAEs occurring at a rate ≥2% in either treatment group