Table 3.
Treatment-Emergent Adverse Eventsa Observed during the Extension Phase
| 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) |
Abbreviations: DLX duloxetine, PLA placebo, TEAE treatment-emergent adverse event
aTEAEs occurring at a rate ≥2% in either treatment group