Table 3.
Treatment-emergent adverse events
| 3–6-Month studies | ≥6-Month exposure | 1-Year study | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Time to Onset (days) | Time to Resolution (days) | ||||||||
| Eventa | PBO (N = 535) | DLX (N = 876) | PBO | DLX | PBO | DLX | DLX (N = 721) | DLX (N = 350) | |
| % | % | pb (duloxetine vs. placebo) | Mdn | Mdn | Mdn | Mdn | % | % | |
| Nausea | 11.4 | 29.3 | <0.001 | 10.5 | 1.0 | 9.0 | 6.0 | 30.2 | 40.6 |
| Headache | 12.0 | 20.0 | <0.001 | 14.0 | 9.0 | 9.0 | 8.0 | 26.1 | 29.4 |
| Dry mouth | 5.2 | 18.2 | <0.001 | 13.0 | 4.0 | 32.0 | 73.0 | 22.2 | 17.1 |
| Insomnia | 9.2 | 14.5 | 0.003 | 26.0 | 8.0 | 43.0 | 34.0 | 16.4 | 19.7 |
| Fatigue | 7.1 | 13.5 | <0.001 | 26.0 | 7.0 | 39.0 | 54.0 | 12.2 | 11.1 |
| Constipation | 3.6 | 14.5 | <0.001 | 16.0 | 10.0 | 74.0 | 47.0 | 18.3 | 17.4 |
| Diarrhea | 7.9 | 11.6 | 0.018 | 14.0 | 3.0 | 5.0 | 4.0 | 14.3 | 12.9 |
| Dizziness | 6.7 | 11.0 | 0.011 | 10.5 | 6.0 | 7.5 | 7.5 | 15.5 | 18.9 |
| Somnolence | 2.8 | 9.6 | <0.001 | 2.0 | 3.0 | 59.0 | 50.5 | 11.8 | 14.0 |
| Hyperhidrosis | 1.1 | 6.8 | <0.001 | 31.5 | 22.0 | 33.0 | 49.0 | 13.7 | 11.4 |
| Decreased appetite | 0.6 | 6.5 | <0.001 | 7.0 | 2.0 | 68.0 | 32.0 | 5.7 | 4.6 |
Estimates of median times for the adverse events are based on the first new occurrence after initiation of treatment for the subsample of patients who experienced each event.
PBO placebo, DLX duloxetine, Mdn median
aEvent list comprises those treatment-emergent adverse events in the 3–6-month studies for which the rate for duloxetine was ≥5.0% and significantly higher than placebo
bCochran–Mantel–Haenszel test for general association, controlling for study