Treatment-emergent adverse events | Acute phase | Extension phase | ||
---|---|---|---|---|
 | Duloxetine (n= 263) | Placebo (n= 267) | Duloxetine/Duloxetine (n= 176) | Placebo/Duloxetine (n= 187) |
Chronic fatigue syndrome | 0 | 0.4 | 0 | 0 |
Fatigue | 9.5 | 7.1 | 3.4 | 4.8 |
Insomnia | 9.1 | 7.1 | 3.4 | 3.7 |
Lethargy | 1.9 | 0.7 | 0 | 0.5 |
Sedation | 2.3 | 1.1 | 2.3 | 2.1 |
Sluggishness | 0.4 | 0 | 0 | 0 |
Somnolence | 5.7 | 3.4 | 1.1 | 3.7 |