Table 4 Adverse events (safety analysis set)
|  | Placebo (n = 196) | Duloxetine (n = 194) | p Valuea |
|---|---|---|---|
AEs | 123 (62.8) | 148 (76.3) | 0.0042b |
ADRs | 70 (35.7) | 125 (64.4) | <0.0001b |
Serious AEs | 1 (0.5) | 1 (0.5) | 1.000 |
Serious ADRs | 0 (0.0) | 1 (0.5) | 0.4974 |
Discontinuations due to AEs | 15 (7.7) | 14 (7.2) | 1.000 |
Discontinuations due to ADRs | 10 (5.1) | 14 (7.2) | 0.4077 |
AEs by preferred term | Â | Â | Â |
 Somnolence | 21 (10.7) | 51 (26.3) | <0.0001b |
 Nausea | 9 (4.6) | 42 (21.6) | <0.0001b |
 Constipation | 8 (4.1) | 29 (14.9) | 0.0002b |
 Nasopharyngitis | 29 (14.8) | 26 (13.4) | 0.7715 |
 Dry mouth | 7 (3.6) | 14 (7.2) | 0.1218 |
 Decreased appetite | 1 (0.5) | 13 (6.7) | 0.0008b |
 Dizziness | 2 (1.0) | 11 (5.7) | 0.0112b |
 Headache | 6 (3.1) | 9 (4.6) | 0.4437 |
 Fatigue | 6 (3.1) | 9 (4.6) | 0.4437 |
 Diarrhea | 7 (3.6) | 8 (4.1) | 0.7990 |