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 | |||
| 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 |
ADR adverse drug reaction, AE adverse event
Values are n (%)
aFisher’s exact test
bStatistically significant at a two-sided level of 0.05