Table 3. Incidence of adverse events reported by ≥5% patients in any group and adverse drug reactions.
| Preferred term | Adverse events | Adverse drug reactions | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Combined duloxetine (n = 171) | 40 mg (n = 85) | 60 mg (n = 86) | Placebo (n = 167) | Combined duloxetine (n = 171) | 40 mg (n = 85) | 60 mg (n = 86) | Placebo (n = 167) | |||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | |
| Somnolence | 37 | 21.6* | 16 | 18.8 | 21 | 24.4 | 14 | 8.4 | 37 | 21.6* | 16 | 18.8 | 21 | 24.4 | 13 | 7.8 |
| Nausea | 24 | 14.0** | 10 | 11.8 | 14 | 16.3 | 3 | 1.8 | 24 | 14.0** | 10 | 11.8 | 14 | 16.3 | 3 | 1.8 |
| Nasopharyngitis | 24 | 14.0 | 10 | 11.8 | 14 | 16.3 | 24 | 14.4 | – | 0.0 | – | 0.0 | – | 0.0 | – | 0.0 |
| AST increased | 13 | 7.6 | 5 | 5.9 | 8 | 9.3 | 6 | 3.6 | 7 | 4.1 | 3 | 3.5 | 4 | 4.7 | 4 | 2.4 |
| Constipation | 11 | 6.4 | 6 | 7.1 | 5 | 5.8 | 9 | 5.4 | 9 | 5.3 | 5 | 5.9 | 4 | 4.7 | 6 | 3.6 |
| Diarrhea | 11 | 6.4 | 4 | 4.7 | 7 | 8.1 | 6 | 3.6 | 7 | 4.1 | 4 | 4.7 | 3 | 3.5 | 3 | 1.8 |
| Dizziness | 10 | 5.8* | 6 | 7.1 | 4 | 4.7 | 2 | 1.2 | 7 | 4.1 | 4 | 4.7 | 3 | 3.5 | 2 | 1.2 |
| ALT increased | 10 | 5.8 | 5 | 5.9 | 5 | 5.8 | 6 | 3.6 | 6 | 3.5 | 3 | 3.5 | 3 | 3.5 | 4 | 2.4 |
| Malaise | 9 | 5.3 | 3 | 3.5 | 6 | 7.0 | 3 | 1.8 | 9 | 5.3 | 3 | 3.5 | 6 | 7.0 | 3 | 1.8 |
| Vomiting | 9 | 5.3 | 4 | 4.7 | 5 | 5.8 | 2 | 1.2 | 8 | 4.7* | 4 | 4.7 | 4 | 4.7 | 1 | 0.6 |
| WBC increased | 9 | 5.3 | 4 | 4.7 | 5 | 5.8 | 4 | 2.4 | 1 | 0.6 | – | 0.0 | 1 | 1.2 | 1 | 0.6 |
| GGT increased | 7 | 4.1 | 2 | 2.4 | 5 | 5.8 | 5 | 3.0 | 4 | 2.3 | 1 | 1.2 | 3 | 3.5 | 2 | 1.2 |
| LDH increased | 7 | 4.1 | 2 | 2.4 | 5 | 5.8 | 4 | 2.4 | 3 | 1.8 | 1 | 1.2 | 2 | 2.3 | 3 | 1.8 |
| CK increased | 6 | 3.5 | 6 | 7.1 | – | 0.0 | 6 | 3.6 | 1 | 0.6 | 1 | 1.2 | – | 0.0 | 3 | 1.8 |
| HbA1c increased | 6 | 3.5 | 1 | 1.2 | 5 | 5.8 | 4 | 2.4 | 4 | 2.3 | – | 0.0 | 4 | 4.7 | 3 | 1.8 |
*P < 0.05 vs placebo; **P < 0.0001 vs placebo.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine phosphokinase; GGT, γ‐glutamyltransferase; HbA1c, glycosylated hemoglobin; LDH, lactate dehydrogenase; WBC, white blood cell count.