Table 2.
Incidence of adverse events during the long‐term study
| Preferred terma | Duloxetine 40 mg/day (n = 129) | Duloxetine 60 mg/day (n = 129) | Combined Duloxetine (n = 258) |
|---|---|---|---|
| Symptoms | |||
| Somnolence |
17 (17) 13.2% |
18 (18) 14.0% |
35 (35) 13.6% |
| Nausea |
14 (16) 10.9% |
13 (15) 10.1% |
27 (31) 10.5% |
| Dizziness |
10 (12) 7.8% |
8 (11) 6.2% |
18 (23) 7.0% |
| Malaise |
6 (6) 4.7% |
5 (5) 3.9% |
11 (11) 4.3% |
| Vomiting |
9 (11) 7.0% |
10 (12) 7.8% |
19 (23) 7.4% |
| Laboratory measures | |||
| AST increased |
13 (13) 10.1% |
12 (14) 9.3% |
25 (27) 9.7% |
| WBC count increased |
13 (16) 10.1% |
8 (8) 6.2% |
21 (24) 8.1% |
a
According to the Medical Dictionary for Regulatory Activities, Version 11.1. AST, aspartate aminotransferase; WBC, white blood cell.
Data are presented as number of participants, (number of events), and percentage incidence. The table presents events that were experienced by at least 5% of participants in any group during the double‐blind study and were at least twice as common in the combined duloxetine group compared with the placebo group22.