Summary of treatment-emergent adverse events (TEAE).*
| Duloxetine, N = 239 n (%) | Placebo, N = 248 n (%) | NNH Estimate (95% CI) | Relative Risk Estimate (95% CI) | p** | |
|---|---|---|---|---|---|
| Patients with ≥ TEAE | 120 (50.2) | 91 (36.7) | 8 (5, 21) | 1.37 (1.11, 1.68) | 0.003 |
| Nausea | 20 (8.4) | 5 (2.0) | 16 (10, 42) | 4.15 (1.58, 10.88) | 0.002 |
| Constipation | 14 (5.9) | 2 (0.8) | 20 (13, 54) | 7.26 (1.67, 31.62) | 0.002 |
| Erectile dysfunction† | 4 (5.0) | 0 | 20 (11, 447) | # | 0.107 |
| Fatigue | 10 (4.2) | 2 (0.8) | 30 (17, 166) | 5.19 (1.15, 23.43) | 0.015 |
| Hyperhidrosis | 8 (3.3) | 1 (0.4) | 34 (19, 189) | 8.30 (1.05, 65.87) | 0.017 |
| Upper abdominal pain | 7 (2.9) | 1 (0.4) | 40 (21, 405) | 7.26 (0.90, 58.59) | 0.031 |
| Asthenia | 6 (2.5) | 0 | 40 (23, 190) | # | 0.013 |
| Decreased libido | 5 (2.1) | 0 | 48 (26, 361) | # | 0.020 |
| Anorexia | 4 (1.7) | 0 | 60 (31, 2115) | # | 0.043 |
| Discontinuation from any | AE 39 (16.3) | 14 (5.6) | 10 (7, 20) | 2.89 (1.61, 5.18) | < 0.001 |
↵* Events with ≥ 5% incidence for duloxetine or p ≤ 0.05.
↵** Frequencies analyzed using Cochran-Mantel-Haenszel test with study as stratification variable.
↵† Males only; n = 80 for duloxetine and n = 60 for placebo.
↵# The relative risk cannot be estimated when there are no patients with the event in at least 1 treatment group. NNH: number needed to harm; AE: adverse event.