TABLE 3.
Incidence of most common adverse events (double-blind phase)*
| Controlled-release tramadol, n (%) | Mean maximum severity | Placebo, n (%) | Mean maximum severity | P* | |
|---|---|---|---|---|---|
| Nausea | 40 (42.6) | 1.8 | 22 (25.0) | 1.5 | 0.0326 |
| Somnolence | 35 (37.2) | 1.6 | 19 (21.6) | 1.5 | 0.0833 |
| Constipation | 22 (23.4) | 1.3 | 5 (5.7) | 1.6 | 0.0011 |
| Anorexia | 6 (6.4) | 1.0 | 1 (1.1) | 1.0 | 0.1025 |
| Vomiting | 6 (6.4) | 1.8 | 2 (2.3) | 2.0 | 0.3173 |
| Dizziness | 5 (5.3) | 1.4 | 3 (3.4) | 1.0 | 0.4142 |
| Sweating | 5 (5.3) | 1.6 | 0 (0.0) | 0 | 0.0253 |
| Asthenia | 3 (3.2) | 1.7 | 3 (3.4) | 1.3 | 0.6547 |
| Pruritus | 3 (3.2) | 1.0 | 0 (0.0) | 0 | 0.0833 |
| Headache | 2 (2.1) | 1.5 | 6 (6.8) | 1.3 | 0.1573 |
| Nervousness | 2 (2.1) | 1.5 | 0 (0.0) | 0 | 0.1573 |
| Insomnia | 0 (0.0) | 0 | 4 (4.5) | 1.8 | 0.0455 |
| Overall | 75 (79.8) | 1.7 | 58 (65.9) | 1.5 | 0.0833 |
*
Based on 94 patients who received controlled-release tramadol and 88 patients who received placebo