TABLE 5.
Incidence of most common adverse events (open label phase)*
| Double-blind, n (%) | Mean maximum severity | Open label, n (%) | Mean maximum severity | |
|---|---|---|---|---|
| Constipation | 17 (32.1) | 1.3 | 19 (35.9) | 1.4 |
| Nausea | 23 (43.4) | 1.7 | 8 (15.1) | 1.5 |
| Dyspepsia | 1 (1.9) | 2.0 | 5 (9.4) | 2.0 |
| Somnolence | 22 (41.5) | 1.5 | 5 (9.4) | 1.4 |
| Anorexia | 5 (9.4) | 1.0 | 4 (7.5) | 1.5 |
| Dizziness | 4 (7.5) | 1.5 | 4 (7.5) | 1.0 |
| Pain | 4 (7.5) | 1.5 | 4 (7.5) | 1.8 |
| Vasodilatation | 4 (7.5) | 1.8 | 4 (7.5) | 2.0 |
| Urinary tract infection | 0 (0) | 0 | 4 (7.5) | 1.5 |
| Vomiting | 3 (5.7) | 2.0 | 3 (5.7) | 1.7 |
| Dry mouth | 9 (17.0) | 1.0 | 3 (5.7) | 1.0 |
| Insomnia | 0 (0) | 0 | 3 (5.7) | 1.7 |
| Hypertension | 1 (1.9) | 1.0 | 3 (5.7) | 1.3 |
| Accidental injury | 1 (1.9) | 2.0 | 3 (5.7) | 1.7 |
*
Based on 53 patients exposed to open label controlled-release tramadol treatment.