Table 3.
Summary of treatment-emergent adverse events (safety population)
| Tramadol/paracetamol (n = 132) | Tramadol (n = 129) | |
|---|---|---|
| Any adverse event | 54 (40.9%) | 74 (57.4%) |
| Any severe adverse event | 8 (6.1%) | 7 (5.4%) |
| Any serious adverse event | 1 (0.8%) | 0 |
| Any drug-related adverse eventa | ||
| Possible relationship | 29 (22%) | 51 (39.5%) |
| Probable/likely relationship | 24 (18.2%) | 29 (22.5%) |
| Certain relationship | 1 (0.8%) | 5 (3.9%) |
| Any adverse event causing premature discontinuation from trial | 6 (4.5%) | 8 (6.2%) |
| Time to premature withdrawal due to adverse event (h)b | 12.1 ± 9.5 | 11.5 ± 9.5 |
| Any adverse event ≥5% incidence in either groupc | ||
| Nausea | 34 (25.8%) | 47 (36.4%) |
| Dizziness | 21 (15.9%) | 24 (18.6%) |
| Somnolence | 12 (9.1%) | 18 (14.0%) |
| Vomiting | 9 (6.8%) | 16 (12.4%) |
| Sweating increased | 6 (4.5%) | 9 (7.0%) |
Note: Data are number of patients (%).
a
Patients can appear in all 3 categories;
b
Calculated for full analysis set;
c
Listed in order of decreasing frequency in the tramadol/paracetamol group.