Table 5.
Overall TEAE experience
| TEAEs | OXN (n=128), n (%) | TAP (n=133), n (%) | Significance |
|---|---|---|---|
| Number of TEAEs | 35 | 34 | |
| Number of serious TEAEs | − | − | |
| Subjects with TEAEs | 18 (14.1) | 16 (12.0) | ns |
| Subjects with ≤2 TEAEs | 9 (7.0) | 9 (6.8) | ns |
| Most common TEAEs | |||
| Somnolence | 9 (7) | 10 (7.5) | ns |
| Constipation | 6 (4.7) | 1 (0.8) | ns |
| Headache | − (−) | 6 (4.5) | 0.017 |
| Nausea | 2 (1.6) | 3 (2.3) | ns |
| Dizziness | 4 (3.1) | 4 (3) | ns |
| Abdominal pain | 7 (5.5) | 2 (1.5) | ns |
| Sleep problems | 3 (2.3) | − (−) | ns |
| Vomiting | − (−) | 1 (0.8) | ns |
| Sweating | 1 (0.8) | 1 (0.8) | ns |
| Others | 3 (2.3) | 6 (4.5) | ns |
| Affected organ classes | |||
| Nervous system | 18 (14.1) | 25 (18.8) | ns |
| Gastrointestinal system | 15 (11.7) | 6 (4.5) | 0.032 |
| Skin | 2 (1.6) | 2 (1.5) | ns |
| Metabolic system | − (−) | 1 (0.8) | ns |
| Intensity | |||
| Mild | 10 (7.8) | 7 (5.3) | ns |
| Moderate | 18 (14.1) | 18 (14.1) | ns |
| Severe | 7 (5.5) | 9 (6.8) | ns |
| Countermeasures | |||
| Pharmacotherapy | 15 (11.7) | 12 (9) | ns |
| Treatment discontinuation (TEAEs) | 20 (15.6) | 22 (16.5) | ns |
| Treatment discontinuation (patients) | 9 (7) | 10 (7.5) | ns |
| Treatment discontinuation for any reasons (patients) | 35 (27.3) | 30 (22.6) | ns |
Abbreviations: OXN, oxycodone/naloxone; TAP, tapentadol; n, number of patients; %, percentage of patients; TEAEs, treatment-emergent adverse events; ns, not significant.