Table 2.
Treatment-relateda adverse events during double-blind treatment (≥ 2%, safety population)
| Adverse event, n (%) | OXN PR N = 116 | OXY PR (N = 115) |
|---|---|---|
| Nausea | 6 (5) | 7 (6) |
| Dizziness | 5 (4) | 5 (4) |
| Vomiting | 3 (3) | 6 (5) |
| Abdominal discomfort | 0 | 3 (3) |
| Pruritis | 2 (2) | 1 (1) |
| Somnolence | 2 (2) | 1 (1) |
| Abdominal pain, upper | 0 | 2 (2) |
| Decreased appetite | 0 | 2 (2) |
| Withdrawal syndrome | 0 | 2 (2) |
OXN PR prolonged-release oxycodone/naloxone, OXY PR prolonged-release oxycodone
aReasonable possibility of a causal relationship with study medication, per investigator assessment