Table 3.
Summary of patients in the OXN-CR and OX-CR groups who experienced adverse events (AEs) during the study (safety analysis population)
| Variable | OXN-CR [cases (%)] | OX-CR [cases (%)] | P value |
|---|---|---|---|
| AEs | |||
| Any AEs | 55 (85.9) | 57 (89.1) | 0.593 |
| Serious AEs | 15 (23.4) | 28 (43.8) | 0.013 |
| Most common AEsa | NA | ||
| Constipation | 30 (46.9) | 35 (54.7) | |
| Nausea | 10 (15.6) | 18 (28.1) | |
| Anorexia | 8 (12.5) | 5 (7.8) | |
| Vomiting | 8 (12.5) | 7 (10.9) | |
| Dizziness | 6 (9.4) | 14 (21.9) | |
| Dyspnea | 1 (1.6) | 7 (10.9) | |
| ADRs | |||
| Any ADRs | 38 (59.4) | 41 (64.1) | 0.585 |
| Serious ADRs | 1 (1.6) | 4 (6.3) | 0.168 |
| Most common ADRsa | NA | ||
| Constipation | 27 (42.2) | 28 (43.8) | |
| Nausea | 7 (10.9) | 11 (17.2) | |
| Dizziness | 5 (7.8) | 12 (18.8) | |
ADR adverse drug reaction, NA not applicable
aAEs or ADRs reported by at least 10% of patients in either treatment group