Table 5.
List of adverse events with incidence of ≥5% (safety analysis set)
| Preferred terma | Hydromorphone group (n=88) n (%) |
Oxycodone group (n=92)* n (%) |
Total (n=180 n (%) |
|---|---|---|---|
| Patients with adverse event/s | 71(80.7) | 77 (83.7) | 148 (82.2) |
| Nausea | 36 (40.9) | 21 (22.8) | 57 (31.7) |
| Vomiting | 32 (36.4) | 16 (17.4) | 48 (26.7) |
| Somnolence | 23 (26.1) | 18 (19.6) | 41 (22.8) |
| Diarrhea# 16 (18.2) | 17 (18.5) | 33 (18.3) | |
| Constipation | 11 (12.5) | 14 (15.2) | 25 (13.9) |
| Fever | 7 (8) | 5 (5.4) | 12 (6.7) |
| Dizziness | 6 (6.8) | 5 (5.4) | 11 (6.1) |
| Appetite loss | 7 (8) | 3 (3.3) | 10 (5.6) |
| Malaise | 3 (3.4) | 6 (6.5) | 9 (5) |
Notes:
a
As per MedDRA (Medical Dictionary for Regulatory Activities) version 18.1;
*
major protocol deviation in one patient;
#
the reason for high diarrhea incidence was not clear and may have been the use of prophylactic laxatives.