Table 5 Adverse events reported by at least 5% of patients in any group during the IR or SR phase
IR phase | SR phase | |||
|---|---|---|---|---|
Adverse event | Hydromorphone (N = 99) | Morphine (N = 101) | OROS® hydromorphone (N = 77) | CR morphine (N = 86) |
Constipation | 23 (23.2%) | 11 (10.9%) | 30 (39.0%) | 19 (22.1%) |
Nausea | 18 (18.2%) | 23 (22.8%) | 15 (19.5%) | 25 (29.1%) |
Vomiting | 16 (16.2%) | 19 (18.8%) | 7 (9.1%) | 19 (22.1%) |
Somnolence | 11 (11.1%) | 11 (10.9%) | 8 (10.4%) | 12 (14.0%) |
Dizziness | 8 (8.1%) | 6 (5.9%) | 4 (5.2%) | 8 (9.3%) |
Headache | 8 (8.1%) | 6 (5.9%) | 3 (3.9%) | 2 (2.3%) |
Diarrhea | 8 (8.1%) | 1 (1.0%) | 7 (9.1%) | 2 (2.3%) |
Pruritus | 4 (4.0%) | 5 (5.0%) | 3 (3.9%) | 5 (5.8%) |
Asthenia | 5 (5.1%) | 1 (1.0%) | 6 (7.8%) | 4 (4.7%) |
Fatigue | 3 (3.0%) | 3 (3.0%) | 4 (5.2%) | 6 (7.0%) |
Confusion | 2 (2.0%) | 2 (2.0%) | 7 (9.1%) | 2 (2.3%) |
Anemia | 2 (2.0%) | 1 (1.0%) | 3 (3.9%) | 6 (7.0%) |
Anorexia | 1 (1.0%) | 4 (4.0%) | 2 (2.6%) | 5 (5.8%) |
Insomnia | 1 (1.0%) | 2 (2.0%) | 5 (6.5%) | 4 (4.7%) |
Peripheral edema | 0 | 3 (3.0%) | 1 (1.3%) | 8 (9.3%) |
Pyrexia | 2 (2.0%) | 1 (1.0%) | 4 (5.2%) | 2 (2.3%) |
Anxiety | 1 (1.0%) | 1 (1.0%) | 5 (6.5%) | 1 (1.2%) |