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%)

Abbreviations: CR, controlled-release; IR, immediate-release; SR, sustained-release