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

Hanna et al. BMC Palliative Care 2008 7:17   doi:10.1186/1472-684X-7-17

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