Table 5.
Adverse events reported by at least 5% of patients (overall and by previous treatment)
| Treatment in previous study | |||
|
OROS® hydromorphone (n = 35) |
CR morphine (n = 33) |
Overall (n = 68) |
|
| Adverse event | Number (%) of patients with adverse event | ||
| Nausea | 13 (37.1) | 11 (33.3) | 24 (35.3) |
| Constipation | 13 (37.1) | 9 (27.3) | 22 (32.4) |
| Vomiting | 8 (22.9) | 7 (21.2) | 15 (22.1) |
| Anaemia | 7 (20.0) | 5 (15.2) | 12 (17.6) |
| Peripheral oedema | 5 (14.3) | 6 (18.2) | 11 (16.2) |
| Dyspnoea | 4 (11.4) | 5 (15.2) | 9 (13.2) |
| Asthenia | 4 (11.4) | 5 (15.2) | 9 (13.2) |
| Somnolence | 6 (17.1) | 2 (6.1) | 8 (11.8) |
| Disease progression | 6 (17.1) | 2 (6.1) | 8 (11.8) |
| Urinary tract infection | 4 (11.4) | 3 (9.1) | 7 (10.3) |
| Headache | 4 (11.4) | 2 (6.1) | 6 (8.8) |
| Diarrhoea | 5 (14.3) | 1 (3.0) | 6 (8.8) |
| Back pain | 4 (11.4) | 1 (3.0) | 5 (7.4) |
| Anorexia | 3 (8.6) | 2 (6.1) | 5 (7.4) |
| Oedema | 3 (8.6) | 2 (6.1) | 5 (7.4) |
| Dehydration | 0 | 5 (15.2) | 5 (7.4) |
| Confusional state | 4 (11.4) | 1 (3.0) | 5 (7.4) |
| Pyrexia | 4 (11.4) | 1 (3.0) | 5 (7.4) |
| Pain | 1 (2.9) | 4 (12.1) | 5 (7.4) |
| Insomnia | 1 (2.9) | 3 (9.1) | 4 (5.9) |
| Dry mouth | 2 (5.7) | 2 (6.1) | 4 (5.9) |
| Anxiety | 3 (8.6) | 1 (3.0) | 4 (5.9) |
CR, controlled-release