Table 5.
Incidence of adverse events reported by system organ class (≥ 10%) and preferred term (≥ 6%): bowel function study extension population
| Oxycodone PR/Naloxone PR | ||
|---|---|---|
| (n = 258) | % | |
| Any adverse event | 211 | 81.8 |
| GI disorders | 94 | 36.4 |
| Constipation | 40 | 15.5 |
| Diarrhoea | 18 | 7.0 |
| General disorders and administration site conditions | 28 | 10.9 |
| Infections and infestations | 104 | 40.3 |
| Musculoskeletal and connective tissue disorders | 104 | 40.3 |
| Arthralgia | 23 | 8.9 |
| Back pain | 35 | 13.6 |
| Osteoarthritis | 16 | 6.2 |
| Nervous system disorders | 58 | 22.5 |
| Headache | 18 | 7.0 |
| Psychiatric disorders | 31 | 12.0 |
| Respiratory, thoracic and mediastinal disorders | 34 | 13.2 |
| Skin and subcutaneous tissue disorders | 41 | 15.9 |