Table 3.
Treatment-related adverse events (considered by study investigator to be definitely, probably, possibly, or unlikely related to study medication) by organ class (≥5%) and preferred term (adverse events occurring in ≥1.0%)
| System organ class and MedDRA preferred term | OXN PR (N = 474) n (%) |
|---|---|
| Gastrointestinal disorders | 96 (20.3) |
| Abdominal pain | 6 (1.3) |
| Abdominal pain upper | 9 (1.9) |
| Constipation | 46 (9.7) |
| Diarrhea | 18 (3.8) |
| Dyspepsia | 5 (1.1) |
| Nausea | 17 (3.6) |
| Vomiting | 7 (1.5) |
| General disorders and administrative site conditions | 45 (9.5) |
| Drug withdrawal syndrome | 7 (1.5) |
| Fatigue | 11 (2.3) |
| Oedema peripheral | 7 (1.5) |
| Pain | 9 (1.9) |
| Infections and infestations | 32 (6.8) |
| Sinusitis* | 5 (1.1) |
| Musculoskeletal and connective tissue disorders | 47 (9.9) |
| Arthralgia* | 8 (1.7) |
| Back pain | 19 (4.1) |
| Osteoarthritis | 7 (1.5) |
| Pain in extremity | 6 (1.3) |
| Nervous system disorders | 41 (8.6) |
| Dizziness | 6 (1.3) |
| Headache | 9 (1.9) |
| Psychiatric disorders | 26 (5.5) |
| Depression | 7 (1.5) |
| Insomnia | 7 (1.5) |
| Skin and subcutaneous tissue disorders | 38 (8.0) |
| Hyperhidrosis | 21 (4.4) |
| Rash | 5 (1.1) |
MedDRA, Medical Dictionary for Regulatory Activities.
*
All treatment-related events were considered unlikely to be related to study medication.