Table 3 Incidence of adverse events by organ class (≥ 10%) and preferred term (≥ 1%; Safety population)
Oxycodone PR n = 295 n (%) | Oxycodone/naloxone PR n = 292 n (%) | Total n = 587 n (%) | |
|---|---|---|---|
Gastrointestinal disorders | 64 (21.7) | 61 (20.9) | 125 (21.3) |
Dry mouth | 3 (1.0) | 3 (1.0) | 6 (1.0) |
Diarrhoea | 11 (3.7) | 15 (5.1) | (26) 4.4 |
Constipation | 10 (3.4) | 2 (0.7) | 12 (2.0) |
Upper abdominal pain | 4 (1.4) | 6 (2.1) | 10 (1.7) |
Abdominal pain | 7 (2.4) | 11 (3.8) | 18 (3.1) |
Vomiting | 8 (2.7) | 5 (1.7) | 13 (2.2) |
Nausea | 25 (8.5) | 23 (7.9) | 48 (8.2) |
General disorders and administrative site conditions | 26 (8.8) | 34 (11.6) | 60 (10.2) |
Pain | 5 (1.7) | 9 (3.1) | 14 (2.4) |
Peripheral oedema | 4 (1.4) | 5 (1.7) | 9 (1.5) |
Fatigue | 7 (2.4) | 6 (2.1) | 13 (2.2) |
Chills | 3 (1.0) | 5 (1.7) | 8 (1.4) |
Infections and infestations | 56 (19.0) | 47 (16.1) | 103 (17.5) |
Nasopharyngitis | 10 (3.4) | 4 (1.7) | 103 (17.5) |
Lower respiratory tract infection | 3 (1.0) | 3 (1.0) | 6 (1.0) |
Gastroenteritis | 7 (2.4) | 5 (1.7) | 12 (2.0) |
Bronchitis | 3 (1.0) | 3 (1.0) | 6 (1.0) |
Urinary tract infection | 6 (2.0) | 13 (4.5) | 19 (3.2) |
Musculoskeletal and connective tissue disorders | 34 (11.5) | 39 (13.4) | 73 (12.4) |
Back pain | 9 (3.1) | 11 (3.8) | 20 (3.4) |
Arthralgia | 5 (1.7) | 6 (2.1) | 11 (1.9) |
Myalgia | 2 (0.7) | 4 (1.4) | 6 (1.0) |
Nervous system disorders | 35 (11.9) | 40 (13.7) | 75 (12.8) |
Sciatica | 1 (0.3) | 6 (2.1) | 7 (1.2) |
Headache | 11 (3.7) | 12 (4.1) | 23 (3.9) |
Dizziness | 10 (3.4) | 5 (1.7) | 15 (2.6) |