Table 3 ADRs - by system organ class /preferred term, by treatment group and overall
System organ class | Preferred term | DKP 12.5 mg + TRAM 37.5 mg | DKP 12.5 mg + TRAM 75 mg | DKP 25 mg + TRAM 37.5 mg | DKP 25 mg + TRAM 75 mg | DKP 12.5 mg | DKP 25 mg | TRAM 37.5 mg | TRAM 75 mg | Ibuprofen | Placebo | Overall |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
n = 61 | n = 63 | n = 63 | n = 61 | n = 60 | n = 61 | n = 59 | n = 60 | n = 61 | n = 62 | n = 611 | ||
Gastrointestinal disorders | 3 (4.9)|5 | 4 (6.3)|4 | 3 (4.8)|3 | 6 (9.8)|8 | 1 (1.7)|1 | 3 (4.9)|3 | 0 | 8 (13.3)|13 | 1 (1.6)|1 | 0 | 29 (4.7)|38 | |
Abdominal pain upper | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 1 (0.2)|1 | |
Nausea | 3 (4.9)|3 | 0 | 0 | 3 (4.9)|3 | 1 (1.7)|1 | 1 (1.6)|1 | 0 | 6 (10.0)|7 | 0 | 0 | 14 (2.3)|15 | |
Vomiting | 2 (3.3)|2 | 4 (6.3)|4 | 3 (4.8)|3 | 4 (6.6)|5 | 0 | 2 (3.3)|2 | 0 | 5 (8.3)|5 | 1 (1.6)|1 | 0 | 21 (3.4)|22 | |
General disorders and administration site conditions | 0 | 1 (1.6)|1 | 0 | 2 (3.3)|2 | 0 | 1 (1.6)|1 | 1 (1.7)|1 | 0 | 1 (1.6)|1 | 0 | 6 (1.0)|6 | |
Chills | 0 | 1 (1.6)|1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.2)|1 | |
Discomfort | 0 | 0 | 0 | 1 (1.6)|1 | 0 | 0 | 0 | 0 | 1 (1.6)|1 | 0 | 2 (0.3)|2 | |
Feeling abnormal | 0 | 0 | 0 | 1 (1.6)|1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.2)|1 | |
Pyrexia | 0 | 0 | 0 | 0 | 0 | 1 (1.6)|1 | 1 (1.7)|1 | 0 | 0 | 0 | 2 (0.3)|2 | |
Nervous System disorders | 1 (1.6)|1 | 4 (6.3)|4 | 1 (1.6)|1 | 3 (4.9)|3 | 0 | 0 | 2 (3.4)|2 | 3 (5.0)|4 | 2 (3.3)|2 | 0 | 16 (2.6)|17 | |
Dizziness | 1 (1.6)|1 | 2 (3.2)|2 | 0 | 2 (3.3)|2 | 0 | 0 | 1 (1.7)|1 | 3 (5.0)|3 | 2 (3.3)|2 | 0 | 11 (1.8)|11 | |
Headache | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 0 | 1 (0.2)|1 | |
Somnolence | 0 | 2 (3.2)|2 | 1 (1.6)|1 | 1 (1.6)|1 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 5 (0.8)|5 | |
Psychiatric disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 1 (0.2)|1 | |
Nervousness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 1 (0.2)|1 | |
Vascular disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 1 (0.2)|1 | |
Hypotension | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.7)|1 | 0 | 0 | 1 (0.2)|1 | |
Overall | 3 (4.9)|6 | 6 (9.5)|9 | 4 (6.3)|4 | 7 (11.5)|13 | 1 (1.7)|1 | 3 (4.9)|4 | 3 (5.1)|3 | 10 (16.7)|19 | 3 (4.9)|4 | 0 | 40 (6.5)|63 |