System organ class | DKP/TRAM N = 203 | DKP N = 202 | TRAM N = 201 | Overall N = 606 |
---|---|---|---|---|
Preferred term | ||||
Gastrointestinal disorders | 13 (6.4 %) | 14 | 17 (8.4 %) | 18 | 20 (10 %) | 27 | 50 (8.3 %) | 59 |
Nausea | 8 (3.9 %) | 9 | 7 (3.5 %) | 7 | 13 (6.5 %) | 13 | 28 (4.6 %) | 29 |
Vomiting | 2 (1.0 %) | 2 | 6 (3.0 %) | 6 | 6 (3.0 %) | 6 | 14 (2.3 %) | 14 |
Abdominal distension | 2 (1.0 %) | 2 | 1 (0.5 %) | 1 | 6 (3.0 %) | 6 | 9 (1.5 %) | 9 |
Abdominal pain upper | – | 2 (1.0 %) | 2 | – | 2 (0.3 %) | 2 |
Constipation | 1 (0.5 %) | 1 | – | 1 (0.5 %) | 1 | 2 (0.3 %) | 2 |
Dyspepsia | – | 2 (1.0 %) | 2 | 1 (0.5 %) | 1 | 3 (0.5 %) | 3 |
Investigations | 2 (1.0 %) | 3 | 11 (5.4 %) | 17 | 4 (2.0 %) | 4 | 17 (2.8 %) | 24 |
Platelet count increased | – | 4 (2.0 %) | 4 | 4 (2.0 %) | 4 | 8 (1.3 %) | 8 |
Blood lactate dehydrogenase increased | 1 (0.5 %) | 1 | 5 (2.5 %) | 5 | – | 6 (1.0 %) | 6 |
Gamma-glutamyltransferase increased | 1 (0.5 %) | 1 | 3 (1.5 %) | 3 | – | 4 (0.7 %) | 4 |
Alanine aminotransferase increased | – | 2 (1.0 %) | 2 | – | 2 (0.3 %) | 2 |
Blood alkaline phosphatase increased | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | – | 2 (0.3 %) | 2 |
Aspartate aminotransferase increased | – | 1 (0.5 %) | 1 | – | 1 (0.2 %) | 1 |
Hepatic enzyme increased | – | 1 (0.5 %) | 1 | – | 1 (0.2 %) | 1 |
Blood and lymphatic system disoders | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | 3 (0.5 %) | 3 |
Thrombocytosis | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | 3 (0.5 %) | 3 |
Vascular disorders | 2 (1.0 %) | 3 | – | – | 2 (0.3 %) | 3 |
Hypertension | 1 (0.5 %) | 2 | – | – | 1 (0.2 %) | 2 |
Hypertensive crisis | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Cardiac disorders | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | – | 2 (0.3 %) | 2 |
Tachycardia | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | – | 2 (0.3 %) | 2 |
Nervous system disorders | – | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | 2 (0.3 %) | 2 |
Dizziness | – | 1 (0.5 %) | 1 | – | 1 (0.2 %) | 1 |
Headache | – | – | 1 (0.5 %) | 1 | 1 (0.2 %) | 1 |
Psychiatric disorders | 1 (0.5 %) | 1 | 1 (0.5 %) | 1 | – | 2 (0.3 %) | 2 |
Insomnia | – | 1 (0.5 %) | 1 | – | 1 (0.2 %) | 1 |
Psychotic disorder | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Skin and subcutaneous tissue disorders | 1 (0.5 %) | 1 | – | 1 (0.5 %) | 1 | 2 (0.3 %) | 2 |
Pruritus | – | – | 1 (0.5 %) | 1 | 1 (0.2 %) | 1 |
Urticaria | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Ear and labyrinth disorders | – | – | 1 (0.5 %) | 1 | 1 (0.2 %) | 1 |
Vertigo | – | – | 1 (0.5 %) | 1 | 1 (0.2 %) | 1 |
General disorders and administration site conditions | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Asthenia | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Metabolism and nutrition disorders | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Hypokalaemia | 1 (0.5 %) | 1 | – | – | 1 (0.2 %) | 1 |
Overall | 19 (9.4 %) | 26 | 30 (15 %) | 39 | 27 (13 %) | 35 | 76 (13 %) | 100 |