Xarelto Enoxaparin/Placebo (10 mg od) (40 mg od) N = 4657 N = 4692 System Organ Clas AE ADR AE ADR Medical Entity / Preferred Term Anaemia (incl. respective lab 54 (1.16%) 55 (1.17%) parameters) Cardiac disorders Hypertension 77 (1.65%) 86 (1.83%) Hypotension 244 (5.24%) 238 (5.07%) Tachycardia 74 (1.59%) 71 (1.51%) Procedural hypotension 47 (1.01%) 34 (0.72%) Endocrine disorders Hyperglycaemia 43 (0.92%) 53 (1.13%) Gastrointestinal disorders Nausea 517 (11.10%) 69 (1.48%) 519 (11.06%) 86 (1.83%) Constipation 318 (6.83%) 335 (7.14%) Diarrhoea 106 (2.28%) 137 (2.92%) Dyspepsia 42 (0.90%) 51 (1.09%) GI and abdominal pain 89 (1.91%) 93 (1.98%) Vomiting 452 (9.71%) 482 (10.27%) Feeling unwell 92 (1.98%) 81 (1.73%) Fever 430 (9.23%) 444 (9.46%) Headache 108 (2.32%) 108 (2.30%) Peripheral Oedema 202 (4.34%) 168 (3.58%) Unspecific pain 285 (6.12%) 295 (6.29%) Urinary tract infection 82 (1.76%) 90 (1.92%) Injury, Poisoning and Procedural Complications Arthralgia 65 (1.40%) 81 (1.73%) Post procedural haemorrhage 292 (6.27%) 123 (2.64%) 279 (5.95%) 109 (2.32%) (incl. postoperative anaemia and wound haemorrhage) Wound healing complications 199 (4.27%) 161 (3.43%) Investigations
Xarelto (10 mg od) N = 4657 Enoxaparin/Placebo (40 mg od) N = 4692 System Organ Clas Medical Entity / Preferred Term AE ADR AE ADR Anaemia (incl. respective lab parameters) 54 (1.16%) 55 (1.17%) Cardiac disorders Hypertension 77 (1.65%) 86 (1.83%) Hypotension 244 (5.24%) 238 (5.07%) Tachycardia 74 (1.59%) 71 (1.51%) Procedural hypotension 47 (1.01%) 34 (0.72%) Endocrine disorders Hyperglycaemia 43 (0.92%) 53 (1.13%) Gastrointestinal disorders Nausea 517 (11.10%) 69 (1.48%) 519 (11.06%) 86 (1.83%) Constipation 318 (6.83%) 335 (7.14%) Diarrhoea 106 (2.28%) 137 (2.92%) Dyspepsia 42 (0.90%) 51 (1.09%) GI and abdominal pain 89 (1.91%) 93 (1.98%) Vomiting 452 (9.71%) 482 (10.27%) Feeling unwell 92 (1.98%) 81 (1.73%) Fever 430 (9.23%) 444 (9.46%) Headache 108 (2.32%) 108 (2.30%) Peripheral Oedema 202 (4.34%) 168 (3.58%) Unspecific pain 285 (6.12%) 295 (6.29%) Urinary tract infection 82 (1.76%) 90 (1.92%) Injury, Poisoning and Procedural Complications Arthralgia 65 (1.40%) 81 (1.73%) Post procedural haemorrhage (incl. postoperative anaemia and wound haemorrhage) 292 (6.27%) 123 (2.64%) 279 (5.95%) 109 (2.32%) Wound healing complications 199 (4.27%) 161 (3.43%) Investigations
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