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Table 5 Incidence of SAE’s according to EC-GCP-guidelines

From: Comparison of 3,000 and 5,000 IU aXa/day certoparin in the prevention of deep-vein thrombosis after total hip replacement

Serious Adverse Events 3,000 IU aXa/d Certoparin 5,000 IU aXa/d Certoparin
Death 2 2
Bleeding-related SAE
Wound hematoma 2 5
Wound hematoma infection - -
Wound infection - -
Bleeding events 3 9
Non-Bleeding-related SAE
Chest pain 1 1
Myocardial infarction 1 2
AV-Block 0 1
Pulmonary embolism 0 1
Staphylococcus aureus infection 3 0
Metastatic carcinoma - -
Coxarthrosis - -
Prostata-adenoma - -
Retention of urine - -
Implant dislocation 2 3
Implant change 0 1
Second hip surgery 3 0
Further fracture 0 1
Any other re-operation 0 1
  1. SAE, Serious Adverse Event; all differences are statistically not significant.