Viewing Study NCT00657150

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Ignite Creation Date: 2025-12-24 @ 5:09 PM
Ignite Modification Date: 2026-01-31 @ 11:42 PM
Study NCT ID: NCT00657150
Status: COMPLETED
Last Update Posted: 2014-07-02
First Post: 2008-03-27
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '31 - 38 days', 'description': 'Treatment emergent events (last medication + 3 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral', 'otherNumAtRisk': 1010, 'otherNumAffected': 389, 'seriousNumAtRisk': 1010, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous', 'otherNumAtRisk': 1003, 'otherNumAffected': 389, 'seriousNumAtRisk': 1003, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 166}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 62}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 51}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oesophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Secretion discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dislocation of joint prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fat embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Genital injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oesophageal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Operative haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1010, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1003, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '792', 'groupId': 'OG000'}, {'value': '786', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-3.79', 'ciUpperLimit': '1.64', 'pValueComment': 'Superiority p-value = 0.4367', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority Analysis with NI margin 7.7%'}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).\n\nAll of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '805', 'groupId': 'OG000'}, {'value': '795', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-1.91', 'ciLowerLimit': '-3.64', 'ciUpperLimit': '-0.19', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.79', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '-0.12', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '784', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (Percentage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '1.73', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Total Deep Vein Thrombosis as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0612', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Embolism During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6231', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4977', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'All cause death, as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '951', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Total VTE and all-cause mortality', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'asymptomatic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'symptomatic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary Embolism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6870', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with any data available during follow-up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1010', 'groupId': 'OG000'}, {'value': '1003', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Major bleeding events', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Major and clinically relevant bleeding events', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Any bleeding events', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4022', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin for the category major bleeding events', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute Difference (Percentage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '2.3', 'groupDescription': 'Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution', 'testedNonInferiority': False}, {'pValue': '0.2626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute Difference (Percentage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '3.9', 'groupDescription': 'Absolute difference versus Enoxaparin for the category any bleeding events', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28-35 days', 'description': 'Major bleeding events were defined as\n\n* fatal\n* clinically overt associated with loss of haemoglobin \\>=20g/L in excess of what was expected\n* clinically overt leading to the transfusion of \\>=2 units packed cells or whole blood in excess of what was expected\n* symptomatic retroperitoneal, intracranial, intraocular or intraspinal\n* requiring treatment cessation\n* leading to re-operation\n\nClinically-relevant was defined as\n\n* spontaneous skin hematoma \\>=25 cm²\n* wound hematoma \\>=100 cm²\n* spontaneous nose bleed \\>5 min\n* macroscopic hematuria spontaneous or \\>24 hours if associated with an intervention\n* spontaneous rectal bleeding\n* gingival bleeding \\>5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nAny bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.'}, {'type': 'SECONDARY', 'title': 'Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Transfusions required', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Number of treated and operated patients with required blood transfusion on day of surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated and operated patients'}, {'type': 'SECONDARY', 'title': 'Volume of Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '967', 'groupId': 'OG000'}, {'value': '957', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '404.9', 'spread': '259.67', 'groupId': 'OG000'}, {'value': '411.0', 'spread': '275.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Volume of blood loss for treated and operated patients during surgery.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated and operated patients'}, {'type': 'SECONDARY', 'title': 'Laboratory Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '966', 'groupId': 'OG000'}, {'value': '962', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'AST increase N=(964;962)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'AST decrease N=(964;962)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT increase N=(966;962)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'ALT decrease N=(966;962)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin increase N=(966;962)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin decrease N=(966;962)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First administration to end of study', 'description': 'Frequency of patients with possible clinically significant abnormalities.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'FG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1010'}, {'groupId': 'FG001', 'numSubjects': '1003'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '895'}, {'groupId': 'FG001', 'numSubjects': '910'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '93'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Non-compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1010'}, {'groupId': 'FG001', 'numSubjects': '1003'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '903'}, {'groupId': 'FG001', 'numSubjects': '906'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Non-compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.', 'preAssignmentDetails': 'Whilst 2055 patients were randomised to treatment prior to surgery in this trial, only 2013 started treatment. Therefore, 42 patients were randomised but not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1010', 'groupId': 'BG000'}, {'value': '1003', 'groupId': 'BG001'}, {'value': '2013', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'BG001', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '541', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '1042', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '469', 'groupId': 'BG000'}, {'value': '502', 'groupId': 'BG001'}, {'value': '971', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index N=(1003;992;1995)', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '27.8', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Treated set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2055}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2014-06-23', 'studyFirstSubmitDate': '2008-03-27', 'resultsFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2008-04-11', 'lastUpdatePostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-18', 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).\n\nAll of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Total Deep Vein Thrombosis During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Total Deep Vein Thrombosis as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Pulmonary Embolism During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants Who Died During Treatment Period', 'timeFrame': '28-35 days', 'description': 'All cause death, as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period', 'timeFrame': '3 months', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).'}, {'measure': 'Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period', 'timeFrame': '28-35 days', 'description': 'Major bleeding events were defined as\n\n* fatal\n* clinically overt associated with loss of haemoglobin \\>=20g/L in excess of what was expected\n* clinically overt leading to the transfusion of \\>=2 units packed cells or whole blood in excess of what was expected\n* symptomatic retroperitoneal, intracranial, intraocular or intraspinal\n* requiring treatment cessation\n* leading to re-operation\n\nClinically-relevant was defined as\n\n* spontaneous skin hematoma \\>=25 cm²\n* wound hematoma \\>=100 cm²\n* spontaneous nose bleed \\>5 min\n* macroscopic hematuria spontaneous or \\>24 hours if associated with an intervention\n* spontaneous rectal bleeding\n* gingival bleeding \\>5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nAny bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.'}, {'measure': 'Blood Transfusion', 'timeFrame': 'Day 1', 'description': 'Number of treated and operated patients with required blood transfusion on day of surgery.'}, {'measure': 'Volume of Blood Loss', 'timeFrame': 'Day 1', 'description': 'Volume of blood loss for treated and operated patients during surgery.'}, {'measure': 'Laboratory Analyses', 'timeFrame': 'First administration to end of study', 'description': 'Frequency of patients with possible clinically significant abnormalities.'}]}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '26578849', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.'}, {'pmid': '21225098', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, Schnee JM, Friedman RJ; RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011 Apr;105(4):721-9. doi: 10.1160/TH10-10-0679. Epub 2011 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty.\n* Male or female 18 years of age or older.\n* Patients giving written informed consent for study participation.\n\nExclusion criteria:\n\n* Patients weighing less than 40 kg.\n* History of bleeding diathesis.\n* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2).\n* Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment.\n* Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment.\n* Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm.\n* Ongoing treatment for Venous Thromboembolism (VTE).\n* Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment.\n* Gastric or duodenal ulcer within one year of enrolment.\n* Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery.\n* Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) \\>3 x ULN.\n* Known severe renal insufficiency (CrCl \\<30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation.\n* Elevated creatinine that, in the investigators opinion, contraindicates venography.\n* Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin \\>162.5 mg/day or NSAID with t 1/2 \\>12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed).\n* Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb.\n* Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who:\n\n * Are pregnant.\n * Are nursing.\n * Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.\n* Known allergy to radio opaque contrast media.\n* History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count \\<100,000 cells/microliter at randomisation.\n* Allergy to heparins or dabigatran etexilate.\n* Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years.\n* Participation in a clinical trial within 30 days of randomisation.\n* Leg amputee.\n* Known alcohol or drug abuse which would interfere with completion of the study.\n* Contraindications to enoxaparin.\n* Previous participation in this study.'}, 'identificationModule': {'nctId': 'NCT00657150', 'briefTitle': 'Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)', 'orgStudyIdInfo': {'id': '1160.64'}, 'secondaryIdInfos': [{'id': '2007-002630-11', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dabigatran etexilate', 'description': '220 mg once daily', 'interventionNames': ['Drug: Dabigatran etexilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': '40 mg once daily', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'description': '40 mg once daily', 'armGroupLabels': ['Enoxaparin']}, {'name': 'Dabigatran etexilate', 'type': 'DRUG', 'description': '220 mg once daily', 'armGroupLabels': ['Dabigatran etexilate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': '1160.64.01005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': '1160.64.01010 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': '1160.64.01009 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': '1160.64.01012 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': '1160.64.01006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': '1160.64.01003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': '1160.64.01007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Conway', 'state': 'South Carolina', 'country': 'United States', 'facility': '1160.64.01013 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.836, 'lon': -79.04781}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '1160.64.01002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': '1160.64.01011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Daws Park', 'state': 'South Australia', 'country': 'Australia', 'facility': '1160.64.2003 Boehringer Ingelheim Investigational Site'}, {'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': '1160.64.2002 Boehringer Ingelheim Investigational Site', 'geoPoint': 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