Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00168805
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery
Sponsor:
Organization:
Raw JSON
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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': 'First administration to end of study', 'description': 'Treatment emergent events (last medication + 3 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral', 'otherNumAtRisk': 679, 'otherNumAffected': 405, 'seriousNumAtRisk': 679, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral', 'otherNumAtRisk': 703, 'otherNumAffected': 438, 'seriousNumAtRisk': 703, 'seriousNumAffected': 44}, {'id': 'EG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous', 'otherNumAtRisk': 694, 'otherNumAffected': 426, 'seriousNumAtRisk': 694, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 138}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 173}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 36}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 69}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 89}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 34}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 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694, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dislocation of 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Peroneal nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bladder obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Immobilisation prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 694, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], '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': '503', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '512', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6648', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '4.6', 'pValueComment': 'p-value is for superiority testing', '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 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.'}, {'pValue': '0.3553', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '8.7', 'pValueComment': 'p-value is for superiority testing', '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 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.'}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 6-10 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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 (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)'}, {'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': '506', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '511', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3760', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.2', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.8151', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '2.6', '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': 'First administration until 6-10 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 (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4715', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.3', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.9325', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.3', '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': 'First administration until 6-10 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 surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '524', 'groupId': 'OG001'}, {'value': '511', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6463', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '4.5', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.3740', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '8.6', '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': 'First administration until 6-10 days', 'description': 'Total Deep Vein Thrombosis as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}, {'value': '685', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0385', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1414', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 6-10 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who are treated and operated)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Embolism During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}, {'value': '685', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 6-10 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'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}, {'value': '685', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 6-10 days', 'description': 'All cause death, as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op'}, {'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': '658', 'groupId': 'OG000'}, {'value': '679', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Total VTE and all-cause mortality', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'asymptotic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'symptotic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary Embolism', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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': '679', 'groupId': 'OG000'}, {'value': '703', 'groupId': 'OG001'}, {'value': '694', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Clinically relevant', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '569', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}, {'value': '579', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8209', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 6-10 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 greater than or equal to 25 cm²\n* wound hematoma greater than or equal to 100 cm²\n* spontaneous nose bleed lasting longer than 5 min\n* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention\n* spontaneous rectal bleeding (more than a spot on toilet paper)\n* gingival bleeding lasting longer than 5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nMinor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}, {'value': '685', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'Patients with >=1 transfusions', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}]}, {'title': 'Patients with >=1 non-autologous transfusions', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Blood transfusion for treated and operated patients on Day of surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '650', 'groupId': 'OG000'}, {'value': '669', 'groupId': 'OG001'}, {'value': '658', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '187', 'spread': '258', 'groupId': 'OG000'}, {'value': '190', 'spread': '250', 'groupId': 'OG001'}, {'value': '191', 'spread': '254', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Volume of blood loss for treated and operated patients during surgery.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Laboratory Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}, {'value': '637', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'classes': [{'title': 'AST increase N=(620;645;636)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'AST decrease N=(620;645;636)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT increase N=(621;645;637)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'ALT decrease N=(621;645;637)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increase N=(619;644;635)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin decrease N=(619;644;635)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], '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': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'FG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '679'}, {'groupId': 'FG001', 'numSubjects': '703'}, {'groupId': 'FG002', 'numSubjects': '694'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '608'}, {'groupId': 'FG001', 'numSubjects': '625'}, {'groupId': 'FG002', 'numSubjects': '616'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '679'}, {'groupId': 'FG001', 'numSubjects': '703'}, {'groupId': 'FG002', 'numSubjects': '694'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '630'}, {'groupId': 'FG001', 'numSubjects': '647'}, {'groupId': 'FG002', 'numSubjects': '632'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}]}], '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 8 days. The study period is from first administration of study medication until day 84 - 91.', 'preAssignmentDetails': 'Whilst 2101 patients were enrolled/randomised to treatment prior to surgery in this trial, only 2076 started treatment. Therefore, 25 patients were randomised but not treated (treatment was planned to start post surgery).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'BG000'}, {'value': '703', 'groupId': 'BG001'}, {'value': '694', 'groupId': 'BG002'}, {'value': '2076', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran 220mg', 'description': 'qd (once daily) oral'}, {'id': 'BG001', 'title': 'Dabigatran 150mg', 'description': 'qd (once daily) oral'}, {'id': 'BG002', 'title': 'Enoxaparin', 'description': '40mg qd (once daily) subcutaneous'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '67.7', 'spread': '8.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '441', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}, {'value': '1370', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '706', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index N=(677;702;692;2071)', 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '30.1', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '4.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-18', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period', 'timeFrame': 'First administration until 6-10 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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': 'First administration until 6-10 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': 'First administration until 6-10 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': 'First administration until 6-10 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': 'First administration until 6-10 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee'}, {'measure': 'Number of Participants With Pulmonary Embolism During Treatment Period', 'timeFrame': 'First administration until 6-10 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': 'First administration until 6-10 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 bilateral venography), symptomatic DVT (confirmed by venous compression 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': 'First administration until 6-10 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 greater than or equal to 25 cm²\n* wound hematoma greater than or equal to 100 cm²\n* spontaneous nose bleed lasting longer than 5 min\n* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention\n* spontaneous rectal bleeding (more than a spot on toilet paper)\n* gingival bleeding lasting longer than 5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nMinor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.'}, {'measure': 'Blood Transfusion', 'timeFrame': 'Day 1', 'description': 'Blood transfusion for treated and operated patients 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': ['Arthroplasty, Replacement, Knee', 'Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '22995531', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.'}, {'pmid': '22709460', 'type': 'DERIVED', 'citation': 'Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.'}]}, 'descriptionModule': {'briefSummary': 'A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \\[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nInclusion criteria (selected):\n\n* Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement\n* Written Informed Consent\n\nExclusion criteria\n\nExclusion criteria (selected):\n\n* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.\n* Active malignant disease or current cytostatic treatment\n* Known severe renal insufficiency\n* Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) \\> 2x upper limit of normal\n* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months\n* Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control\n* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran\n* Contraindications to enoxaparin\n* Participation in a clinical trial during the last 30 days'}, 'identificationModule': {'nctId': 'NCT00168805', 'briefTitle': 'RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) 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