Viewing Study NCT01139658

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Ignite Creation Date: 2025-12-25 @ 12:18 AM
Ignite Modification Date: 2025-12-31 @ 10:56 AM
Study NCT ID: NCT01139658
Status: COMPLETED
Last Update Posted: 2014-01-16
First Post: 2010-06-07
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
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'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Data for the following secondary endpoints were not collected:\n\nMedical appointments with a general practitioner or specialist at visit 3, Frequency of medical appointments at visit 3, Prescription received at visit 3.'}}, 'adverseEventsModule': {'timeFrame': '11 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.', 'otherNumAtRisk': 746, 'otherNumAffected': 0, 'seriousNumAtRisk': 746, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.', 'otherNumAtRisk': 929, 'otherNumAffected': 0, 'seriousNumAtRisk': 929, 'seriousNumAffected': 37}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Abdominal strangulated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Joint dislocation postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Operative haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Patellectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Phlebitis deep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 746, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 929, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Symptomatic Venous Thromboembolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'description': 'Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Major Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'description': 'Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.\n\na confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Dosage of Pradaxa at Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'title': '75 mg/day', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': '110 mg/day', 'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': '150 mg/day', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': '220mg/day', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Duration Between Surgery and First Dose of Pradaxa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11 weeks', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11 weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With a Preoperative ALT Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Adherence to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '97.3', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11 weeks', 'description': 'The adherence to treatment was measured by patient declaration.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Concomitant Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'title': 'NSAID', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Amiodarone', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hydroquinidin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Verapamil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'description': 'Concomitant treatments prescribed at hospital discharge.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Switched to Another Anticoagulant Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'description': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '420', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Reasons for Nurse Visits on the Day of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'title': 'Wound dressing care', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}]}, {'title': 'Blood sample for platelet count', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Other care', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Frequency of Nurse Visits on the Day of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'title': 'Wound dressing care', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Blood sample for platelet count', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11 weeks', 'unitOfMeasure': 'times per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'type': 'SECONDARY', 'title': 'Duration of Unplanned Hospitalizations at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'timeFrame': '11 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Reasons for Unplanned Hospitalizations at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'timeFrame': '11 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Reasons for Usual Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'OG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'classes': [{'title': 'Re-hospitalization', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Consultation in the context of usual follow-up', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}]}, {'title': 'Consultation outside the context of usual follow-u', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'FG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '747'}, {'groupId': 'FG001', 'numSubjects': '929'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '691'}, {'groupId': 'FG001', 'numSubjects': '816'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '113'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'No documentation of treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '75'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'BG000'}, {'value': '929', 'groupId': 'BG001'}, {'value': '1675', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Knee Replacement', 'description': 'Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'BG001', 'title': 'Total Hip Replacement', 'description': 'Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '68.69', 'spread': '10.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '497', 'groupId': 'BG000'}, {'value': '494', 'groupId': 'BG001'}, {'value': '991', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '435', 'groupId': 'BG001'}, {'value': '684', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Creatinine clearance', 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'spread': '29.6', 'groupId': 'BG000'}, {'value': '85.1', 'spread': '31.9', 'groupId': 'BG001'}, {'value': '85.7', 'spread': '30.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '74.5', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '76.8', 'spread': '15.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogramm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.6', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '166.8', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '165.8', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participants with a Alanine Aminotransferase (ALT) of >2x normal upper limit', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with at least one thromboembolic risk factor', 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with at least one cardiovascular risk factor', 'classes': [{'categories': [{'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '586', 'groupId': 'BG001'}, {'value': '1129', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with at least one concomitant disease', 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous treatment', 'classes': [{'title': 'NSAID', 'categories': [{'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '509', 'groupId': 'BG001'}, {'value': '911', 'groupId': 'BG002'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Amiodarone', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Hydroquindin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Verapimil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current treatment', 'classes': [{'title': 'NSAID', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Amiodarone', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Hydroquinidin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Verapamil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of orthopedic surgery', 'classes': [{'categories': [{'measurements': [{'value': '746', 'groupId': 'BG000'}, {'value': '929', 'groupId': 'BG001'}, {'value': '1675', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication for the surgery', 'classes': [{'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '701', 'groupId': 'BG000'}, {'value': '818', 'groupId': 'BG001'}, {'value': '1519', 'groupId': 'BG002'}]}]}, {'title': 'Repair of existing prothesis', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Osteonecrosis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Post-trauma', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Inflammatory arthritis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of the surgery', 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '27.5', 'groupId': 'BG000'}, {'value': '70.1', 'spread': '28.6', 'groupId': 'BG001'}, {'value': '74.9', 'spread': '28.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of anesthesia', 'classes': [{'title': 'General', 'categories': [{'measurements': [{'value': '463', 'groupId': 'BG000'}, {'value': '742', 'groupId': 'BG001'}, {'value': '1205', 'groupId': 'BG002'}]}]}, {'title': 'Spinal', 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '468', 'groupId': 'BG002'}]}]}, {'title': 'Epidural', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1676}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2010-06-07', 'resultsFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-27', 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Symptomatic Venous Thromboembolic Events', 'timeFrame': '11 weeks', 'description': 'Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).'}, {'measure': 'Occurrence of Major Bleeding Events', 'timeFrame': '11 weeks', 'description': 'Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.\n\na confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).'}], 'secondaryOutcomes': [{'measure': 'Dosage of Pradaxa at Initiation', 'timeFrame': 'Baseline'}, {'measure': 'Duration Between Surgery and First Dose of Pradaxa', 'timeFrame': '11 weeks'}, {'measure': 'Duration of Treatment', 'timeFrame': '11 weeks'}, {'measure': 'Proportion of Patients With a Preoperative ALT Measurement', 'timeFrame': '11 weeks'}, {'measure': 'Adherence to Treatment', 'timeFrame': '11 weeks', 'description': 'The adherence to treatment was measured by patient declaration.'}, {'measure': 'Concomitant Treatments', 'timeFrame': '11 weeks', 'description': 'Concomitant treatments prescribed at hospital discharge.'}, {'measure': 'Number of Patients Who Switched to Another Anticoagulant Therapy', 'timeFrame': '11 weeks', 'description': 'Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.'}, {'measure': 'Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge', 'timeFrame': '11 weeks'}, {'measure': 'Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge', 'timeFrame': '11 weeks'}, {'measure': 'Reasons for Nurse Visits on the Day of Hospital Discharge', 'timeFrame': '11 weeks'}, {'measure': 'Frequency of Nurse Visits on the Day of Hospital Discharge', 'timeFrame': '11 weeks'}, {'measure': 'Duration of Unplanned Hospitalizations at Visit 3', 'timeFrame': '11 weeks'}, {'measure': 'Reasons for Unplanned Hospitalizations at Visit 3', 'timeFrame': '11 weeks'}, {'measure': 'Reasons for Usual Follow-up', 'timeFrame': '11 weeks'}]}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Demographic, medical and chirurgical characteristics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement\n2. Patients 18 years of age or older at the time of recruitment\n\nExclusion criteria:\n\n1. Patients presenting contraindication to prescription of Pradaxa\n2. Patients in whom long term Anti vitamin K treatment is indicated'}, 'identificationModule': {'nctId': 'NCT01139658', 'briefTitle': 'Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA', 'orgStudyIdInfo': {'id': '1160.102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All comers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'Boehringer Ingelheim Investigational Site 30', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Arles', 'country': 'France', 'facility': 'Boehringer Ingelheim Investigational Site 41', 'geoPoint': {'lat': 43.67681, 'lon': 4.63031}}, {'city': 'Beauvais', 'country': 'France', 'facility': 'Boehringer 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