Viewing Study NCT00558259

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Ignite Creation Date: 2025-12-24 @ 3:00 PM
Ignite Modification Date: 2026-04-11 @ 4:20 AM
Study NCT ID: NCT00558259
Status: COMPLETED
Last Update Posted: 2014-06-27
First Post: 2007-11-13
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'There were 3 patients who were randomised to placebo but who were treated with dabigatran only.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid', 'otherNumAtRisk': 684, 'otherNumAffected': 0, 'seriousNumAtRisk': 684, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo', 'otherNumAtRisk': 659, 'otherNumAffected': 0, 'seriousNumAtRisk': 659, 'seriousNumAffected': 60}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Salmonella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthrofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metastases to bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rectal cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic inflammatory demyelinating polyradiculoneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetic hyperglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal wall operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '37', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'Dabigatran vs placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'Dabigatran vs placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as randomised.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.06', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '2.21', 'ciUpperLimit': '5.17', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as randomised.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Dabigatran vs. Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.82', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.16', 'ciUpperLimit': '3.52', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as randomised.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Unexplained Deaths During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2428', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Dabigatran vs. Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.54', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.09', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as randomised.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Bleeding Event During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'title': 'MBE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MBE or CRBE', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'All Bleeding', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4998', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'As the Cox model did not converge due to too few events, hazard ratios are not estimable.', 'groupDescription': 'Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.05', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage of participants with events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.56', 'estimateComment': 'The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.92', 'ciLowerLimit': '1.52', 'ciUpperLimit': '5.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.97', 'groupDescription': 'Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.23', 'ciUpperLimit': '2.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:\n\n* Fatal bleeding\n* Associated with a fall in haemoglobin of ≥2 g/dL\n* Led to the transfusion of ≥2 units packed cells or whole blood\n* Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal\n\nOther clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.\n\nExamples of these bleedings were:\n\n* Bleeding that compromised haemodynamics\n* Bleeding that led to hospitalisation\n\nTrivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.\n\nAll bleeding events include MBEs, CRBEs, and trivial bleeding events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.'}, {'type': 'SECONDARY', 'title': 'Centrally Confirmed Cardiovascular Events During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures, Especially Liver Function Tests (LFTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'classes': [{'title': 'AST increase (N=655, 629)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ALT increase (N=655, 629)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase increase (N=658, 629)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin increase (N=658, 628)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants with possible clinically significant abnormalities during the treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - As Treated Assignment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid (twice daily)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number who started treatment. There were 4 patients randomised to Dabigatran and not treated.', 'groupId': 'FG000', 'numSubjects': '681'}, {'comment': 'Number who started treatment. There were 6 patients randomised to placebo and not treated.', 'groupId': 'FG001', 'numSubjects': '662'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed treatment.', 'groupId': 'FG000', 'numSubjects': '610'}, {'comment': 'Completed treatment.', 'groupId': 'FG001', 'numSubjects': '563'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'There were 3 patients randomised to placebo who received Dabigatran only. For all analyses of efficacy, these patients are analysed as randomised. For all analyses of safety, these patients are analysed as treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'BG000'}, {'value': '662', 'groupId': 'BG001'}, {'value': '1343', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran', 'description': 'Dabigatran 150mg bid'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '381', 'groupId': 'BG000'}, {'value': '364', 'groupId': 'BG001'}, {'value': '745', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI) continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.45', 'spread': '5.44', 'groupId': 'BG000'}, {'value': '28.41', 'spread': '5.56', 'groupId': 'BG001'}, {'value': '28.43', 'spread': '5.50', 'groupId': 'BG002'}]}]}], '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': 1353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2007-11-13', 'resultsFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-31', 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period', 'timeFrame': '6 months', 'description': 'Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.'}], 'secondaryOutcomes': [{'measure': 'Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period', 'timeFrame': '6 months', 'description': 'Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.'}, {'measure': 'Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period', 'timeFrame': '6 months', 'description': 'Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.'}, {'measure': 'Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period', 'timeFrame': '6 months', 'description': 'Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.'}, {'measure': 'Centrally Confirmed Unexplained Deaths During the Intended Treatment Period', 'timeFrame': '6 months', 'description': 'Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.'}, {'measure': 'Centrally Confirmed Bleeding Event During the Treatment Period', 'timeFrame': '6 months', 'description': 'Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:\n\n* Fatal bleeding\n* Associated with a fall in haemoglobin of ≥2 g/dL\n* Led to the transfusion of ≥2 units packed cells or whole blood\n* Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal\n\nOther clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.\n\nExamples of these bleedings were:\n\n* Bleeding that compromised haemodynamics\n* Bleeding that led to hospitalisation\n\nTrivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.\n\nAll bleeding events include MBEs, CRBEs, and trivial bleeding events.'}, {'measure': 'Centrally Confirmed Cardiovascular Events During the Treatment Period', 'timeFrame': '6 months', 'description': 'Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.'}, {'measure': 'Laboratory Measures, Especially Liver Function Tests (LFTs)', 'timeFrame': '6 months', 'description': 'Number of participants with possible clinically significant abnormalities during the treatment period.'}]}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '24081972', 'type': 'DERIVED', 'citation': 'Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.'}, {'pmid': '23425163', 'type': 'DERIVED', 'citation': 'Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.'}]}, 'descriptionModule': {'briefSummary': 'The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.\n2. Written informed consent\n\nExclusion criteria:\n\n1. Younger then 18 years of age\n2. Indication for VKA other than DVT and/or PE\n3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued\n4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \\> 3 x ULN\n5. Creatinine clearance \\< 30 ml/min\n6. Acute bacterial endocarditis\n7. Active bleeding or high risk for bleeding.\n8. Uncontrolled hypertension (investigators judgement)\n9. Intake of another experimental drug within the 30 days prior to randomization into the study\n10. Life expectancy \\<6 months\n11. Childbearing potential without proper contraceptive measures\\*, pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00558259', 'acronym': 'RE-SONATE', 'briefTitle': 'Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.', 'orgStudyIdInfo': {'id': '1160.63'}, 'secondaryIdInfos': [{'id': '2007-002586-12', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dabigatran etexilate 150 mg BID', 'description': 'Patient to receive dabigatran etexilatate capsules 150 mg twice daily', 'interventionNames': ['Drug: dabigatran etexilate 150 mg twice daily (BID)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo twice daily (BID)', 'description': 'Patient to receive dabigatran extexilate matching placebo capsules twice daily', 'interventionNames': ['Drug: matching placebo twice daily (BID)']}], 'interventions': [{'name': 'dabigatran etexilate 150 mg twice daily (BID)', 'type': 'DRUG', 'description': 'dabigatran etexilate capsules 150 mg BID', 'armGroupLabels': ['dabigatran etexilate 150 mg BID']}, {'name': 'matching placebo twice daily (BID)', 'type': 'DRUG', 'description': 'Matching placebo BID', 'armGroupLabels': ['matching placebo twice daily (BID)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': '1160.63.01025 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': '1160.63.01023 Boehringer 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