Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT00633893
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Malaysia', 'Taiwan', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban 2.5mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID', 'otherNumAtRisk': 840, 'otherNumAffected': 341, 'seriousNumAtRisk': 840, 'seriousNumAffected': 112}, {'id': 'EG001', 'title': 'Apixaban 5mg', 'description': 'Participants received 5 mg oral tablet apixaban BID', 'otherNumAtRisk': 811, 'otherNumAffected': 305, 'seriousNumAtRisk': 811, 'seriousNumAffected': 107}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received oral tablet of placebo BID', 'otherNumAtRisk': 826, 'otherNumAffected': 318, 'seriousNumAtRisk': 826, 'seriousNumAffected': 158}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ARTERIOSCLEROSIS CORONARY ARTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CONGESTIVE CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MITRAL VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'SICK SINUS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HIP DYSPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'OTOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'THYROIDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'EYE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MACULAR OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'RETINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'URETERIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'METRORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'OVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ALLERGIC GRANULOMATOUS ANGIITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ASTHMATIC CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'BRONCHITIS CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'LARYNGEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PLEURITIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'RESPIRATORY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DECUBITUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DIABETIC FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MISCARRIAGE OF PARTNER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PREGNANCY OF PARTNER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HOSPITALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ARTERIAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 40}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'EMBOLISM VENOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'FEMORAL ARTERY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'MALIGNANT HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'THROMBOPHLEBITIS SUPERFICIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VARICOPHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VENOUS INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'VENOUS THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 840, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 811, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 826, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0381', 'groupId': 'OG000', 'lowerLimit': '0.0252', 'upperLimit': '0.0510'}, {'value': '0.0418', 'groupId': 'OG001', 'lowerLimit': '0.0281', 'upperLimit': '0.0556'}, {'value': '0.1158', 'groupId': 'OG002', 'lowerLimit': '0.0940', 'upperLimit': '0.1376'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3283', 'ciLowerLimit': '0.2225', 'ciUpperLimit': '0.4844', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3615', 'ciLowerLimit': '0.2475', 'ciUpperLimit': '0.5281', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=32, 34, 96 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively; number of events imputed=13, 20, 19, respectively. Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0321', 'groupId': 'OG000', 'lowerLimit': '0.0202', 'upperLimit': '0.0441'}, {'value': '0.0418', 'groupId': 'OG001', 'lowerLimit': '0.0281', 'upperLimit': '0.0556'}, {'value': '0.1110', 'groupId': 'OG002', 'lowerLimit': '0.0896', 'upperLimit': '0.1324'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2891', 'ciLowerLimit': '0.1902', 'ciUpperLimit': '0.4395', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3774', 'ciLowerLimit': '0.2577', 'ciUpperLimit': '0.5525', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=27, 34, 92 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. Number of imputed events=13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on Wald asymptotic confidence limits.'}, {'type': 'PRIMARY', 'title': 'Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0226', 'groupId': 'OG000', 'lowerLimit': '0.0126', 'upperLimit': '0.0327'}, {'value': '0.0172', 'groupId': 'OG001', 'lowerLimit': '0.0083', 'upperLimit': '0.0262'}, {'value': '0.0929', 'groupId': 'OG002', 'lowerLimit': '0.0731', 'upperLimit': '0.1126'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2422', 'ciLowerLimit': '0.1476', 'ciUpperLimit': '0.3975', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1861', 'ciLowerLimit': '0.1062', 'ciUpperLimit': '0.3261', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 months', 'description': 'VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned.(n)number of events = 19, 14, 77 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. All events were counted; no events were imputed.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0321', 'groupId': 'OG000', 'lowerLimit': '0.0202', 'upperLimit': '0.0441'}, {'value': '0.0418', 'groupId': 'OG001', 'lowerLimit': '0.0281', 'upperLimit': '0.0556'}, {'value': '0.1146', 'groupId': 'OG002', 'lowerLimit': '0.0929', 'upperLimit': '0.1363'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2799', 'ciLowerLimit': '0.1844', 'ciUpperLimit': '0.4247', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3653', 'ciLowerLimit': '0.2500', 'ciUpperLimit': '0.5338', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with consent.(n)number of events=27, 34, 95 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. The (n)number of imputed events were = 13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits'}, {'type': 'SECONDARY', 'title': 'Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0226', 'groupId': 'OG000', 'lowerLimit': '0.0126', 'upperLimit': '0.0327'}, {'value': '0.0344', 'groupId': 'OG001', 'lowerLimit': '0.0219', 'upperLimit': '0.0470'}, {'value': '0.0869', 'groupId': 'OG002', 'lowerLimit': '0.0677', 'upperLimit': '0.1060'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2615', 'ciLowerLimit': '0.1593', 'ciUpperLimit': '0.4292', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3972', 'ciLowerLimit': '0.2595', 'ciUpperLimit': '0.6079', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 19, 28, 72 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0274', 'groupId': 'OG000', 'lowerLimit': '0.0163', 'upperLimit': '0.0384'}, {'value': '0.0308', 'groupId': 'OG001', 'lowerLimit': '0.0189', 'upperLimit': '0.0426'}, {'value': '0.0446', 'groupId': 'OG002', 'lowerLimit': '0.0306', 'upperLimit': '0.0587'}]}]}], 'analyses': [{'pValue': '0.1084', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6087', 'ciLowerLimit': '0.3653', 'ciUpperLimit': '1.0145', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1329', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6846', 'ciLowerLimit': '0.4164', 'ciUpperLimit': '1.1257', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 23, 25, 37 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0202', 'groupId': 'OG000', 'lowerLimit': '0.0107', 'upperLimit': '0.0298'}, {'value': '0.0295', 'groupId': 'OG001', 'lowerLimit': '0.0179', 'upperLimit': '0.0412'}, {'value': '0.0314', 'groupId': 'OG002', 'lowerLimit': '0.0195', 'upperLimit': '0.0432'}]}]}], 'analyses': [{'pValue': '0.3059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6470', 'ciLowerLimit': '0.3543', 'ciUpperLimit': '1.1813', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8288', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9416', 'ciLowerLimit': '0.5458', 'ciUpperLimit': '1.6245', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 17, 24, 26 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0202', 'groupId': 'OG000', 'lowerLimit': '0.0107', 'upperLimit': '0.0298'}, {'value': '0.0295', 'groupId': 'OG001', 'lowerLimit': '0.0179', 'upperLimit': '0.0412'}, {'value': '0.0350', 'groupId': 'OG002', 'lowerLimit': '0.0225', 'upperLimit': '0.0475'}]}]}], 'analyses': [{'pValue': '0.1316', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5794', 'ciLowerLimit': '0.3215', 'ciUpperLimit': '1.0443', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5288', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8433', 'ciLowerLimit': '0.4959', 'ciUpperLimit': '1.4341', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. number of events (n)= 17, 24, 29 in the apixaban 2.5 mg, 5 mg, placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0262', 'groupId': 'OG000', 'lowerLimit': '0.0154', 'upperLimit': '0.0370'}, {'value': '0.0308', 'groupId': 'OG001', 'lowerLimit': '0.0189', 'upperLimit': '0.0426'}, {'value': '0.0398', 'groupId': 'OG002', 'lowerLimit': '0.0265', 'upperLimit': '0.0531'}]}]}], 'analyses': [{'pValue': '0.2361', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6577', 'ciLowerLimit': '0.3874', 'ciUpperLimit': '1.1169', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3155', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7708', 'ciLowerLimit': '0.4631', 'ciUpperLimit': '1.2832', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. (n) number of events = 22, 25, 33 in apixaban 2.5 mg, apixaban 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'title': 'First event: Participants with nonfatal DVT', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'First event: Participants with nonfatal PE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'First event: All-Cause Death', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'CV-related Death (included in all-cause total)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'VTE-related Death (included in all-cause total)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Participants with event: nonfatal DVT', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Participants with event: nonfatal PE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Participants with event: All cause death', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. In first event (first primary event) each participant counted once. In event category, each participant was counted only once in each event category but could have been counted in multiple categories.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Major Bleeding During the Treatment Period - Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0024', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0057'}, {'value': '0.0012', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.0036'}, {'value': '0.0048', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0096'}]}]}], 'analyses': [{'pValue': '0.3925', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4850', 'ciLowerLimit': '0.0891', 'ciUpperLimit': '2.6391', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3551', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2457', 'ciLowerLimit': '0.0269', 'ciUpperLimit': '2.2437', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 2, 1, 4 in apixaban 2.5 mg, and 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0321', 'groupId': 'OG000', 'lowerLimit': '0.0202', 'upperLimit': '0.0441'}, {'value': '0.0432', 'groupId': 'OG001', 'lowerLimit': '0.0292', 'upperLimit': '0.0571'}, {'value': '0.0266', 'groupId': 'OG002', 'lowerLimit': '0.0157', 'upperLimit': '0.0376'}]}]}], 'analyses': [{'pValue': '0.5148', 'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2027', 'ciLowerLimit': '0.6897', 'ciUpperLimit': '2.0975', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1412', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6160', 'ciLowerLimit': '0.9554', 'ciUpperLimit': '2.7336', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants were those who received at least 1 dose of study drug. (n)number of events = 27, 35, 22 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0298', 'groupId': 'OG000', 'lowerLimit': '0.0183', 'upperLimit': '0.0413'}, {'value': '0.0419', 'groupId': 'OG001', 'lowerLimit': '0.0281', 'upperLimit': '0.0557'}, {'value': '0.0230', 'groupId': 'OG002', 'lowerLimit': '0.0128', 'upperLimit': '0.0332'}]}]}], 'analyses': [{'pValue': '0.3932', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2928', 'ciLowerLimit': '0.7158', 'ciUpperLimit': '2.3348', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciPctValue': '95', 'paramValue': '1.8235', 'ciLowerLimit': '1.0470', 'ciUpperLimit': '3.1760', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 months', 'description': 'Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 25, 34, 19 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0893', 'groupId': 'OG000', 'lowerLimit': '0.0700', 'upperLimit': '0.1086'}, {'value': '0.1208', 'groupId': 'OG001', 'lowerLimit': '0.0984', 'upperLimit': '0.1433'}, {'value': '0.0702', 'groupId': 'OG002', 'lowerLimit': '0.0528', 'upperLimit': '0.0876'}]}]}], 'analyses': [{'pValue': '0.1691', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2579', 'ciLowerLimit': '0.9064', 'ciUpperLimit': '1.7457', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6971', 'ciLowerLimit': '1.2468', 'ciUpperLimit': '2.3102', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 months', 'description': 'All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 75, 98, 58 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Total Bleeding During the Treatment Period - Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1119', 'groupId': 'OG000', 'lowerLimit': '0.0906', 'upperLimit': '0.1332'}, {'value': '0.1492', 'groupId': 'OG001', 'lowerLimit': '0.1247', 'upperLimit': '0.1737'}, {'value': '0.0896', 'groupId': 'OG002', 'lowerLimit': '0.0701', 'upperLimit': '0.1091'}]}]}], 'analyses': [{'pValue': '0.1466', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2374', 'ciLowerLimit': '0.9276', 'ciUpperLimit': '1.6507', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6468', 'ciLowerLimit': '1.2552', 'ciUpperLimit': '2.1606', 'pValueComment': 'Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.', 'groupDescription': 'Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 months', 'description': 'All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 94, 121, 74 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0167', 'groupId': 'OG000', 'lowerLimit': '0.0080', 'upperLimit': '0.0253'}, {'value': '0.0172', 'groupId': 'OG001', 'lowerLimit': '0.0083', 'upperLimit': '0.0262'}, {'value': '0.0881', 'groupId': 'OG002', 'lowerLimit': '0.0688', 'upperLimit': '0.1073'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 73 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0167', 'groupId': 'OG000', 'lowerLimit': '0.0080', 'upperLimit': '0.0253'}, {'value': '0.0172', 'groupId': 'OG001', 'lowerLimit': '0.0083', 'upperLimit': '0.0262'}, {'value': '0.0917', 'groupId': 'OG002', 'lowerLimit': '0.0720', 'upperLimit': '0.1113'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 76 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0071', 'groupId': 'OG000', 'lowerLimit': '0.0014', 'upperLimit': '0.0128'}, {'value': '0.0098', 'groupId': 'OG001', 'lowerLimit': '0.0031', 'upperLimit': '0.0166'}, {'value': '0.0639', 'groupId': 'OG002', 'lowerLimit': '0.0473', 'upperLimit': '0.0806'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 6, 8, 53 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0095', 'groupId': 'OG000', 'lowerLimit': '0.0030', 'upperLimit': '0.0161'}, {'value': '0.0049', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0097'}, {'value': '0.0181', 'groupId': 'OG002', 'lowerLimit': '0.0090', 'upperLimit': '0.0272'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 8, 4, 15 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0024', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0057'}, {'value': '0.0037', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.0079'}, {'value': '0.0084', 'groupId': 'OG002', 'lowerLimit': '0.0022', 'upperLimit': '0.0147'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 7 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0024', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0057'}, {'value': '0.0037', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.0079'}, {'value': '0.0121', 'groupId': 'OG002', 'lowerLimit': '0.0046', 'upperLimit': '0.0195'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 10 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'type': 'SECONDARY', 'title': 'Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '829', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'OG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0083', 'groupId': 'OG000', 'lowerLimit': '0.0022', 'upperLimit': '0.0145'}, {'value': '0.0049', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0097'}, {'value': '0.0169', 'groupId': 'OG002', 'lowerLimit': '0.0081', 'upperLimit': '0.0257'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 7, 4, 14 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban twice a day (BID)'}, {'id': 'FG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '840'}, {'comment': '2 participants were randomized to 5 mg study drug but not treated.', 'groupId': 'FG001', 'numSubjects': '813'}, {'comment': '3 participants were randomized to placebo but not treated.', 'groupId': 'FG002', 'numSubjects': '829'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '726'}, {'groupId': 'FG001', 'numSubjects': '684'}, {'groupId': 'FG002', 'numSubjects': '641'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '188'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Not meet/no longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'First participant, first visit: 16 May 2008; Last participant, last visit: 24 August 2012.', 'preAssignmentDetails': '2711 enrolled/2482 randomized: 133 did not meet inclusion, exclusion criteria; 48 withdrew consent; 8 non-compliance; 3 each administrative and clinical reasons; 2 lost to follow up; 1 death; 1 adverse event (AE), 30 other. Data from 4 participants in site 0650 not analyzed/included in randomized population because source for data not confirmed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'BG000'}, {'value': '813', 'groupId': 'BG001'}, {'value': '829', 'groupId': 'BG002'}, {'value': '2482', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban 2.5 mg', 'description': 'Participants received 2.5 mg oral tablet apixaban BID.'}, {'id': 'BG001', 'title': 'Apixaban 5 mg', 'description': 'Participants received 5 mg oral tablet apixaban BID.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo oral tablet BID.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '15.2', 'groupId': 'BG002'}, {'value': '56.7', 'spread': '15.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}, {'value': '1058', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '468', 'groupId': 'BG002'}, {'value': '1424', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Index Event Classification', 'classes': [{'title': 'Proximal DVT', 'categories': [{'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}, {'value': '1622', 'groupId': 'BG003'}]}]}, {'title': 'PE', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}, {'value': '860', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with Proximal DVT (defined at the site) and number with PE (defined at the site). In the event a participant had both proximal DVT and PE, the participant was classified to PE.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants regardless of whether treatment was actually received were included; intent to treat (ITT) principle.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2711}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2008-03-05', 'resultsFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-19', 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.'}, {'measure': 'Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 months', 'description': 'VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.'}], 'secondaryOutcomes': [{'measure': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.'}, {'measure': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.'}, {'measure': 'Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'measure': 'Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'measure': 'Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).'}, {'measure': 'Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'measure': 'Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'measure': 'Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.'}, {'measure': 'Adjudicated Major Bleeding During the Treatment Period - Treated Population', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.'}, {'measure': 'Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.'}, {'measure': 'Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants', 'timeFrame': 'Day 1 up to 12 months', 'description': 'Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.'}, {'measure': 'Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants', 'timeFrame': 'Day 1 up to 12 months', 'description': 'All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.'}, {'measure': 'Adjudicated Total Bleeding During the Treatment Period - Treated Participants', 'timeFrame': 'Day 1 up to 12 months', 'description': 'All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.'}, {'measure': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.'}, {'measure': 'Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.'}, {'measure': 'Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.'}, {'measure': 'Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.'}, {'measure': 'Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.'}, {'measure': 'Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.'}, {'measure': 'Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation', 'timeFrame': 'Day 1 up to 12 Months', 'description': 'DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '35570249', 'type': 'DERIVED', 'citation': 'Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.'}, {'pmid': '26446706', 'type': 'DERIVED', 'citation': 'Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.'}, {'pmid': '23216615', 'type': 'DERIVED', 'citation': 'Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years of age;\n* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);\n* Anticoagulant treatment completed\n* No recurrence of Venous Thromboembolism (VTE)\n\nExclusion Criteria:\n\n* Subjects with indications for long-term treatment with a vitamin K antagonist\n* Active bleeding or high risk for serious bleeding\n* Short life expectancy\n* Uncontrolled high blood pressure\n* Impaired kidney or liver function'}, 'identificationModule': {'nctId': 'NCT00633893', 'briefTitle': 'Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'CV185-057'}, 'secondaryIdInfos': [{'id': 'EUDRACT: 2007-004953-27'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '2.5 mg', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '5.0 mg', 'interventionNames': ['Drug: Apixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '0 mg', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['BMS-562247'], 'description': 'Tablets, Oral, twice daily, 12 months', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, twice daily, 12 months', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, Llc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Robert J. 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