Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 12:15 AM
Study NCT ID:
NCT00313300
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2006-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Apixaban in Recent Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular 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 30 days post last dose of study drug, up to approximately 2 years: A+B treatment groups. March 2007 up to 30 days post last dose in October 2007 (termination of high doses), are presented in Phase B Treatment groups.', 'description': 'Participants treated with at least 1 dose of study drug are presented. Note: during Phase B, high dose apixaban arms (10 mg BID and 20 mg QD) were terminated but participants could continue to be randomized to Placebo, 2.5 mg BID and 10 mg QD apixaban and treated post termination of the high dose arms (October 2007), up to approximately 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase A+B Apixaban 10mg QD', 'description': 'Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.', 'otherNumAtRisk': 315, 'otherNumAffected': 122, 'seriousNumAtRisk': 315, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'Phase A+B Apixaban 2.5mg BID', 'description': 'Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.', 'otherNumAtRisk': 315, 'otherNumAffected': 101, 'seriousNumAtRisk': 315, 'seriousNumAffected': 73}, {'id': 'EG002', 'title': 'Phase A+B Placebo', 'description': 'Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.', 'otherNumAtRisk': 599, 'otherNumAffected': 175, 'seriousNumAtRisk': 599, 'seriousNumAffected': 125}, {'id': 'EG003', 'title': 'Phase B Apixaban 10mg BID', 'description': 'Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)', 'otherNumAtRisk': 244, 'otherNumAffected': 84, 'seriousNumAtRisk': 244, 'seriousNumAffected': 55}, {'id': 'EG004', 'title': 'Phase B Apixaban 10mg QD', 'description': 'Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)', 'otherNumAtRisk': 108, 'otherNumAffected': 30, 'seriousNumAtRisk': 108, 'seriousNumAffected': 22}, {'id': 'EG005', 'title': 'Phase B Apixaban 20mg QD', 'description': 'Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)', 'otherNumAtRisk': 218, 'otherNumAffected': 67, 'seriousNumAtRisk': 218, 'seriousNumAffected': 36}, {'id': 'EG006', 'title': 'Phase B Apixaban 2.5mg BID', 'description': 'Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)', 'otherNumAtRisk': 119, 'otherNumAffected': 22, 'seriousNumAtRisk': 119, 'seriousNumAffected': 19}, {'id': 'EG007', 'title': 'Phase B Placebo', 'description': 'Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)', 'otherNumAtRisk': 362, 'otherNumAffected': 80, 'seriousNumAtRisk': 362, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Electrocardiogram change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'In-stent arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 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{'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac myxoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '4.7'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '8.9'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '11.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '5.4', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '0.4', 'ciUpperLimit': '7.3', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study', 'description': 'Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.19', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.04', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to 182 days after randomization (183 days)', 'description': 'Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.'}, {'type': 'SECONDARY', 'title': 'Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '13.3'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '25.5'}, {'value': '22.5', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '27.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '1.8', 'ciUpperLimit': '11.3', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '4.8', 'ciUpperLimit': '15.2', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study', 'description': 'Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of randomization to 182 days after day of randomization (183 days)', 'description': 'Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants were summarized.'}, {'type': 'SECONDARY', 'title': 'Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.7'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '2.0', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.7', 'estimateComment': 'adjusted difference of event rates takes into consideration stratification factors.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of placebo or low dose apixaban were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}, {'value': '221', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}, {'id': 'OG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.88', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.29', 'ciUpperLimit': '2.57', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.66', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.74', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of randomization and ends on high dose termination date, 1-Oct-2007', 'description': 'Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .'}, {'type': 'SECONDARY', 'title': 'Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}, {'value': '218', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}, {'id': 'OG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '10.7'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '11.7'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '11.9'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '11.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '8.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '0.0', 'ciUpperLimit': '9.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '3.4', 'ciUpperLimit': '10.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '1.4', 'ciUpperLimit': '8.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.'}, {'type': 'SECONDARY', 'title': 'Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}, {'value': '218', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}, {'id': 'OG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '9.1'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '22.8'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '26.1'}, {'value': '24.2', 'groupId': 'OG003', 'lowerLimit': '18.9', 'upperLimit': '30.1'}, {'value': '23.9', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '30.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '1.8', 'ciUpperLimit': '14.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.9', 'ciLowerLimit': '3.4', 'ciUpperLimit': '18.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '11.6', 'ciUpperLimit': '23.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '5.6', 'ciUpperLimit': '15.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}, {'value': '221', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}, {'id': 'OG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.88', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.29', 'ciUpperLimit': '2.57', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.66', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.74', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of randomization up to high dose termination, 1-Oct-2007', 'description': 'Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were concomitantly randomized in Phase B were summarized.'}, {'type': 'SECONDARY', 'title': 'Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}, {'value': '218', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'OG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}, {'id': 'OG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B this treatment group was terminated."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '5.8'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '7.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '2.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '0.6', 'ciUpperLimit': '5.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '1.3', 'ciUpperLimit': '6.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': "Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator's discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."}, {'id': 'FG001', 'title': 'Apixaban 2.5mg BID', 'description': "In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."}, {'id': 'FG002', 'title': 'Apixaban 10mg QD', 'description': "In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."}, {'id': 'FG003', 'title': 'Apixaban 10mg BID', 'description': "Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."}, {'id': 'FG004', 'title': 'Apixaban 20 mg QD', 'description': "Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."}], 'periods': [{'title': 'Randomized in Phase A (26 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '179'}, {'groupId': 'FG002', 'numSubjects': '184'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'no longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Administrative reason (arm terminated)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Randomized in Phase B (26 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '427'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '248'}, {'groupId': 'FG004', 'numSubjects': '221'}]}, {'type': 'Start of Phase B to High Dose Terminated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '110'}, {'groupId': 'FG003', 'numSubjects': '248'}, {'groupId': 'FG004', 'numSubjects': '221'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '233'}, {'groupId': 'FG004', 'numSubjects': '208'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'no longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Administrative reason by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '193'}, {'groupId': 'FG004', 'numSubjects': '164'}]}, {'type': 'non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up(30days)-Randomized Phase A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '174'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '172'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up(30days)-Randomized Phase B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '383'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '222'}, {'groupId': 'FG004', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '380'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '217'}, {'groupId': 'FG004', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'missing end of study status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1741 enrolled; 1715 randomized. Non-randomization reasons: 6 withdrew consent, 1 death, 1 poor/non-compliance, 18 no longer met study criteria. Phase A: placebo and 2 low doses of apixaban; Phase B: placebo, 2 low doses and 2 high doses of apixaban. High dose arms terminated, Phase B continued to enroll participants into placebo and low dose arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}, {'value': '1715', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': "Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'BG001', 'title': 'Apixaban 2.5mg BID', 'description': "Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'BG002', 'title': 'Apixaban 10mg QD', 'description': "Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion."}, {'id': 'BG003', 'title': 'Apixaban 10mg BID', 'description': "Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B, this treatment group was terminated"}, {'id': 'BG004', 'title': 'Apixaban 20 mg QD', 'description': "Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator's discretion.\n\nApproximately 6 months after the start of Phase B, this treatment group was terminated."}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '11.25', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '11.64', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '11.35', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '11.00', 'groupId': 'BG003'}, {'value': '60.9', 'spread': '11.95', 'groupId': 'BG004'}, {'value': '60.7', 'spread': '11.38', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}, {'value': '1055', 'groupId': 'BG005'}]}]}, {'title': 'Greater than, equal to 65 and < 75 years', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '447', 'groupId': 'BG005'}]}]}, {'title': 'Greater than (>) 75 years', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '413', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '454', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}, {'value': '1302', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '442', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '191', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '219', 'groupId': 'BG005'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '111', 'groupId': 'BG005'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '166', 'groupId': 'BG005'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '163', 'groupId': 'BG005'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants were summarized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1741}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2006-04-10', 'resultsFirstSubmitDate': '2015-09-11', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-11', 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses', 'timeFrame': 'From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study', 'description': 'Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants', 'timeFrame': 'Randomization to 182 days after randomization (183 days)', 'description': 'Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.'}, {'measure': 'Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses', 'timeFrame': 'first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study', 'description': 'Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.'}, {'measure': 'Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants', 'timeFrame': 'Day of randomization to 182 days after day of randomization (183 days)', 'description': 'Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B'}, {'measure': 'Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses', 'timeFrame': 'from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).'}, {'measure': 'Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B', 'timeFrame': 'Day of randomization and ends on high dose termination date, 1-Oct-2007', 'description': 'Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.'}, {'measure': 'Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).'}, {'measure': 'Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).'}, {'measure': 'Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B', 'timeFrame': 'Day of randomization up to high dose termination, 1-Oct-2007', 'description': 'Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.'}, {'measure': 'Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B', 'timeFrame': 'From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007', 'description': 'Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome (ACS)']}, 'referencesModule': {'references': [{'pmid': '19470889', 'type': 'DERIVED', 'citation': 'APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Recent (\\< = 7 days) Acute Coronary Syndrome (ACS).\n* Clinically stable on optimal treatment\n\nKey Exclusion Criteria:\n\n* High bleeding risk.\n* Ongoing anticoagulant use.\n* Need for chronic (\\>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (\\>325 mg/day'}, 'identificationModule': {'nctId': 'NCT00313300', 'briefTitle': 'Safety Study of Apixaban in Recent Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.', 'orgStudyIdInfo': {'id': 'CV185-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A1', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'A2', 'interventionNames': ['Drug: Apixaban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A3', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A4', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': 'Tablets, Oral, 2.5 mg, twice daily, 26 weeks', 'armGroupLabels': ['A1']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Tablets, Oral, 10 mg, once daily, 26 weeks', 'armGroupLabels': ['A2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0, twice daily, 26 weeks', 'armGroupLabels': ['A3']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Tablets, Oral 10 mg, twice daily, 26 weeks', 'armGroupLabels': ['A4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Cardiovasular Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County & University Of Southern Ca. 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