Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2026-06-15 @ 3:32 PM
Study NCT ID:
NCT01884350
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'From date of first dose to date of last dose plus 30 days', 'description': 'All randomized participants were analyzed. Participants in the safety analysis set were categorized according to the counseling actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary SOC (Period 1)', 'description': 'Apixaban 2.5 mg or 5 mg by mouth twice daily for 24 weeks and Primary SOC information.', 'otherNumAtRisk': 604, 'otherNumAffected': 40, 'seriousNumAtRisk': 604, 'seriousNumAffected': 69}, {'id': 'EG001', 'title': 'Continued Additional Educational Program (CAEP) (Period 2)', 'description': 'Subjects enrolled in AEP program during the first 24 weeks continued receiving AEP program up to 48 weeks.', 'otherNumAtRisk': 308, 'otherNumAffected': 5, 'seriousNumAtRisk': 308, 'seriousNumAffected': 40}, {'id': 'EG002', 'title': 'Secondary SOC (Period 2)', 'description': 'Subjects who received AEP for 24 weeks then revert to SOC after the second randomization.', 'otherNumAtRisk': 223, 'otherNumAffected': 5, 'seriousNumAtRisk': 223, 'seriousNumAffected': 29}, {'id': 'EG003', 'title': 'Additional Educational Program (Period 1)', 'description': 'Apixaban 2.5 mg or 5 mg by mouth twice daily for 24 weeks and Additional Educational Program.', 'otherNumAtRisk': 558, 'otherNumAffected': 46, 'seriousNumAtRisk': 558, 'seriousNumAffected': 79}, {'id': 'EG004', 'title': 'Primary SOC (Period 2)', 'description': 'Subjects who received Apixaban 2.5 mg or 5 mg by mouth twice daily for initial 24 weeks and Primary SOC information continued for a period 48 Weeks.', 'otherNumAtRisk': 604, 'otherNumAffected': 21, 'seriousNumAtRisk': 604, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Aneurysm ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthroscopic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast conserving surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cancer surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac pacemaker battery replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Corneal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Heart valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrointestinal endoscopic therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Joint arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lung lobectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mitral valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Scar excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Varicose vein operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vascular graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Streptococcal endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 558, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.64', 'spread': '17.143', 'groupId': 'OG000'}, {'value': '91.88', 'spread': '16.140', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '1.7', 'pValueComment': 'P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to week 24', 'description': 'The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \\*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set (Week 24), which consists of all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}], 'classes': [{'title': 'Day 1 to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '14.18', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '15.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.3', 'spread': '20.64', 'groupId': 'OG000'}, {'value': '90.9', 'spread': '18.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.', 'groupDescription': 'Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'pValueComment': 'P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.', 'groupDescription': 'Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Week 12, Week 12 to Week 24', 'description': 'The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence \\*100 / total number of eligible days for the time period.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set (Week 24) with available data at both study days 85 and 169'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}, {'id': 'OG002', 'title': 'Apixaban (Secondary SOC)', 'description': 'Participants were originally in the Apixaban (AEP) arm and treated with Apixaban 2.5 mg or 5 mg by mouth twice daily and Additional Educational Program (AEP) for the first 24 weeks. After the initial 24-week primary endpoint period participants stopped receiving AEP and were transferred from Apixaban (AEP) arm, stopped the Additional Educational Program (AEP), and switched to the Standard of Care (SOC) information for an additional 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.59', 'spread': '22.921', 'groupId': 'OG000'}, {'value': '88.41', 'spread': '22.148', 'groupId': 'OG001'}, {'value': '87.51', 'spread': '21.125', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8707', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'F-test p-value is obtained from the one-way ANOVA model'}, {'pValue': '0.6399', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '-2.88', 'ciUpperLimit': '4.68', 'pValueComment': 'P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9616', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-3.45', 'ciUpperLimit': '3.29', 'pValueComment': 'P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '4.24', 'pValueComment': 'P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 to Week 48', 'description': 'The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \\*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in 24 to 48-week period. Participants that had not been using the EMD consistently throughout the study were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}], 'classes': [{'title': '<=2 Alcoholic Drink/Day Average vs None', 'categories': [{'measurements': [{'value': '1.251', 'groupId': 'OG000', 'lowerLimit': '0.691', 'upperLimit': '2.265'}, {'value': '0.994', 'groupId': 'OG001', 'lowerLimit': '0.558', 'upperLimit': '1.682'}]}]}, {'title': '>=3 Alcoholic Drink/Day Average vs None', 'categories': [{'measurements': [{'value': '4.268', 'groupId': 'OG000', 'lowerLimit': '1.226', 'upperLimit': '14.859'}, {'value': '3.782', 'groupId': 'OG001', 'lowerLimit': '0.884', 'upperLimit': '16.178'}]}]}, {'title': 'Mini-mental state examination score', 'categories': [{'measurements': [{'value': '0.808', 'groupId': 'OG000', 'lowerLimit': '0.686', 'upperLimit': '0.952'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Higher mgmt., adm. and professional jobs vs UKSOC1', 'categories': [{'measurements': [{'value': '0.827', 'groupId': 'OG000', 'lowerLimit': '0.136', 'upperLimit': '5.033'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Higher professional occupations vs UKSOC1', 'categories': [{'measurements': [{'value': '0.898', 'groupId': 'OG000', 'lowerLimit': '0.197', 'upperLimit': '4.091'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Intermediate occupations vs UKSOC1', 'categories': [{'measurements': [{'value': '1.230', 'groupId': 'OG000', 'lowerLimit': '0.401', 'upperLimit': '3.769'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Large employers and mgmt. and adm. jobs vs UKSOC1', 'categories': [{'measurements': [{'value': '2.823', 'groupId': 'OG000', 'lowerLimit': '0.412', 'upperLimit': '19.338'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Lower mgmt., adm. and professional jobs vs UKSOC1', 'categories': [{'measurements': [{'value': '0.948', 'groupId': 'OG000', 'lowerLimit': '0.256', 'upperLimit': '3.515'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Lower supervisory and tech. occupations vs UKSOC1', 'categories': [{'measurements': [{'value': '3.587', 'groupId': 'OG000', 'lowerLimit': '1.008', 'upperLimit': '12.766'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Never worked and long-term unemployed vs UKSOC1', 'categories': [{'measurements': [{'value': '1.289', 'groupId': 'OG000', 'lowerLimit': '0.419', 'upperLimit': '3.962'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Routine occupations vs UKSOC1', 'categories': [{'measurements': [{'value': '0.508', 'groupId': 'OG000', 'lowerLimit': '0.181', 'upperLimit': '1.425'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Semi-routine occupations vs UKSOC1', 'categories': [{'measurements': [{'value': '0.450', 'groupId': 'OG000', 'lowerLimit': '0.083', 'upperLimit': '2.453'}, {'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Paroxysmal vs Persistant Atrial Fibrillation', 'categories': [{'measurements': [{'value': '1.626', 'groupId': 'OG000', 'lowerLimit': '0.766', 'upperLimit': '3.453'}, {'value': '1.911', 'groupId': 'OG001', 'lowerLimit': '0.940', 'upperLimit': '3.885'}]}]}, {'title': 'Permanent vs Persistant Atrial Fibrillation', 'categories': [{'measurements': [{'value': '2.560', 'groupId': 'OG000', 'lowerLimit': '1.152', 'upperLimit': '5.688'}, {'value': '1.846', 'groupId': 'OG001', 'lowerLimit': '0.819', 'upperLimit': '4.158'}]}]}, {'title': 'VKA Naïve vs Non-Naïve', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not retained in model (p-value \\> 0.2)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.686', 'groupId': 'OG001', 'lowerLimit': '0.932', 'upperLimit': '3.049'}]}]}], 'analyses': [{'pValue': '0.1924', 'groupIds': ['OG000'], 'pValueComment': '\\<=2 Drink/Day Average vs None', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0305', 'groupIds': ['OG000'], 'pValueComment': '\\>=3 Drink/Day Average vs None', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0107', 'groupIds': ['OG000'], 'pValueComment': 'Mini-mental state examination score', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6982', 'groupIds': ['OG000'], 'pValueComment': 'Higher managerial, administrative and professional occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7277', 'groupIds': ['OG000'], 'pValueComment': 'Higher professional occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7581', 'groupIds': ['OG000'], 'pValueComment': 'Intermediate occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2328', 'groupIds': ['OG000'], 'pValueComment': 'Large employers and higher managerial and adm. occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7507', 'groupIds': ['OG000'], 'pValueComment': 'Lower managerial, administrative and professional occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0091', 'groupIds': ['OG000'], 'pValueComment': 'Lower supervisory and technical occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6730', 'groupIds': ['OG000'], 'pValueComment': 'Never worked and long-term unemployed vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0117', 'groupIds': ['OG000'], 'pValueComment': 'Routine occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1910', 'groupIds': ['OG000'], 'pValueComment': 'Semi-routine occupations vs UKSOC1', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9559', 'groupIds': ['OG000'], 'pValueComment': 'Paroxysmal vs Persistent Atrial Fibrillation', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0264', 'groupIds': ['OG000'], 'pValueComment': 'Permanent vs Persistant Atrial Fibrillation', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1087', 'groupIds': ['OG001'], 'pValueComment': '\\<=2 Drink/Day Average vs None', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0679', 'groupIds': ['OG001'], 'pValueComment': '\\>=3 Drink/Day Average vs None', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2128', 'groupIds': ['OG001'], 'pValueComment': 'Paroxysmal vs Persistant Atrial Fibrillation', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3739', 'groupIds': ['OG001'], 'pValueComment': 'Permanent vs Persistant Atrial Fibrillation', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.843', 'groupIds': ['OG001'], 'pValueComment': 'VKA status: Naive vs. Non-Naive', 'statisticalMethod': 'Wald Chi-square test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value \\<= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value \\<= 0.2). Odds ratios are presented for predictors of non-adherence.', 'unitOfMeasure': 'Odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Set participants with evaluable data at week 24'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Drug related AE', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to week 24', 'description': 'AEs with onset date from day 1 through week 24 are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Participants in the safety analysis set were categorized according to the counseling actually received'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'OG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}, {'id': 'OG002', 'title': 'Apixaban (Secondary SOC)', 'description': 'Participants were originally in the Apixaban (AEP) arm and treated with Apixaban 2.5 mg or 5 mg by mouth twice daily and Additional Educational Program (AEP) for the first 24 weeks. After the initial 24-week primary endpoint period participants stopped receiving AEP and were transferred from Apixaban (AEP) arm, stopped the Additional Educational Program (AEP), and switched to the Standard of Care (SOC) information for an additional 24 weeks.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Drug related AE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'AE leading to discontinuation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 up to Week 48', 'description': 'Adverse events with onset date after 24 weeks are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants remaining in the study after week 24. All randomized participants. Participants in the safety analysis set were categorized according to the counseling actually received'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban (Primary SOC)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'FG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}, {'id': 'FG002', 'title': 'Apixaban (Secondary SOC)', 'description': 'Participants were originally in the Apixaban (AEP) arm and treated with Apixaban 2.5 mg or 5 mg by mouth twice daily and Additional Educational Program (AEP) for the first 24 weeks. After the initial 24-week primary endpoint period participants stopped receiving AEP and were transferred from Apixaban (AEP) arm, stopped the Additional Educational Program (AEP), and switched to the Standard of Care (SOC) information for an additional 24 weeks.'}], 'periods': [{'title': 'Primary Efficacy Analysis Set (24 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'Primary Efficacy Analysis set:\n\nAll randomized patients.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '583'}, {'groupId': 'FG001', 'numSubjects': '579'}, {'comment': 'Participants were not randomized to this arm until after initial 24-week period', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Safety Analysis Set', 'comment': 'All randomized patients who received any study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}, {'groupId': 'FG001', 'numSubjects': '558'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '529'}, {'groupId': 'FG001', 'numSubjects': '525'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Drug Interruption >30 Consecutive Days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inclusion/exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Helping Hand not used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Helping Hand not used, treatment taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Primary Efficacy Analysis Set (48 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'Primary Efficacy Analysis Set. 1 completed initial period but was not rand. to 2nd 24-week period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '583'}, {'comment': 'After 24 weeks participants were randomized to continue AEP or stop AEP and revert to SOC.', 'groupId': 'FG001', 'numSubjects': '263'}, {'comment': 'After 24 weeks participants were randomized to continue AEP or stop AEP and revert to SOC.', 'groupId': 'FG002', 'numSubjects': '261'}]}, {'type': 'Safety Analysis Set', 'comment': 'All randomized patients who received any study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '503'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Drug Interruption >30 Consecutive Days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Helping Hand not used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Helping Hand not used, treatment taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inclusion / Exclusion Criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1217 participants were enrolled, 1162 randomized (583 Primary SOC,579 AEP). 55 were enrolled but not randomized. Of the 55, 13 no longer met study criteria, 13 withdrew consent, 3 lost to follow-up, 10 other and 16 unknown.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'BG000'}, {'value': '579', 'groupId': 'BG001'}, {'value': '1162', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban (Primary SOC Information)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received Primary Standard of Care (SOC) information.'}, {'id': 'BG001', 'title': 'Apixaban (Additional Educational Program)', 'description': 'Participants were treated with Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and received the Additional Educational Program (AEP). After the initial 24-week primary endpoint period, participants in the AEP group were randomized 1:1 to continue receiving AEP or stop receiving AEP and revert to Standard of Care (SOC) information via the Apixaban (Secondary SOC) group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '8.94', 'groupId': 'BG000'}, {'value': '73.1', 'spread': '9.05', 'groupId': 'BG001'}, {'value': '72.9', 'spread': '9.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<64 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': '64-74 years', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}, {'title': '>=75 years', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '696', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Primary Efficacy Analysis Set (24 week)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2013-06-13', 'resultsFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-10', 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen', 'timeFrame': 'Day 1 up to week 24', 'description': 'The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \\*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks', 'timeFrame': 'Day 1 to Week 12, Week 12 to Week 24', 'description': 'The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence \\*100 / total number of eligible days for the time period.'}, {'measure': 'Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period', 'timeFrame': 'Week 24 to Week 48', 'description': 'The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \\*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.'}, {'measure': 'Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks', 'timeFrame': 'Week 24', 'description': 'Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value \\<= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value \\<= 0.2). Odds ratios are presented for predictors of non-adherence.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death', 'timeFrame': 'Day 1 up to week 24', 'description': 'AEs with onset date from day 1 through week 24 are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death', 'timeFrame': 'Week 24 up to Week 48', 'description': 'Adverse events with onset date after 24 weeks are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-valvular Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '31243691', 'type': 'DERIVED', 'citation': "Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators. Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks', 'detailedDescription': 'SPAF=Stroke Prevention in Atrial Fibrillation\n\nISTH=International Society on Thrombosis and Hemostasis\n\nPrimary Purpose: Other: To measure adherence to the study medication using an electronic monitoring device over the first 24 weeks on study medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with diagnosed non-valvular Atrial Fibrillation (AF) or atrial flutter (documented by 12-lead electrocardiogram (ECG) or Holter recording) and eligible for oral anticoagulant (OAC) therapy\n2. Presence of at least one of the following risk factors for stroke:\n\n Prior stroke or transient ischaemic attack (TIA)\n * Age ≥75 years\n * Hypertension\n * Diabetes mellitus\n * Symptomatic heart failure \\[New York Heart Association (NYHA) Class ≥II\\]\n3. Must be able to self-administer treatment\n4. Either Vitamin K antagonists (VKA) treated or VKA naive. Patients treated with VKA should have received the VKA treatment for ≥3 months. VKA naïve patients should not have received VKA treatment for more than 30 days within the last 12 months. Patients who are not described by either of the above criteria are not eligible for the study\n5. Patients previously treated with acetylsalicylic acid (ASA) for stroke prevention are allowed (and will switch to Apixaban)\n6. Patients with screening mini-mental state examination (MMSE) more than 24\n7. Subject Re-enrollment: This study does not permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure\n\nAge and Reproductive Status:\n\n* i) Men and women ≥18 years of age\n* ii) Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in protocol. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication\n* iv) Women must not be breastfeeding\n* v) Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year\n* vi) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile); and azoospermic men do not require contraception\n\nExclusion Criteria:\n\n1. Target Disease Exceptions:\n\n 1. Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)\n 2. Clinically significant (moderate or severe) mitral stenosis\n 3. Cardiac valvular disease requiring surgery\n 4. Planned major surgery or/and invasive procedure and/or atrial fibrillation or flutter, ablation procedure and/or cardioversion\n 5. Patients receiving Rivaroxaban, Dabigatran or Apixaban\n2. Medical History and Concurrent Diseases:\n\n 1. Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments)\n 2. Patient with serious bleeding in the last 6 months or with a lesion or condition at high risk of bleeding such as:\n\n * Active peptic ulcer disease, current or recent gastrointestinal ulceration\n * Known or suspected esophageal varices\n * Recent ischemic stroke (within 7 days)\n * Recent brain or spinal injury or intracranial hemorrhage\n * Recent brain, spinal or ophthalmic surgery\n * Arteriovenous malformations\n * Vascular aneurysms\n * Major intraspinal or intracerebral vascular abnormalities\n * Documented hemorrhagic tendencies or blood dyscrasias\n * Presence of malignant neoplasms at high risk of bleeding'}, 'identificationModule': {'nctId': 'NCT01884350', 'acronym': 'AEGEAN', 'briefTitle': 'Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)', 'orgStudyIdInfo': {'id': 'CV185-220'}, 'secondaryIdInfos': [{'id': '2013-000055-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Apixaban (Primary SOC information)', 'description': 'Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Apixaban (Additional Educational Program)', 'description': 'Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['Eliquis', 'BMS-562247'], 'armGroupLabels': ['Arm 1: Apixaban (Primary SOC information)', 'Arm 2: Apixaban (Additional Educational Program)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 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