Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-03 @ 2:18 PM
Study NCT ID:
NCT02043808
Status:
COMPLETED
Last Update Posted:
2015-07-03
First Post:
2014-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'This is a retrospective observational study, therefore all patient data was de-identified and analysed in aggregate. Thus, individual patient data is not available and reporting of adverse events is not applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroke (Hemorrhagic, Ischemic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.15', 'groupId': 'OG000', 'lowerLimit': '7.41', 'upperLimit': '11.19'}, {'value': '13.19', 'groupId': 'OG001', 'lowerLimit': '10.74', 'upperLimit': '16.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.92', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of stroke (hemorrhagic, ischemic).\n\nVariables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'PRIMARY', 'title': 'Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.84', 'groupId': 'OG000', 'lowerLimit': '27.55', 'upperLimit': '34.42'}, {'value': '37.04', 'groupId': 'OG001', 'lowerLimit': '32.82', 'upperLimit': '41.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.98', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of major bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Ischemic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '6.80', 'upperLimit': '10.45'}, {'value': '10.69', 'groupId': 'OG001', 'lowerLimit': '8.49', 'upperLimit': '13.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.07', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of ischemic stroke.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Hemorrhagic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '1.51'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '3.90'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.70', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of hemorrhagic stroke.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Intracranial Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '3.88'}, {'value': '5.65', 'groupId': 'OG001', 'lowerLimit': '4.09', 'upperLimit': '7.62'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.77', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major intracranial bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Extracranial Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.13', 'groupId': 'OG000', 'lowerLimit': '24.99', 'upperLimit': '31.55'}, {'value': '31.30', 'groupId': 'OG001', 'lowerLimit': '27.44', 'upperLimit': '35.56'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.07', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major extracranial bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.40', 'groupId': 'OG000', 'lowerLimit': '22.42', 'upperLimit': '28.66'}, {'value': '23.69', 'groupId': 'OG001', 'lowerLimit': '20.34', 'upperLimit': '27.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.30', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Upper GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000', 'lowerLimit': '4.15', 'upperLimit': '7.10'}, {'value': '7.63', 'groupId': 'OG001', 'lowerLimit': '5.80', 'upperLimit': '9.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.03', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major upper gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Lower GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.25', 'groupId': 'OG000', 'lowerLimit': '17.60', 'upperLimit': '23.18'}, {'value': '16.38', 'groupId': 'OG001', 'lowerLimit': '13.62', 'upperLimit': '19.52'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.54', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major lower gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Urogenital Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '1.89'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '4.54'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.72', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major urogenital bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Major Other Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '2.97'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '7.01'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.64', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major other bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Transient Ischemic Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG000', 'lowerLimit': '3.40', 'upperLimit': '6.12'}, {'value': '5.53', 'groupId': 'OG001', 'lowerLimit': '3.99', 'upperLimit': '7.48'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.26', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of transient ischemic attacks.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '3.82', 'upperLimit': '6.66'}, {'value': '7.77', 'groupId': 'OG001', 'lowerLimit': '5.92', 'upperLimit': '10.03'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.95', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of myocardial infarction.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '2.25'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '3.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.31', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of venous thromboembolism.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Deep Vein Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '1.25'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '0.63', 'upperLimit': '2.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.16', 'ciUpperLimit': '1.21', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of deep vein thrombosis.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Pulmonary Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '1.51'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '1.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.34', 'ciUpperLimit': '2.81', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of pulmonary embolism.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'OG000'}, {'value': '12793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.28', 'groupId': 'OG000', 'lowerLimit': '27.98', 'upperLimit': '34.87'}, {'value': '52.41', 'groupId': 'OG001', 'lowerLimit': '47.40', 'upperLimit': '57.82'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Crude event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.69', 'estimateComment': 'Crude event rate ratio for dabigatran with warfarin as the reference group', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of death, due to any cause.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.', 'unitOfMeasure': 'Events per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the post-propensity score matching cohort'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'FG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12793'}, {'groupId': 'FG001', 'numSubjects': '12793'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12793'}, {'groupId': 'FG001', 'numSubjects': '12793'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Existing data cohort design with propensity score matching (PSM). Variables included in the final propensity score model were: age, gender index year, baseline CHADS(2) score, baseline CHA(2)DS(2)-VASc score, baseline HAS-BLED score, baseline use of several medications and presence of several baseline co-morbidities.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12793', 'groupId': 'BG000'}, {'value': '12793', 'groupId': 'BG001'}, {'value': '25586', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '74.0', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '73.9', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5277', 'groupId': 'BG000'}, {'value': '5253', 'groupId': 'BG001'}, {'value': '10530', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7516', 'groupId': 'BG000'}, {'value': '7540', 'groupId': 'BG001'}, {'value': '15056', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Post-PSM set'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-01', 'studyFirstSubmitDate': '2014-01-10', 'resultsFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-01', 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke (Hemorrhagic, Ischemic)', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of stroke (hemorrhagic, ischemic).\n\nVariables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of major bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}], 'secondaryOutcomes': [{'measure': 'Ischemic Stroke', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period)', 'description': 'Event rate of ischemic stroke.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Hemorrhagic Stroke', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of hemorrhagic stroke.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Intracranial Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major intracranial bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Extracranial Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major extracranial bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major GI Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Upper GI Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major upper gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Lower GI Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major lower gastrointestinal (GI) bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Urogenital Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major urogenital bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Major Other Bleeding', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of major other bleeding.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Transient Ischemic Attack', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of transient ischemic attacks.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Myocardial Infarction', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of myocardial infarction.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Venous Thromboembolism', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of venous thromboembolism.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Deep Vein Thrombosis', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of deep vein thrombosis.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Pulmonary Embolism', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of pulmonary embolism.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}, {'measure': 'Death', 'timeFrame': 'From October 1, 2009 through July 31, 2013 (the study period).', 'description': 'Event rate of death, due to any cause.\n\nThe 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.', 'detailedDescription': 'Study Design:\n\nRetrospective'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NVAF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients must be continuously enrolled in a health plan during the pre-index period;\n* Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;\n* Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);\n* Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;\n* Aged 18-89 on the index date;\n\nExclusion criteria:\n\n* Patients with valvular procedures related to the baseline AF diagnosis will be excluded;\n* Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;'}, 'identificationModule': {'nctId': 'NCT02043808', 'briefTitle': 'The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis', 'orgStudyIdInfo': {'id': '1160.183'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dabigatran'}, {'label': 'Warfarin'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lexington', 'state': 'Massachusetts', 'country': 'United States', 'facility': '1160.183.01 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.44732, 'lon': -71.2245}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}