Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-02 @ 8:35 AM
Study NCT ID:
NCT03026556
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
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, in which all patient data were de-identified and analyzed in aggregate. Individual patient safety related information were not captured during this study. Thus, individual safety reporting (including adverse events reporting) was not applicable for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rivaroxaban', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Apixaban', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroke Overall (Hemorrhagic, Ischemic, Uncertain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.66'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.84'}, {'value': '0.46', 'groupId': 'OG002', 'lowerLimit': '0.28', 'upperLimit': '0.70'}, {'value': '0.36', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '0.58'}]}]}], 'analyses': [{'pValue': '0.0844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.766', 'ciLowerLimit': '0.566', 'ciUpperLimit': '1.037', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4892', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.255', 'ciLowerLimit': '0.659', 'ciUpperLimit': '2.390', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nLength of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:\n\n1. The day of discontinuation of the index NOAC exposure;\n2. The day before a switch to an anticoagulant different from the index exposure;\n3. The day before a change in dose for the index NOAC;\n4. The end of continuous eligibility of a patient in the health plan (disenrollment);\n5. The end of the study observation period; or\n6. The date of death of the patient.', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'PRIMARY', 'title': 'Overall Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.05'}, {'value': '2.24', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '2.49'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.33', 'upperLimit': '2.11'}, {'value': '1.24', 'groupId': 'OG003', 'lowerLimit': '0.94', 'upperLimit': '1.60'}]}]}], 'analyses': [{'pValue': '0.0182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.696', 'ciUpperLimit': '0.967', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0702', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.374', 'ciLowerLimit': '0.974', 'ciUpperLimit': '1.939', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Ischemic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.62'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.67'}, {'value': '0.39', 'groupId': 'OG002', 'lowerLimit': '0.23', 'upperLimit': '0.62'}, {'value': '0.36', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '0.58'}]}]}], 'analyses': [{'pValue': '0.6307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.667', 'ciUpperLimit': '1.278', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8777', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.054', 'ciLowerLimit': '0.540', 'ciUpperLimit': '2.055', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of ischemic stroke in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Hemorrhagic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.08'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.25'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.19'}, {'value': 'NA', 'comment': 'As there is no person with the event of interest in apixaban groups thus event rate and 95% CI is not calculated', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.223', 'ciLowerLimit': '0.085', 'ciUpperLimit': '0.585', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Major Intracranial Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.37'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.53'}, {'value': '0.24', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '0.43'}, {'value': '0.21', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '0.39'}]}]}], 'analyses': [{'pValue': '0.0406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.654', 'ciLowerLimit': '0.435', 'ciUpperLimit': '0.982', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8124', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.469', 'ciUpperLimit': '2.630', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major intracranial bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Major Extracranial Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.76'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '1.62', 'upperLimit': '2.07'}, {'value': '1.44', 'groupId': 'OG002', 'lowerLimit': '1.12', 'upperLimit': '1.84'}, {'value': '1.03', 'groupId': 'OG003', 'lowerLimit': '0.76', 'upperLimit': '1.36'}]}]}], 'analyses': [{'pValue': '0.0901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.856', 'ciLowerLimit': '0.716', 'ciUpperLimit': '1.025', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0616', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.431', 'ciLowerLimit': '0.983', 'ciUpperLimit': '2.083', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Major GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '1.66'}, {'value': '1.66', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '1.89'}, {'value': '1.36', 'groupId': 'OG002', 'lowerLimit': '1.04', 'upperLimit': '1.74'}, {'value': '0.92', 'groupId': 'OG003', 'lowerLimit': '0.66', 'upperLimit': '1.24'}]}]}], 'analyses': [{'pValue': '0.2073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.887', 'ciLowerLimit': '0.736', 'ciUpperLimit': '1.069', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0417', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.504', 'ciLowerLimit': '1.015', 'ciUpperLimit': '2.228', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Major Urogenital Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'As there is no person with the event of interest for dabigatran in dabigatran vs rivaroxaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.04'}, {'value': 'NA', 'comment': 'As there is no person with the event of interest for dabigatran in dabigatran vs apixaban groups and also for the apixaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran and for apixaban.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As there is no person with the event of interest for dabigatran in dabigatran vs apixaban groups and also for the apixaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran and for apixaban.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major urogenital bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Major Other Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.20'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.26'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.25'}, {'value': '0.13', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '0.28'}]}]}], 'analyses': [{'pValue': '0.2663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.709', 'ciLowerLimit': '0.387', 'ciUpperLimit': '1.299', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8112', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.864', 'ciLowerLimit': '0.261', 'ciUpperLimit': '2.863', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major other bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Upper GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.52'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.69'}, {'value': '0.37', 'groupId': 'OG002', 'lowerLimit': '0.22', 'upperLimit': '0.59'}, {'value': '0.34', 'groupId': 'OG003', 'lowerLimit': '0.19', 'upperLimit': '0.55'}]}]}], 'analyses': [{'pValue': '0.1227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.766', 'ciLowerLimit': '0.546', 'ciUpperLimit': '1.075', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7115', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.138', 'ciLowerLimit': '0.573', 'ciUpperLimit': '2.260', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'Lower GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG001', 'title': 'Rivaroxaban (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG002', 'title': 'Dabigatran (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}, {'id': 'OG003', 'title': 'Apixaban (Dabigatran vs Apixaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.26'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.36'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.72', 'upperLimit': '1.32'}, {'value': '0.58', 'groupId': 'OG003', 'lowerLimit': '0.38', 'upperLimit': '0.84'}]}]}], 'analyses': [{'pValue': '0.4727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.741', 'ciUpperLimit': '1.149', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0275', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.721', 'ciLowerLimit': '1.062', 'ciUpperLimit': '2.790', 'groupDescription': 'Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first', 'unitOfMeasure': 'Event Rate in 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).'}, {'type': 'SECONDARY', 'title': 'TIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'OG000'}, {'value': '12763', 'groupId': 'OG001'}, {'value': '4802', 'groupId': 'OG002'}, {'value': '4802', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs Rivaroxaban)', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 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Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '17177', 'groupId': 'BG001'}, {'value': '12594', 'groupId': 'BG002'}, {'value': '42534', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran', 'description': 'Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran .'}, {'id': 'BG001', 'title': 'Rivaroxaban', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban .'}, {'id': 'BG002', 'title': 'Apixaban', 'description': 'OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '17177', 'groupId': 'BG001'}, {'value': '12594', 'groupId': 'BG002'}, {'value': '42534', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '70.89', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '71.28', 'spread': '9.70', 'groupId': 'BG001'}, {'value': '72.35', 'spread': '8.93', 'groupId': 'BG002'}, {'value': '71.48', 'spread': '9.60', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Rivaroxaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '12763', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25526', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '70.89', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '70.92', 'spread': '10.07', 'groupId': 'BG001'}, {'value': '70.91', 'spread': '10.05', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Apixaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4802', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4802', 'groupId': 'BG002'}, {'value': '9604', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '70.15', 'spread': '10.23', 'groupId': 'BG000'}, {'value': '70.20', 'spread': '10.02', 'groupId': 'BG002'}, {'value': '70.18', 'spread': '10.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '17177', 'groupId': 'BG001'}, {'value': '12594', 'groupId': 'BG002'}, {'value': '42534', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '7902', 'groupId': 'BG000'}, {'value': '10389', 'groupId': 'BG001'}, {'value': '7499', 'groupId': 'BG002'}, {'value': '25790', 'groupId': 'BG003'}]}, {'title': 'Female', 'measurements': [{'value': '4861', 'groupId': 'BG000'}, {'value': '6788', 'groupId': 'BG001'}, {'value': '5095', 'groupId': 'BG002'}, {'value': '16744', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Rivaroxaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '12763', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25526', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '7902', 'groupId': 'BG000'}, {'value': '7839', 'groupId': 'BG001'}, {'value': '15741', 'groupId': 'BG003'}]}, {'title': 'Female', 'measurements': [{'value': '4861', 'groupId': 'BG000'}, {'value': '4924', 'groupId': 'BG001'}, {'value': '9785', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Apixaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4802', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4802', 'groupId': 'BG002'}, {'value': '9604', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '3028', 'groupId': 'BG000'}, {'value': '3039', 'groupId': 'BG002'}, {'value': '6067', 'groupId': 'BG003'}]}, {'title': 'Female', 'measurements': [{'value': '1774', 'groupId': 'BG000'}, {'value': '1763', 'groupId': 'BG002'}, {'value': '3537', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '17177', 'groupId': 'BG001'}, {'value': '12594', 'groupId': 'BG002'}, {'value': '42534', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '3771', 'groupId': 'BG000'}, {'value': '5388', 'groupId': 'BG001'}, {'value': '3744', 'groupId': 'BG002'}, {'value': '12903', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}, {'value': '932', 'groupId': 'BG003'}]}, {'title': 'Other/Unknown/Missing', 'measurements': [{'value': '8690', 'groupId': 'BG000'}, {'value': '11431', 'groupId': 'BG001'}, {'value': '8578', 'groupId': 'BG002'}, {'value': '28699', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Rivaroxaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12763', 'groupId': 'BG000'}, {'value': '12763', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25526', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '3771', 'groupId': 'BG000'}, {'value': '3779', 'groupId': 'BG001'}, {'value': '7550', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '599', 'groupId': 'BG003'}]}, {'title': 'Other/Unknown/Missing', 'measurements': [{'value': '8690', 'groupId': 'BG000'}, {'value': '8687', 'groupId': 'BG001'}, {'value': '17377', 'groupId': 'BG003'}]}]}, {'title': 'Dabigatran vs Apixaban (matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4802', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4802', 'groupId': 'BG002'}, {'value': '9604', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '1621', 'groupId': 'BG000'}, {'value': '1622', 'groupId': 'BG002'}, {'value': '3243', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG002'}, {'value': '309', 'groupId': 'BG003'}]}, {'title': 'Other/Unknown/Missing', 'measurements': [{'value': '3024', 'groupId': 'BG000'}, {'value': '3028', 'groupId': 'BG002'}, {'value': '6052', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity information was not collected for this trial.', 'unitOfMeasure': 'Participants', 'populationDescription': 'The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.'}], 'populationDescription': 'The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-15', 'size': 553832, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-16T12:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-01-18', 'resultsFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-20', 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Overall (Hemorrhagic, Ischemic, Uncertain)', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nLength of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:\n\n1. The day of discontinuation of the index NOAC exposure;\n2. The day before a switch to an anticoagulant different from the index exposure;\n3. The day before a change in dose for the index NOAC;\n4. The end of continuous eligibility of a patient in the health plan (disenrollment);\n5. The end of the study observation period; or\n6. The date of death of the patient.'}, {'measure': 'Overall Major Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Ischemic Stroke', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of ischemic stroke in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Hemorrhagic Stroke', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.'}, {'measure': 'Major Intracranial Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major intracranial bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Major Extracranial Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Major GI Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Major Urogenital Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major urogenital bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.'}, {'measure': 'Major Other Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of major other bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Upper GI Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'Lower GI Bleeding', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'TIA', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}, {'measure': 'All-cause Mortality', 'timeFrame': 'Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years', 'description': 'The event rate of all-cause mortality in patients matched on propensity scores without index year.\n\nEvent rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.\n\nFollow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NVAF patients, ≥18 years of age, enrolled within the DoD Military Health System, who have newly initiated dabigatran, rivaroxaban, or apixaban. Patients must be treatment naïve from OAC use prior to first (index) NOAC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ on index date\n* Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;\n* Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.\n* Patients must have at least 12 months of continuous eligibility prior to the index date;\n* Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.\n\nExclusion Criteria:\n\nLess than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period\n\nHaving at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) \\& PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):\n\n* Cardiac surgery\n* Pericarditis\n* Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):\n* Mitral stenosis\n* Mitral stenosis with insufficiency\n* Mitral valve stenosis and aortic valve stenosis\n* Mitral valve stenosis and aortic valve insufficiency\n* Diseases of other endocardial structures\n* Other and unspecified rheumatic heart diseases\n* Open heart valvuloplasty without replacement\n* Open and other replacement of unspecified heart valve\n* Open and other replacement of aortic valve\n* Open and other replacement of mitral valve\n* Open and other replacement of pulmonary valve\n* Open and other replacement of tricuspid valve\n* Heart valve replaced by transplant\n* Heart valve replaced by a mechanical device/prosthesis\n* Atrioventricular valve repair\n* Aortic valve valvuloplasty\n* Unlisted procedure, cardiac surgery\n* Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach\n* Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass\n* Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass\n* Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve\n* Valvuloplasty, mitral valve, with cardiopulmonary bypass\n* Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring\n* Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring\n* Replacement, mitral valve, with cardiopulmonary bypass\n* Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach\n* Replacement, pulmonary valve\n* Valvectomy, tricuspid valve, with cardiopulmonary bypass\n* Valvuloplasty, tricuspid valve; without ring insertion\n* Valvuloplasty, tricuspid valve; with ring insertion\n* Replacement, tricuspid valve, with cardiopulmonary bypass'}, 'identificationModule': {'nctId': 'NCT03026556', 'briefTitle': 'The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System', 'orgStudyIdInfo': {'id': '1160-0274'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dabigatran vs. Rivaroxaban', 'description': 'OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).', 'interventionNames': ['Drug: Dabigatran vs. Rivaroxaban']}, {'label': 'Dabigatran vs. Apixaban', 'description': 'OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).', 'interventionNames': ['Drug: Dabigatran vs. Apixaban']}], 'interventions': [{'name': 'Dabigatran vs. Rivaroxaban', 'type': 'DRUG', 'description': 'observed for 6 years', 'armGroupLabels': ['Dabigatran vs. Rivaroxaban']}, {'name': 'Dabigatran vs. Apixaban', 'type': 'DRUG', 'description': 'Observed for 6 years', 'armGroupLabels': ['Dabigatran vs. Apixaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08450', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Inventiv Health', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Health ResearchTx, LLC (HRTX)', 'class': 'UNKNOWN'}, {'name': 'inVentiv Health Clinical (iVH)', 'class': 'UNKNOWN'}, {'name': 'United States Department of Defense (DOD)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}