Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 10:09 AM
Study NCT ID:
NCT01847560
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anticoagulant Utilization Pattern
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 Centre', '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': {'timeFrame': 'Safety related information was not captured during this study.', 'description': 'This was an observational study based on existing data (secondary data use); all patient data are de-identified and analyzed in aggregate. Individual patient safety related information was not designed to assess for this study; therefore the individual safety reporting was not applicable for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort UnitedHealth Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort UnitedHealth Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort UnitedHealth Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort MarketScan Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort MarketScan Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort MarketScan Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort MarketScan WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort MarketScan WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Description of the Characteristics of Anticoagulant Initiators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13464', 'groupId': 'OG000'}, {'value': '56655', 'groupId': 'OG001'}, {'value': '19955', 'groupId': 'OG002'}, {'value': '9731', 'groupId': 'OG003'}, {'value': '28343', 'groupId': 'OG004'}, {'value': '77547', 'groupId': 'OG005'}, {'value': '40971', 'groupId': 'OG006'}, {'value': '19829', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort UnitedHealth Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'OG001', 'title': 'Cohort UnitedHealth Warfarin Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'OG002', 'title': 'Cohort UnitedHealth Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'OG003', 'title': 'Cohort UnitedHealth Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'OG004', 'title': 'Cohort MarketScan Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'OG005', 'title': 'Cohort MarketScan Warfarin Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'OG006', 'title': 'Cohort MarketScan Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'OG007', 'title': 'Cohort MarketScan Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}], 'classes': [{'title': 'CHA2DS2-VASc score', 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '3.59', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '3.82', 'spread': '1.72', 'groupId': 'OG003'}, {'value': '2.92', 'spread': '1.58', 'groupId': 'OG004'}, {'value': '3.62', 'spread': '1.69', 'groupId': 'OG005'}, {'value': '3.12', 'spread': '1.68', 'groupId': 'OG006'}, {'value': '3.34', 'spread': '1.73', 'groupId': 'OG007'}]}]}, {'title': 'HAS-BLED score', 'categories': [{'measurements': [{'value': '2.52', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '2.76', 'spread': '1.16', 'groupId': 'OG003'}, {'value': '2.18', 'spread': '1.02', 'groupId': 'OG004'}, {'value': '2.51', 'spread': '1.12', 'groupId': 'OG005'}, {'value': '2.32', 'spread': '1.1', 'groupId': 'OG006'}, {'value': '2.47', 'spread': '1.14', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Initiating Specific Anticoagulant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609201', 'groupId': 'OG000'}, {'value': '609201', 'groupId': 'OG001'}, {'value': '609201', 'groupId': 'OG002'}, {'value': '609201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Warfarin in source cohort.'}, {'id': 'OG001', 'title': 'Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Dabigatran in source cohort.'}, {'id': 'OG002', 'title': 'Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Rivaroxaban in source cohort.'}, {'id': 'OG003', 'title': 'Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with Apixaban in source cohort.'}], 'classes': [{'title': 'January 2009 - September2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72574', 'groupId': 'OG000'}, {'value': '72574', 'groupId': 'OG001'}, {'value': '72574', 'groupId': 'OG002'}, {'value': '72574', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG003'}]}]}, {'title': 'October2010 - June2011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67422', 'groupId': 'OG000'}, {'value': '67422', 'groupId': 'OG001'}, {'value': '67422', 'groupId': 'OG002'}, {'value': '67422', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG003'}]}]}, {'title': 'July2011 -Dec 2011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66458', 'groupId': 'OG000'}, {'value': '66458', 'groupId': 'OG001'}, {'value': '66458', 'groupId': 'OG002'}, {'value': '66458', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG003'}]}]}, {'title': 'January2012-June2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64745', 'groupId': 'OG000'}, {'value': '64745', 'groupId': 'OG001'}, {'value': '64745', 'groupId': 'OG002'}, {'value': '64745', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG003'}]}]}, {'title': 'July2012-December2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55742', 'groupId': 'OG000'}, {'value': '55742', 'groupId': 'OG001'}, {'value': '55742', 'groupId': 'OG002'}, {'value': '55742', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No treatment initiation during this period', 'groupId': 'OG003'}]}]}, {'title': 'January2013-June2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51641', 'groupId': 'OG000'}, {'value': '51641', 'groupId': 'OG001'}, {'value': '51641', 'groupId': 'OG002'}, {'value': '51641', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'July2013-December2013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52563', 'groupId': 'OG000'}, {'value': '52563', 'groupId': 'OG001'}, {'value': '52563', 'groupId': 'OG002'}, {'value': '52563', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'January2014-June2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46437', 'groupId': 'OG000'}, {'value': '46437', 'groupId': 'OG001'}, {'value': '46437', 'groupId': 'OG002'}, {'value': '46437', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'July2014-December2014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45483', 'groupId': 'OG000'}, {'value': '45483', 'groupId': 'OG001'}, {'value': '45483', 'groupId': 'OG002'}, {'value': '45483', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'January2015-June2015', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43806', 'groupId': 'OG000'}, {'value': '43806', 'groupId': 'OG001'}, {'value': '43806', 'groupId': 'OG002'}, {'value': '43806', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'July2015-September2015', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42330', 'groupId': 'OG000'}, {'value': '42330', 'groupId': 'OG001'}, {'value': '42330', 'groupId': 'OG002'}, {'value': '42330', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.', 'unitOfMeasure': 'Percentage of initiators (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Source cohort in a calendar time window includes all patients with at least one day eligibility. A random date within the time window selected and set as the index date. Patients dispensed of an anticoagulant before assigned index date will be removed, unless they are identified as new initiators for that particular time period.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13464', 'groupId': 'OG000'}, {'value': '28343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort UnitedHealth Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with dabigatran in UnitedHealth cohort.'}, {'id': 'OG001', 'title': 'Cohort MarketScan Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with dabigatran in MarketScan cohort.'}], 'classes': [{'title': '150 milligram (mg)', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000'}, {'value': '90.7', 'groupId': 'OG001'}]}]}, {'title': '75 mg', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.', 'unitOfMeasure': 'Percentage of initiators (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients initiating treatment in source cohort.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9731', 'groupId': 'OG000'}, {'value': '19829', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort UnitedHealth Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with apixaban in UnitedHealth cohort.'}, {'id': 'OG001', 'title': 'Cohort MarketScan Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with apixaban in MarketScan cohort.'}], 'classes': [{'title': '5 mg', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}, {'title': '2.5 mg', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.', 'unitOfMeasure': 'Percentage of initiators (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients initiating treatment in source cohort.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19955', 'groupId': 'OG000'}, {'value': '40971', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort UnitedHealth Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with rivaroxaban in UnitedHealth cohort.'}, {'id': 'OG001', 'title': 'Cohort MarketScan Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) initiating treatment with rivaroxaban in MarketScan cohort.'}], 'classes': [{'title': '20 mg', 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000'}, {'value': '76.4', 'groupId': 'OG001'}]}]}, {'title': '15 mg', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': '10 mg', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.', 'unitOfMeasure': 'Percentage of initiators (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients initiating treatment in source cohort.'}, {'type': 'SECONDARY', 'title': 'Treatment Persistence Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11927', 'groupId': 'OG000'}, {'value': '11927', 'groupId': 'OG001'}, {'value': '15522', 'groupId': 'OG002'}, {'value': '15522', 'groupId': 'OG003'}, {'value': '7712', 'groupId': 'OG004'}, {'value': '7712', 'groupId': 'OG005'}, {'value': '24141', 'groupId': 'OG006'}, {'value': '24141', 'groupId': 'OG007'}, {'value': '26066', 'groupId': 'OG008'}, {'value': '26066', 'groupId': 'OG009'}, {'value': '12578', 'groupId': 'OG010'}, {'value': '12578', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort UnitedHealth Dabigatran (Dabigatran vs Warfarin)', 'description': 'Patients exposed to dabigatran were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG001', 'title': 'Cohort UnitedHealth Warfarin (Warfarin vs Dabigatran)', 'description': 'Patients exposed to warfarin were matched to dabigatran on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG002', 'title': 'Cohort Unitedhealth Rivaroxaban (Rivaroxaban vs Warfarin)', 'description': 'Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG003', 'title': 'Cohort Unitedhealth Warfarin (Warfarin vs Rivaroxaban)', 'description': 'Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG004', 'title': 'Cohort Unitedhealth Apixaban (Apixaban vs Warfarin)', 'description': 'Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG005', 'title': 'Cohort Unitedhealth Warfarin (Warfarin vs Apixaban)', 'description': 'Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG006', 'title': 'Cohort MarketScan Dabigatran (Dabigatran vs Warfarin)', 'description': 'Patients exposed to dabigatran were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG007', 'title': 'Cohort MarketScan Warfarin (Warfarin vs Dabigatran)', 'description': 'Patients exposed to warfarin were matched to dabigatran on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG008', 'title': 'Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)', 'description': 'Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG009', 'title': 'Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)', 'description': 'Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG010', 'title': 'Cohort MarketScan Apixaban (Apixaban vs Warfarin)', 'description': 'Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}, {'id': 'OG011', 'title': 'Cohort MarketScan Warfarin (Warfarin vs Apixaban)', 'description': 'Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}], 'classes': [{'title': 'After 3 months of follow-up', 'categories': [{'measurements': [{'value': '52.19', 'groupId': 'OG000'}, {'value': '52.86', 'groupId': 'OG001'}, {'value': '53.17', 'groupId': 'OG002'}, {'value': '51.58', 'groupId': 'OG003'}, {'value': '51.84', 'groupId': 'OG004'}, {'value': '48.29', 'groupId': 'OG005'}, {'value': '57.92', 'groupId': 'OG006'}, {'value': '53.25', 'groupId': 'OG007'}, {'value': '58.33', 'groupId': 'OG008'}, {'value': '53.27', 'groupId': 'OG009'}, {'value': '58.24', 'groupId': 'OG010'}, {'value': '51.17', 'groupId': 'OG011'}]}]}, {'title': 'After 6 months of follow-up', 'categories': [{'measurements': [{'value': '30.96', 'groupId': 'OG000'}, {'value': '28.16', 'groupId': 'OG001'}, {'value': '31.53', 'groupId': 'OG002'}, {'value': '26.11', 'groupId': 'OG003'}, {'value': '27.71', 'groupId': 'OG004'}, {'value': '21.68', 'groupId': 'OG005'}, {'value': '33.09', 'groupId': 'OG006'}, {'value': '26.78', 'groupId': 'OG007'}, {'value': '35.49', 'groupId': 'OG008'}, {'value': '25.83', 'groupId': 'OG009'}, {'value': '33.25', 'groupId': 'OG010'}, {'value': '23.11', 'groupId': 'OG011'}]}]}, {'title': 'After 12 months of follow-up', 'categories': [{'measurements': [{'value': '15.07', 'groupId': 'OG000'}, {'value': '11.86', 'groupId': 'OG001'}, {'value': '13.54', 'groupId': 'OG002'}, {'value': '9.63', 'groupId': 'OG003'}, {'value': '9.14', 'groupId': 'OG004'}, {'value': '5.56', 'groupId': 'OG005'}, {'value': '15.47', 'groupId': 'OG006'}, {'value': '10.18', 'groupId': 'OG007'}, {'value': '16.50', 'groupId': 'OG008'}, {'value': '8.93', 'groupId': 'OG009'}, {'value': '13.20', 'groupId': 'OG010'}, {'value': '6.22', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.', 'unitOfMeasure': 'Percentage of participants (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were matched within calendar quarters (3 months period) the various NOACs were individually matched to warfarin on an exposure propensity score (PS) in a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort UnitedHealth Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'FG001', 'title': 'Cohort UnitedHealth Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'FG002', 'title': 'Cohort UnitedHealth Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'FG003', 'title': 'Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'FG004', 'title': 'Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'FG005', 'title': 'Cohort MarketScan Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'FG006', 'title': 'Cohort MarketScan Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'FG007', 'title': 'Cohort MarketScan Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'FG008', 'title': 'Cohort MarketScan WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'FG009', 'title': 'Cohort MarketScan WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13464'}, {'groupId': 'FG001', 'numSubjects': '19955'}, {'groupId': 'FG002', 'numSubjects': '9731'}, {'groupId': 'FG003', 'numSubjects': '56655'}, {'groupId': 'FG004', 'numSubjects': '27731'}, {'groupId': 'FG005', 'numSubjects': '28343'}, {'groupId': 'FG006', 'numSubjects': '40971'}, {'groupId': 'FG007', 'numSubjects': '19829'}, {'groupId': 'FG008', 'numSubjects': '77547'}, {'groupId': 'FG009', 'numSubjects': '39438'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13464'}, {'groupId': 'FG001', 'numSubjects': '19955'}, {'groupId': 'FG002', 'numSubjects': '9731'}, {'groupId': 'FG003', 'numSubjects': '56655'}, {'groupId': 'FG004', 'numSubjects': '27731'}, {'groupId': 'FG005', 'numSubjects': '28343'}, {'groupId': 'FG006', 'numSubjects': '40971'}, {'groupId': 'FG007', 'numSubjects': '19829'}, {'groupId': 'FG008', 'numSubjects': '77547'}, {'groupId': 'FG009', 'numSubjects': '39438'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study used a cohort design with descriptive analyses, using data from January 2009 through September 2015. The study was conducted within two US-based longitudinal healthcare claims databases (MarketScan and UnitedHealth Research Database).', 'preAssignmentDetails': 'The data source for this project was a combination of claims data from UnitedHealth, a commercial health insurer, and MarketScan, a research claims database from commercial employer-sponsored health plans both of which provide comprehensive medical coverage for members with active policies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13464', 'groupId': 'BG000'}, {'value': '19955', 'groupId': 'BG001'}, {'value': '9731', 'groupId': 'BG002'}, {'value': '56655', 'groupId': 'BG003'}, {'value': '27731', 'groupId': 'BG004'}, {'value': '28343', 'groupId': 'BG005'}, {'value': '40971', 'groupId': 'BG006'}, {'value': '19829', 'groupId': 'BG007'}, {'value': '77547', 'groupId': 'BG008'}, {'value': '39438', 'groupId': 'BG009'}, {'value': '333664', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort UnitedHealth Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'BG001', 'title': 'Cohort UnitedHealth Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'BG002', 'title': 'Cohort UnitedHealth Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'BG003', 'title': 'Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'BG004', 'title': 'Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.'}, {'id': 'BG005', 'title': 'Cohort MarketScan Dabigatran Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'BG006', 'title': 'Cohort MarketScan Rivaroxaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'BG007', 'title': 'Cohort MarketScan Apixaban Users', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'BG008', 'title': 'Cohort MarketScan WarfarinUsers (After Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'BG009', 'title': 'Cohort MarketScan WarfarinUsers(Before Dabigatran Available)', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13464', 'groupId': 'BG000'}, {'value': '19955', 'groupId': 'BG001'}, {'value': '9731', 'groupId': 'BG002'}, {'value': '56655', 'groupId': 'BG003'}, {'value': '27731', 'groupId': 'BG004'}, {'value': '28343', 'groupId': 'BG005'}, {'value': '40971', 'groupId': 'BG006'}, {'value': '19829', 'groupId': 'BG007'}, {'value': '77547', 'groupId': 'BG008'}, {'value': '39438', 'groupId': 'BG009'}, {'value': '333664', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '69.07', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '70.04', 'spread': '11.45', 'groupId': 'BG001'}, {'value': '72.18', 'spread': '11.05', 'groupId': 'BG002'}, {'value': '73.64', 'spread': '10.28', 'groupId': 'BG003'}, {'value': '71.7', 'spread': '10.8', 'groupId': 'BG004'}, {'value': '67.17', 'spread': '12.11', 'groupId': 'BG005'}, {'value': '67.63', 'spread': '12.21', 'groupId': 'BG006'}, {'value': '69.42', 'spread': '12.32', 'groupId': 'BG007'}, {'value': '71.03', 'spread': '12.11', 'groupId': 'BG008'}, {'value': '69.1', 'spread': '12.4', 'groupId': 'BG009'}, {'value': '70.4', 'spread': '11.9', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13464', 'groupId': 'BG000'}, {'value': '19955', 'groupId': 'BG001'}, {'value': '9731', 'groupId': 'BG002'}, {'value': '56655', 'groupId': 'BG003'}, {'value': '27731', 'groupId': 'BG004'}, {'value': '28343', 'groupId': 'BG005'}, {'value': '40971', 'groupId': 'BG006'}, {'value': '19829', 'groupId': 'BG007'}, {'value': '77547', 'groupId': 'BG008'}, {'value': '39438', 'groupId': 'BG009'}, {'value': '333664', 'groupId': 'BG010'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5017', 'groupId': 'BG000'}, {'value': '7939', 'groupId': 'BG001'}, {'value': '4225', 'groupId': 'BG002'}, {'value': '24620', 'groupId': 'BG003'}, {'value': '11699', 'groupId': 'BG004'}, {'value': '10096', 'groupId': 'BG005'}, {'value': '15305', 'groupId': 'BG006'}, {'value': '7776', 'groupId': 'BG007'}, {'value': '30293', 'groupId': 'BG008'}, {'value': '15539', 'groupId': 'BG009'}, {'value': '132509', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '8447', 'groupId': 'BG000'}, {'value': '12016', 'groupId': 'BG001'}, {'value': '5506', 'groupId': 'BG002'}, {'value': '32035', 'groupId': 'BG003'}, {'value': '16032', 'groupId': 'BG004'}, {'value': '18247', 'groupId': 'BG005'}, {'value': '25666', 'groupId': 'BG006'}, {'value': '12053', 'groupId': 'BG007'}, {'value': '47254', 'groupId': 'BG008'}, {'value': '23899', 'groupId': 'BG009'}, {'value': '201155', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-31', 'size': 436805, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-25T04:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333664}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2013-04-18', 'resultsFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2013-05-02', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-26', 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the Characteristics of Anticoagulant Initiators', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).'}, {'measure': 'Percentage of Patients Initiating Specific Anticoagulant', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.'}, {'measure': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.'}, {'measure': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.'}, {'measure': 'Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.'}], 'secondaryOutcomes': [{'measure': 'Treatment Persistence Over Time', 'timeFrame': 'From January 2009 to September 2015 (The study period)', 'description': 'Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* A recorded diagnosis of atrial fibrillation\n* Initiation of oral anticoagulant medication\n* Congestive Heart Failure, Hypertension, Age \\> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score \\>=1\n* At least 18 years of age on the date of anticoagulant initiation\n\nExclusion criteria:\n\n* Patients with missing or ambiguous age or sex information\n* Patients with documented evidence of valvular disease\n* Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing\n* Patients with prior use of any oral anticoagulant'}, 'identificationModule': {'nctId': 'NCT01847560', 'briefTitle': 'Anticoagulant Utilization Pattern', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation', 'orgStudyIdInfo': {'id': '1160.177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dabigatran'}, {'label': 'Warfarin or other New Oral Anticoagulant (NOAC)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}