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This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | |||
| Warfarin |
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) | The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events. | From October 2010 to September 2015 (the study period) |
| Major Bleeding | The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding). | From October 2010 to September 2015 (the study period) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or Systemic Embolism | The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification). |
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Inclusion criteria:
Exclusion criteria:
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Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
In this non-interventional study based on existing data, no patients were screened.
Data for the patients included in this cohort study arose from two de-identified research databases, US MarketScan and Optum Research Database
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| ID | Title | Description |
|---|---|---|
| FG000 | Optum Clinformatics - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| FG001 | Optum Clinformatics - Warfarin | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| FG002 | Optum Clinformatics - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| FG003 | Optum Clinformatics - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| FG004 | MarketScan - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| FG005 | MarketScan - Warfarin | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| FG006 | MarketScan - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| FG007 | MarketScan - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, warfarin, rivaroxaban or apixaban during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation
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| ID | Title | Description |
|---|---|---|
| BG000 | Optum Clinformatics - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| BG001 | Optum Clinformatics - Warfarin |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) | The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events. | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
Individual safety reporting was not applicable for this study
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 captured during this study; therefore the individual safety reporting was not applicable for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optum Clinformatics - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2014 | Oct 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| From October 2010 to September 2015 (the study period) |
| Systemic Embolism | The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism. | From October 2010 to September 2015 (the study period) |
| Ischemic Stroke | The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction | From October 2010 to September 2015 (the study period) |
| Hemorrhagic Stroke | The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH) | From October 2010 to September 2015 (the study period) |
| Stroke Uncertain Classification | The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease). | From October 2010 to September 2015 (the study period) |
| Major Intracranial Bleeding | The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage | From October 2010 to September 2015 (the study period) |
| Major Extra-cranial Bleeding | The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding). | From October 2010 to September 2015 (the study period) |
| Major Gastrointestinal (GI) Bleeding | The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding). | From October 2010 to September 2015 (the study period) |
| Major Upper Gastrointestinal Bleeding | The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method). | From October 2010 to September 2015 (the study period) |
| Major Lower Gastrointestinal Bleeding | The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9 | From October 2010 to September 2015 (the study period) |
| Major Urogenital Bleeding | The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible. | From October 2010 to September 2015 (the study period) |
| Other Major Bleeding | The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x | From October 2010 to September 2015 (the study period) |
| Transient Ischemic Attack (TIA) | The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis | From October 2010 to September 2015 (the study period) |
| Myocardial Infarction (MI) | The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is < 3 days | From October 2010 to September 2015 (the study period) |
| Venous Thromboembolism (VTE) | The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)). | From October 2010 to September 2015 (the study period) |
| Deep Vein Thrombosis (DVT) | The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis) | From October 2010 to September 2015 (the study period) |
| Pulmonary Embolism (PE) | The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction) | From October 2010 to September 2015 (the study period) |
Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| BG002 | Optum Clinformatics - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| BG003 | Optum Clinformatics - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation |
| BG004 | MarketScan - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| BG005 | MarketScan - Warfarin | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| BG006 | MarketScan - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| BG007 | MarketScan - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation |
| BG008 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin |
| OG001 | Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with dabigatran |
| OG002 | MarketScan - Dabigatran vs. Warfarin (Dabigatran) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin |
| OG003 | MarketScan - Dabigatran vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with dabigatran |
| OG004 | Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin |
| OG005 | Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with rivaroxaban |
| OG006 | MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin |
| OG007 | MarketScan - Rivaroxaban vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with rivaroxaban |
| OG008 | Optum Clinformatics - Apixaban vs. Warfarin (Apixaban) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with warfarin |
| OG009 | Optum Clinformatics - Apixaban vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation and matched on propensity scores with apixaban |
| OG010 | MarketScan - Apixaban vs. Warfarin (Apixaban) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with warfarin |
| OG011 | MarketScan - Apixaban vs. Warfarin (Warfarin) | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation and matched on propensity scores with apixaban |
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| Primary | Major Bleeding | The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Stroke or Systemic Embolism | The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Systemic Embolism | The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism. | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Ischemic Stroke | The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Hemorrhagic Stroke | The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH) | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Stroke Uncertain Classification | The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Major Intracranial Bleeding | The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Major Extra-cranial Bleeding | The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
|
| Secondary | Major Gastrointestinal (GI) Bleeding | The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
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|
| Secondary | Major Upper Gastrointestinal Bleeding | The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
|
|
| Secondary | Major Lower Gastrointestinal Bleeding | The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9 | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
| Secondary | Major Urogenital Bleeding | The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible. | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
| Secondary | Other Major Bleeding | The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
|
| Secondary | Transient Ischemic Attack (TIA) | The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
| Secondary | Myocardial Infarction (MI) | The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is < 3 days | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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|
| Secondary | Venous Thromboembolism (VTE) | The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)). | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Deep Vein Thrombosis (DVT) | The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis) | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
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| Secondary | Pulmonary Embolism (PE) | The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. Event 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. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction) | Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach. | Posted | Number | 95% Confidence Interval | Incidence rate per 100 person-years | From October 2010 to September 2015 (the study period) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Optum Clinformatics - Warfarin | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Optum Clinformatics - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Optum Clinformatics - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | MarketScan - Dabigatran | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | MarketScan - Warfarin | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of warfarin, during October 2010 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | MarketScan - Rivaroxaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of rivaroxaban, during July 2011 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | MarketScan - Apixaban | Patients with non- valvular atrial fibrillation (NVAF) and new initiators of apixaban, during January 2013 to September 2015 who were enrolled for a minimum of 12 months in MarketScan before treatment initiation | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|
MarketScan-Dabigatran vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI). |
| Hazard Ratio (HR) |
| 0.76 |
| 2-Sided |
| 95 |
| 0.68 |
| 0.86 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.72 | 2-Sided | 95 | 0.65 | 0.80 | Other |
| Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI). | Hazard Ratio (HR) | 1.06 | 2-Sided | 95 | 0.88 | 1.26 | Other |
| MarketScan-Rivaroxaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI). | Hazard Ratio (HR) | 1.01 | 2-Sided | 95 | 0.92 | 1.12 | Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 1.02 | 2-Sided | 95 | 0.94 | 1.12 | Other |
| Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI). | Hazard Ratio (HR) | 0.51 | 2-Sided | 95 | 0.39 | 0.66 | Other |
| MarketScan-Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI). | Hazard Ratio (HR) | 0.58 | 2-Sided | 95 | 0.49 | 0.68 | Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.56 | 2-Sided | 95 | 0.49 | 0.64 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.82 |
| 2-Sided |
| 95 |
| 0.66 |
| 1.02 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.64 | 2-Sided | 95 | 0.47 | 0.88 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.05 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.71 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.31 | 2-Sided | 95 | 0.10 | 0.96 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.74 |
| 2-Sided |
| 95 |
| 0.57 |
| 0.96 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.65 | 2-Sided | 95 | 0.45 | 0.94 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.00 |
| 2-Sided |
| 95 |
| 0.58 |
| 1.72 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.85 | 2-Sided | 95 | 0.38 | 1.87 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.70 |
| 2-Sided |
| 95 |
| 0.51 |
| 0.95 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.67 | 2-Sided | 95 | 0.43 | 1.03 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.06 |
| 2-Sided |
| 95 |
| 0.97 |
| 1.16 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.54 | 2-Sided | 95 | 0.47 | 0.63 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.21 |
| 2-Sided |
| 95 |
| 1.07 |
| 1.36 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.59 | 2-Sided | 95 | 0.48 | 0.72 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.24 |
| 2-Sided |
| 95 |
| 0.98 |
| 1.57 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.79 | 2-Sided | 95 | 0.54 | 1.14 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.19 |
| 2-Sided |
| 95 |
| 1.05 |
| 1.35 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.54 | 2-Sided | 95 | 0.44 | 0.67 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.93 |
| 1.16 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.56 | 2-Sided | 95 | 0.47 | 0.67 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.55 |
| 1.29 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.76 | 2-Sided | 95 | 0.41 | 1.42 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.85 |
| 2-Sided |
| 95 |
| 0.63 |
| 1.14 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.79 | 2-Sided | 95 | 0.53 | 1.18 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.69 |
| 1.01 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.53 | 2-Sided | 95 | 0.37 | 0.76 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.82 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.04 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.60 | 2-Sided | 95 | 0.39 | 0.92 | Other |
This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group). |
| Regression, Cox |
Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. |
| Hazard Ratio (HR) |
| 0.79 |
| 2-Sided |
| 95 |
| 0.60 |
| 1.05 |
| Other |
| This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group). | Regression, Cox | Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis. | Hazard Ratio (HR) | 0.42 | 2-Sided | 95 | 0.24 | 0.73 | Other |