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| ID | Type | Description | Link |
|---|---|---|---|
| CER3 | Other Identifier | Alias Study Number |
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An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan
An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan. This study will evaluate the risk of stroke/SE as well as the risk of bleeding in the real world settings in Japan in patients with NVAF who initiated any of OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)
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| Measure | Description | Time Frame |
|---|---|---|
| Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date | Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date | Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date | Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date | Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. |
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Inclusion criteria
Patients must meet all of the following criteria to be eligible for the study:
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
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Patients with NVAF who initiated any of oral anti-coagulants
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Japan | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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In this study, inverse probability of treatment weighted (IPTW) method was used in analysis of outcome measures to balance participant's characteristics among reporting groups.
It is a retrospective population-based register study. Data of each participant diagnosed with non-valvular atrial fibrillation (NAVF) was retrieved from Medical Data Vision (MDV) database for the duration of approximately 7 years (March 2011 to December 2017).
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| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin | Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| FG001 | Apixaban | OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| FG002 | Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| FG003 | Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| FG004 | Edoxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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OACs treatment-naive participants diagnosed with NVAF initiating any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) treatment were included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin | OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date | Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years |
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Due to observational nature of study, adverse events were not collected in 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 | Warfarin | OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Oct 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2018 | Oct 12, 2019 | SAP_001.pdf |
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| During the observation period of approximately 7 years |
| During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date | Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date | Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported. Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date | Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported. Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date | Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported. Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes. If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date | Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported. Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "major intracranial hemorrhage" if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date | Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported. Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "any intracranial hemorrhagic event" if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | During the observation period of approximately 7 years |
| BG001 | Apixaban | OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| BG002 | Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| BG003 | Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| BG004 | Edoxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Pseudo datasets |
| Pseudo datasets |
|
|
|
|
| Primary | Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date | Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
|
|
| Primary | Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date | Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date | Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
|
| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date | Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date | Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported. Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date | Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported. Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date | Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported. Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes. If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date | Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported. Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "major intracranial hemorrhage" if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
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| Secondary | Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date | Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported. Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "any intracranial hemorrhagic event" if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm. | OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field. | Posted | Number | Events Per 100 Participant-Years | During the observation period of approximately 7 years | Pseudo datasets | Pseudo datasets |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Apixaban | OACs treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Dabigatran | OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Rivaroxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Edoxaban | OACs treatment-naive participants diagnosed with NVAF, who initiated edoxaban on the index date, were included in this study cohort and their data (for the duration of approximately 7 years observation period, i.e. 2011-2017) available in MDV database was retrospectively observed. Index date was defined as the date of the first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during observation period. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Pseudo datasets |
|
| Hazard Ratio (HR) |
| 0.66 |
| 2-Sided |
| 95 |
| 0.529 |
| 0.825 |
| Other |
| Cox proportional hazards model | 0.0007 | Hazard Ratio (HR) | 0.74 | 2-Sided | 95 | 0.618 | 0.879 | Other |
| Cox proportional hazards model | 0.0011 | Hazard Ratio (HR) | 0.71 | 2-Sided | 95 | 0.583 | 0.874 | Other |
| Pseudo datasets |
|
| Hazard Ratio (HR) |
| 0.96 |
| 95 |
| 0.881 |
| 1.039 |
| Other |
| Cox proportional hazards model | 0.0640 | Hazard Ratio (HR) | 0.94 | 2-Sided | 95 | 0.881 | 1.004 | Other |
| Cox proportional hazards model | 0.4404 | Hazard Ratio (HR) | 1.03 | 2-Sided | 95 | 0.958 | 1.103 | Other |
| Pseudo datasets |
|
| Pseudo datasets |
|
| Pseudo datasets |
|
| Pseudo datasets |
|
| Pseudo datasets |
|
| Pseudo datasets |
|
| Pseudo datasets |
|