| Primary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using Inverse probability treatment weighting (IPTW) method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. | | OG001 | Warfarin: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00061.352(59.413 to 63.354)
- OG00175.078(72.748 to 77.483)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | COX Proportional Hazards Regression | | <0.001 | | Hazard Ratio (HR) | 0.752 | | | 2-Sided | 95 | 0.719 | 0.787 | | | | | Other | | |
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| Primary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
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| Secondary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. Ischemic stroke after index date not including the index date was identified using hospital claims which had an ischemic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
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| Secondary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of hemorrhagic stroke event after index date was reported. Hemorrhagic stroke after index date not including the index date was identified using hospital claims which had a hemorrhagic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
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| Secondary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of SE event after index date was reported. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. | |
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| Secondary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial Bleeding Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of major intracranial bleeding event after index date was reported. Major intracranial bleeding after index date was identified using hospital claims which had an intracranial bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
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| Secondary | Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) Bleeding Event After Index Date: Balanced Cohorts | Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. Any GI bleeding after index date was identified using hospital claims which had a GI bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first. | Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm. | Posted | | Number | 95% Confidence Interval | Events Per 1000 Participant-Years | | Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study | | | | ID | Title | Description |
|---|
| OG000 | Apixaban: Balanced Cohort | Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics. |
|