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Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)

Primary Purpose

Stroke, Atrial Fibrillation, Embolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
warfarin tablets
Edoxaban tablets (high dose regimen-60mg)
Edoxaban tablets (low dose regimen-30mg)
placebo warfarin
placebo edoxaban
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Systemic embolic events

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 21 years of age or older; male or female.
  • Able to provide written informed consent.
  • History of documented AF within the prior 12 months
  • A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

  • Transient atrial fibrillation secondary to other reversible disorders
  • Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
  • Subjects with any contraindication for anticoagulant agents;
  • Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders

  • Females of childbearing potential including the following:

    • Females with a history of tubal-ligation
    • Females less than 2 years post-menopausal

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Warfarin/placebo edoxaban

high dose edoxaban/placebo warfarin

low dose edoxaban/placebo warfarin

Arm Description

Warfarin tablets plus placebo Edoxaban tablets

Edoxaban tablets (60mg) plus warfarin placebo tablets

Edoxaban tablets (30mg) plus warfarin placebo tablets

Outcomes

Primary Outcome Measures

Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.

Secondary Outcome Measures

Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
Adjudicated Bleeding Events
Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set. Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.

Full Information

First Posted
October 28, 2008
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo, Inc.
Collaborators
The TIMI Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00781391
Brief Title
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Acronym
EngageAFTIMI48
Official Title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
The TIMI Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Atrial Fibrillation, Embolism
Keywords
Systemic embolic events

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warfarin/placebo edoxaban
Arm Type
Active Comparator
Arm Description
Warfarin tablets plus placebo Edoxaban tablets
Arm Title
high dose edoxaban/placebo warfarin
Arm Type
Experimental
Arm Description
Edoxaban tablets (60mg) plus warfarin placebo tablets
Arm Title
low dose edoxaban/placebo warfarin
Arm Type
Experimental
Arm Description
Edoxaban tablets (30mg) plus warfarin placebo tablets
Intervention Type
Drug
Intervention Name(s)
warfarin tablets
Intervention Description
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Edoxaban tablets (high dose regimen-60mg)
Intervention Description
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Edoxaban tablets (low dose regimen-30mg)
Intervention Description
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
placebo warfarin
Intervention Description
placebo warfarin
Intervention Type
Drug
Intervention Name(s)
placebo edoxaban
Intervention Description
placebo edoxaban
Primary Outcome Measure Information:
Title
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
Time Frame
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
Time Frame
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Description
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Description
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary Outcome Measure Information:
Title
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
Description
Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
Description
Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
Description
Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
Time Frame
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Title
Adjudicated Bleeding Events
Description
Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set. Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.
Time Frame
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21 years of age or older; male or female. Able to provide written informed consent. History of documented AF within the prior 12 months A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2 Exclusion Criteria: Transient atrial fibrillation secondary to other reversible disorders Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve Subjects with any contraindication for anticoagulant agents; Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders Females of childbearing potential including the following: Females with a history of tubal-ligation Females less than 2 years post-menopausal
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Lincoln
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Buffalo
State/Province
New York
Country
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City
Cortlandt Manor
State/Province
New York
Country
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Hawthorne
State/Province
New York
Country
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Country
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State/Province
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Country
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New York
State/Province
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Country
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State/Province
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Country
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Country
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Country
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Country
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Chapel Hill
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Country
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Charlotte
State/Province
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ZIP/Postal Code
28207
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
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State/Province
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Country
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Morehead City
State/Province
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ZIP/Postal Code
28557
Country
United States
City
Morganton
State/Province
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ZIP/Postal Code
28655
Country
United States
City
Morganton
State/Province
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Country
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Oxford
State/Province
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Country
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Country
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State/Province
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State/Province
Ohio
Country
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State/Province
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Country
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State/Province
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Country
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Columbus
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Country
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State/Province
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Country
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Dayton
State/Province
Ohio
Country
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Fairfield
State/Province
Ohio
Country
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Marion
State/Province
Ohio
Country
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Middletown
State/Province
Ohio
Country
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Pitsburg
State/Province
Ohio
Country
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Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
City
Thornville
State/Province
Ohio
Country
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Toledo
State/Province
Ohio
Country
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State/Province
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Country
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State/Province
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State/Province
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State/Province
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Country
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State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
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Beaver
State/Province
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Country
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State/Province
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Country
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State/Province
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Country
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State/Province
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Country
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Doylestown
State/Province
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Country
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State/Province
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Country
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Feasterville
State/Province
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Country
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Fleetwood
State/Province
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ZIP/Postal Code
19522
Country
United States
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Greenville
State/Province
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Country
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Johnstown
State/Province
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Country
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Lancaster
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Country
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Country
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Country
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Philadelphia
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Country
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Pittsburgh
State/Province
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Country
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State/Province
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Country
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Scranton
State/Province
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Country
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Sellersville
State/Province
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Somerset
State/Province
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Country
United States
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State College
State/Province
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Country
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Uniontown
State/Province
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Country
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Wilkes-Barre
State/Province
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Country
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Country
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Providence
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Rhode Island
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Anderson
State/Province
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Country
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Charleston
State/Province
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Country
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Columbia
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Country
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Florence
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Country
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Greenville
State/Province
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Country
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Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29302
Country
United States
City
Summerville
State/Province
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Country
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Taylors
State/Province
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Country
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Walterboro
State/Province
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Country
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Rapid City
State/Province
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Country
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Columbia
State/Province
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Jackson
State/Province
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Johnson City
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Country
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State/Province
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Country
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State/Province
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Country
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Arlington
State/Province
Texas
Country
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Austin
State/Province
Texas
Country
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Carrollton
State/Province
Texas
Country
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Corsicana
State/Province
Texas
Country
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Dallas
State/Province
Texas
Country
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Fort Worth
State/Province
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Country
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Georgetown
State/Province
Texas
Country
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Grapevine
State/Province
Texas
Country
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Houston
State/Province
Texas
Country
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Lubbock
State/Province
Texas
Country
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McAllen
State/Province
Texas
Country
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Odessa
State/Province
Texas
Country
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Plano
State/Province
Texas
Country
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San Antonio
State/Province
Texas
Country
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Tomball
State/Province
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Country
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Wichita Falls
State/Province
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Country
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Provo
State/Province
Utah
Country
United States
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West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
City
Danville
State/Province
Virginia
Country
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Hopewell
State/Province
Virginia
Country
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Newport News
State/Province
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Country
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Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
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Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Springfield
State/Province
Virginia
Country
United States
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Suffolk
State/Province
Virginia
Country
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Virginia Beach
State/Province
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Country
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Winchester
State/Province
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Country
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Bellevue
State/Province
Washington
Country
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Kirkland
State/Province
Washington
Country
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Renton
State/Province
Washington
Country
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Seattle
State/Province
Washington
Country
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Spokane
State/Province
Washington
Country
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Tacoma
State/Province
Washington
Country
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Clarksburg
State/Province
West Virginia
Country
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Madison
State/Province
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Manitowoc
State/Province
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State/Province
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Country
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Buenos Aires
Country
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Cordoba
Country
Argentina
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Corrientes
Country
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Formosa
Country
Argentina
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Godoy Cruz
Country
Argentina
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Jujuy
Country
Argentina
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Mar del Plata
Country
Argentina
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Mendoza
Country
Argentina
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Paraguay
Country
Argentina
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Provincia De Chaco
Country
Argentina
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Provincia De Rio Negro
Country
Argentina
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Provincia De Salta
Country
Argentina
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San Luis
Country
Argentina
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Santa Fe
Country
Argentina
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Tucuman
Country
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Broken Hill
State/Province
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Country
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Milton
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Australia
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State/Province
Victoria
Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Ruse
Country
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Country
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Country
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State/Province
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Country
Canada
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State/Province
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Country
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State/Province
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Country
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State/Province
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Country
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State/Province
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Country
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State/Province
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Country
Canada
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New Westminster
State/Province
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Country
Canada
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Penticton
State/Province
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Country
Canada
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Quesnel
State/Province
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Country
Canada
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Victoria
State/Province
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Country
Canada
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Saint John
State/Province
New Brunswick
Country
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State/Province
Nova Scotia
Country
Canada
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Halifax
State/Province
Nova Scotia
Country
Canada
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Liverpool
State/Province
Nova Scotia
Country
Canada
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Ajax
State/Province
Ontario
Country
Canada
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Beamsville
State/Province
Ontario
Country
Canada
City
Brampton
State/Province
Ontario
Country
Canada
City
Corunna
State/Province
Ontario
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Kitchener
State/Province
Ontario
Country
Canada
City
Listowel
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Oshawa
State/Province
Ontario
Country
Canada
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Ottawa
State/Province
Ontario
Country
Canada
City
Richmond Hill
State/Province
Ontario
Country
Canada
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Sarnia
State/Province
Ontario
Country
Canada
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Scarborough
State/Province
Ontario
Country
Canada
City
Sudbury
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Greenfield Park
State/Province
Quebec
Country
Canada
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Longueuil
State/Province
Quebec
Country
Canada
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Montreal
State/Province
Quebec
Country
Canada
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Quebec City
State/Province
Quebec
Country
Canada
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Saint Georges De Beauce
State/Province
Quebec
Country
Canada
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State/Province
Quebec
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State/Province
Quebec
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State/Province
Quebec
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Canada
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Terrebonne
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Quebec
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State/Province
Quebec
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Westmount
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Quebec
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State/Province
Saskatchewan
Country
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Country
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Quebec
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Country
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Iquique
Country
Chile
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Country
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Country
Chile
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Country
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Santiago
Country
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Country
Chile
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Temuco
Country
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Victoria
Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Slavonski Brod
Country
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Split
Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Usti nad Labem
Country
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Aarhus N
Country
Denmark
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Country
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Country
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Country
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Country
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Country
Denmark
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Country
Denmark
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Country
Denmark
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Country
Denmark
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Haabneeme
State/Province
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Country
Estonia
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Tartu
Country
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Country
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Tallinn
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Tallin
Country
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Tartu
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Jyvaskyla
Country
Finland
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Country
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France
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Country
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Country
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Country
France
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Country
France
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Country
France
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Massy
Country
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Nantes
Country
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Paris
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Pau
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Country
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Country
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Country
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Country
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Country
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Country
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Frankfurt
Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
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Country
Guatemala
City
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Country
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City
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Country
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Country
Hungary
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Baja
Country
Hungary
City
Bekescsaba
Country
Hungary
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Hodmezovasarhely
Country
Hungary
City
Kecskemet
Country
Hungary
City
Keeskemet
Country
Hungary
City
Kistarcsa
Country
Hungary
City
Komarom
Country
Hungary
City
Mako
Country
Hungary
City
Nagykanizsa
Country
Hungary
City
Nyiregyhaza
Country
Hungary
City
Pecs
Country
Hungary
City
Sopron
Country
Hungary
City
Szekszard
Country
Hungary
City
Szombathely
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Hyderabad
State/Province
AP
Country
India
City
Vijayawada
State/Province
AP
Country
India
City
Angamaly
State/Province
Kerala
Country
India
City
Kochi
State/Province
Kerala
Country
India
City
Thrissur
State/Province
Kerala
Country
India
City
Ahmedabad
Country
India
City
Anddhra Pradesh
Country
India
City
Andhra Pradesh
Country
India
City
Aurangabad
Country
India
City
Bangalore
Country
India
City
Bikaner
Country
India
City
Chennai
Country
India
City
Coimbatore
Country
India
City
Delhi
Country
India
City
Gujrat
Country
India
City
Indore
Country
India
City
Jaipur
Country
India
City
Karnataka
Country
India
City
Kerala
Country
India
City
Kolkata
Country
India
City
Ludhiana
Country
India
City
Madhya Pradesh
Country
India
City
Maharashtra
Country
India
City
Mangalore
Country
India
City
Mumbai
Country
India
City
Nagpur
Country
India
City
Nashik
Country
India
City
New Delhi
Country
India
City
Pune
Country
India
City
Puni
Country
India
City
Punjab
Country
India
City
Rajasthan
Country
India
City
Ramnagar
Country
India
City
Shimoga
Country
India
City
Surat
Country
India
City
Trivandrum
Country
India
City
Vadodara
Country
India
City
Afula
Country
Israel
City
Beer-Sheva
Country
Israel
City
Dimona
Country
Israel
City
Givatayim
Country
Israel
City
Hadera
Country
Israel
City
Haifa
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Kfar Saba
Country
Israel
City
Nahariya
Country
Israel
City
Nazareth
Country
Israel
City
Petach Tikva
Country
Israel
City
Petah-Tikva
Country
Israel
City
Poriya
Country
Israel
City
Raanana
Country
Israel
City
Rehovot
Country
Israel
City
Tel Aviv
Country
Israel
City
Tel Hashomer
Country
Israel
City
Zerifin
Country
Israel
City
Bologna
Country
Italy
City
Brescia
Country
Italy
City
Cantania
Country
Italy
City
Casarano
Country
Italy
City
Caserta
Country
Italy
City
Chieti
Country
Italy
City
Cremona
Country
Italy
City
Genova
Country
Italy
City
Grosseto
Country
Italy
City
Legnano
Country
Italy
City
Manerbio
Country
Italy
City
Milano
Country
Italy
City
Monserrato
Country
Italy
City
Napoli
Country
Italy
City
Novara
Country
Italy
City
Ostia
Country
Italy
City
Pavia
Country
Italy
City
Pisa
Country
Italy
City
Pozzuoli
Country
Italy
City
Roma
Country
Italy
City
Santa Maria Capua Vetere
Country
Italy
City
Sassari
Country
Italy
City
Seriate
Country
Italy
City
Siena
Country
Italy
City
Trieste
Country
Italy
City
Venezia Mestre
Country
Italy
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Lida-shi
State/Province
Nagano
Country
Japan
City
Ueda-shi
State/Province
Nagano
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Aichi
Country
Japan
City
Aomori
Country
Japan
City
Chiaki
Country
Japan
City
Chiba
Country
Japan
City
Ehime
Country
Japan
City
Fukuoka
Country
Japan
City
Fukushima
Country
Japan
City
Gifu
Country
Japan
City
Gunma
Country
Japan
City
Hiroshima
Country
Japan
City
Hokkai-do
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Ibaraki
Country
Japan
City
Isesaki-shi
Country
Japan
City
Ishikawa
Country
Japan
City
Iwate
Country
Japan
City
Kagawa
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Kyota
Country
Japan
City
Mie
Country
Japan
City
Miyagi
Country
Japan
City
Nagaoka-shi
Country
Japan
City
Nagasaki
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Shimane
Country
Japan
City
Shizuoka
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
City
Yamaguchi
Country
Japan
City
Yokohama-shi
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gangwon-do
Country
Korea, Republic of
City
Gwangju-si
Country
Korea, Republic of
City
Gyeonggi-do
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Pusan
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Xalapa
State/Province
Veracruz
Country
Mexico
City
Aguascalientes
Country
Mexico
City
Chihuahua
Country
Mexico
City
Distrito Federal
Country
Mexico
City
Durango
Country
Mexico
City
Monterrey
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Yucatan
Country
Mexico
City
Almere
Country
Netherlands
City
Amstelveen
Country
Netherlands
City
Amsterdam
Country
Netherlands
City
Dordrecht
Country
Netherlands
City
Eindhoven
Country
Netherlands
City
Ewijk
Country
Netherlands
City
Leiderdorp
Country
Netherlands
City
Maastricht
Country
Netherlands
City
Rotterdam
Country
Netherlands
City
Venlo
Country
Netherlands
City
Wildervlank
Country
Netherlands
City
Lower Hutt
State/Province
Wellington
Country
New Zealand
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
Dunedin
Country
New Zealand
City
Hamilton
Country
New Zealand
City
Nelson
Country
New Zealand
City
Tauranga
Country
New Zealand
City
Bodo
Country
Norway
City
Harstad
Country
Norway
City
Haugesund
Country
Norway
City
Oslo
Country
Norway
City
Rud
Country
Norway
City
Arequipa
Country
Peru
City
Callao
Country
Peru
City
Lima
Country
Peru
City
Cebu City
Country
Philippines
City
Cebu
Country
Philippines
City
Davao City
Country
Philippines
City
Pasig City
Country
Philippines
City
Quezon City
Country
Philippines
City
Ostrow
State/Province
Mazowiecka
Country
Poland
City
Bydgoszcz
Country
Poland
City
Chojnice
Country
Poland
City
Elblag
Country
Poland
City
Elk
Country
Poland
City
Gdansk
Country
Poland
City
Inowroclaw
Country
Poland
City
Jaroslaw
Country
Poland
City
Katowice
Country
Poland
City
Kolobrzeg
Country
Poland
City
Komenskiego
Country
Poland
City
Krakow
Country
Poland
City
Kutno
Country
Poland
City
Libiaz
Country
Poland
City
Lodz
Country
Poland
City
Lubartow
Country
Poland
City
Lublin
Country
Poland
City
Plock
Country
Poland
City
Pomorskie
Country
Poland
City
Pulawy
Country
Poland
City
Ruda Slaska
Country
Poland
City
Rzeszow
Country
Poland
City
Skierniewice
Country
Poland
City
Sopot
Country
Poland
City
Sucharskiego
Country
Poland
City
Szczecin
Country
Poland
City
Tarnow
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Warzawa
Country
Poland
City
Wroclaw
Country
Poland
City
Amadora
Country
Portugal
City
Aveiro
Country
Portugal
City
Braga
Country
Portugal
City
Coimbra
Country
Portugal
City
Leiria
Country
Portugal
City
Lisboa
Country
Portugal
City
Lisbon
Country
Portugal
City
Ponta Delgada
Country
Portugal
City
Setubal
Country
Portugal
City
Viseu
Country
Portugal
City
Bacau
Country
Romania
City
Braila
Country
Romania
City
Brasov
Country
Romania
City
Buccuresti
Country
Romania
City
Bucuresti
Country
Romania
City
Buzau
Country
Romania
City
Covasna
Country
Romania
City
Dambovita
Country
Romania
City
Iasi
Country
Romania
City
Judetul Maramures
Country
Romania
City
Judetul Mures
Country
Romania
City
Judetul Suceava
Country
Romania
City
Judetul Vrancea
Country
Romania
City
Oradea
Country
Romania
City
Timisoara
Country
Romania
City
Barnaul
Country
Russian Federation
City
Chelyabinsk
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Krasnoyarsk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Perm
Country
Russian Federation
City
Ryazan
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Tula
Country
Russian Federation
City
Tyumen
Country
Russian Federation
City
Volgograd
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Niska Banja
Country
Serbia
City
Nis
Country
Serbia
City
Sremska Kamenica
Country
Serbia
City
Zemun
Country
Serbia
City
Zmaj Jovina
Country
Serbia
City
Bardejov
Country
Slovakia
City
Bratislava
Country
Slovakia
City
Dolny Kubin
Country
Slovakia
City
Galanta
Country
Slovakia
City
Kosice
Country
Slovakia
City
Levice
Country
Slovakia
City
Lucenec
Country
Slovakia
City
Nitra
Country
Slovakia
City
Nove Zamky
Country
Slovakia
City
Presov
Country
Slovakia
City
Rimavska Sobota
Country
Slovakia
City
Alberton
Country
South Africa
City
Benoni
Country
South Africa
City
Bloemfontein
Country
South Africa
City
Cape Town
Country
South Africa
City
Diepkloof
Country
South Africa
City
Durban
Country
South Africa
City
Lyttelton
Country
South Africa
City
Parktown West
Country
South Africa
City
Port Elizabeth
Country
South Africa
City
Potchefstroom
Country
South Africa
City
Pretoria
Country
South Africa
City
Somerset West
Country
South Africa
City
Worcester
Country
South Africa
City
Alcoy
Country
Spain
City
Almeria
Country
Spain
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
City
De La Castellana
Country
Spain
City
Donostia-San Sebastian
Country
Spain
City
Figueras
Country
Spain
City
Jaen
Country
Spain
City
La Coruna
Country
Spain
City
Lleida
Country
Spain
City
Madrid
Country
Spain
City
Murcia
Country
Spain
City
Santiago De Compostela
Country
Spain
City
Sevilla
Country
Spain
City
Vigo
Country
Spain
City
Vitoria
Country
Spain
City
Alingsas
Country
Sweden
City
Enkoping
Country
Sweden
City
Goteborg
Country
Sweden
City
Halmstad
Country
Sweden
City
Karlshamn
Country
Sweden
City
Koping
Country
Sweden
City
Lindesberg
Country
Sweden
City
Lulea
Country
Sweden
City
Lund
Country
Sweden
City
Malmo
Country
Sweden
City
Molndal
Country
Sweden
City
Mora
Country
Sweden
City
Orebro
Country
Sweden
City
Skene
Country
Sweden
City
Umea
Country
Sweden
City
Uppsala
Country
Sweden
City
Varberg
Country
Sweden
City
Lausanne
Country
Switzerland
City
Lugano
Country
Switzerland
City
Changhua City
Country
Taiwan
City
Hualien City
Country
Taiwan
City
Kaohsiung City
Country
Taiwan
City
Taichung City
Country
Taiwan
City
Taipei City
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan County
Country
Taiwan
City
Yongkang City
Country
Taiwan
City
Bangkok
Country
Thailand
City
Chang Mai
Country
Thailand
City
Khon Kaen
Country
Thailand
City
Nakhon Ratchasima
Country
Thailand
City
Pathumthani
Country
Thailand
City
Sai Mai
Country
Thailand
City
Songkhla
Country
Thailand
City
Adana
Country
Turkey
City
Ankara
Country
Turkey
City
Antalya
Country
Turkey
City
Aydin
Country
Turkey
City
Erzurum
Country
Turkey
City
Eskisehir
Country
Turkey
City
Isparta
Country
Turkey
City
Istanbul
Country
Turkey
City
Izmir
Country
Turkey
City
Konya
Country
Turkey
City
Sivas
Country
Turkey
City
Cherkasy
Country
Ukraine
City
Chernigiv
Country
Ukraine
City
Dnipropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Ivano-Frankivsh
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kherson
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Lugansk
Country
Ukraine
City
Lutsk
Country
Ukraine
City
Lviv
Country
Ukraine
City
Mykolayiv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Poltava
Country
Ukraine
City
Uzhgorod
Country
Ukraine
City
Vinnytsya
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine
City
Birmingham
Country
United Kingdom
City
Blackpool
Country
United Kingdom
City
Bournemouth
Country
United Kingdom
City
Bradford
Country
United Kingdom
City
Cambridge
Country
United Kingdom
City
Chesterfield
Country
United Kingdom
City
Coventry
Country
United Kingdom
City
Devon
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
East Horsley
Country
United Kingdom
City
East Sussex
Country
United Kingdom
City
Edinburgh
Country
United Kingdom
City
Essex
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Harrow
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Middlesbrough
Country
United Kingdom
City
Orpington
Country
United Kingdom
City
Peterborough
Country
United Kingdom
City
Portadown
Country
United Kingdom
City
Sheffield
Country
United Kingdom
City
Stirling
Country
United Kingdom
City
Stockport
Country
United Kingdom
City
Surrey
Country
United Kingdom
City
Sutton Coldfield
Country
United Kingdom
City
Swindon
Country
United Kingdom
City
Warwickshire
Country
United Kingdom
City
Wolverhampton
Country
United Kingdom
City
York
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
34962979
Citation
Bonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089.
Results Reference
derived
PubMed Identifier
33760027
Citation
Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.
Results Reference
derived
PubMed Identifier
33663737
Citation
Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.
Results Reference
derived
PubMed Identifier
33357217
Citation
Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.
Results Reference
derived
PubMed Identifier
33148013
Citation
Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.
Results Reference
derived
PubMed Identifier
31777160
Citation
Inciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27.
Results Reference
derived
PubMed Identifier
31597460
Citation
Bergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10.
Results Reference
derived
PubMed Identifier
30586727
Citation
Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.
Results Reference
derived
PubMed Identifier
30236308
Citation
Corbalan R, Nicolau JC, Lopez-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.
Results Reference
derived
PubMed Identifier
29967197
Citation
Yin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933.
Results Reference
derived
PubMed Identifier
29748353
Citation
Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998.
Results Reference
derived
PubMed Identifier
28862934
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Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

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