GLORIA-AF Registry Program - Second and Third Phases | NCT01468701 | Trialant
NCT01468701
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Mar 29, 2021Actual
Enrollment
37,235Actual
Phase
Not provided
Conditions
Stroke
Atrial Fibrillation
Interventions
Not provided
Countries
United States
Argentina
Brazil
Canada
Chile
China
Colombia
Ecuador
Hong Kong
Japan
Lebanon
Mexico
Peru
Russia
Saudi Arabia
Singapore
South Africa
South Korea
Taiwan
United Arab Emirates
Venezuela
Protocol Section
Identification Module
NCT ID
NCT01468701
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1160.129
Secondary IDs
Not provided
Brief Title
GLORIA-AF Registry Program - Second and Third Phases
Official Title
GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 7, 2011Actual
Primary Completion Date
Jan 10, 2020Actual
Completion Date
Jan 10, 2020Actual
First Submitted Date
Oct 28, 2011
First Submission Date that Met QC Criteria
Nov 7, 2011
First Posted Date
Nov 9, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2020
Results First Submitted that Met QC Criteria
Mar 3, 2021
Results First Posted Date
Mar 29, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 3, 2021
Last Update Posted Date
Mar 29, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Detailed Description
Not provided
Conditions Module
Conditions
Stroke
Atrial Fibrillation
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
37,235Actual
Arms/Interventions Module
No data available
No data is available for this block.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Age =>18 years at enrollment
Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.
Other inclusion criteria apply.
Exclusion criteria:
Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
AF with a generally reversible cause;
Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply
Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.
Bergler-Klein J, Gotcheva N, Kalejs O, Kalarus Z, Kovacic D, Persic V, Shlyakhto E, Uuetoa T, Huisman MV, Lip GYH, Vinereanu D; GLORIA-AF Investigators. Antithrombotic Usage, Including Three-Year Outcomes With Dabigatran and Vitamin K Antagonists for Atrial Fibrillation, in Eastern Europe: A Descriptive Analysis From Phase 3 of the GLORIA-AF Registry. Am J Ther. 2024 Jan-Feb 01;31(1):e1-e12. doi: 10.1097/MJT.0000000000001655. Epub 2023 Jan 10.
All patients were screened for eligibility prior to participation in the study. Patients attended a participating site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria.
Recruitment Details
GLORIA-AF was an international, multicentre, non-interventional study based on prospectively collected data for patients (pts) with newly diagnosed non-valvular atrial fibrillation (NVAF). In Ph II, pts baseline characteristics (BC), their antithrombotic treatment patterns and outcomes with 2 years of follow-up for dabigatran alone were collected prospectively. Ph III collected prospective data on pts BC, their treatments and outcomes with 3 years of follow-up for all pts in real-world setting.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Nov 9, 2018
Dec 17, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Croatia
Puerto Rico
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke or Systemic Embolism - Phase III
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke - Phase II
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Stroke - Phase III
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Systemic Embolism (SE) - Phase II
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Systemic Embolism (SE) - Phase III
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Life-threatening Bleeding Events - Phase II
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Life-threatening Bleeding Events - Phase III
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Myocardial Infarction (MI) - Phase II
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Myocardial Infarction (MI) - Phase III
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of All-cause Death - Phase II
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of All-cause Death - Phase III
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Death - Phase II
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Death - Phase III
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Northport
Alabama
35476
United States
Scottsboro Quick Care Clinic
Scottsboro
Alabama
35768
United States
Alaska Heart Institute
Anchorage
Alaska
99508
United States
Phoenix Heart PLLC
Glendale
Arizona
85306
United States
Mercy Cinic Hot Springs Communities
Hot Springs
Arizona
71913
United States
Midwest Internal Medicine, PLLC
Lake Havasu City
Arizona
86403
United States
Sparks Regional Medical Center
Fort Smith
Arkansas
72901
United States
Dr. Michael A. Frais, Cardiologist, P.A.
Hot Springs
Arkansas
71913
United States
Cardiology and Medicine Clinic
Little Rock
Arkansas
72204
United States
Donald W. Reynolds Institute on Aging
Little Rock
Arkansas
72205-7199
United States
Arkansas Cardiology, PA
Little Rock
Arkansas
72205
United States
Diagnamics, Inc
Encinitas
California
92024
United States
Allianz Medical and Research Center
Fountain Valley
California
92708
United States
B&K Medical Research Center
Fresno
California
93721
United States
American Clinical Trials
Hawaiian Gardens
California
90716
United States
Scripps Clinic
La Jolla
California
92037
United States
La Mesa Cardiac Center
La Mesa
California
91942
United States
Los Alamitos Cardiovascular
Los Alamitos
California
90720
United States
VA Greater Los Angeles Healthcare System
Los Angeles
California
90073
United States
Mehrdad Kevin Ariani, MD, Incorporated
Northridge
California
91325
United States
VA Palo Alto Health Care System
Palo Alto
California
94304
United States
Eisenhower Desert Cardiology Center
Rancho Mirage
California
92270
United States
Ritchken and First MD's
San Diego
California
92117
United States
Coastal Heart Group Inc
Santa Ana
California
92704
United States
Pacific Heart and Vascular
Stockton
California
95210
United States
Southwest Heart Institute
Temecula
California
92591
United States
University of California Los Angeles
Torrance
California
90509
United States
Cardiology Associates Medical Group Inc
Ventura
California
93003
United States
Ventura Cardiology Consultants Medical Group, Inc
Ventura
California
93003
United States
Ventura Clinical Trials
Ventura
California
93003
United States
Office of Dr. David J Cislowski MD
Visalia
California
93291
United States
Aurora Denver Cardiology Associates, PC
Aurora
Colorado
80012
United States
Lynn Institute of the Rockies
Colorado Springs
Colorado
80909
United States
Pikes Peak Cardiology
Colorado Springs
Colorado
80909
United States
Denver Health Medical Center
Denver
Colorado
80204
United States
South Denver Cardiology Associates, PC
Littleton
Colorado
80120
United States
Connecticut Clinical Research, LLC
Bridgeport
Connecticut
06606
United States
Connecticut Heart and Vascular Center
Bridgeport
Connecticut
06606
United States
Bridgeport Hospital
Bridgeport
Connecticut
06610
United States
Cardiology Associates of Fairfield County
Norwalk
Connecticut
06851
United States
Norwalk Medical Group
Norwalk
Connecticut
06851
United States
Heart Specialists, PC of Southern CT
Shelton
Connecticut
06484
United States
Red Clay Research LLC.
Newark
Delaware
19713
United States
Howard University Hospital
Washington D.C.
District of Columbia
20006
United States
Cardiac Arrhythmia Center
Washington D.C.
District of Columbia
20010
United States
Medical Faculty Associates, Inc
Washington D.C.
District of Columbia
20037
United States
Aventura Institute for Cardiovascular Wellness, PA
Aventura
Florida
33180
United States
Bay Area Cardiology
Brandon
Florida
33511
United States
Tampa Bay Medical Research
Clearwater
Florida
33761
United States
Seidman Clinical Trials
Delray Beach
Florida
33484
United States
Universal Clinical Research Associates
Doral
Florida
33166
United States
Cardiovascular Research of North Florida LLC
Gainesville
Florida
32605
United States
Magi Research Clinic, Inc
Hialeah
Florida
33013
United States
Global Research Solutions Corporation
Hollywood
Florida
33021
United States
St. Vincent's Ambulatory Care
Jacksonville
Florida
32216
United States
Tenet Florida Physician Services
Jupiter
Florida
33458
United States
Watson Clinic Center for Research, Inc
Lakeland
Florida
33805
United States
A&L Clinical Research
Miami
Florida
33126
United States
Miami Center for Cardiovascular Disease
Miami
Florida
33136
United States
Global Research Solutions Corporation
Miami
Florida
33144
United States
Cardiovascular Research Center of South Florida
Miami
Florida
33173
United States
New Horizon Research Center
Miami
Florida
33175
United States
Sacred Heart Medical Specialty Group
Miramar Beach
Florida
32550
United States
Collier HMA Physician Management
Naples
Florida
34119
United States
Edgewater Medical Research
New Smyrna Beach
Florida
32169
United States
SouthEast Medical Centre
Oakland Park
Florida
33309
United States
Research One
Orlando
Florida
32806
United States
South Florida Research Solutions, LLC
Pembroke Pines
Florida
33028
United States
Langhorne Cardiology Consultants, Inc
Pensacola
Florida
32501
United States
VNH Heart Center Research
Port Charlotte
Florida
33952
United States
Brevard Cardiovascular Research Associates, Inc
Rockledge
Florida
32955
United States
Velella Research, Inc
Sarasota
Florida
34233
United States
Cardiovascular Center of Sarasota
Sarasota
Florida
34239
United States
James C. Neiman, MD
Seminole
Florida
33772
United States
Suncoast Cardiovascular Research Inc.
St. Petersburg
Florida
33701
United States
Northside Hospital
St. Petersburg
Florida
33709
United States
Alternative Solutions Medical Research and Prevention Center
St. Petersburg
Florida
33711
United States
Tallahassee Research Instutite
Tallahassee
Florida
32308
United States
University of South Florida
Tampa
Florida
33606
United States
Indian River Medical Associates Cardiology
Vero Beach
Florida
32960
United States
Cardiology Partners Clinical Research Institute
Wellington
Florida
33449
United States
Executive Health and Research Associates
Atlanta
Georgia
30342
United States
Saint Joseph's Research Institute
Atlanta
Georgia
30342
United States
Atlanta Heart Specialists, LLC
Cumming
Georgia
30041
United States
William C McGarity, Jr, MD, PC
Decatur
Georgia
30035
United States
Coliseum Medical Center
Macon
Georgia
31217
United States
Kootenai Heart Clinics, LLC
Coeur d'Alene
Idaho
83814
United States
Northwest Heart Clinical Research, LLC
Arlington Heights
Illinois
60005
United States
Prairie Cardiovascular Memorial Hospital
Carbondale
Illinois
62901
United States
Captain James A. Lovell Federal Health Care Center
Chicago
Illinois
60064
United States
Medex Healthcare Research
Chicago
Illinois
60602
United States
John H. Stroger Jr. Hospital of Cook Country
Chicago
Illinois
60612
United States
University of Illinois at Chicago
Chicago
Illinois
60612
United States
North Shore Cardiology Consultants
Chicago
Illinois
60631
United States
University of Chicago
Chicago
Illinois
60637
United States
Northwestern University
Evanston
Illinois
60208
United States
Advanced Heart Care, LLC, Medicoricum, LLC
Fairview Heights
Illinois
62208
United States
Adventist Health Partners, Inc
Hinsdale
Illinois
60521
United States
Consultants in Cardiovascular Medicine
Melrose Park
Illinois
60160
United States
Koch Family Medicine
Morton
Illinois
61550
United States
Advanced Cardiovascular Consultants
Rock Island
Illinois
61201
United States
DuPage Medical Group
Winfield
Illinois
60190
United States
Hendricks Family Medicine
Brownsburg
Indiana
46112
United States
Parkview Research Center
Fort Wayne
Indiana
46845
United States
St. Vincent Medical Group
Indianapolis
Indiana
46260
United States
Beacon Medical Group Clinical Research
La Porte
Indiana
46350
United States
Cardiology Associates of Northwest Indiana, PC
Munster
Indiana
46321
United States
Beacon Medical Group Clinical Research
South Bend
Indiana
46601
United States
McFarland Clinic PC
Ames
Iowa
50010
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
Northeast Iowa Medical Education Foundation
Waterloo
Iowa
50702
United States
The Iowa Clinic, PC
West Des Moines
Iowa
50266
United States
Midwest Heart and Vascular Specialists
Overland Park
Kansas
66211
United States
Central Cardiology Associates
Elizabethtown
Kentucky
42701
United States
Robley Rex VA Medical Center
Louisville
Kentucky
40206
United States
Baptist Health Clinical Studies
Madisonville
Kentucky
42431
United States
Office of Dr. Paul McLaughlin, M.D.
Mount Sterling
Kentucky
40353
United States
Research Integrity, LLC
Owensboro
Kentucky
42303
United States
Cambridge Medical Trials
Alexandria
Louisiana
71301
United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge
Louisiana
70808
United States
Grace Research, LLC
Bossier City
Louisiana
71111
United States
Heart Clinic of Hammond
Hammond
Louisiana
70403
United States
Cardiovascular Specialists of Southwest Louisiana, LLC
Lake Charles
Louisiana
70601
United States
Medpharmics, LLC
Metairie
Louisiana
70006
United States
LSU Health Sciences Center
New Orleans
Louisiana
70112
United States
Advanced Cardiovascular Specialists
Shreveport
Louisiana
71103
United States
Louisiana Heart Center
Slidell
Louisiana
70458
United States
Southern Maine Health Care
Biddeford
Maine
04005
United States
Cardiac Consultants, LLC
Annapolis
Maryland
21401
United States
MedStar Health Research Institute
Baltimore
Maryland
21218
United States
MedStar Southern Maryland Hospital Center
Clinton
Maryland
20735
United States
Cardiovascular Specialists of Central Maryland
Columbia
Maryland
21044
United States
Delmarva Heart Research Foundation, Inc
Salisbury
Maryland
21804
United States
Peninsula Cardiology Associates
Salisbury
Maryland
21804
United States
Chesapeake Cardiovascular Associates
Towson
Maryland
21204
United States
Primary Care Cardiology Research, Inc
Ayer
Massachusetts
01432
United States
Genesys Research Institute, Incorporated
Brighton
Massachusetts
02135
United States
NECCR Internal Med and Cardio
Fall River
Massachusetts
02720
United States
Newton-Wellesley Hospital
Newton
Massachusetts
02462
United States
Endeavor Medical Research
Alpena
Michigan
49707
United States
McLaren Bay Region Medical Center
Bay City
Michigan
48708
United States
Henry Ford Hospital K-15
Detroit
Michigan
48202
United States
St. Vincent Consultants in Cardiovascular Disease, LLC
Erie
Michigan
16502
United States
Cardiology Consultants of East Michigan
Flint
Michigan
48532
United States
Genesys Heart Institute
Grand Blanc
Michigan
48439
United States
Regional Cardiology Associates
Grand Blanc
Michigan
48439
United States
Thoracic and Cardiovascular Healthcare Foundation
Lansing
Michigan
48910
United States
Upper Michigan Cardiovascular Associates, PC
Marquette
Michigan
49855
United States
McLaren-Macomb
Mount Clemens
Michigan
48043
United States
South Western Medical Clinic
Niles
Michigan
49120
United States
Providence Park Hospital
Novi
Michigan
48374
United States
Covenant Medical Center, Inc.
Saginaw
Michigan
48602
United States
MId-MIchigan Heart and Vascular Center
Saginaw
Michigan
48604
United States
Essentia Heart and Vascular Clinic
Duluth
Minnesota
55805
United States
Minneapolis Heart Institute Foundation
Minneapolis
Minnesota
55407
United States
CentraCare Heart and Vascular Center
Saint Cloud
Minnesota
56303
United States
United Heart and Vascular Clinic
Saint Paul
Minnesota
55102
United States
The Center for Clinical Trials, Inc.
Biloxi
Mississippi
39531
United States
University Of Mississippi Medical Center
Jackson
Mississippi
39216
United States
Health Midwest Ventures Group, Inc
Kansas City
Missouri
64132
United States
Heartland Regional Medical Center
Saint Joseph
Missouri
64506
United States
Saint Louis University
St Louis
Missouri
63110
United States
Consult and Research Associates
St Louis
Missouri
63122
United States
Gateway Cardiology, PC
St Louis
Missouri
63128
United States
Kalispell Regional Medical Center
Kalispell
Montana
59901
United States
MidAmerica Cardiovascular Institute
Omaha
Nebraska
68131
United States
Meridian Clinical Research, LLC
Omaha
Nebraska
68134
United States
Board of Regents of the University of Nebraska
Omaha
Nebraska
68198-7835
United States
Alegent Health Heart and Vascular Specialists
Papillion
Nebraska
68046
United States
Renown Institute for Heart and Vascular Health
Reno
Nevada
89502
United States
VA Sierra Nevada Health Care System
Reno
Nevada
89502
United States
Medicor Cardiology
Bridgewater
New Jersey
08807
United States
Cooper University Hospital
Camden
New Jersey
08014
United States
Monmouth Cardiology Associates
Eatontown
New Jersey
07724
United States
Electrophysiology Associates of Northern New Jersey
Hackensack
New Jersey
07601
United States
Advocare Heights Primary Care
Haddon Heights
New Jersey
08035
United States
Associated Cardiovascular Consultants Lourdes
Hammonton
New Jersey
08037
United States
NJ Heart LLC
Linden
New Jersey
07036
United States
Garden State Heart Care, PC
Manalapan
New Jersey
07726
United States
Atlantic Cardiology, LLC
Neptune City
New Jersey
07753
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick
New Jersey
08901
United States
Saint Joseph's Regional Medical Center
Paterson
New Jersey
07503
United States
The Valley Hospital
Ridgewood
New Jersey
07450
United States
Heart and Vascular Center of New Brunswick
Somerset
New Jersey
08873
United States
Central New Jersey Cardiology
South Plainfield
New Jersey
07080
United States
Associated Cardiovascular Consultants Lourdes
Voorhees Township
New Jersey
08043
United States
NJ Cardiology Associates
West Orange
New Jersey
07052
United States
Lovelace Scientific Resources, Inc.
Albuquerque
New Mexico
87108
United States
Albany Medical Center / Albany Medical College
Albany
New York
12208
United States
New York -Presbyterian Brooklyn Methodist Hospital
Brooklyn
New York
11215
United States
Community Cardiology
Camillus
New York
13031
United States
Bassett Medical Center
Cooperstown
New York
13326
United States
New York Hospital Queens
Flushing
New York
11355
United States
UHS Office of Clinical Trials
Johnson City
New York
13790
United States
Long Island Heart Associates
Mineola
New York
11501
United States
Chinatown Cardiology, PC
New York
New York
10013
United States
Lenox Hill Hospital
New York
New York
10021
United States
Saint Luke - Roosevelt Hospital Center
New York
New York
10025
United States
Saratoga Clinical Research, LLC
Saratoga Springs
New York
12866
United States
Stony Brook Cardiology/Electrophysiology
Stony Brook
New York
11794-8167
United States
SUNY Upstate Medical University
Syracuse
New York
13202
United States
New York Heart Center
Syracuse
New York
13210
United States
Cardiac Care and Vascular Medicine, PLLC
The Bronx
New York
10469
United States
Great Lakes Medical Research
Westfield
New York
14787
United States
Cardiology Group of Western New York, PC
Williamsville
New York
14221
United States
Kernodle Clinic West
Burlington
North Carolina
27215
United States
Clinical Trials of America, Inc
Hickory
North Carolina
28601
United States
Carolina Cardiology Cornerstone
High Point
North Carolina
27262
United States
Profen Research Network at East Carolina Medical Associates
Jacksonville
North Carolina
28546
United States
Kannapolis Internal Medicine
Kannapolis
North Carolina
28083
United States
Clinical Trials of America, Inc
Lenoir
North Carolina
28645
United States
Pinehurst Medical Clinic, Inc
Pinehurst
North Carolina
28374
United States
Wake Heart Research
Raleigh
North Carolina
27610
United States
Wake Heart and Vascular Associates
Wilson
North Carolina
27893
United States
Lillestol Research, LLC
Fargo
North Dakota
58103
United States
Trinity Health Center Medical Arts
Minot
North Dakota
58701
United States
Aultman Hospital
Canton
Ohio
44710
United States
University of Cincinnati
Cincinnati
Ohio
45267
United States
The MetroHealth System
Cleveland
Ohio
44109-1998
United States
Mercy Health Fairfield Hospital
Fairfield
Ohio
45014
United States
Cleveland Cardiovascular Research Foundation
Fairview Park
Ohio
44126
United States
Emil Hayek, M.D., Inc
Hudson
Ohio
44236
United States
Innovation Center, Kettering Medical Center
Kettering
Ohio
45429
United States
RAS Health Ltd
Marion
Ohio
43302
United States
Frederick C Smith Clinic Inc
Marion
Ohio
43342
United States
Mound Family Practice
Miamisburg
Ohio
45342
United States
Heart House Research Foundation, LLC
Springfield
Ohio
45504
United States
Cardiovascular Research Center
Toledo
Ohio
43608
United States
Toledo Clinic Incorporated
Toledo
Ohio
43623
United States
Great Lakes Medical Research, LLC
Willoughby
Ohio
44094
United States
Ohio Heart Institute
Youngstown
Ohio
44504
United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City
Oklahoma
73120
United States
INTEGRIS Ambulatory Care Corporation
Yukon
Oklahoma
73099
United States
Good Samaritan Hospital Corvallis
Corvallis
Oregon
97330
United States
Fanno Creek Clinic, LLC
Portland
Oregon
97219
United States
Sacred Heart Medical Center at RiverBend
Springfield
Oregon
97477
United States
Abington Medical Specialists
Abington
Pennsylvania
19003
United States
Capital Area Research, LLC
Camp Hill
Pennsylvania
17011
United States
Preferred Primary Care Phys
Carnegie
Pennsylvania
15106
United States
Chambersburg Hospital
Chambersburg
Pennsylvania
17201
United States
Central Bucks Cardiology
Doylestown
Pennsylvania
18901
United States
Physician Specialist of Northern Lancaster County Medcl Grp
Ephrata
Pennsylvania
17522
United States
Harleysville Medical Associates
Harleysville
Pennsylvania
19438
United States
Lycoming Internal Medicine, Inc
Jersey Shore
Pennsylvania
17740
United States
Cardiology Consultants of Philadelphia
Lansdale
Pennsylvania
19446-3748
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104-6205
United States
Pennsylvania Cardiology Associates
Philadelphia
Pennsylvania
19106
United States
Einstein Medical Center Philadelphia
Philadelphia
Pennsylvania
19141
United States
Allegheny Neurology Associates
Pittsburgh
Pennsylvania
15212
United States
Grand View - Lehigh Valley Health Services
Sellersville
Pennsylvania
18960
United States
Warminster Medical Associates, PC
Warminster
Pennsylvania
18974
United States
Cardiology Consultants of Philadelphia
Yardley
Pennsylvania
19067
United States
Memorial Hospital of RI
Pawtucket
Rhode Island
02860
United States
South County Cardiology
Wakefield
Rhode Island
02879
United States
AnMed Health Clinical Research
Anderson
South Carolina
29621
United States
Internal Medicine Associates of Anderson, PA
Anderson
South Carolina
29621
United States
Lowcountry Medical Group, LLC
Beaufort
South Carolina
29906
United States
South Carolina Heart Center
Columbia
South Carolina
29204
United States
Piedmont Cardiology Associates, P.A.
Greenwood
South Carolina
29646
United States
Family Medicine of SayeBrook
Myrtle Beach
South Carolina
29588
United States
Black Hills Cardiovascular Research
Rapid City
South Dakota
57701
United States
Office of Yvonne Chester
Chattanooga
Tennessee
37404
United States
The Jackson Clinic, PA
Jackson
Tennessee
38301
United States
Center For Cardiovascular Research
Johnson City
Tennessee
37604
United States
PMG Research of Knoxville
Knoxville
Tennessee
37912
United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville
Tennessee
37934
United States
PMG Research of Knoxville
Knoxville
Tennessee
37938
United States
THV Research, LLC
Austin
Texas
78745
United States
Southeast Texas Clinical Research Center
Beaumont
Texas
77702
United States
Dallas VA Medical Center
Dallas
Texas
75216
United States
Heartplace
Dallas
Texas
75226
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390-8837
United States
Amir Malik Research
Fort Worth
Texas
76104
United States
State of the Heart Cardiology
Grapevine
Texas
76051
United States
Angiocardiac Care of Texas
Houston
Texas
77025
United States
Houston Methodist DeBakey Cardiology Associates
Houston
Texas
77030
United States
Barry Troyan, M.D, PA
Houston
Texas
77043
United States
Centex Studies, Inc.
Houston
Texas
77062
United States
Dairy Ashford Family Pratice
Houston
Texas
77077
United States
Cardiovascular Associates PLLC
Humble
Texas
77338
United States
Cardiology Center of Houston, PA
Katy
Texas
77450
United States
Texas Cardiology Research Center PLLC
Kingwood
Texas
77339
United States
Caprock Cardiac Center Research Institute
Lubbock
Texas
79410
United States
Mission Research Institute, LLC
New Braunfels
Texas
78130
United States
Mercury Medical ,LLC
San Antonio
Texas
78229
United States
Texas Medical Research Associates
San Antonio
Texas
78238
United States
Sealy Urgent Care Center and Medical Clinic
Sealy
Texas
77474
United States
Seguin Institute of Cardiovascular Research
Seguin
Texas
78155
United States
Sugarland Cardiology
Sugar Land
Texas
77479
United States
Cardiovascular Associates of East Texas, PA
Tyler
Texas
75701
United States
Trinity Clinic
Tyler
Texas
75702
United States
University of Texas Health Science Center at Tyler
Tyler
Texas
75708
United States
Providence Health Services of Waco
Waco
Texas
76712
United States
Hill County Primary Care
Whitney
Texas
76692
United States
Heart Center at Saint Mark's
Salt Lake City
Utah
84124
United States
Highland Clinical Research
Salt Lake City
Utah
84124
United States
Burke Internal Medicine and Research
Burke
Virginia
22015
United States
University of Virginia Health System
Charlottesville
Virginia
22908
United States
Cardiovascular Associates, Ltd
Chesapeake
Virginia
23320
United States
Cardiology Consultants of Danville, Inc
Danville
Virginia
24541
United States
Inova Research Center
Falls Church
Virginia
22042
United States
Virginia Heart
Falls Church
Virginia
22042
United States
Mary Washington Hospital Research Department
Fredericksburg
Virginia
22401
United States
Harrisonburg Medical Associates
Harrisonburg
Virginia
22801
United States
Manassas Clinical Research Center
Manassas
Virginia
20110
United States
Cardiovascular Associates of Virginia
Midlothian
Virginia
23114
United States
CJW Medical Center - Chippenham
Richmond
Virginia
23225
United States
Carilion Clinic
Roanoke
Virginia
24014
United States
Salem VA Medical Center
Salem
Virginia
24153
United States
Selma Medical Associates, Winchester
Winchester
Virginia
22601
United States
Sound Medical Research
Port Orchard
Washington
98366
United States
The Polyclinic
Seattle
Washington
98133
United States
Franciscan Heart and Vascular Associates
Tacoma
Washington
98405
United States
Cardiac and Thoracic Institute of Central Washington
Yakima
Washington
98902
United States
CAMC Clinical Trials Center
Charleston
West Virginia
25304
United States
University Cardiovascular Services
Huntington
West Virginia
25701
United States
St. Mary's Medical Center
Huntington
West Virginia
25702
United States
Mayo Clinic-Sparta
La Crosse
Wisconsin
54601
United States
Karim Bakhtiar MD, SC
Milwaukee
Wisconsin
53215
United States
Family Medical Clinic
Milwaukee
Wisconsin
53216
United States
Wheaton Franciscan
Milwaukee
Wisconsin
53221
United States
Milwaukee VA Medical Center
Milwaukee
Wisconsin
53295
United States
ProHealth Care Research Institute and Cardiology Associates
Waukesha
Wisconsin
53188
United States
Consultorios Hematologicos SRL
Buenos Aires
1188
Argentina
Clinica Coronel Suárez
Buenos Aires
B7540GHD
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires
C1181ACH
Argentina
Instituto Cardiovascular de Buenos Aires
Buenos Aires
C1428
Argentina
Instituto Cardiovascular de Corrientes Juana Francisca Cabra
Corrientes
C3400
Argentina
Hospital Espanol de Mendonza
Godoy Cruz
5501
Argentina
Hospital Privado de Comunidad
Mar del Plata
7602
Argentina
DIM Clinica Privada
Ramos MejÃa
B1704ETD
Argentina
Hospital Privado de Rosario
Rosario
S2000GAP
Argentina
Consultorio del Dr. Aiub
San Isidro
1642
Argentina
Sanatorio San Lucas
San Isidro
B1642DJG
Argentina
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán
4000
Argentina
Centro Privado de CardiologÃa
San Miguel de Tucumán
T4000NIL
Argentina
Unidad Coronaria San Geronimo S.R.L.
Santa Fe
3000
Argentina
Clinical Juncal
Temperley
1834
Argentina
CEMEDIC - Centro de Especialidades Medicas
Villa Luro
1407
Argentina
Hospital Vera Cruz
Belo Horizonte
30140-092
Brazil
Clinica Procardio Ltda
Blumenau
89010-500
Brazil
Hospital do Coracao do Brasil
BrasÃlia
70390-903
Brazil
Instituto de Cardiologia do Distrito Federal
BrasÃlia
70658-700
Brazil
Hospital Angelina Caron
Campina Grande do Sul
83430-000
Brazil
Centro Especializado em Cardiol Loema Instituto de Pesq Clin
Campinas
13010-001
Brazil
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas
13060-904
Brazil
Hospital Nossa Senhora de Pompeia
Caxias do Sul
95084-900
Brazil
Irmandade da Santa Casa de Misericordia de Curitiba
Curitiba
80010-030
Brazil
Barroso e Sebba Ltda
Goiânia
74223-130
Brazil
CLINICOR-Clinica de Exames Cardiolog e Ecografias S S LTDA
Maceió
57051-500
Brazil
Hospital São Vicente de Paulo
Passo Fundo
99010-080
Brazil
Hospital de ClÃnicas de Porto Alegre
Porto Alegre
90035-903
Brazil
Fundacao Universitaria de Cardiologia - Inst de Cardiologia
Porto Alegre
90620-001
Brazil
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares
Recife
50100-130
Brazil
Hospital Copa D'or
Rio de Janeiro
22031-011
Brazil
Fundacao Pro-Coracao FUNDACOR
Rio de Janeiro
22240-004
Brazil
Instituto Cardiopulmonar da Bahia LTDA
Salvador
40170-130
Brazil
Fundacao Bahiana de Cardiologia
Salvador
41810-010
Brazil
Instituto de Ensino E Pesquisa Do Hospital Da Bahia
Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.
Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.
Liu X, Feng G, Marler SV, Huisman MV, Lip GYH, Ma C. Real world time trends in antithrombotic treatment for newly diagnosed atrial fibrillation in China: reports from the GLORIA-AF Phase III registry : Trends in antithrombotic therapy use in China. Thromb J. 2023 Aug 1;21(1):83. doi: 10.1186/s12959-023-00527-x.
Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.
Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.
Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.
Lopez-Sendon JL, Alonso-Rodriguez D, Baron-Esquivias G, Cosin-Sales J, Marin F, Galera-Llorca J, Jimenez N, Marler S, Huisman MV, Lip GYH; Spanish GLORIA-AF investigators. Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program. Med Clin (Barc). 2022 Aug 26;159(4):177-182. doi: 10.1016/j.medcli.2021.09.016. Epub 2021 Dec 8. English, Spanish.
Mazurek M, Halperin JL, Huisman MV, Diener HC, Dubner SJ, Ma CS, Rothman KJ, Healey JS, Teutsch C, Paquette M, Franca LR, Lu S, Bartels DB, Lip GYH. Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme. Europace. 2020 Jan 1;22(1):47-57. doi: 10.1093/europace/euz278.
Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.
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FG001
Vitamin K Antagonist (VKA) - Baseline (Phase II)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG002
Rivaroxaban - Baseline (Phase II)
Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG003
Apixaban - Baseline (Phase II)
Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG004
Acetylsalicylic Acid (ASA) - Baseline (Phase II)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG005
Antiplts Other Than ASA - Baseline (Phase II)
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG006
No Treatment - Baseline (Phase II)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG007
Combinations With Oral Anticoagulants - Baseline (Phase II)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG008
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG009
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG010
Rivaroxaban - Baseline (Phase III)
Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG011
Apixaban - Baseline (Phase III)
Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG012
Edoxaban - Baseline (Phase III)
Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG013
Acetylsalicylic Acid (ASA) - Baseline (Phase III)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG014
Antiplts Other Than ASA - Baseline (Phase III)
Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG015
No Treatment - Baseline (Phase III)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG016
Combinations With Oral Anticoagulants - Baseline (Phase III)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
FG0004964 subjects
FG0015103 subjects
FG0021784 subjects
FG003715 subjects
FG0041736 subjects
FG005128 subjects
FG0061209 subjects
FG0075 subjects
FG0083879 subjects
FG0094962 subjects
FG0104054 subjects
FG0114538 subjects
FG012333 subjects
FG0132182 subjects
FG014214 subjects
FG0151418 subjects
FG01611 subjects
All Eligible Patient
FG0004873 subjects
FG0014963 subjects
FG0021755 subjects
FG003703 subjects
FG0041714 subjects
FG005126 subjects
FG0061170 subjects
FG0074 subjects
FG0083839 subjects
FG0094836 subjects
FG0104015 subjects
FG0114505 subjects
FG012332 subjects
FG0132163 subjects
FG014213 subjects
FG0151386 subjects
FG01611 subjects
COMPLETED
FG0003965 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083219 subjects
FG0093780 subjects
FG0103256 subjects
FG0113672 subjects
FG012284 subjects
FG0131712 subjects
FG014151 subjects
FG0151056 subjects
FG01610 subjects
NOT COMPLETED
FG000999 subjects
FG0015103 subjects
FG0021784 subjects
FG003715 subjects
FG0041736 subjects
FG005128 subjects
FG0061209 subjects
FG0075 subjects
FG008660 subjects
FG0091182 subjects
FG010798 subjects
FG011866 subjects
FG01249 subjects
FG013470 subjects
FG01463 subjects
FG015362 subjects
FG0161 subjects
Type
Comment
Reasons
Not eligible
FG00091 subjects
FG001140 subjects
FG00229 subjects
FG00312 subjects
FG00422 subjects
FG0052 subjects
FG00639 subjects
FG0071 subjects
FG00840 subjects
FG009126 subjects
FG01039 subjects
FG01133 subjects
FG0121 subjects
FG01319 subjects
FG0141 subjects
FG01532 subjects
FG0160 subjects
Lost to Follow-up
FG000306 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG000165 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reasons than listed
FG000437 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No end of study case report form
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not being followed up
FG0000 subjects
FG0014963 subjects
FG0021755 subjects
FG003703 subjects
FG004
All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG001
Vitamin K Antagonist (VKA) - Baseline (Phase II)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG002
Rivaroxaban - Baseline (Phase II)
Patients who were prescribed Rivaroxaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG003
Apixaban - Baseline (Phase II)
Patients who were prescribed Apixaban at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG004
Acetylsalicylic Acid (ASA) - Baseline (Phase II)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG005
Antiplts Other Than ASA - Baseline (Phase II)
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG006
No Treatment - Baseline (Phase II)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG007
Combinations With Oral Anticoagulants - Baseline (Phase II)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase II were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG008
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG009
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG010
Rivaroxaban - Baseline (Phase III)
Patients who were prescribed Rivaroxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG011
Apixaban - Baseline (Phase III)
Patients who were prescribed Apixaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG012
Edoxaban - Baseline (Phase III)
Patients who were prescribed Edoxaban at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG013
Acetylsalicylic Acid (ASA) - Baseline (Phase III)
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG014
Antiplts Other Than ASA - Baseline (Phase III)
Patients who were prescribed Antiplatelets other than ASA at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may be used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG015
No Treatment - Baseline (Phase III)
Patients who were not prescribed any antithrombotic treatments at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG016
Combinations With Oral Anticoagulants - Baseline (Phase III)
Patients who were prescribed combinations with oral anticoagulants treatments at baseline of Phase III were included in this group. Patients in this group were not included in the safety analysis as no specific treatment can be defined.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004873
BG0014963
BG0021755
BG003703
BG0041714
BG005126
BG0061170
BG0074
BG0083839
BG0094836
BG0104015
BG0114505
BG012332
BG0132163
BG014213
BG0151386
BG01611
BG01736608
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00070.2± 10.4
BG00171.4± 10.6
BG00271.5± 10.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002162
BG0012304
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00020
BG00114
BG002
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
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0002.06(1.74 to 2.42)
Primary
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Primary
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Stroke or Systemic Embolism - Phase III
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Stroke - Phase II
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Stroke - Phase III
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Systemic Embolism (SE) - Phase II
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Systemic Embolism (SE) - Phase III
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Life-threatening Bleeding Events - Phase II
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Life-threatening Bleeding Events - Phase III
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Myocardial Infarction (MI) - Phase II
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Myocardial Infarction (MI) - Phase III
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of All-cause Death - Phase II
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Primary
Incidence Rate of All-cause Death - Phase III
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Primary
Incidence Rate of Vascular Death - Phase II
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
All eligible patients who were prescribed DE at baseline in phase II excluding prescribed but not taken. All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Primary
Incidence Rate of Vascular Death - Phase III
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Restricted patient set: was defined only for eligible dabigatran and vitamin K antagonist patients (pts) of phase III who were within region of propensity score (PS) overlap excluding pts in non-overlapping tails of PS distribution, using cut-offs at 1.5th percentile of the PS distribution for dab-exposed group, and 98.5th percentile of distribution for VKA-exposed group. Excluding these pts from the tails of PS distribution reduces channeling bias and improves the validity of comparisons.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
ID
Title
Description
OG000
Dabigatran Etexilate - Baseline (Phase III)
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Time Frame
Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.
Description
Enrolled+treated: Patients(pts) entered electronic data system who signed informed consent+treated at least once with study treatments(trt). Only trt-related AEs collected +reported according to protocol-specified requirements. PhII: only AEs for pts who presribed DE at baseline collected+reported. PhIII:"Combinations of oral anticoagulants at baseline" excluded as no specific trt could be defined for AEs that occurred on trt interval on which they were on combination of oral anticoagulants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dabigatran Etexilate - Baseline (Phase II)
Patients who were prescribed Dabigatran etexilate at baseline of Phase II were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
184
4,943
985
4,943
0
4,943
EG001
Dabigatran Etexilate - at Least Once During Phase III of the Study
All patients who received at least once dabigatran etexilate during phase III of the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
199
4,477
118
4,477
0
4,477
EG002
Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study
All patients who received at least once Vitamin K Antagonist (VKA) during phase III of the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
465
5,894
296
5,894
0
5,894
EG003
Rivaroxaban - at Least Once During Phase III of the Study
All patients who received at least once Rivaroxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
292
5,177
185
5,177
0
5,177
EG004
Apixaban - at Least Once During Phase III of the Study
All patients who received at least once Apixaban during phase III of the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
392
6,024
217
6,024
0
6,024
EG005
Edoxaban - at Least Once During Phase III of the Study
All patients who received at least once Edoxaban during phase III of the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
23
686
16
686
0
686
EG006
Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study
All patients who received at least once Acetylsalicylic acid (ASA) during phase III of the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
469
6,263
225
6,263
0
6,263
EG007
Antiplts Other Than ASA - at Least Once During Phase III of the Study
All patients who received at least once Antiplts other than ASA during phase III of the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group.
Patients can take any Antithrombotic treatments during phase III of the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gastrointestinal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0008 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sarcomatoid carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ataxia
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Basal ganglia haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Brain injury
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Brain stem haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Carotid artery stenosis
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Cerebellar infarction
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Cerebellar stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cerebral haematoma
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0011 affected4,477 at risk
EG00210 affected5,894 at risk
EG003
Cerebral infarction
Nervous system disorders
22.1
Systematic Assessment
EG0007 affected4,943 at risk
EG0011 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Cerebrovascular accident
Nervous system disorders
22.1
Systematic Assessment
EG00020 affected4,943 at risk
EG0010 affected4,477 at risk
EG0029 affected5,894 at risk
EG003
Dizziness
Nervous system disorders
22.1
Systematic Assessment
EG0007 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Embolic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0011 affected4,477 at risk
EG00210 affected5,894 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0012 affected4,477 at risk
EG0027 affected5,894 at risk
EG003
Haemorrhagic transformation stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Headache
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Intracranial haematoma
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Intraventricular haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ischaemic stroke
Nervous system disorders
22.1
Systematic Assessment
EG00019 affected4,943 at risk
EG0017 affected4,477 at risk
EG0029 affected5,894 at risk
EG003
Lethargy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Presyncope
Nervous system disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0011 affected4,477 at risk
EG0023 affected5,894 at risk
EG003
Syncope
Nervous system disorders
22.1
Systematic Assessment
EG00018 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Transient ischaemic attack
Nervous system disorders
22.1
Systematic Assessment
EG00015 affected4,943 at risk
EG0015 affected4,477 at risk
EG00213 affected5,894 at risk
EG003
Vascular dementia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Anxiety
Psychiatric disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Acute kidney injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Haematuria
Renal and urinary disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0013 affected4,477 at risk
EG00212 affected5,894 at risk
EG003
Haemorrhage urinary tract
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypertensive nephropathy
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Renal haematoma
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Renal infarct
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Renal injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Urinary retention
Renal and urinary disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0027 affected5,894 at risk
EG003
Breast haematoma
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0012 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG00023 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0013 affected4,477 at risk
EG00219 affected5,894 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0011 affected4,477 at risk
EG0025 affected5,894 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0011 affected4,477 at risk
EG0022 affected5,894 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aneurysm
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Arterial haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Deep vein thrombosis
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Embolism arterial
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Haematoma
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0011 affected4,477 at risk
EG00210 affected5,894 at risk
EG003
Haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0013 affected4,477 at risk
EG0028 affected5,894 at risk
EG003
Hypovolaemic shock
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0022 affected5,894 at risk
EG003
Ischaemia
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Orthostatic hypotension
Vascular disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral embolism
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0011 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral ischaemia
Vascular disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Shock haemorrhagic
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0011 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Subgaleal haematoma
Vascular disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Venous haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0021 affected5,894 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lung abscess
Infections and infestations
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Subcutaneous abscess
Infections and infestations
22.1
Systematic Assessment
EG0000 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Haemorrhagic disorder
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Normochromic anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Splenic lesion
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute coronary syndrome
Cardiac disorders
22.1
Systematic Assessment
EG0008 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aortic valve incompetence
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aortic valve stenosis
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Arrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Atrial tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Atrioventricular block
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Atrioventricular block complete
Cardiac disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bradyarrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiac disorder
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiac failure acute
Cardiac disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiac failure chronic
Cardiac disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiogenic shock
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiomegaly
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiomyopathy
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Coronary artery disease
Cardiac disorders
22.1
Systematic Assessment
EG0007 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Coronary artery stenosis
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Left ventricular failure
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Myocardial fibrosis
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Myocardial ischaemia
Cardiac disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Nodal arrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pericarditis constrictive
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Prinzmetal angina
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Right ventricular failure
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sinoatrial block
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sinus arrest
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sinus bradycardia
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sinus node dysfunction
Cardiac disorders
22.1
Systematic Assessment
EG00016 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tachyarrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ventricular tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0005 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hyperthyroidism
Endocrine disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypothyroidism
Endocrine disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Thyroid mass
Endocrine disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Open angle glaucoma
Eye disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Abdominal distension
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Abdominal incarcerated hernia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Anal fissure
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Diaphragmatic hernia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dysphagia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Faecaloma
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Intestinal infarction
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Oesophagitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tongue haematoma
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tooth pulp haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Asthenia
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cardiac death
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Catheter site haemorrhage
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chest discomfort
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chest pain
General disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Death
General disorders
22.1
Systematic Assessment
EG00048 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Fatigue
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gait disturbance
General disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hernia
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Malaise
General disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Non-cardiac chest pain
General disorders
22.1
Systematic Assessment
EG00010 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Oedema peripheral
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Organ failure
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pain
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pyrexia
General disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sudden cardiac death
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sudden death
General disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ulcer
General disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cholangitis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chronic hepatic failure
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hepatic congestion
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Anaphylactic shock
Immune system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Appendicitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Arthritis infective
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Clostridium difficile colitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Clostridium difficile infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Diabetic foot infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Diarrhoea infectious
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Echinococciasis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Endocarditis
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Endocarditis bacterial
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Endophthalmitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Erysipelas
Infections and infestations
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Infection
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Influenza
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Localised infection
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lower respiratory tract infection
Infections and infestations
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lyme disease
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Meningitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Necrotising fasciitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Paraspinal abscess
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peritonitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pneumonia haemophilus
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Post procedural infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Post procedural sepsis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Postoperative wound infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pulmonary sepsis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pyelonephritis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Respiratory tract infection
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Septic arthritis streptococcal
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Septic shock
Infections and infestations
22.1
Systematic Assessment
EG0007 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sinusitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Streptococcal sepsis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tracheobronchitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Upper respiratory tract infection
Infections and infestations
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Viral infection
Infections and infestations
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Wound infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Accident
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Electric shock
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Face injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Intestinal anastomosis complication
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pocket erosion
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Procedural shock
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Blood creatinine increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Blood glucose increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Blood pressure increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
C-reactive protein increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Electrocardiogram QT prolonged
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Glomerular filtration rate decreased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Haematocrit decreased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Heart rate increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Troponin increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
White blood cell count increased
Investigations
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gout
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metabolic disorder
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Obesity
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gallbladder adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Glioblastoma multiforme
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Malignant genitourinary tract neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Malignant respiratory tract neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rectal cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Transitional cell carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aphasia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Balance disorder
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Brain stem infarction
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cerebral ischaemia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cognitive disorder
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Coma
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Complex regional pain syndrome
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dementia
Nervous system disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dysarthria
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Encephalopathy
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Epilepsy
Nervous system disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hemiparesis
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hydrocephalus
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypoaesthesia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Intracranial mass
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Lacunar stroke
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Motor dysfunction
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Myelopathy
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Parkinson's disease
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Polyneuropathy
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Seizure
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Spinal cord haematoma
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Device battery issue
Product Issues
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Device dislocation
Product Issues
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Device loosening
Product Issues
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Device malfunction
Product Issues
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aggression
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Bipolar disorder
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Confusional state
Psychiatric disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Delirium
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Derailment
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Homicidal ideation
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Mental status changes
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Restlessness
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sleep disorder
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Stress
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Suicidal ideation
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Calculus bladder
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dysuria
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hydronephrosis
Renal and urinary disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Nephropathy
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Renal aneurysm
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Renal failure
Renal and urinary disorders
22.1
Systematic Assessment
EG00012 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Renal impairment
Renal and urinary disorders
22.1
Systematic Assessment
EG0004 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Urinary incontinence
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Breast hyperplasia
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG00019 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Alcoholic
Social circumstances
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Aortic stenosis
Vascular disorders
22.1
Systematic Assessment
EG0006 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Circulatory collapse
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypertension
Vascular disorders
22.1
Systematic Assessment
EG00011 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypertensive crisis
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Hypotension
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
22.1
Systematic Assessment
EG0003 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral artery occlusion
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral artery stenosis
Vascular disorders
22.1
Systematic Assessment
EG0002 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Peripheral venous disease
Vascular disorders
22.1
Systematic Assessment
EG0001 affected4,943 at risk
EG0010 affected4,477 at risk
EG0020 affected5,894 at risk
EG003
Other Adverse Events
Not provided
Phase II part of 1160.129 includes Phase II data from 1160.129, 1160.136 and 1160.171.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Patients who were prescribed Dabigatran etexilate at baseline of Phase III were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0002.21(1.88 to 2.57)
OG0013.23(2.83 to 3.62)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
Regression, Cox
Hazard Ratio (HR)
0.74
2-Sided
95
0.60
0.90
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0001.74(1.45 to 2.07)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0001.91(1.59 to 2.24)
OG0012.62(2.27 to 2.96)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
Regression, Cox
Hazard Ratio (HR)
0.79
2-Sided
95
0.63
0.98
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.80(0.61 to 1.01)
OG0011.00(0.80 to 1.22)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
Regression, Cox
Hazard Ratio (HR)
0.79
2-Sided
95
0.57
1.11
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.65(0.48 to 0.87)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.77(0.58 to 0.97)
OG0010.96(0.76 to 1.17)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
Regression, Cox
Hazard Ratio (HR)
0.81
2-Sided
95
0.57
1.14
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.21(0.12 to 0.34)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.29(0.17 to 0.42)
OG0010.32(0.21 to 0.45)
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.04(0.01 to 0.12)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.04(0.00 to 0.09)
OG0010.05(0.01 to 0.09)
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.07(0.02 to 0.16)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.07(0.01 to 0.13)
OG0010.06(0.01 to 0.11)
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.97(0.76 to 1.23)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.69(0.51 to 0.89)
OG0011.44(1.20 to 1.70)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.
Regression, Cox
Hazard Ratio (HR)
0.52
2-Sided
95
0.38
0.73
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.46(0.32 to 0.64)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.47(0.32 to 0.63)
OG0011.07(0.86 to 1.30)
Units
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.50(0.35 to 0.69)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0000.40(0.27 to 0.55)
OG0010.53(0.38 to 0.68)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.
Regression, Cox
Hazard Ratio (HR)
0.97
2-Sided
95
0.60
1.57
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0002.48(2.13 to 2.87)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.
Units
Counts
Participants
OG0003611
OG0014413
Title
Denominators
Categories
Title
Measurements
OG0002.16(1.84 to 2.48)
OG0013.57(3.19 to 3.96)
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
OG000
OG001
A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.
Regression, Cox
Hazard Ratio (HR)
0.66
2-Sided
95
0.54
0.80
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Counts
Participants
OG0004859
Title
Denominators
Categories
Title
Measurements
OG0000.85(0.65 to 1.09)
OG001
Vitamin K Antagonist (VKA) - Baseline (Phase III)
Patients who were prescribed at baseline of Phase III the Vitamin K Antagonist (VKA) were included in this group. Patients could take other Antithrombotic treatments later during the study.
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments may used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.