GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
Official Title
GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Dec 2020
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
Aug 22, 2012Actual
Primary Completion Date
Dec 13, 2019Actual
Completion Date
Dec 13, 2019Actual
First Submitted Date
Aug 20, 2012
First Submission Date that Met QC Criteria
Aug 22, 2012
First Posted Date
Aug 23, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 7, 2020
Results First Submitted that Met QC Criteria
Dec 7, 2020
Results First Posted Date
Dec 31, 2020Actual
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
Dec 7, 2020
Last Update Posted Date
Dec 31, 2020Actual
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 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
10,471Actual
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)
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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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 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)
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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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 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
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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.
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
patients with non-valvular AF
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth
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.
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.
All subjects were screened for eligibility prior to participation in the study. Subjects attended a participating site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Recruitment Details
This study investigated characteristics of patients with non-valvular atrial fibrillation influencing the choice of antithrombotic treatment for the prevention of stroke, and the safety and effectiveness of dabigatran versus Vitamin K Antagonist for up to 3-year follow-up period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dabigatran Etexilate - Baseline
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Prot
Yes
No
No
Study Protocol
Oct 22, 2014
Dec 7, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
El Salvador
Lithuania
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.
Incidence Rate of Stroke
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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 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)
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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 (SEE)
Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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)
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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 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
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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 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
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
From baseline visit 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.
Linz
4010
Austria
Kepler Univ. Klinikum Linz
Linz
4021
Austria
Ordination Dr. Martin Koschutnik, Oberwart
Oberwart
7400
Austria
KH d. Barmherzigen Brüder Wien, Neurologie
Vienna
1020
Austria
AKH - Medical University of Vienna
Vienna
1090
Austria
Namur - HOSP St-Luc de Bouge
Bouge/Namur
5004
Belgium
AZ Sint-Lucas
Bruges
8310
Belgium
Brussels - HOSP St-Jan
Brussels
1000
Belgium
ULB Hopital Erasme
Brussels
1070
Belgium
Brussels - HOSP Europe (Ste-Elisabeth)
Brussels
1180
Belgium
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk
3600
Belgium
Liège - HOSP CHR de la Citadelle
Liège
4000
Belgium
Ottignies - HOSP St-Pierre
Ottignies
1340
Belgium
Tienen - PRAC De Wolf, Luc
Tienen
3300
Belgium
MHAT "Deva Maria", Dept. of Cardiology, Burgas
Burgas
5800
Bulgaria
MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak
Kazanlak
6100
Bulgaria
UMHAT Sv.Georgi EAD
Plovdiv
4002
Bulgaria
MHAT, Fourth Dept. of Internal Medicine, Rousse
Rousse
7002
Bulgaria
MHAT Akta Medika OOD, Sevlievo
Sevlievo
5400
Bulgaria
Multiprofile Hospital for Active Treatment, Sliven
Sliven
8800
Bulgaria
Diagnostic & Consultancy Center "Ascendent", Sofia
Sofia
1202
Bulgaria
MHAT "National Cardiology Hosp." Cardiology Dept., Sofia
Sofia
1309
Bulgaria
University Multiprofile Hospital 'Alexandrovska', Sofia
Sofia
1431
Bulgaria
MHAT, "Vita" Surgery Department, Sofia
Sofia
1505
Bulgaria
MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia
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.
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.
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.
Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.
FG001
Vitamin K Antagonist (VKA) - Baseline
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can 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
Patients who were prescribed Apixaban at baseline were included in this group. Patients can 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
Edoxaban - Baseline
Patients who were prescribed Edoxaban at baseline were included in this group. Patients can 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
Acetylsalicylic Acid (ASA) - Baseline
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can 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
Antiplts Other Than ASA - Baseline
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can 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
No Treatment - Baseline
Patients who were prescribed no treatment at baseline were included in this group. Patients can 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.
FG008
Combinations With Oral Anticoagulants - Baseline
Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients 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.
FG0002089 subjects
FG0012834 subjects
FG0022033 subjects
FG0032214 subjects
FG004180 subjects
FG005513 subjects
FG00680 subjects
FG007526 subjects
FG0082 subjects
All Eligible
FG0002066 subjects
FG0012758 subjects
FG0022008 subjects
FG0032197 subjects
FG004180 subjects
FG005507 subjects
FG00679 subjects
FG007507 subjects
FG0082 subjects
COMPLETED
FG0001768 subjects
FG0012183 subjects
FG0021667 subjects
FG0031846 subjects
FG004155 subjects
FG005401 subjects
FG00659 subjects
FG007394 subjects
FG0082 subjects
NOT COMPLETED
FG000321 subjects
FG001651 subjects
FG002366 subjects
FG003368 subjects
FG00425 subjects
FG005112 subjects
FG00621 subjects
FG007132 subjects
FG0080 subjects
Type
Comment
Reasons
Other reasons than listed
FG000166 subjects
FG001373 subjects
FG002197 subjects
FG003228 subjects
FG00414 subjects
FG00571 subjects
FG00617 subjects
FG00766 subjects
FG0080 subjects
Withdrawal by Subject
FG00036 subjects
FG00159 subjects
FG00253 subjects
FG00358 subjects
FG004
Lost to Follow-up
FG00093 subjects
FG001142 subjects
FG00291 subjects
FG00363 subjects
FG004
No end of study case report form
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Not eligible
FG00023 subjects
FG00176 subjects
FG00225 subjects
FG00317 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can 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
Patients who were prescribed Apixaban at baseline were included in this group. Patients can 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
Edoxaban - Baseline
Patients who were prescribed Edoxaban at baseline were included in this group. Patients can 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
Acetylsalicylic Acid (ASA) - Baseline
Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can 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
Antiplts Other Than ASA - Baseline
Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can 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
No Treatment - Baseline
Patients who were prescribed no treatment at baseline were included in this group. Patients can 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.
BG008
Combinations With Oral Anticoagulants - Baseline
Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients 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.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002066
BG0012758
BG0022008
BG0032197
BG004180
BG005507
BG00679
BG007507
BG0082
BG00910304
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
BG00071.3± 9.4
BG00172.8± 9.5
BG00271.1± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000942
BG0011252
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0005
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)
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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0002.30(1.86 to 2.73)
OG0013.02(2.54 to 3.54)
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)
0.83
2-Sided
95
0.64
1.08
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Primary
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)
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) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. 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: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Stroke
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Transient Ischaemic Attack (TIA)
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Systemic Embolism (SEE)
Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Pulmonary Embolism (PE)
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Major Bleeding Events
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) 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: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of Myocardial Infarction
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Primary
Incidence Rate of All-cause Death
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.
Posted
Number
95% Confidence Interval
Events per 100 person-years
From baseline visit 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
Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can 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
Time Frame
From baseline visit until study completion or discontinuation, up to 3 years of follow-up.
Description
Enrolled and treated: All patients entered in the electronic data capture system who signed the informed consent and treated with at least once with the study treatments. Patients who were prescribed the combinations of oral anticoagulants at enrollment were excluded as no specific treatment can be defined for this group. For patients from the 'No treatment-initial' group, only their adverse events that happened when receiving certain treatment were reported in the respective treatment group.
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 - at Least Once During the Study
All patients received at least once dabigatran etexilate during 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 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.
116
2,385
79
2,385
0
2,385
EG001
Vitamin K Antagonist (VKA) - at Least Once During the Study
All patients received at least once Vitamin K Antagonist (VKA) during 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 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.
264
3,258
157
3,258
0
3,258
EG002
Rivaroxaban - at Least Once During the Study
All patients received at least once Rivaroxaban during 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 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.
166
2,576
92
2,576
0
2,576
EG003
Apixaban - at Least Once During the Study
All patients received at least once Apixaban during 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 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.
207
2,934
99
2,934
0
2,934
EG004
Edoxaban - at Least Once During the Study
All patients received at least once Edoxaban during 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 the study. Adverse events were reported in the treatment group a patient actually received when the adverse event happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.
17
368
10
368
0
368
EG005
Acetylsalicylic Acid (ASA) - at Least Once During the Study
All patients received at least once Acetylsalicylic acid (ASA) during 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 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.
141
1,940
70
1,940
0
1,940
EG006
Antiplts Other Than ASA - at Least Once During the Study
All patients received at least once Antiplts other than Acetylsalicylic acid (ASA) during 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 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.
33
427
14
427
0
427
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0004 affected2,385 at risk
EG0017 affected3,258 at risk
EG0027 affected2,576 at risk
EG00311 affected2,934 at risk
EG0041 affected368 at risk
EG0056 affected1,940 at risk
EG0060 affected427 at risk
Blood loss anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0002 affected2,385 at risk
EG0013 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Splenic haematoma
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Atrial fibrillation
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Atrial thrombosis
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Bradycardia
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cardiac arrest
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cardiac failure
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected2,385 at risk
EG0014 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cardiac failure congestive
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cardiac tamponade
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Hypertensive cardiomyopathy
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Mitral valve incompetence
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Myocardial infarction
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected2,385 at risk
EG0012 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Vertigo
Ear and labyrinth disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Eye haemorrhage
Eye disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Retinal artery embolism
Eye disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Abdominal pain
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Acute abdomen
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Colitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Diarrhoea
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Discoloured vomit
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Dyspepsia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected2,385 at risk
EG0011 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Gastritis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Gastroduodenal ulcer
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0008 affected2,385 at risk
EG00110 affected3,258 at risk
EG00214 affected2,576 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haematemesis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Haematochezia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0008 affected2,385 at risk
EG0016 affected3,258 at risk
EG0024 affected2,576 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Melaena
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0023 affected2,576 at risk
EG003
Mesenteric haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Nausea
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Oesophageal ulcer haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0005 affected2,385 at risk
EG0012 affected3,258 at risk
EG0024 affected2,576 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0004 affected2,385 at risk
EG00112 affected3,258 at risk
EG0027 affected2,576 at risk
EG003
Vomiting
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Vomiting projectile
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Asthenia
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Death
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Medical device site haematoma
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Non-cardiac chest pain
General disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Puncture site haemorrhage
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Sudden death
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Suprapubic pain
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Vessel puncture site haematoma
General disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cholecystitis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Hepatic failure
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Bronchitis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cystitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Diverticulitis intestinal haemorrhagic
Infections and infestations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Empyema
Infections and infestations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Gastroenteritis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Pneumonia
Infections and infestations
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Urinary tract infection
Infections and infestations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Urosepsis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Contusion
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Fall
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0014 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Head injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Overdose
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0012 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Splenic injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0003 affected2,385 at risk
EG0015 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0013 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Traumatic renal injury
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Bleeding time prolonged
Investigations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
International normalised ratio increased
Investigations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0015 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Liver function test increased
Investigations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Occult blood
Investigations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Transaminases increased
Investigations
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0011 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Gastrointestinal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Ataxia
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Basal ganglia haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Brain injury
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebellar infarction
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebellar stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebral haematoma
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0018 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Cerebral infarction
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Cerebrovascular accident
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Embolic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0014 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0013 affected3,258 at risk
EG0024 affected2,576 at risk
EG003
Haemorrhagic transformation stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Headache
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Intracranial haematoma
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Ischaemic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0007 affected2,385 at risk
EG0015 affected3,258 at risk
EG0023 affected2,576 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0012 affected3,258 at risk
EG0022 affected2,576 at risk
EG003
Syncope
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Transient ischaemic attack
Nervous system disorders
22.1
Systematic Assessment
EG0004 affected2,385 at risk
EG0016 affected3,258 at risk
EG0023 affected2,576 at risk
EG003
Vascular dementia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Anxiety
Psychiatric disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Acute kidney injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haematuria
Renal and urinary disorders
22.1
Systematic Assessment
EG0003 affected2,385 at risk
EG0018 affected3,258 at risk
EG0026 affected2,576 at risk
EG003
Haemorrhage urinary tract
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Hypertensive nephropathy
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Renal haematoma
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Renal infarct
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Renal injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Urinary retention
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0014 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Breast haematoma
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected2,385 at risk
EG00116 affected3,258 at risk
EG0026 affected2,576 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0012 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0012 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Arterial haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Embolism arterial
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Haematoma
Vascular disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0018 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0014 affected3,258 at risk
EG0021 affected2,576 at risk
EG003
Ischaemia
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Peripheral embolism
Vascular disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Peripheral ischaemia
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Shock haemorrhagic
Vascular disorders
22.1
Systematic Assessment
EG0001 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Subgaleal haematoma
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Venous haemorrhage
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0011 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Deep vein thrombosis
Vascular disorders
22.1
Systematic Assessment
EG0000 affected2,385 at risk
EG0010 affected3,258 at risk
EG0020 affected2,576 at risk
EG003
Other Adverse Events
Not provided
The data used in this analysis included only patients participating in Phase III of this study. Patients participating in Phase II were reported and analyzed in the 1160.129 phase II report, and were not planned to be reported separately for 1160.136.
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 Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0001.91(1.52 to 2.32)
OG0012.36(1.93 to 2.82)
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)
0.94
2-Sided
95
0.70
1.27
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.69(0.45 to 0.94)
OG0011.01(0.76 to 1.30)
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)
0.67
2-Sided
95
0.43
1.06
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Vitamin K Antagonist (VKA) - Baseline
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.64(0.42 to 0.89)
OG0010.96(0.70 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)
0.68
2-Sided
95
0.43
1.09
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.30(0.16 to 0.47)
OG0010.26(0.12 to 0.41)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.07(0.00 to 0.16)
OG0010.06(0.00 to 0.14)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.09(0.02 to 0.18)
OG0010.06(0.00 to 0.14)
OG001
Vitamin K Antagonist (VKA) - Baseline
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.73(0.49 to 0.98)
OG0011.42(1.09 to 1.75)
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)
0.58
2-Sided
95
0.38
0.88
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
OG001
Vitamin K Antagonist (VKA) - Baseline
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.50(0.31 to 0.71)
OG0011.04(0.77 to 1.34)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.76(0.51 to 1.02)
OG0011.00(0.73 to 1.29)
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0000.34(0.18 to 0.53)
OG0010.45(0.27 to 0.64)
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)
0.95
2-Sided
95
0.49
1.84
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).
Other
Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can 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
OG0001946
OG0012509
Title
Denominators
Categories
Title
Measurements
OG0002.08(1.69 to 2.51)
OG0013.27(2.80 to 3.77)
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)
0.78
2-Sided
95
0.60
1.01
Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).