Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Study Overview
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Brief Summary
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According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15). Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.

Detailed Description
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Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country. Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.

Official Title
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Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established acute initial or recurrent VTE Clinical decision for treatment with edoxaban is made at the time of enrollment Written informed consent for participation in the study (ICF) Not simultaneously participating in any interventional study Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with Edoxaban<br>Patients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. | Drug: Edoxaban<br>* Prescribed according to approved label<br>* Other names: Lixiana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall | Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. | Baseline up to end of observation period (18 months) | 
| Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment | Descriptive statistics were used to report the number of participants with bleeding events. | Baseline up to end of observation period (18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing At Least 1 Real World Safety Event - Overall | Descriptive statistics were used to report the number of participants experiencing recurrent VTE and at least 1 real world safety event. VTE recurrence data were reported by recurrent deep vein thrombosis (DVT), recurrent pulmonary embolism (PE) with DVT, and recurrent PE only. Recurrent VTE events were based on adjudicated events. Real world safety events included all-cause death, cardiovascular (CV)-related death, VTE-related death, stroke, systemic embolic event, and hospitalization related to CV. | Baseline up to end of observation period (18 months) | 
| Number of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment | Descriptive statistics were used to report the number of participants with overall symptomatic VTE recurrence. VTE recurrence data were further reported by recurrent deep venous thrombosis (DVT), recurrent pulmonary embolism (PE) with deep venous thrombosis (DVT), and recurrent PE only. Recurrent VTE events were based on adjudicated events. | Baseline up to end of observation period (18 months) | 
| Total Number of Venous Thromboembolism Recurrences By Type - Overall | Descriptive statistics were used to describe the number of VTE events reported by the patient. | Baseline up to end of observation period (18 months) | 
| Duration of Venous Thromboembolism Recurrences, by Type - Overall | Descriptive statistics were used to assess the duration of VTE events reported by the patient. | Baseline up to end of observation period (18 months) | 
| Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment) | Descriptive statistics were used to assess the number of recurrent VTE events reported by the patient. | Baseline up to end of observation period (18 months) | 
| Duration of Venous Thromboembolism Events (On Edoxaban Treatment) | Descriptive statistics were used to assess the duration of VTE events reported by the patient. | Baseline up to end of observation period (18 months) | 
| Number of Participants With Risk Factors for Thromboembolic Events at Baseline | Descriptive statistics were used to assess the number of participants with risk factors for thromboembolic events. | at Baseline | 
| Duration of Edoxaban Treatment | Descriptive statistics were used to report the duration of edoxaban treatment. | Baseline up to end of observational period (18 months) | 
| Number of Stroke Events | Descriptive statistics were used to report the number of stroke events. | Baseline up to end of observation period (18 months) | 
| Number of Systemic Embolic Events - Overall | Descriptive statistics were used to report the number of systemic embolic events (SEE). | Baseline up to end of observation period (18 months) | 
| Overview of Participants With Adverse Drug Reactions | Descriptive statistics were used to report an overview of participants with adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1. | Baseline up to end of observation period (18 months) | 
| Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%) | Adverse drug reactions were reported and coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1. | Baseline up to end of observational period (18 months) | 
| Number of Participants With Pre-defined Adverse Drug Reactions | Descriptive statistics were used to report the number of participants with pre-defined adverse drug reactions (ADR). ADRs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1. | Baseline up to end of observation period (18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Authorisation Safety Study, Real World Evidence, Edoxaban, Efficacy/Safety