on-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients with Venous Thromboembolism in Europe
- Conditions
- MedDRA - 10066899: Venous thromboembolismI82Other venous embolism and thrombosis
- Registration Number
- DRKS00007934
- Lead Sponsor
- Daiichi Sankyo Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2809
Inclusion Criteria
Established acute initial or recurrent VTE
- Patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
As this is a non-interventional study, no additional selection criteria apply. Patients will only be included in the study after the treating physician has made the clinical decision to prescribe Edoxaban. The prescription behavior will not be influenced.
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is the analysis of the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. <br><br>The co-primary objective of this study is to collect real world safety data on bleeding events, drug related adverse events such as liver adverse events, and mortality (VTE-related and all-cause) in patients treated with edoxaban. Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.<br>
- Secondary Outcome Measures
Name Time Method To assess the effect of edoxaban on relevant patient outcomes as recurrence rate of symptomatic VTE during edoxaban treatment, recurrence rate of symptomatic VTE after cessation of edoxaban treatment, hospitalisations, post-thrombotic syndrome, persistence to therapy, patient/physician reported outcomes, health care utilization, resource use