Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)
- Registration Number
- NCT01855100
- Lead Sponsor
- Bayer
- Brief Summary
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Inclusion Criteria
- Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy
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Exclusion Criteria
- Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban (Xarelto, BAY59-7939) -
- Primary Outcome Measures
Name Time Method Number of patients with major bleedings up to 1 year or 30 days after end of rivaroxaban All-cause mortality up to 1 year or 30 days after end of rivaroxaban Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) up to 1 year or 30 days after end of rivaroxaban Adverse events up to 1 year or 30 days after end of rivaroxaban Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) up to 1 year or 30 days after end of rivaroxaban Quantities of resource use consumption up to 1 year or 30 days after end of rivaroxaban
- Secondary Outcome Measures
Name Time Method