A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)

Study Overview
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Brief Summary
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This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied. VTE is a condition in which a patient has problems due to the formation of blood clots in the veins. Blood clots can reduce the flow of blood to vital organs such as the heart and lungs, which can lead to them becoming damaged. VTE can also be recurrent. This means that the blood clots have returned after treatment. People who have cancer have an increased risk of developing VTE. Three main types of anticoagulation treatments (blood thinners) have been available for patients with cancer who also have VTE Low molecular weight heparins (LMWHs) Vitamin K antagonists (VKAs) Non-vitamin K antagonist oral anticoagulants (NOACs) The treatment rivaroxaban belongs to the NOACs. Compared to other treatments available to patients who have cancer and VTE, NOACs may cause fewer medical problems and can be easier for patients to take correctly. In this study, the researchers will collect data about: the type of VTE treatments given and for how long the treatments are taken the risk of blood clots returning in the veins after treatment, any events of major bleeding, and the number of deaths in patients with cancer who do not have a high risk of bleeding The researchers will compare this information in the patients who received rivaroxaban to the patients who received LMWHs who received NOACs to the patients who received LMWHs. There will be no required visits with a study doctor or required tests in this study. The researchers will look at the health information from adult patients in Sweden who were diagnosed with cancer between 2013 and 2019 and also have VTE. The researchers will collect this information from Swedish health registers including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Official Title
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Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)

Conditions
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Treatment of Venous Thromboembolism in Cancer Patients

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Low molecular weight heparin (LMWH)
* Drug: vitamin K antagonist (VKA)
* Drug: other NOACs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A resident in Sweden of 18+ years of age A Swedish Person Identification Number A diagnosis of cancer ((ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis. Exclusion Criteria: A diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis A dispensed prescription for any oral anticoagulant (OAC) before the date of VTE diagnosis A cancer diagnosis associated with high bleeding risk, including upper gastrointestinal cancer, malignant immunoproliferative diseases and leukemia

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 |
| --- | --- |
| Cancer patients with VTE<br>Cancer patients who received anticoagulation treatment. | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.<br>Drug: Low molecular weight heparin (LMWH)<br>* Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.<br>Drug: vitamin K antagonist (VKA)<br>* Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.<br>Drug: other NOACs<br>* Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of VTE |  | Retrospective data analysis from 2013 to 2020 | 
| Major bleedings |  | Retrospective data analysis from 2013 to 2020 | 
| All-cause death |  | Retrospective data analysis from 2013 to 2020 | 
| Choice of anticoagulation treatments for VTE |  | Retrospective data analysis from 2013 to 2020 | 
| Duration of anticoagulation treatments for VTE |  | Retrospective data analysis from 2013 to 2020 | 
| Recurrence of VTE with different treatment types of LMWH, VKA and NOAC |  | Retrospective data analysis from 2013 to 2020 | 
| Major bleedings with different treatment types of LMWH, VKA and NOAC |  | Retrospective data analysis from 2013 to 2020 | 
| All-cause death with different treatment types of LMWH, VKA and NOAC |  | Retrospective data analysis from 2013 to 2020 |