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Cancer patients who received anticoagulation treatment.

Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Rivaroxaban (Xarelto, BAY59-7939)

Low molecular weight heparin (LMWH)

vitamin K antagonist (VKA)

other NOACs

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.

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

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

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Janssen Research & Development, LLC

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)	NCT05150938	Treatment of Ve...	Rivaroxaban (Xa... Low molecular w... vitamin K antag... other NOACs	18 Years -	Bayer
A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)	NCT05150938	Treatment of Ve...	Rivaroxaban (Xa... Low molecular w... vitamin K antag... other NOACs	18 Years -	Bayer
A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)	NCT05150938	Treatment of Ve...	Rivaroxaban (Xa... Low molecular w... vitamin K antag... other NOACs	18 Years -	Bayer

Spots Global Cancer Trial Database for vitamin k antagonist (vka)