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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46344
• EU PAS number:
  EUPAS43355
• Study ID:
  46344
• Official title and acronym:
  Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  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. 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, i.e. Low molecular weight heparins (LMWHs), Vitamin K antagonists (VKAs) and 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 cessation, any events of major bleeding, and the number of deaths in patients with cancer The researchers will compare this information in the patients who received rivaroxaban versus LMWHs and NOACs versus LMWHs respectively. 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 30/08/2021

Actual: 30/08/2021

Study start date

Planned: 15/03/2022

Actual: 18/03/2022

Date of final study report

Planned: 31/03/2023

Actual: 05/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

21616_Study Protocol_Redacted_V1.0_2021-08-30

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable