An observational study in Treatment of Venous Thromboembolism in Cancer Patients, sponsored by Bayer. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Bayer · Observational
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
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 researchers will compare this information in the patients
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 5,737 is above the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients diagnosed with cancer in Sweden from year 2013 to 2019.
Exclusion Criteria:
Cancer patients who received anticoagulation treatment.
Drug: Rivaroxaban (Xarelto, BAY59-7939) · Drug: Low molecular weight heparin (LMWH) · Drug: vitamin K antagonist (VKA) · Drug: other NOACs
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Recurrence of VTE
Time frame: Retrospective data analysis from 2013 to 2020
Major bleedings
Time frame: Retrospective data analysis from 2013 to 2020
All-cause death
Time frame: Retrospective data analysis from 2013 to 2020
Choice of anticoagulation treatments for VTE
Time frame: Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatments for VTE
Time frame: Retrospective data analysis from 2013 to 2020
Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
Time frame: Retrospective data analysis from 2013 to 2020
Major bleedings with different treatment types of LMWH, VKA and NOAC
Time frame: Retrospective data analysis from 2013 to 2020
All-cause death with different treatment types of LMWH, VKA and NOAC
Time frame: Retrospective data analysis from 2013 to 2020
Plan to share: No — 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.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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