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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients with VTE | Cancer patients who received anticoagulation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients diagnosed with cancer in Sweden from year 2013 to 2019.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish registries | Multiple Locations | Many Locations | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38735015 | Derived | Linder M, Ekbom A, Brobert G, Vogtlander K, Balabanova Y, Becattini C, Carrier M, Cohen AT, Coleman CI, Khorana AA, Lee AYY, Psaroudakis G, Abdelgawwad K, Rivera M, Schaefer B, Giunta DH. Comparison of rivaroxaban and low molecular weight heparin in the treatment of cancer-associated venous thromboembolism: a Swedish national population-based register study. J Thromb Thrombolysis. 2024 Aug;57(6):973-983. doi: 10.1007/s11239-024-02992-1. Epub 2024 May 12. |
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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.
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| Low molecular weight heparin (LMWH) | Drug | Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. |
|
| vitamin K antagonist (VKA) | Drug | Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. |
|
| other NOACs | Drug | Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. |
|
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D006495 | Heparin, Low-Molecular-Weight |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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