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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men with Prostate Cancer (PCa) |
| ||
| Men without PCa |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Follow clinical administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's socio-demographic at the date of an incident PCa diagnosis | Among men with PCa | Retrospective analysis between 2007 and 2016 |
| Subject's clinical characteristics at the date of an incident PCa diagnosis | Among men with PCa | Retrospective analysis between 2007 and 2016 |
| Incidence rate of cancer-related VTE | Among men with PCa | Retrospective analysis between 2007 and 2016 |
| Cancer therapies in PCa at the initial time after diagnosis | Among men with PCa | Retrospective analysis between 2007 and 2016 |
| Choice of drug | Among men with PCa and a first cancer-related VTE eventï¼› To characterize the long-term anticoagulation treatment | Retrospective analysis between 2007 and 2016 |
| Duration of treatment | Among men with PCa and a first cancer-related VTE eventï¼› To characterize the long-term anticoagulation treatment | Retrospective analysis between 2007 and 2016 |
| Occurrence of recurrent VTE events | Among men with PCa and a first cancer-related VTE eventï¼› By long-term anticoagulation treatment (LMWH (Low molecular weight heparin), VKA (Vitamin K anticoagulants) or NOAC (Non-vitamin K oral anticoagulation)) and its estimated duration (up 3 months, 3-6 months, more than 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's socio-demographic at the time of inclusion into the database | Among PCa-free men from the general population | Retrospective analysis between 2007 and 2016 |
| Subject's clinical characteristics at the time of inclusion into the database |
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Inclusion Criteria:
Exclusion Criteria:
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Based on the data from the Prostate Cancer Database Sweden (PCBaSe), containing information from many national registries other than the Cancer register, such as Patient register, Dispensed drug register, Cause of Death registry and Population registries.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Sweden |
Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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| Apixaban(Eliquis) |
| Drug |
Follow clinical administration |
|
| Pradaxa (Dabigatran etexilate) | Drug | Follow clinical administration |
|
| Retrospective analysis between 2007 and 2016 |
| Time between a first cancer-related and a recurrent VTE event | Among men with PCa and a first cancer-related VTE event | Retrospective analysis between 2007 and 2016 |
| Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment | Among men with PCa and a first cancer-related VTE event | Retrospective analysis between 2007 and 2016 |
Among PCa-free men from the general population
| Retrospective analysis between 2007 and 2016 |
| Incidence rate of VTE events | Among PCa-free men from the general population | Retrospective analysis between 2007 and 2016 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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