Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners

Study Overview
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Brief Summary
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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.

Official Title
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Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE

Conditions
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Venous Thromboembolism (VTE)

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Apixaban(Eliquis)
* Drug: Pradaxa (Dabigatran etexilate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included. From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected. Exclusion Criteria: None
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men with Prostate Cancer (PCa)<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Follow clinical administration<br>Drug: Apixaban(Eliquis)<br>* Follow clinical administration<br>Drug: Pradaxa (Dabigatran etexilate)<br>* Follow clinical administration<br>|
| Men without PCa<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 event； 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 event； 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 event； 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |