Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners
- Conditions
- Venous Thromboembolism (VTE)
- Interventions
- Registration Number
- NCT03965741
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 97765
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Men with Prostate Cancer (PCa) Rivaroxaban (Xarelto, BAY59-7939) - Men with Prostate Cancer (PCa) Apixaban(Eliquis) - Men with Prostate Cancer (PCa) Pradaxa (Dabigatran etexilate) -
- Primary Outcome Measures
Name Time Method Subject's socio-demographic at the date of an incident PCa diagnosis Retrospective analysis between 2007 and 2016 Among men with PCa
Incidence rate of cancer-related VTE Retrospective analysis between 2007 and 2016 Among men with PCa
Duration of treatment Retrospective analysis between 2007 and 2016 Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
Time between a first cancer-related and a recurrent VTE event Retrospective analysis between 2007 and 2016 Among men with PCa and a first cancer-related VTE event
Subject's clinical characteristics at the date of an incident PCa diagnosis Retrospective analysis between 2007 and 2016 Among men with PCa
Cancer therapies in PCa at the initial time after diagnosis Retrospective analysis between 2007 and 2016 Among men with PCa
Choice of drug Retrospective analysis between 2007 and 2016 Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
Occurrence of recurrent VTE events Retrospective analysis between 2007 and 2016 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)
Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment Retrospective analysis between 2007 and 2016 Among men with PCa and a first cancer-related VTE event
- Secondary Outcome Measures
Name Time Method Subject's socio-demographic at the time of inclusion into the database Retrospective analysis between 2007 and 2016 Among PCa-free men from the general population
Subject's clinical characteristics at the time of inclusion into the database Retrospective analysis between 2007 and 2016 Among PCa-free men from the general population
Incidence rate of VTE events Retrospective analysis between 2007 and 2016 Among PCa-free men from the general population
Trial Locations
- Locations (1)
Many Locations
🇸🇪Multiple Locations, Sweden