A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database

Study Overview
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Brief Summary
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This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. This study looks at the bleeding risk in Japanese patients who are already receiving long-term rivaroxaban treatment for their VTE. Some common causes of VTE are surgery, lack of movement, being bed-ridden and cancer. VTE that is caused by cancer is called cancer-associated venous thromboembolism (Ca-VTE). The study treatment, rivaroxaban, is a blood thinner prescribed by doctors to help treat conditions like VTE. By thinning the blood, rivaroxaban can help keep blood flowing normally and prevent blood clots. But, rivaroxaban can lead to increased bleeding in some people. There have been studies done in which participants with VTE and Ca-VTE received treatment with rivaroxaban for a long period of time. The overall results of those studies showed that long-term treatment with rivaroxaban helped prevent blood clots in those participants. Some of the participants had increased bleeding after this long-term treatment, while some did not. Participants with certain types of cancers, such as Ca-VTE, also had an increased risk of bleeding. These studies, however, did not include Japanese participants. So, the researchers in this study want to learn more about the risk of bleeding in Japanese patients with VTE or Ca-VTE who receive long-term treatment with rivaroxaban. To do this, the researchers plan to use a medical database to find information for patients with VTE and Ca-VTE who have already been taking rivaroxaban for their condition. This database will help the researchers collect information about the bleeding risk of long-term rivaroxaban treatment in Japanese patients. In this study, the researchers will learn more about: the characteristics of patients with VTE who are treated with rivaroxaban for a period of less than 3 months to more than 1 year the bleeding risk for all of the patients throughout the study the bleeding risk for the patients with Ca-VTE throughout the study the cause of any bleeding that happens The researchers will follow and record these results for Japanese patients from October 2015 to December 2020.

Official Title
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Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database

Conditions
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Treatment of Venous Thromboembolism

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of VTE recorded during the selection period (01-Apr-2016 to 31-May-2020 inclusive), Having a rivaroxaban prescription claim within 30 days after the VTE diagnosis , Being age 18 years or older at the index date, Having at least 180 days baseline period. Exclusion Criteria: Having evidence of atrial fibrillation, atrial flutter, dialysis, CTEPH (Chronic Thromboembolic Pulmonary Hypertension) or pregnancy during the baseline period, Having a claim of rivaroxaban during the baseline period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Japanese VTE patients including Ca-VTE patients<br>Include a large number of adult VTE patients (including Ca-VTE patients) prescribed rivaroxaban who visited facilities covered by the MDV database | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Dosage at the discretion of the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive summary of bleeding risk profile of rivaroxaban, e.g.: incidence rate of / time to bleeding | A bleeding defined as a composite of intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion. | Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive summary of individual components of the composite primary outcome. e.g.: incidence rate of / time to each individual components of the composite primary outcome | Components of the composite primary outcome: intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion. | Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020 | 
| Descriptive summary of recurrent PE/DVT event. e.g.: incidence rate of / time to recurrent PE/DVT | PE: Pulmonary Embolism DVT: Deep Vein Thrombosis | Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020 | 
| Descriptive summary of VTE patient characteristics that treated with Rivaroxaban | Patient demographic and clinical characteristics including age, gender, comorbidities, medical history and medication | Retrospective analysis from baseline period [180 days before index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis)] up to 31-Dec-2020 |