A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

Study Overview
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Brief Summary
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This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: Age, gender, and other information about the child and their illness Type of VTE treatment given to the child Occurrence of medically important bleeding and its severity Further information that researchers will collect: Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE Return of VTE symptoms Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: end of the anticoagulation treatment period e.g. discontinuation of all study drugs, their information is no longer available, or the study ends.

Official Title
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Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

Conditions
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Venous Thromboembolism, Children Under 2 Years

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Standard of care (SOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of initiation of an anticoagulant therapy (index drug), either rivaroxaban oral suspension or other anticoagulation therapies (heparins, Vitamin K antagonists (VKAs), other Direct oral anticoagulants (DOACs)). Initiation will be defined as a first record of any anticoagulation therapy (rivaroxaban or SOC) without any anticoagulation therapy in the previous 6 months, or since date of birth for children less than 6 months Evidence of a prior VTE diagnosis (index VTE), defined as the presence of at least one primary/main or secondary diagnosis code for VTE recorded in inpatient setting in the previous 30 days Age less than two years on index date. Baseline period for availability of patient data history in the data source. A minimal baseline period of six months before index date for children aged between six months and two years, and a baseline period since birth for children less than six months of age will be required. Exclusion Criteria: - None

Ages Eligible for Study
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Maximum Age: 2 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 |
| --- | --- |
| Pediatric patients with VTE<br>Pediatric patients under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or Standard of care (SOC) following a VTE diagnosis. | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain<br>Drug: Standard of care (SOC)<br>* Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain. SOC including heparins, Vitamin K antagonists (VKAs) and Other Direct oral anticoagulants (DOACs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive summary of demographic characteristics of patients |  | Retrospective data analysis from 2021 to 2026 | 
| Descriptive summary of characteristics of index venous thromboembolism (VTE) |  | Retrospective data analysis from 2021 to 2026 | 
| Co-morbidities reported in the previous six months before index date, or since date of birth for children less than six months |  | Retrospective data analysis from 2021 to 2026 | 
| Prior treatments reported in the previous six months before index date (or since date of birth for children less than six months) |  | Retrospective data analysis from 2021 to 2026 | 
| Comedication during follow-up |  | Retrospective data analysis from 2021 to 2027 | 
| Descriptive summary of Health resource utilization in the previous six months before index date (or since date of birth for children less than six months) |  | Retrospective data analysis from 2021 to 2026 | 
| Duration of oral, nasogastric/gastric feeding before index date, if available |  | Retrospective data analysis from 2021 to 2026 | 
| Substance and class of anticoagulant drug therapy | For analyzing Index drug therapy and Maintenance therapy. | Retrospective data analysis from 2021 to 2027 | 
| Duration of use anticoagulant drug therapy | For analyzing Index drug therapy and Maintenance therapy. | Retrospective data analysis from 2021 to 2027 | 
| Dosing of anticoagulant drug administration | For analyzing Index drug therapy and Maintenance therapy. | Retrospective data analysis from 2021 to 2027 | 
| Route of anticoagulant drug administration | For analyzing Index drug therapy and Maintenance therapy. | Retrospective data analysis from 2021 to 2027 | 
| Switching to other anticoagulant therapy (Yes/No) |  | Retrospective data analysis from 2021 to 2027 | 
| Number of successive anticoagulation agents during an anticoagulant treatment period |  | Retrospective data analysis from 2021 to 2027 | 
| Sequence of successive anticoagulation agents during an anticoagulant treatment period |  | Retrospective data analysis from 2021 to 2027 | 
| Incidence and severity of major bleeding according to anticoagulation therapy |  | Retrospective data analysis from 2021 to 2027 | 
| Incidence and severity of clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy |  | Retrospective data analysis from 2021 to 2027 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time trends by calendar year in patient characteristics | Description by calendar year of age group at index date and medical history at index date. | Retrospective data analysis from 2021 to 2026 | 
| Time trends by calendar year in anticoagulation treatment patterns | Description by calendar year of class of anticoagulation therapy at initiation. | Retrospective data analysis from 2021 to 2026 | 
| Incidence of recurrent symptomatic VTE according to anticoagulation therapy |  | Retrospective data analysis from 2021 to 2027 | 
| Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy |  | Retrospective data analysis from 2021 to 2027 |