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.
Study Type
OBSERVATIONAL
Enrollment
850
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
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).
Many locations
Multiple Locations, Denmark
Many locations
Multiple Locations, France
Many locations
Multiple Locations, Spain
Many locations
Multiple Locations, Sweden
Descriptive summary of demographic characteristics of patients
Time frame: Retrospective data analysis from 2021 to 2026
Descriptive summary of characteristics of index venous thromboembolism (VTE)
Time frame: 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
Time frame: 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)
Time frame: Retrospective data analysis from 2021 to 2026
Comedication during follow-up
Time frame: 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)
Time frame: Retrospective data analysis from 2021 to 2026
Duration of oral, nasogastric/gastric feeding before index date, if available
Time frame: Retrospective data analysis from 2021 to 2026
Substance and class of anticoagulant drug therapy
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Duration of use anticoagulant drug therapy
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Dosing of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Route of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Switching to other anticoagulant therapy (Yes/No)
Time frame: Retrospective data analysis from 2021 to 2027
Number of successive anticoagulation agents during an anticoagulant treatment period
Time frame: Retrospective data analysis from 2021 to 2027
Sequence of successive anticoagulation agents during an anticoagulant treatment period
Time frame: Retrospective data analysis from 2021 to 2027
Incidence and severity of major bleeding according to anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
Incidence and severity of clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
Time trends by calendar year in patient characteristics
Description by calendar year of age group at index date and medical history at index date.
Time frame: 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.
Time frame: Retrospective data analysis from 2021 to 2026
Incidence of recurrent symptomatic VTE according to anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
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