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 (XAPAEDUS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AF01) rivaroxaban

  rivaroxaban
• Medical condition to be studied:
  Embolism venous

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  850

Study design details

• Main study objective:
  - Clinical characteristics and demographics of patients when using anticoagulation therapy for the treatment of VTE (rivaroxaban oral suspension or SOC) ; - Use of anticoagulation therapy (including selected drug, dose, and duration) for treatment of VTE ; - Incidence and severity of bleeding (major bleeding, and clinically relevant non-major bleeding) according to anticoagulation therapy
• Outcomes:
  - Demographic characteristics of patients - Characteristics of index VTE - Co-morbidities reported in the previous six months before index date, or since date of birth for children less than six months ; - Major bleeding according to anticoagulation therapy ; - Clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy Please see more in protocol, - Time trends by calendar year in patient characteristics ; - Time trends by calendar year in anticoagulation treatment patterns ; - Incidence of recurrent symptomatic VTE according to anticoagulation therapy ; - Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy
• Data analysis plan:
  Given the study objectives the analyses will be descriptive, with no intent for hypothesis generating or testing between exposure categories. Incidences in Rivaroxaban and SOC cohorts will be compared only in an exploratory sense and no confirmatory statistical tests will be performed. All analyses will be conducted separately by country and data source. Besides, combined analyses of aggregated data across data sources will be provided, as applicable. ; Categorical variables will be presented as counts (n), and proportions (%), with 95% CI where relevant. Continuous variables will be presented as means with standard deviation and as medians with interquartile range, where appropriate.