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)

10/05/2023
04/12/2025
EU PAS number:
EUPAS46800
Study
Planned

ENCePP Code of conduct

No
Data sources

Data source(s)

Data source(s), other

Système National Des Données De Santé (SNDS) France, Danish Register of Medicinal Products Statistics (RMPS) Denmark, Danish Hospital Patient Medication Register (SMR) Denmark, Swedish National Patient Register (NPR) Sweden, Swedish Cause of Death Register Sweden

Data sources (types)

Administrative healthcare records (e.g., claims)
Electronic healthcare records (EHR)
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No