A Comparative Observational Study Evaluating the Incidence Rate of Endometrial Cancer in Women aged 50 Years and Over Who Use Low dose Vaginal Estrogen Unopposed by a Progestogen: A Post-authorization Safety Study in the United States and Sweden (Low dose vaginal estrogen and endometrial cancer)

18/02/2022
07/01/2026
EU PAS number:
EUPAS45602
Study
Ongoing

ENCePP Code of conduct

No
Data sources

Data source(s)

Data source(s), other

HealthCore Ingegrated Research DatabaseSM HIRD United States, Swedish National Register Sweden, Swedish Cancer Registry Sweden, Cause of Death Registry Sweden, Total population register Sweden

Data sources (types)

Administrative healthcare records (e.g., claims)
Other

Data sources (types), other

The HIRD is a longitudinally integrated research database comprising automated payment claims for healthcare encounters. The Swedish registry data include five large, nationally held registers: the Swedish NPR, the Swedish Prescribed Drug Register (SPDR), the Swedish Cancer Register (SCR), the Cause of Death Registry, and the Total Population Register (TPR).
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