An Observational Study Assessing the Long-term Risk of Non-Melanoma Skin Cancer (NMSC) Among New Users of OpzeluraTM (Ruxolitinib) Cream in a Vitiligo Patient Population: Post-Authorization Safety Study (PASS)

20/01/2025
21/05/2025
EU PAS number:
EUPAS1000000413
Study
Planned

ENCePP Code of conduct

Yes
Data sources

Data source(s)

Data source(s), other

United States - PharMetrics Plus and US Ambulatory Electronic Medical Records (AEMR) Merged, and the Guardian Research Network (GRN) database
Germany - German Statutory Health Insurance (SHI)
France - French Longitudinal Patient Data linked with French National Health Data System- Système National Des Données De Santé [SNDS].

Data sources (types)

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

CDM mapping

Yes
Data quality specifications

Check conformance

Yes

Check completeness

Yes

Check stability

Yes

Check logical consistency

Yes
Data characterisation

Data characterisation conducted

Yes
Procedures
No information provided.