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)

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Système National des Données de Santé (French national health system main database)

  Longitudinal Patient Data - France
• 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