Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe

ENCePP Code of conduct

Yes

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

DeclarationofInterests-Annex5-JReutfors

Composition of steering group and observers

EUPAS107124-107878

Signed code of conduct

ENCePP Declaration of compliance_signed.pdf

Signed code of conduct checklist

ENCePP Checklist Code of conduct_signed.pdf

Signed checklist for study protocols

Signed ENCePP checklist for Upa IBD PASS v1.0 Study Protocol.pdf

Data sources

• Data source(s):
  Danish registries (access/analysis)

  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  Sweden National Cancer Register / Cancerregistret
• Data source(s), other:
  SWIBREG (Sweden), ENEIDA (Spain), SMINET (Sweden), Swedish national patient register (Sweden), Swedish cause of death register (Sweden)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Drug dispensing/prescription data

  Laboratory tests and analyses

  Other

  Population registry
• Data sources (types), other:
  Medical chart abstraction, quality register

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