TARGET-EU: Rivaroxaban and risk of major gastrointestinal bleeding in elderly patients with non-valvular atrial fibrillation

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  The Information System for Research in Primary Care (SIDIAP)
• Data source(s), other:
  Danish Health Care Registries
• Data sources (types):
  Population registry

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

• CDM version:
  V 2.2

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation details:
  The feasibility assessment for this case study, (appendix of the study protocol), was conducted as part of the broader TARGET-EU feasibility assessment (EUPAS1000000791). Data source suitability was evaluated using a structured framework based on the EMA data quality framework, assessing system characteristics, data quality, and fitness for the research question.; ; Both Danish national registers and SIDIAP were deemed feasible for studying rivaroxaban versus apixaban on major GI bleeding in adults aged 75 and older with NVAF, with sufficient sample size and exposure prevalence. The Danish registers offer nationwide, population-based coverage with high reliability of demographic and hospital data, but exact treatment duration must be estimated from prescription records. SIDIAP provides broad primary care coverage of the Catalan population (~78%) with hospital linkage, but cause of death is not directly captured in the data source and treatment duration must also be estimated.