Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy

Data sources

• Data source(s), other:
  - Prospective patient-based data collection; - Routine primary care electronic patient registry; - Spontaneous pharmacovigilance reporting
• Data sources (types):
  Electronic healthcare records (EHR)

  Other

  Patient surveys

  Published literature

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  - Prospective patient-based data collection; - Routine primary care electronic patient registry

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