Post-authorization Safety Study: Ponesimod Pregnancy Outcomes Program Utilizing Enhanced Pharmacovigilance Monitoring (POEM)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  Prospective patient-based data collection, Enhanced pharmacovigilance monitoring

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