Evaluation of pregnancy and infant outcomes in Kesimpta patients using PRegnancy outcomes Intensive Monitoring (PRIM) data - The Kesimpta-PRIM study. (The Kesimpta PRIM study.)

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  Novartis Global Safety Database Switzerland
• Data sources (types):
  Other

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  Prospective patient-based data collection, Case-control surveillance database

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