A Non-interventional Post Authorisation Safety Study (PASS) of Patients with MoCD Type A Treated with NULIBRY (fosdenopterin)

ENCePP Code of conduct

Yes

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  The data will be recorded using a Case Report Form (CRF) for data collected from routine clinical care at the HCP’s office and from the infusion diary, with a unique identification for each patient. Source may include reviews of medical records, taking into account that only existing data will be entered in the CRF.

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:
  Unknown