A Post-Authorization Safety Study (PASS) to characterize the risk of secondary primary malignancy including MDS/AML among metastatic prostate cancer patients exposed to AKEEGA (niraparib/abiraterone acetate fixed-dose combination tablet) plus Prednisone/Prednisolone

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  Swedish Medical Registries, Optum Clinformatics DOD database

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes