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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Medicinal product name:
  AKEEGA
• Study drug International non-proprietary name (INN) or common name:
  NIRAPARIB

  ABIRATERONE ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XK52) niraparib and abiraterone

  niraparib and abiraterone
• Medical condition to be studied:
  Prostate cancer metastatic