Neuropsychiatric Adverse Events of Abiraterone Acetate and Enzalutamide: Meta-analysis of Randomized Clinical Trials with Real World Reporting Patterns from Eudravigilance

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35921
• EU PAS number:
  EUPAS35920
• Study ID:
  35921
• Official title and acronym:
  Neuropsychiatric Adverse Events of Abiraterone Acetate and Enzalutamide: Meta-analysis of Randomized Clinical Trials with Real World Reporting Patterns from Eudravigilance
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study status:
  Finalised

Research institution and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Actual: 01/02/2017

Study start date

Actual: 01/02/2017

Date of final study report

Actual: 27/02/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable