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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABIRATERONE ACETATE

  ENZALUTAMIDE
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Patients treated with abiraterone+prednisone and enzalutamide.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  12000

Study design details

• Main study objective:
  Meta-analysis on the incidence of neuropsychiatric adverse events associated with abiraterone+prednisone and enzalutamide observed in clinical trials and analysis of neuropsychiatric suspected adverse drug reactions reported in EudraVigilance for AAP and ENZ.
• Outcomes:
  Meta-analysis on the incidence of neuropsychiatric adverse events associated with abiraterone+prednisone and enzalutamide observed in clinical trials. And analysis of neuropsychiatric suspected adverse drug reactions reported in EudraVigilance for abiraterone+prednisone (AAP) and enzalutamide (ENZ)
• Data analysis plan:
  Meta-analysis was performed to estimate the pooled relative risk of neuropsychiatric adverse events (as listed in each clinical trial: COU-AA-302, COU-AA-301, Prevail and AFFIRM studies) for AAP vs control group and ENZ vs control group. The analyses were conducted using the Mantel–Haenszel fixed-effects model to obtain the average effect and the distribution of relative risk estimates. EudraVigilance: all reports have the same layout, data elements and functionalities. The figure displayed online is always a running total of serious/non-serious spontaneous cases reported in EEA countries. Each individual case in EudraVigilance refers generally to a single patient and it is composed of at least one report, called the initial report, which might be complemented by follow-up reports.