Cyproterone-containing medicines and Meningiomas - An EudraVigilance analysis

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case series review of Pharmacovigilance data
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

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

  CYPROTERONE ACETATE
• Medical condition to be studied:
  Meningioma malignant

  Meningioma benign

Population studied

• Short description of the study population:
  Case reports of meningioma cases to cyproterone -containing medicinal products in EudraVigilance database.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  871

Study design details

• Main study objective:
  The primary objective of the EudraVigilance analysis was to identify and describe case reports to cyproterone-containing medicinal products and to identify and characterise case reports to these products where meningiomas were also reported.
• Data analysis plan:
  Descriptive statistics were performed by age, gender, indication for use, route of administration and origin of reports for all case reports. Where feasible, boxplots of age and time to onset were plotted.