RRA-12037, Risperidone breast cancer study - Sweden

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

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AX08) risperidone

  risperidone
• Medical condition to be studied:
  Breast cancer female

Population studied

• Short description of the study population:
  Adult females with breast cancer who were treated with Risperidone.
• Age groups:
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast cancer patients
• Estimated number of subjects:
  55976

Study design details

• Main study objective:
  To compare the exposure of risperidone and other atypical anti-psychotics in association with breast cancer incidence. To estimate and compare the incidence of breast cancer in users of risperidone, users of other atypical antipsychotics, and users of conventional antipsychotics.
• Outcomes:
  Case Control Study: Estimation of the odds ratios (ORs) of breast cancer comparing exposure to risperidone with exposure to OAA among cases and controls. Estimation of the ORs of breast cancer, for each cancer stage, comparing exposure to risperidone with exposure to OAA among cases and controls.
• Data analysis plan:
  To compare the exposure of risperidone and other atypical antipsychotics in association with breast cancer incidence. To estimate and compare the incidence of breast cancer in users of risperidone, users of other atypical antipsychotics, and users of conventional antipsychotics.