Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol

Study type

• Study topic:
  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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G04BD12) mirabegron

  mirabegron

Population studied

• Short description of the study population:
  New users of medications used for the treatment of Overactive Bladder (OAB).
• 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:
  Overactive Bladder patients
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  Estimate the incidence of sex-specific composite cancer endpoint among users of mirabegron relative to antimuscarinic medication, overall and restricted to patients 65+ years. Estimate the incidence of 10 individual sex-specific cancers among users of mirabegron relative to antimuscarinic medication. Examine protopathic bias by comparing incidence in post-treatment initiation intervals.
• Outcomes:
  Composite cancer endpoints: lung & bronchus, colon & rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney & renal pelvis, pancreas, prostate (males), breast (females), corpus uteri (females), 10 individual cancers included in the composite, sex-specific.
• Data analysis plan:
  Within each data source, patients’ baseline characteristics will be determined through analysis of data available up to and including the cohort entry date. All covariates at baseline will be evaluated based on all available information, except for the evaluation of health care utilization and concomitant medications which will only be based on the 12 months before cohort entry. Accounting for potential confounders will be performed by matching on a PS estimated from available covariates to balance cohorts with respect to those covariates. Cox proportional hazards regression models of the time from the day after cohort entry until the occurrence of an event or censoring will be built. Censoring occurs on the last day of cohort eligibility and events occur on the dates of diagnosis of events. Primary analysis results will be stratified into time periods before or after 1 year since index exposure. S

Documents

Study results

178-cl-113-clrr-04-disc01-en-final-02