Safety and efficacy evaluation of Mirvaso gel 0.33 % (brimonidine tartrate) by Post marketing surveillance

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non interventional study aiming at collecting supplementary safety data on Mirvaso under real life medical practice

Study drug and medical condition

• Name of medicine:
  MIRVASO
• Medical condition to be studied:
  Rosacea

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 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:
  600

Study design details

• Main study objective:
  This Post Marketing Study (PMS) aims to evaluate follow items after launching Mirvaso gel 0.33% (brimonidiine tartrate) in general medical circumstances. 1) Serious adverse eventsadverse drug reactions2) Unlabelled, unexpected adverse events, adverse drug reactions3) Known adverse drug reactions4) Non-serious adverse drug reactions5) Other safety, efficacy related information
• Outcomes:
  AE/SAE: number of occurrence case, occurrence rate with 95% confidence interval, Efficacy as assesed by CEA and PSA
• Data analysis plan:
  AE or SAE will be analysed the number of occurrence case, and occurrence rate with 95% confidence interval