Post Marketing Surveillance Study for Mircera

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine:
  Mircera
• Medical condition to be studied:
  Anaemia

Population studied

• Short description of the study population:
  Patients who were prescribed Mircera® by their physician according to the local Korean Mircera® label, for the treatment of anemia associated with chronic kidney disease who require Erythropoiesis-Stimulating Agents (ESA) therapy.
• 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:
  Renal impaired
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The main objectives are to evaluate the following items under routine practice:1) Serious adverse event(AE)/adverse drug reaction (ADR) 2) Unexpected ADR 3) Expected ADR 4) Non-serious AE 5) AE occurred by misuse, abuse and drug interaction 6) Any factors influencing safety and efficacy parameters (influencing lab. data, etc)
• Data analysis plan:
  According to the data, t-test or chi-square test was performed.Adverse events were tabulated in summary tables as followings:Summary table of incidence status of AEs/ADRs by System Organ ClassSummary table of drug - adverse events relationshipSummary table of Intensity of Adverse events/Adverse Drug ReactionsSummary table of Incidence rate Unexpected AEs/ADRs by System Organ Class