A non-intervention trial of the time to relapse of iron deficiency anemia after standard treatment with a new intravenous iron (Monofer®) (Monofer®-NIS-14)

Study type

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

  Drug utilisation

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

Study drug and medical condition

• Medicinal product name, other:
  Monofer

Population studied

• Short description of the study population:
  Participants aged > 17 years and diagnosed with iron deficiency anaemia following local clinical guidelines.
• 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)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The objective is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.
• Outcomes:
  The primary endpoint is time to relapse of iron deficiency anemia and need of a new course of Monofer® treatment. Laboratory assessments, i.e. anemia work-up/treatment evaluation
• Data analysis plan:
  The data will be analysed by descriptive statistics.