Ferumoxytol-5005: Hypersensitivity events occurring proximal to administration of intravenous iron

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

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IRON SUCROSE
• Medical condition to be studied:
  Iron deficiency anaemia

Population studied

• Short description of the study population:
  1) Dialysis population using CMS end-stage renal disease (ESRD) data, and 2) Non-dialysis chronic kidney disease (CKD) and non-CKD population using Medicare 20% sample data.
• 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:
  693999

Study design details

• Main study objective:
  To assess incidence of hypersensitivity events, and all-cause mortality rates proximal to intravenous (IV) iron administration, overall and by type of IV iron.
• Outcomes:
  To assess hypersensitivity/hypotension adverse events, including death, proximal to IV iron administration in 2010 and 2011 dialysis patients, nondialysis CKD patients, and non-CKD patients a. Overall, b. By IV iron type, and c. By age and sex. To describe patient characteristics and frequency of IV iron use in 2010 and 2011 dialysis patients, nondialysis CKD patients, and non-CKD patients.
• Data analysis plan:
  Analyses were carried out at the event level (IV iron administration level). Hypersensitivity events: Annual incidence (per 100,000 IV iron administrations) of hypersensitivity events occurring on the day of/day after IV iron administration was calculated. Mortality: Deaths occurring in the seven days following IV iron administration were captured to calculate age-standardised mortality rates (ASMRs). The above incidence and ASMR estimates were reported 1) overall, 2) by IV iron type, 3) by gender and age-group, and were stratified by indication (i.e. CKD (dialysis and nondialysis), and non-CKD).