Severe hypersensitivity reactions associated with high dose iv iron containing medicinal products

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case-population study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pharmacoepidemiologic study with case-population design using established data sources

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FERRIC CARBOXYMALTOSE

  IRON(III) ISOMALTOSIDE 1000
• Medical condition to be studied:
  Anaphylactoid shock

  Anaphylactic reaction

Population studied

• Short description of the study population:
  Patients with an injection or infusion of ferric carboxymaltose or iron (III) isomaltoside 1000 s in the inpatient and outpatient setting in European countries.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • 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:
  99999999

Study design details

• Main study objective:
  To evaluate the reported rate of anaphylactic/anaphylactoid reactions associated with single high dose IV iron products with respect to overall exposure of single iron products in European countries, including:ferric carboxymaltose and iron isomaltoside
• Data analysis plan:
  In a descriptive analysis reported rates of severe hypersensitivity AEs including anaphylactic reaction, anaphylactic shock, anaphylactoid reaction and anaphylactoid shock for the period 1 Jan 2014 – 31 Dec 2017 will be determined by number of reports divided by the number of 100 mg DEq (=DDD) of iron sold.Odds Ratios and corresponding 95 % CI will be calculated.