Safety profile of Ultravist in children and elderly (UV Age)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part. Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 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:
  132850

Study design details

• Main study objective:
  To describe the risk of hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults
• Outcomes:
  Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults, Profile of HSRs (hypersensitivity reactions) in the three age groups General reported ADR (adverse drug reactions) profile in the three age groups
• Data analysis plan:
  Cases of hypersensitivity reactions will be identified following a preset case definition. Controls are patients without any adverse event (AE) after the contrast administration. Logistic regression will be used to analyse the data with adjustment for potential confounders: sex, history of adverse reactions, mode of administration etc. The entire planned analysis will be described in a statistical analysis plan, which will be finalized before the analysis starts.