Safety profile of Ultravist in patients with different sexes, races and from different countries/regions

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Nested Case-Control analysis

Study drug and medical condition

• Name of medicine, other:
  Ultravist

Population studied

• Short description of the study population:
  The study population comprised of patients of all age groups received a contrast enhanced X-ray based examination with Ultravist for various indications identified from the four company sponsored non-interventional studies.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  152233

Study design details

• Main study objective:
  To describe the relative risk / odds ratio of HSRs to Ultravist in patients with different sex, race and from different countries/regions.
• Outcomes:
  HSRs to Ultravist in patients with different sex, race and from different countries/regions. Differences regarding specific HSRs in patient groups
• Data analysis plan:
  Statistical analysis will be of exploratory nature only. Unadjusted and adjusted odds ratios (ORs) for the risk factors of interest will be estimated. The adjusted ORs will be based on a logistic regression model that includes the predefined potential confounders.