Risk of anaphylactoid reactions of Iopromide after intra-arterial administration (UVIA Study)

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:
  Primary data collection

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 who received a contrast enhanced x-ray based examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.
• 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:
  150000

Study design details

• Main study objective:
  The primary objective is to evaluate the risk of anaphylactoid reactions of Iopromide after intra-arterial administration compared to intravenous administration.
• Outcomes:
  Number of patients with anaphylactoid reactions of Iopromide after administration, Number of patients with anaphylactoid reactions after intra-arterial administration of IopromideNumber of patients with anaphylactoid reactions after intra-venous administration of Iopromide
• Data analysis plan:
  Statistical analyses will be of exploratory and descriptive nature only. No confirmatory hypothesis tests will be performed. In case that statistical test is performed p-values will be interpreted as a metric for uncertainty thus no adjustment for multiplicity is necessary.

Documents

Study results

EU-PAS_Abstract_study 19677

Study report

19677 UVIA_CSR_v1.0_final_Redacted