A Study, Called UV Population, to Learn More About the Safety of the Study Drug Ultravist, Which is Given to Get Clearer X-ray Pictures, in People of Different Sexes, Races, and From Different Countries/Regions

Safety Profile of Ultravist in Patients With Different Sexes, Races and From Different Countries/Regions

This is an observational study in which patient data from the past of people who received Ultravist prior to an X-ray based scan are studied.

In observational studies, only observations are made without specified advice or interventions.

X-ray based imaging like computed tomography or angiography is used to make pictures of the structures inside the body. These pictures are needed in various medical situations. In some X-ray tests, the patient is given a compound called "contrast agent" that is injected into the vein. It helps to create clearer pictures as it makes internal body structures easier to see. With such contrast-enhanced imaging techniques, doctors can better see certain problems.

Ultravist is an iodine-based contrast agent. It is also called iopromide, and it is available for doctors to give patients before they have X-ray based scans.

Clinical studies on the overall safety of Ultravist have shown that hypersensitivity reactions (HSRs) may rarely occur. HSRs are undesirable reactions of the body's defense system (immune system) to the study drug. However, more information on HSRs is needed.

The main aim of this study is to find out whether certain groups of people are more likely to have HSRs after Ultravist injection than others (e.g., depending on gender, race, or country/region).

To do this, researchers will collect data from people with HSRs (all ages) after contrast-enhanced X-ray scans with Ultravist. These data come from four observational studies that have already been completed. Participants who had HSRs will be compared with participants in these studies who had no medical problems after receiving Ultravist to learn more about the characteristics of people at higher risk.

Data will be from the year 1999 up to 2011. No visits or tests are required as part of this study.

Study Overview

• Status: Completed
• Conditions: Contrast Enhanced X-ray Based Examination
• Intervention / Treatment: Diagnostic test: Iopromide (Ultravist, BAY86-4877)

• Study Type: Observational
• Enrollment (Actual): 152233

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, 42096
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

In this integrated analysis, the data of four company sponsored non-interventional studies with Ultravist in contrast-enhanced X-ray examination have been pooled. This pool consists of studies 'PMS I', 'IMAGE', 'TRUST', 'Ultravist in CT'.The total data pool consists of 152,233 patients. The timeframe of these 4 studies is from 6/1999 until 11/2011. The study utilizes data collected as a part of clinical practice across 37 countries and including Europe (mostly Germany and Spain), Asia (mostly China and South Korea) and USA. It will not include any new and not yet published data. Patients of all ages, both sexes, multiple races and across various health conditions/indications are represented in this pooled database.

Description

Inclusion Criteria:

• Patients of all age groups which were referred to any iodine-based contrast-enhanced procedure after administration of either Ultravist 300 mg I/mL or 370 mg I/mL.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contrast enhanced X-ray based examination with Ultravist; Patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons and having experienced a hypersensitivity reaction.	Diagnostic test: Iopromide (Ultravist, BAY86-4877); X-Ray/CT Diagnostic Imaging; Other Names: BAY86-4877_Iopromide_IV_X-Ray/CT Diagnostic Agents
Control group; Patient who received contrast enhanced X-ray based examination with Ultravist for various indications who had not adverse event.	Diagnostic test: Iopromide (Ultravist, BAY86-4877); X-Ray/CT Diagnostic Imaging; Other Names: BAY86-4877_Iopromide_IV_X-Ray/CT Diagnostic Agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex	Cases (based on MedDRA version 21.0): Patients with any typical and unequivocal hypersensitivity reaction: anaphylactoid shock, angioedema, asthma, bronchospasm, conjunctivitis, cough, dysphagia, dyspnea, edema mucosal, erythema/exanthema/rash, hoarseness, lacrimation, laryngeal/pharyngeal/face edema, laryngeal/pharyngeal spasm, nasal stuffiness, pruritus/itching, respiratory arrest, rhinitis, sneezing, stridor, swelling (eyes/face), throat irritation, tongue edema, urticaria/hives/blisters, wheezing.	≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race		≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions		≤1 hour after contrast administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences regarding specific HSRs in patients with different sex	≤1 hour after contrast administration
Differences regarding specific HSRs in patients with different race	≤1 hour after contrast administration
Differences regarding specific HSRs in patients from different countries/regions	≤1 hour after contrast administration

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Palkowitsch P, Lengsfeld P, Stauch K, Heinsohn C, Kwon ST, Zhang SX, Liang CH. Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE). Acta Radiol. 2012 Mar 1;53(2):179-86. doi: 10.1258/ar.2011.110359. Epub 2011 Dec 19.
• Chen W, Mempel M, Schober W, Behrendt H, Ring J. Gender difference, sex hormones, and immediate type hypersensitivity reactions. Allergy. 2008 Nov;63(11):1418-27. doi: 10.1111/j.1398-9995.2008.01880.x.
• Chen JY, Liu Y, Zhou YL, Tan N, Zhang B, Chen PY, Chen LB. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial. Int J Cardiovasc Imaging. 2015 Oct;31(7):1281-91. doi: 10.1007/s10554-015-0688-9. Epub 2015 Jun 10.
• Kopp AF, Mortele KJ, Cho YD, Palkowitsch P, Bettmann MA, Claussen CD. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol. 2008 Oct;49(8):902-11. doi: 10.1080/02841850802282811.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Computed tomography; CT; Contrast enhancement; Angiography; Hypersensitivity reaction
• Other Study ID Numbers: 22133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No