A Study to Learn More About the Safety of Ultravist in Children and in the Elderly

Safety Profile of Ultravist in Children and Elderly (UV Age)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04605471

Enrollment

132850

Registered

2020-10-28

Start date

2020-10-31

Completion date

2021-03-31

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity

Brief summary

Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety. Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults. The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study. All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.

Interventions

DRUGIopromide(Ultravist, BAY86-4877)

The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.

Exclusion criteria

* Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.

Design outcomes

Primary

Measure	Time frame
Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults	Analysis will be done in 2 months

Secondary

Measure	Time frame
Profile of HSRs (hypersensitivity reactions) in the three age groups	Analysis will be done in 2 months
General reported ADR (adverse drug reactions) profile in the three age groups	Analysis will be done in 2 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026