NCT04605471

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
• Phase: —
• Study type: Observational
• Enrollment: 132,850 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Iopromide(Ultravist, BAY86-4877)	The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.

Timeline

• Start date: 2020-10-31
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-10-28
• Last updated: 2021-07-20

Locations

1 site across 1 country: Germany