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临床试验/NCT05428397
NCT05428397已完成不适用

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

Bayer1 个研究点 分布在 1 个国家目标入组 152,233 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
152,233
试验地点
1
主要终点
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex

时间窗: ≤1 hour after contrast administration

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.

Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race

时间窗: ≤1 hour after contrast administration

Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions

时间窗: ≤1 hour after contrast administration

次要结局

  • Differences regarding specific HSRs in patients with different race(≤1 hour after contrast administration)
  • Differences regarding specific HSRs in patients with different sex(≤1 hour after contrast administration)
  • Differences regarding specific HSRs in patients from different countries/regions(≤1 hour after contrast administration)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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