Worldwide clinical safety assessment of gadoteridol injection: an update

Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Eur...

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Bibliographic Details
Published in:European radiology 1997-01, Vol.7 Suppl 5 (S5), p.243-S245
Main Authors: Runge, V M, Parker, J R
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Child
Contrast Media - adverse effects
Drug therapy
Female
Gadolinium - administration & dosage
Gadolinium - adverse effects
Heterocyclic Compounds - administration & dosage
Heterocyclic Compounds - adverse effects
Humans
Infusions, Intravenous
Magnetic Resonance Imaging - methods
Male
Medical research
Middle Aged
Molecular weight
Organometallic Compounds - administration & dosage
Organometallic Compounds - adverse effects
Safety
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Summary:Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies.
ISSN:0938-7994
1432-1084
DOI:10.1007/pl00006900