| Evaluation of the clinical safety of gadodiamide injection, a new nonionic MRI contrast medium for the central nervous system: a European perspective. | |
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MedLine Citation:
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PMID: 8880714 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Gadodiamide injection is a new nonionic paramagnetic, extracellular contrast medium. Its safety at a dose of 0.1 mmol/kg body weight was evaluated in a large European multicentre trial on adults referred for contrast-enhanced MRI of the central nervous system. Safety analysis was performed on 2102 patients, in whom adverse events during and up to 24 h after injection were recorded. Adverse events related or possibly related to gadodiamide injection were observed in 102 patients. Injection-associated reactions classified as discomfort (sensation of heat or coldness, pain or pressure at the injection site) occurred in 37 patients (1.8%) and other adverse events (e.g. headache, nausea) were observed in 65 patients (3.1%). No serious adverse event was reported. Efficacy analysis, performed on 2273 patients, and based on comparison of T1- and T2-weighted images before and T1-weighted images after injection showed that more diagnostic information was obtained after gadodiamide injection in 1424 (62.6%) patients: management of 386 (17.0%) patients was affected by the new information given and that a new diagnosis was made in 755 (33.3%) patients. Gadodiamide injection was shown to be safe and well tolerated. It represents a nonionic alternative to the current products for MRI of the central nervous system. |
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Authors:
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V Aslanian; H Lemaignen; P Bunouf; M G Svaland; A Borseth; B Lundby |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study |
Journal Detail:
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Title: Neuroradiology Volume: 38 ISSN: 0028-3940 ISO Abbreviation: Neuroradiology Publication Date: 1996 Aug |
Date Detail:
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Created Date: 1997-02-21 Completed Date: 1997-02-21 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 1302751 Medline TA: Neuroradiology Country: GERMANY |
Other Details:
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Languages: eng Pagination: 537-41 Citation Subset: IM |
Affiliation:
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Laboratoires Nycomed SA, Paris, France. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Adverse Drug Reaction Reporting Systems Aged Aged, 80 and over Central Nervous System Diseases / diagnosis* Contrast Media / adverse effects* Europe Female Gadolinium DTPA* Humans Injections, Intravenous Magnetic Resonance Imaging* Male Middle Aged Organometallic Compounds / adverse effects*, diagnostic use Pentetic Acid / adverse effects, analogs & derivatives*, diagnostic use |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Organometallic Compounds; 122795-43-1/gadodiamide; 67-43-6/Pentetic Acid; 80529-93-7/Gadolinium DTPA |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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