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Comparison of the safety of the standard dose and a higher dose of gadodiamide injection for MR imaging of the central nervous system
Author(s) -
Svaland Marit G.,
Lundby Bjørg,
Kristoffersen Doris T.
Publication year - 1994
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/jmri.1880040330
Subject(s) - gadodiamide , medicine , tolerability , adverse effect , magnetic resonance imaging , lesion , contrast medium , nuclear medicine , central nervous system , radiology , surgery
This study compared the safety and tolerability of gadodiamide injection at the standard dose (0.1 mmol/kg) and at a higher dose (0.3 mmol/kg) in 289 patients participating in a parallel group multiple independent trial program. All patients had a known or suspected central nervous system lesion necessitating investigation with contrast mediumenhanced magnetic resonance imaging. Safety assessments were made before and after injection of the contrast medium, and 1 day later. No adverse events were judged to be related to gadodiamide injection, and only 3.5% of the patients in each dose group reported adverse events that had an uncertain relationship to the contrast medium; both doses were therefore well tolerated. Headache was the most frequently reported event (2%). There were no significant injection‐related changes in neurologic status, laboratory test results, or vital signs. The data obtained indicate that the higher dose of gadodiamide injection is as safe and well tolerated as the standard dose.