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Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients

Authors
Cho, Sung BumLee, A-LeumChang, Hyuk WonKim, Kyeong AhYoo, Won JongYeom, Jeong A.Rho, Myung HoKim, Sung JinLim, Yun-jungHan, Miran
Issue Date
3월-2020
Publisher
WILEY
Keywords
gadolinium-based contrast agents; contrast agent safety; adverse reactions; gadoteridol; prospective; observational studies
Citation
JOURNAL OF MAGNETIC RESONANCE IMAGING, v.51, no.3, pp.861 - 868
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF MAGNETIC RESONANCE IMAGING
Volume
51
Number
3
Start Page
861
End Page
868
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/57539
DOI
10.1002/jmri.26940
ISSN
1053-1807
Abstract
Background The safety of gadolinium-based contrast agents is of fundamental importance. Purpose To determine the frequency and severity of immediate-type adverse reactions to approved doses of gadoteridol in patients referred for routine gadoteridol-enhanced MRI in actual clinical practice settings. Study Type Prospective, observational. Population In all, 6163 subjects were enrolled (mean age: 56.7 +/- 15.4 years; range: 6-93 years). Field Strength/Sequence 1.5T and 3.0T. Assessment Assessment was of immediate adverse reactions by the investigating radiologist using the MedDRA System Organ Class and preferred term. Statistical Tests Summary statistics for continuous variables, descriptive statistics for demographic characteristics. Results Overall, 19 adverse events occurred in 13 (0.21%) patients, of which 15 in 10 (0.16%) patients were considered related to gadoteridol administration. These events were evenly distributed between male and female subjects and all occurred in adults. Twelve of the 15 related events in eight (0.13%) patients were considered mild in intensity (rapidly self-resolving), while the remaining three events in two patients (0.03%) were considered moderate in intensity. None were of severe intensity and no serious adverse events occurred. Data Conclusion The rate of immediate-type adverse events following exposure to approved doses of gadoteridol is extremely low, and mostly limited to transient and self-resolving symptoms. Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2019.
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