Evidence map›Paper›PMID 31663202›Full record

ArticleJournal of magnetic resonance imaging : JMRI2020

Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.

Sung Bum Cho, A-Leum Lee, Hyuk Won Chang, Kyeong Ah Kim, Won Jong Yoo, Jeong A Yeom, Myung Ho Rho, Sung Jin Kim, Yun-Jung Lim, Miran Han

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Journal of magnetic resonance imaging : JMRI, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 10 institutions in 2 countries.

Sung Bum ChoDepartment of Radiology, Anam Hospital, College of Medicine, Korea University, Seoul, Korea.
A-Leum LeeDepartment of Radiology, Soonchunhyang University Hospital, Gyeonggi-do, Korea.
Hyuk Won ChangDepartment of Radiology, Dongsan Medical Center, Keimyung University, Daegu, Korea.
Kyeong Ah KimDepartment of Radiology, Korea University Guro Hospital, Seoul, Korea.
Won Jong YooDepartment of Diagnostic Radiology, Bucheon St. Mary's Hospital, Catholic University of Korea, Gyeonggi-do, Korea.
Jeong A YeomDepartment of Radiology, Pusan National University Yangsan Hospital, Gyeongsangnam-do, Korea.
Myung Ho RhoDepartment of Radiology, Kangbuk Samsung Hospital, Seoul, Korea.
Sung Jin KimDepartment of Radiology, Chungbuk National University Hospital, Chungcheongbuk-do, Korea.
Yun-Jung LimDepartment of Radiology, Haeundae Paik Hospital, Busan, Korea.
Miran HanDepartment of Radiology, Ajou University Medical Center, Suwon-si, Korea.
Ajou University · KRCatholic University of Korea · KRChungbuk National University Hospital · KRInje University Haeundae Paik Hospital · KRKangbuk Samsung Hospital · KRKeimyung University Dongsan Medical Center · KRKorea University · KRKorea University Medical Center · KRPusan National University Yangsan Hospital · KRSoonchunhyang University Hospital Seoul · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

resultsOverall, 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

conclusionThe 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. LEVEL OF EVIDENCE: 2 Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2020;51:861-868.

Indexed as

Heterocyclic CompoundsOrganometallic CompoundsAdolescentAdultAgedAged, 80 and overChildContrast MediaFemaleGadoliniumHumansMagnetic Resonance ImagingMaleMiddle AgedProspective StudiesYoung AdultContrast MediaGadoliniumgadoteridolHeterocyclic CompoundsOrganometallic Compoundsadverse reactionscontrast agent safetygadolinium-based contrast agentsgadoteridolprospective, observational studies

Identifiers

PMID31663202
PMCPMC7027821
OpenAlexW2982297564

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.