Table 3Characteristics of Included Primary Clinical Studies

First Author, Publication Year, CountryStudy DesignPopulation CharacteristicsIntervention and Comparator(s)Clinical Outcomes, Length of Follow-Up
Gutierrez, 2015, USAPhase III, prospective, multicenter, doubleblind, crossover trialMen and women aged ≥ 18 years, referred for contrast-enhanced MRI of the CNS
  • Gadobutrol followed by gadoteridol
  • Gadoteridol followed by gadobutrol
Clinical Outcomes:
  • Adverse events
Length of Follow-up:
  • Adverse events were monitored >72 hours following the crossover MRI study with the second contrast agent
Gutierrez, 2015, USAInternational, multicenter, open-label controlled Phase III studyMen and women aged ≥ 18 years, referred for contrast-enhanced MRI of the CNSIntervention
  • Gadobutrol
Comparator
  • No agent
Clinical Outcomes
  • Monitoring vital signs
  • Adverse events
  • Physical examinations
  • Laboratory parameters
  • Comparison to baseline safety parameters obtained before MR imaging
Length of Follow-up
  • 72 hours
Kuwatsuru, 2015, JapanMulticenter, randomized, controlled single-blind, parallelgroup comparison Phase III studyMale and female patients, age 20 years or older, referred for contrast-enhanced MRI of regions in the body and/or extremitiesIntervention
  • Gadobutrol
Comparator
  • Gadopentetate dimeglumine
Clinical Outcomes
  • Adverse events
  • Delayed drug reactions
  • Clinical laboratory parameters
  • Vital signs
  • Physical examinations
Length of Follow-up
  • 24 ± 4 hours
Liang, 2012, ChinaMulticenter, singleblind, randomized comparative studyChinese patients aged 18 – 65 years with known or suspected cranial and/or spinal CNS lesions requiring contrast-enhanced MRIIntervention
  • Gadobutrol
Comparator
  • Gadopentetate dimeglumine
Clinical Outcomes
  • Incidence and severity of adverse events following injection
Length of Follow-up
  • 24 hours
Naito, 2017, JapanProspective, randomized studyPatients aged 20 to 85 years weighing 45 to 70 kg with normal or mildly-diminished renal function (serum creatinine < 1.6 mg/dL in the 3 months prior to MRI), who were scheduled for contrastenhanced MRI of the brain at Kitasato University HospitalIntervention
  • Gadodiamide
Comparator
  • Gadopentetate dimeglumine
Clinical Outcomes
  • Renal function before and after administration of contrast media
  • Contrast-induced nephropathy (CIN)
Semelka, 2013, USARandomized, controlled, blinded studyPatients who had clinical MR studies ordered of the brain or abdomenIntervention
  • Gadobutrol
Comparator
  • Gadobenate dimeglumine
Clinical Outcomes
  • Acute, visually apparent adverse events
Tanaka, 2016, JapanMulticenter, open-label, controlled study with blinded image evaluationMen and women aged ≥ 18 years referred for a contrast-enhanced MRI of the CNS with any indicationIntervention
  • Gadobutrol
Comparator
  • No agent
Clinical Outcomes
  • Occurrence of adverse events
  • Vital signs
  • Physical examinations
  • Clinical laboratory parameters
Length of Follow-up
  • 72 hours
Zech, 2019, SwitzerlandProspective, multicenter, doubleblind, randomized, inter-individual Phase III studyPatients ≥ 18 years of age with suspected or known focal liver lesions, scheduled for contrast-enhanced liver MRIIntervention
  • Gadoxetate disodium
Comparator
  • Gadobenate dimeglumine
Clinical Outcomes
  • Adverse events

CIN = contrast-induced nephropathy; CNS = central nervous system; MR = magnetic resonance; MRI = magnetic resonance imaging; USA = United States of America

From: Macrocyclic and Linear Gadolinium Based Contrast Agents for Adults Undergoing Magnetic Resonance Imaging: A Review of Safety

Cover of Macrocyclic and Linear Gadolinium Based Contrast Agents for Adults Undergoing Magnetic Resonance Imaging: A Review of Safety
Macrocyclic and Linear Gadolinium Based Contrast Agents for Adults Undergoing Magnetic Resonance Imaging: A Review of Safety [Internet].
Cowling T, Frey N.
Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

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