Trial reportInvestigative radiology2016
Safety of Gadobutrol: Results From 42 Clinical Phase II to IV Studies and Postmarketing Surveillance After 29 Million Applications.
Trial report in Investigative radiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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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.
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.
Who cites it
20 citing papers in PubMed, 36 citations in OpenAlex.
- Comparison of Gadoterate Meglumine and Gadobutrol in the MRI Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study).AJNR. American journal of neuroradiology · 2017Trial
- Gadobutrol in Renally Impaired Patients: Results of the GRIP Study.Investigative radiology · 2017Trial
- Gadoquatrane in Contrast-enhanced Head-and-neck and Liver Magnetic Resonance Imaging: A Preclinical Dose-Response Study in Pigs.Investigative radiology · 2026Article
- Roadmap on magnetic nanoparticles in nanomedicine.Nanotechnology · 2024Review
- Acute adverse reactions after multiple initially well-tolerated gadolinium-based contrast-enhanced abdomen MRIs in pediatric patients.PloS one · 2024Article
- The Emerging Role of MR Urography in Imaging Megaureters in Children.Frontiers in pediatrics · 2022Article
- The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study.Contrast media & molecular imaging · 2021Observational
- Review
- Gadolinium labelled nanoliposomes as the platform for MRI theranostics: in vitro safety study in liver cells and macrophages.Scientific reports · 2020Article
- Comparison of the Relaxivities of Macrocyclic Gadolinium-Based Contrast Agents in Human Plasma at 1.5, 3, and 7 T, and Blood at 3 T.Investigative radiology · 2019Article
- Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children.Acta radiologica (Stockholm, Sweden : 1987) · 2019Article
- Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan.Japanese journal of radiology · 2018Article
- Gadobutrol: A Review in Contrast-Enhanced MRI and MRA.Clinical drug investigation · 2018Review
- Differences in gadolinium retention after repeated injections of macrocyclic MR contrast agents to rats.Journal of magnetic resonance imaging : JMRI · 2018Article
- Fatal anaphylactic reaction to intravenous gadobutrol, a gadolinium-based MRI contrast agent.Radiology case reports · 2018Article
- Article
- Gadolinium-Based Contrast Agents in Kidney Disease: A Comprehensive Review and Clinical Practice Guideline Issued by the Canadian Association of Radiologists.Canadian journal of kidney health and disease · 2018Article
- Accuracy and Repeatability of Automated Injector Versus Manual Administration of an MRI Contrast Agent-Results of a Laboratory Study.Investigative radiology · 2018Article
- Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.BMJ open · 2017Article
- Gadobutrol in India-A Comprehensive Review of Safety and Efficacy.Magnetic resonance insights · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. MATERIALS AND
methodsForty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998-2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups.
resultsIn the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups.The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea.For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded.
conclusionsGadobutrol is well tolerated and has a favorable safety profile for patients of all age groups.
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Registered trials
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.