Trial reportEuropean radiology2017
Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study.
Trial report in European radiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Pooled it
- Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.Annals of internal medicine · 2020Pooled it
- Pulp Revascularization in an Autotransplanted Mature Tooth: Visualization with Magnetic Resonance Imaging and Histopathologic Correlation.Journal of clinical medicine · 2023Article
- Cardiac magnetic resonance assessment of cardiac involvement in autoimmune diseases.Frontiers in cardiovascular medicine · 2023Review
- Nephrogenic Systemic Fibrosis in Patients with Chronic Kidney Disease after the Use of Gadolinium-Based Contrast Agents: A Review for the Cardiovascular Imager.Diagnostics (Basel, Switzerland) · 2022Review
- Simultaneous dual-contrast imaging using energy-integrating detector multi-energy CT: An in vivo feasibility study.Medical physics · 2022Article
- The TRUTH confirmed: validation of an intraindividual comparison of gadobutrol and gadoteridol for imaging of glioblastoma using quantitative enhancement analysis.European radiology experimental · 2021Article
- Stability of MRI contrast agents in high-energy radiation of a 1.5T MR-Linac.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021Article
- Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.Journal of magnetic resonance imaging : JMRI · 2020Article
- Dynamic contrast-enhanced MR imaging of the prostate: intraindividual comparison of gadoterate meglumine and gadobutrol.European 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
- 10 Years of Nephrogenic Systemic Fibrosis: A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016.Investigative radiology · 2018Article
- Gadobutrol: A Review in Contrast-Enhanced MRI and MRA.Clinical drug investigation · 2018Review
- A guide for effective anatomical vascularization studies: useful ex vivo methods for both CT and MRI imaging before dissection.Journal of anatomy · 2018Article
- 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
- Gadobutrol versus gadofosveset-trisodium in MR venography of the lower extremities.European radiology · 2017Article
- Gadobutrol in India-A Comprehensive Review of Safety and Efficacy.Magnetic resonance insights · 2017Review
- Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study.Pediatric radiology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.
methodsGARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.
resultsMedian gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications.
conclusionsThe GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. KEY POINTS: • Gadobutrol at recommended dose shows low rates of adverse drug reactions • Gadobutrol demonstrates a uniform safety profile across diverse patient groups • Gadobutrol provides excellent contrast quality in routine practice.
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