ArticleJapanese journal of radiology2018
Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan.
Article in Japanese journal of radiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02540967 (Drug Use Investigation of Gadovist), which is not on this map. Cited by 8 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.
Drug Use Investigation of Gadovist
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.Annals of internal medicine · 2020Pooled it
- Risk of Nephrogenic Systemic Fibrosis in Patients With Stage 4 or 5 Chronic Kidney Disease Receiving a Group II Gadolinium-Based Contrast Agent: A Systematic Review and Meta-analysis.JAMA internal medicine · 2020Pooled it
- Guidelines for administering gadolinium-based contrast agents to patients with renal dysfunction (version 3: revised may 20th, 2024).Japanese journal of radiology · 2025Article
- Guidelines for administering gadolinium-based contrast agents to patients with renal dysfunction (Version 3: Revised May 20th, 2024).Clinical and experimental nephrology · 2025Review
- 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
- The TRUTH confirmed: validation of an intraindividual comparison of gadobutrol and gadoteridol for imaging of glioblastoma using quantitative enhancement analysis.European radiology experimental · 2021Article
- 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
- Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.Journal of magnetic resonance imaging : JMRI · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan. MATERIALS AND
methodsGadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection.
resultsQuestionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4 years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02 mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1 h post-injection)-including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations.
conclusionGadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.
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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.