Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients

Autor: Susan Dohanish, So Yeon Kim, Josy Breuer, Jan Endrikat, Toshiaki Sakaguchi
Rok vydání: 2016
Předmět:
safety
Adult
Gadolinium DTPA
Male
magnetic resonance imaging (MRI)
Internationality
Adolescent
Drug-Related Side Effects and Adverse Reactions
Contrast Media
liver
030218 nuclear medicine & medical imaging
Gadoxetate Disodium
Young Adult
03 medical and health sciences
Age Distribution
0302 clinical medicine
Risk Factors
Prevalence
medicine
Humans
Radiology
Nuclear Medicine and imaging
Sex Distribution
Child
Aged
Radiological and Ultrasound Technology
medicine.diagnostic_test
business.industry
Liver Diseases
Infant
Newborn
Infant
Nausea
Magnetic resonance imaging
General Medicine
Middle Aged
Magnetic Resonance Imaging
Safety profile
Dyspnea
Treatment Outcome
Child
Preschool
030220 oncology & carcinogenesis
Female
Kidney Diseases
Gadoxetate disodium
Chemical and Drug Induced Liver Injury
Nuclear medicine
business
Zdroj: Acta Radiologica (Stockholm, Sweden : 1987)
ISSN: 1600-0455
0284-1851
DOI: 10.1177/0284185115588126
Popis: Background Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. Purpose To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. Material and Methods Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. Results A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population ( n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. Conclusion Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.
Databáze: OpenAIRE
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