Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

As part of the clinical evaluation of gadoteridol injection, intravenous doses ranging from 0.05 to 0.3 mmol/kg were administered to 1,709 patients and volunteers. Safety monitoring included pre- and postdose physical examinations, vital signs, and clinical laboratory values. Adverse event recording included occurrence, duration, severity, relationship to injection, and clinical importance. No clinically important changes in physical examination results, electrocardiograms, or vital signs were attributed to gadoteridol injection except for one case of hypotension. Four clinically important changes in laboratory values possibly or definitely related to the contrast agent were noted in two patients (0.1%). Adverse events were recorded in 118 subjects (6.9%), including nausea in 24 subjects (1.4%) and taste perversion in 22 subjects (1.3%). All other adverse events occurred with a frequency of less than 1%. Adverse events related to contrast agent administration occurred in 79 subjects (4.6%). Gadoteridol injection demonstrated excellent clinical safety and patient tolerance at various doses and injection rates.
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PMID:Safety of gadoteridol injection: U.S. clinical trial experience. 769 5

Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies.
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PMID:Worldwide clinical safety assessment of gadoteridol injection: an update. 937 May 51