Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).
The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.
Federle
M P
MP
Presbyterian University Hospital, Department of Radiology, Pittsburgh, PA 15213, USA.
Chezmar
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Rubin
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Weinreb
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Freeny
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Semelka
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Brown
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Borello
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Lee
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Mattrey
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Dachman
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Saini
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Harmon
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Fenstermacher
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Pelsang
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Harms
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Mitchell
D G
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Halford
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Anderson
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Johnson
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Francis
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Bova
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Kenney
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Klippenstein
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Foster
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Turner
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D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000139:chemically induced; D003287:Contrast Media / Q000009:adverse effects; D003937:Diagnosis, Differential; D004492:Edetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007275:Injections, Intravenous / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D011247:Pregnancy; D011732:Pyridoxal Phosphate / Q000009:adverse effects / Q000031:analogs & derivatives*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D014839:Vomiting / Q000139:chemically induced
D003287:Contrast Media; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid