Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety)

Autor: Michael P. Federle, Judith L. Chezmar, Daniel L. Rubin, Jeffrey C. Weinreb, Patrick C. Freeny, Richard C. Semelka, Jeffrey J. Brown, Joseph A. Borrello, Joseph K.T. Lee, Robert Mattrey, Abraham H. Dachman, Sanjay Saini, Ben Harmon, Marc Fenstermacher, Retta E. Pelsang, Steven E. Harms, Donald G. Mitchell, Hollis H. Halford III, Mark W. Anderson, C. Daniel Johnson, Isaac R. Francis, James G. Bova, Philip J. Kenney, Donald L. Klippenstein, Gregory S. Foster, David A. Turner, Arthur E. Stillman, Rendon C. Nelson, Stuart W. Young, Richard H. Patt, Matthew Rifkin, Steven E. Seltzer, Spencer B. Gay, Ronald O. Robison, Paul F. Sherwin, Rocco Ballerini
Rok vydání: 2000
Předmět:
Zdroj: Journal of Magnetic Resonance Imaging. 12:186-197
ISSN: 1522-2586
1053-1807
DOI: 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2
Popis: 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.
Databáze: OpenAIRE
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