Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety)
Federle M, Chezmar J, Rubin D, Weinreb J, Freeny P, Semelka R, Brown J, Borrello J, Lee J, Mattrey R, Dachman A, Saini S, Harmon B, Fenstermacher M, Pelsang R, Harms S, Mitchell D, Halford H, Anderson M, Johnson C, Francis I, Bova J, Kenney P, Klippenstein D, Foster G, Turner D, Stillman A, Nelson R, Young S, Patt R, Rifkin M, Seltzer S, Gay S, Robison R, Sherwin P, Ballerini R. Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety). Journal Of Magnetic Resonance Imaging 2000, 12: 186-197. PMID: 10931579, DOI: 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAdultAgedAged, 80 and overCardiovascular DiseasesContrast MediaDiagnosis, DifferentialEdetic AcidFemaleHumansImage EnhancementInjections, IntravenousLiver CirrhosisLiver NeoplasmsMagnetic Resonance ImagingMaleMiddle AgedPainPregnancyPyridoxal PhosphateRisk AssessmentSensitivity and SpecificityVomitingConceptsMagnetic resonance imagingMangafodipir trisodium injectionAdverse eventsMulticenter phase III clinical trialContrast-enhanced computed tomography examinationPhase III clinical trialsUnenhanced magnetic resonance imagingInjection of MnDPDPInjection-associated discomfortSerious adverse eventsShort-term safetyHepatic magnetic resonance imagingComputed tomography examinationSignificant short-term riskShort-term riskFocal liver lesionsClinical trialsTomography examinationLaboratory valuesLiver lesionsResonance imagingVital signsPatientsMnDPDPInjection