2014
Advancing pharmacovigilance through academic–legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis—a research on adverse drug events and reports (RADAR) report
Edwards BJ, Laumann AE, Nardone B, Miller FH, Restaino J, Raisch DW, McKoy JM, Hammel JA, Bhatt K, Bauer K, Samaras AT, Fisher MJ, Bull C, Saddleton E, Belknap SM, Thomsen HS, Kanal E, Cowper SE, Abu Alfa AK, West DP. Advancing pharmacovigilance through academic–legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis—a research on adverse drug events and reports (RADAR) report. British Journal Of Radiology 2014, 87: 20140307. PMID: 25230161, PMCID: PMC4170864, DOI: 10.1259/bjr.20140307.Peer-Reviewed Original ResearchConceptsGadolinium-based contrast agentsAdverse drug eventsDrug eventsMedicines AgencyGadopentetate dimeglumineDrug Administration Adverse Event Reporting SystemAdverse Event Reporting SystemDanish Medicines AgencyNephrogenic systemic fibrosisEvent Reporting SystemEuropean Medicines AgencyNSF casesHistopathological dataContrast agentsSystemic fibrosisDrug AdministrationLegal data setsUnconfounded casesGadobenate dimeglumineMean numberDimeglumineReporting systemPharmacovigilance researchSafety informationPharmacovigilance
2013
Acute Kidney Injury and Bisphosphonate Use in Cancer: A Report From the Research on Adverse Drug Events and Reports (RADAR) Project
Edwards BJ, Usmani S, Raisch DW, McKoy JM, Samaras AT, Belknap SM, Trifilio SM, Hahr A, Bunta AD, Abu-Alfa A, Langman CB, Rosen ST, West DP. Acute Kidney Injury and Bisphosphonate Use in Cancer: A Report From the Research on Adverse Drug Events and Reports (RADAR) Project. JCO Oncology Practice 2013, 9: 101-106. PMID: 23814519, PMCID: PMC3595436, DOI: 10.1200/jop.2011.000486.Peer-Reviewed Original ResearchConceptsAcute kidney injuryZoledronic acidKidney injuryAdverse eventsProportional reporting ratioFDA AERSBisphosphonate useSafety signalsReporting ratioAdverse drug eventsDrug Administration adverse eventsAdverse drug reactionsCancer clinical trialsPremorbid diseaseRenal injuryRenal problemsMean ageMultiple myelomaDrug eventsDrug reactionsClinical trialsProstate cancerBreast cancerCancer settingUS Food