{"description":"Patients are monitored for adverse events in the scanning unit for the entire MRI time and 30 minutes after the final infusion of ferumoxytol An additional phone follow up visit was performed 4-6 weeks after each imaging session to focus on any new adverse events","eventGroups":[{"deathsNumAffected":119,"deathsNumAtRisk":155,"description":"Study patients: adult patients with high grade primary malignant brain tumors\n\nStudy procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.\n\n3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI\n\nDynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI\n\nDynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI\n\nFerumoxytol: Given IV\n\nGadolinium: Given IV\n\nMRI-Based Angiogram: Undergo MRA","id":"EG000","otherNumAffected":12,"otherNumAtRisk":152,"seriousNumAffected":0,"seriousNumAtRisk":152,"title":"Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)"}],"frequencyThreshold":"0.5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":152,"numEvents":14}],"term":"Hypertension"}],"timeFrame":"Subjects were evaluated for adverse events approximately 4-6 weeks after each study visit, up to 5 years."}