{"denomUnitsSelected":"Participants","description":"-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.","reportingStatus":"NOT_POSTED","timeFrame":"Up to 30 days following completion of treatment (estimated to be 106 weeks)","title":"Toxicity of Regimen as Measured by Number of Grade 3-5 Adverse Events","type":"SECONDARY"}