{"denomUnitsSelected":"Participants","description":"Safety analysis will be conducted using the Safety Population defined as any patient receiving one dose of study treatment. For toxicity reporting, all adverse events and laboratory abnormalities will be graded and analyzed using CTCAE version 4 as appropriate.","reportingStatus":"NOT_POSTED","timeFrame":"2 years","title":"Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)","type":"SECONDARY"}