{"denomUnitsSelected":"Participants","description":"A binary variable will be determined for each participant indicating whether or not the subject had at least one treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.03. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start.","reportingStatus":"NOT_POSTED","timeFrame":"From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years.","title":"Number of Participants With at Least One Treatment Emergent Adverse Event","type":"OTHER_PRE_SPECIFIED"}