{"denomUnitsSelected":"Participants","description":"Heterogeneity of treatment effect will be assessed at full information, using a two-sided statistical test for interaction between study arm (ixazomib/lenalidomide vs. placebo/lenalidomide) and baseline 18F-FDG PET/CT status (positive/abnormal vs. negative) in a Cox regression model. If the statistical test for interaction is not significant at the 0.05 level, we will conclude that there is not sufficient evidence for heterogeneity of treatment effect; if the statistical test for interaction is significant, estimated treatment hazard ratios for OS (ixazomib arm vs. placebo arm) will be reported separately for baseline 18FFDG PET/CT-positive and 18F-FDG PET/CT-negative subgroups, along with the corresponding 95% confidence intervals. OS will be defined as the time from randomization until death or the date last known alive.","reportingStatus":"NOT_POSTED","timeFrame":"Assessed every 3 months if patient is <2 years from randomization, every 6 months if patient is 2-5 years from randomization, annually if patient is 5 years or more from randomization.","title":"To Compare Overall Survival (OS) With the Addition of Ixazomib to Lenalidomide Among Baseline 18F-FDG PET/CT-positive and 18F-FDG PET/CT-negative Subgroups.","type":"OTHER_PRE_SPECIFIED"}