{"analyses":[{"ciLowerLimit":"0.524","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.959","estimateComment":"The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.","groupDescription":"Overall survival will be compared between the two treatment arms using a stratified log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0250","pValueComment":"The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).","paramType":"Hazard Ratio (HR)","paramValue":"0.709","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper bound of the confidence interval has not yet been reached.","groupId":"OG000","lowerLimit":"56","upperLimit":"NA","value":"64"},{"comment":"The upper bound of the confidence interval has not yet been reached.","groupId":"OG001","lowerLimit":"65","upperLimit":"NA","value":"75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"Unstratified median overall survival in months.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDexamethasone: Given PO\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nLenalidomide: Given PO","id":"OG000","title":"Arm I (Dexamethasone and Lenalidomide)"},{"description":"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.\n\nBortezomib: Given IV\n\nDexamethasone: Given PO\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nLenalidomide: Given PO","id":"OG001","title":"Arm II (Dexamethasone, Lenalidomide, Bortezomib)"}],"paramType":"MEDIAN","populationDescription":"All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.","reportingStatus":"POSTED","timeFrame":"Up to 6 years","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}