{"analyses":[{"ciLowerLimit":"0.560","ciNumSides":"TWO_SIDED","ciPctValue":"96","ciUpperLimit":"0.906","estimateComment":"The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.","groupDescription":"With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0018","pValueComment":"The p-value is from a one-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":"0.712","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29","upperLimit":"39","value":"30"},{"groupId":"OG001","lowerLimit":"39","upperLimit":"52","value":"43"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"Unstratified median progression-free 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":"From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"Months"}