{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"Stratified log rank test was used to compare progression-free survival between the two arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.092","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"Median PFS was not reached for Arm A (VRD).","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"7.1","upperLimit":"35.4","value":"17.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.\n\nThe PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.\n\nbortezomib: Given IV\n\nlenalidomide: Given PO\n\ndexamethasone: Given PO","id":"OG000","title":"Arm A (VRD)"},{"description":"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.\n\nbortezomib: Given IV\n\ndexamethasone: Given PO","id":"OG001","title":"Arm B (VD)"}],"paramType":"MEDIAN","populationDescription":"All randomized patients","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}