{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.17","upperLimit":"3.77","value":"2.83"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"}],"units":"Participants"}],"description":"PFS was defined as the time from allocation to the first documents PD as assessed by investigator per EBMT criteria or death due to any cause, whichever occurs first. PD: \\>25% increase in level of serum M-paraprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or \\>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median PFS (in months) and associated 95%CIs Kaplan-Meier method was used.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.","id":"OG000","title":"Vorinostat + Bortezomib"}],"paramType":"MEDIAN","populationDescription":"All participants who received at least one dose of study treatment","reportingStatus":"POSTED","timeFrame":"Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)","title":"PFS as Assessed by Investigator Per EBMT Criteria","type":"SECONDARY","unitOfMeasure":"Months"}