{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.419","statisticalMethod":"Exact Test for Binomial Parameter"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.6","upperLimit":"17.7","value":"11.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"}],"units":"Participants"}],"description":"Objective RR was defined as percentage (%) of participants with complete response (CR: disappearance of original monoclonal (M) paraprotein from blood \\& urine on at least 2 determinations for at least 6 weeks (WKs) by immunofixation studies, \\<5% plasma cells in bone marrow on at least 1 determination, no increase in size/number of lytic bone lesions (LBLs) \\& disappearance of soft tissue plasmacytomas (STP) for at least 6 WKs on skeletal survey (SS) if available) or partial response (PR: ≥50% reduction in serum M protein for at least 2 determinations 6 WKs apart, if present, reduction in 24-hour urinary light chain excretion by ≥90% or ≤200 mg for at least 2 determinations 6 WKs apart, ≥50% reduction in STP size for at least 6 WKs, \\& no increase in size/number of LBLs on SS if available) as assessed by Independent Adjudication Committee (IAC) per European Blood \\& Marrow Transplant (EBMT) criteria. To report RR \\& 95% confidence intervals (CIs), exact test of binomial parameter 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":"NUMBER","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":"Objective Response Rate (RR)","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}