{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5","upperLimit":"57","value":"28"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"2-year progression free survival (PFS) is the probability of participants alive and progression free at 2 years from study entry estimated using Kaplan-Meier methods. PFS is defined as the time from enrollment to progressive disease (PD) or death. PD is defined as ≥25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable the disease. Patients alive without PD and not reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment. Patients reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment date prior to post-discontinuation therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG000","title":"Phase II"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Patients were assessed for disease every cycle while on treatment (168 days) and every three months while on maintenance therapy. In long-term follow-up, disease was monitored every 3 months. Study cohort median (range) follow-up was 15 (1 - 23) months.","title":"2 Year Progression-free-survival [Phase II]","type":"SECONDARY","unitOfMeasure":"percent probability of PFS"}