{"analyses":[{"ciLowerLimit":"6.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.8","estimateComment":"Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.","groupIds":["OG000"],"nonInferiorityType":"OTHER","paramType":"median PFS","paramValue":"8.5"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.2","upperLimit":"10.8","value":"8.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"}],"units":"Participants"}],"description":"The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \\>75 years of age.\n\nFollowing implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter","id":"OG000","title":"Ibrutinib+ Bortezomib+ Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"All participant received: see description on Arm/Group description. Following implementation of Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22 and 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter.","reportingStatus":"POSTED","timeFrame":"The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.","title":"Median Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}