{"analyses":[{"groupDescription":"Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \\> 0.25","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":">0.9999","pValueComment":"one-sided p-value","statisticalMethod":"exact binomial distribution"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"9.5","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"units":"Participants"}],"description":"ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p \\<100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to \\<200 mg/24 hours. Cohort 2 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented.","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.","id":"OG000","title":"Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)"}],"paramType":"NUMBER","populationDescription":"All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.","reportingStatus":"POSTED","timeFrame":"Up to approximately 78.5 months","title":"Objective Response Rate (ORR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}