{"analyses":[{"groupIds":["OG002"],"nonInferiorityComment":"Null hypothesis of ORR by BICR was 30%.","nonInferiorityType":"OTHER","pValue":"0.0076","statisticalMethod":"Exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.5","upperLimit":"75.5","value":"37.5"},{"groupId":"OG001","lowerLimit":"34.3","upperLimit":"71.7","value":"53.3"},{"groupId":"OG002","lowerLimit":"33.4","upperLimit":"66.6","value":"50.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"38"}],"units":"Participants"}],"description":"ORR: Percentage of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \\& normal serum free light chain (sFLC) ratio \\& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \\& urine, disappearance of any soft tissue plasmacytoma \\& \\<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \\& urine M-protein detectable by immunofixation but not on electrophoresis; or \\>=90% reduction in serum M-protein \\& urine M-protein level \\<100mg/24h. PR: \\>=50% reduction in serum M-protein \\& reduction in 24h urinary M-protein by \\>=90% or \\<200 mg/24h. If serum \\& urine M-protein were unmeasurable, VGPR \\& PR: \\>=90% \\& \\>=50% decrease in difference respectively between involved \\& uninvolved sFLC levels \\& if present at baseline, \\>=90% \\& \\>=50% reduction in soft tissue plasmacytomas' size.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.","id":"OG000","title":"Phase 1b"},{"description":"Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.","id":"OG001","title":"Phase 2"},{"description":"Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.","id":"OG002","title":"Phase 1b + Phase 2"}],"paramType":"NUMBER","populationDescription":"The primary analysis of ORR as planned per protocol included participants who started with the recommended phase 2 dose \\[RP2D\\] (including the participants from both Phase 1b and Phase 2 parts). Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.","reportingStatus":"POSTED","timeFrame":"From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (approximately up to 16 months)","title":"Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}