{"analyses":[{"ciLowerLimit":"1.158","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.465","groupDescription":"A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.05.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Applied anti-log procedure to convert original scale. Non-inferiority was concluded if lower limit of ratio of geometric mean 90% CI was greater or equal to 0.80.","nonInferiorityType":"NON_INFERIORITY","paramType":"Ratio of geometric mean","paramValue":"1.302"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"117","value":"302"},{"groupId":"OG001","spread":"215","value":"421"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"description":"The CT4W was the observed plasma concentrations collected on pre-dose at Cycle 2 Day 1 (equivalent to prior to Cycle 2 Day 1) of isatuximab administration dose.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG000","title":"Isa-IV + Pd"},{"description":"Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG001","title":"Isa-SC + Pd"}],"paramType":"MEAN","populationDescription":"The CT4W-PK population: all randomized participants who met following: all 4 Isa doses for Cycle 1 administered; Isa pre-dose plasma concentration results from PK samples on Cycle 2 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times.","reportingStatus":"POSTED","timeFrame":"Pre-dose at Cycle 2 Day 1 (at 4 weeks)","title":"Ctrough of Isatuximab at 4 Weeks (CT4W)","type":"SECONDARY","unitOfMeasure":"mcg/mL"}