{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.00","value":"0.00"},{"groupId":"OG001","spread":"0.00","value":"0.00"},{"groupId":"OG002","spread":"0.00","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"Day 1: 0 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.33","value":"78.48"},{"groupId":"OG001","spread":"99.31","value":"217.90"},{"groupId":"OG002","spread":"202.74","value":"434.20"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"title":"Day 1: 0.5 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hours"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"107.44","value":"268.35"},{"groupId":"OG002","spread":"207.28","value":"520.97"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"title":"Day 8: 2 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.28","value":"49.84"},{"groupId":"OG001","spread":"56.36","value":"111.11"},{"groupId":"OG002","spread":"231.17","value":"298.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"Day 15: 0 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.28","value":"140.09"},{"groupId":"OG001","spread":"100.29","value":"282.29"},{"groupId":"OG002","spread":"251.08","value":"661.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"55"}],"units":"Participants"}],"title":"Day 15: 0.5 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"53.66","value":"61.93"},{"groupId":"OG001","spread":"106.83","value":"135.92"},{"groupId":"OG002","spread":"144.61","value":"308.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"54"}],"units":"Participants"}],"title":"Day 22: 0 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"59.31","value":"168.61"},{"groupId":"OG001","spread":"165.14","value":"310.03"},{"groupId":"OG002","spread":"230.41","value":"699.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"54"}],"units":"Participants"}],"title":"Day 22: 0.5 hours"},{"categories":[{"measurements":[{"comment":"The estimated standard deviation of one sample is undefined","groupId":"OG000","spread":"NA","value":"268.53"},{"groupId":"OG001","spread":"114.35","value":"298.85"},{"groupId":"OG002","spread":"234.98","value":"704.48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"40"}],"units":"Participants"}],"title":"Day 22: 2 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"42.04","value":"128.94"},{"groupId":"OG001","spread":"195.35","value":"538.88"},{"groupId":"OG002","spread":"280.28","value":"981.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"}],"units":"Participants"}],"title":"Day 22: 4 hours"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"description":"Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.","dispersionType":"Standard Deviation","groups":[{"description":"Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.","id":"OG000","title":"Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone"},{"description":"Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.","id":"OG001","title":"Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone"},{"description":"Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.","id":"OG002","title":"Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone"}],"paramType":"MEAN","populationDescription":"Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.","reportingStatus":"POSTED","timeFrame":"Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)","title":"Mean Serum Concentrations of Elotuzumab During Cycle 1","type":"SECONDARY","unitOfMeasure":"μg/mL"}