{"analyses":[{"ciLowerLimit":"95.52","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"167.783","groupDescription":"AUC(0-T). The reference arm is NRF participants.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.164","paramType":"Ratio of Adjusted Means","paramValue":"126.596","statisticalMethod":"ANOVA"},{"ciLowerLimit":"88.458","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"152.439","groupDescription":"AUC(0-T). The reference arm is NRF participants.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.355","paramType":"Ratio of Adjusted Means","paramValue":"116.123","statisticalMethod":"ANOVA"},{"ciLowerLimit":"90.366","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"186.609","groupDescription":"AUC (INF). The reference arm is NRF participants.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.228","paramType":"Ratio of Adjusted Means","paramValue":"129.858","statisticalMethod":"ANOVA"},{"ciLowerLimit":"76.825","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"158.647","groupDescription":"AUC(INF). The reference arm is NRF participants.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.642","paramType":"Ratio of Adjusted Means","paramValue":"110.400","statisticalMethod":"ANOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"28","value":"39559"},{"groupId":"OG001","spread":"20","value":"50080"},{"groupId":"OG002","spread":"31","value":"45937"}]}],"title":"AUC (0-T)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"39","value":"46401"},{"groupId":"OG001","spread":"31","value":"60255"},{"groupId":"OG002","spread":"39","value":"51227"}]}],"title":"AUC (INF)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"}],"units":"Participants"}],"description":"The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg\\*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value \\< 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).","id":"OG000","title":"Elotuzumab + LD in Normal Renal Function (NRF) Participants"},{"description":"Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl \\< 30 ml/min but no dialysis.","id":"OG001","title":"Elotuzumab + LD in Severe Renal Impairment (SRI) Participants"},{"description":"Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.","id":"OG002","title":"Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.","reportingStatus":"POSTED","timeFrame":"Day 1 of Cycle 1 to 28 days post dose","title":"Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method","type":"PRIMARY","unitOfMeasure":"µg*h/mL"}