{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"}]}],"title":"ALP Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"ALP Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"}]}],"title":"AST Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"AST Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"title":"ALT Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"ALT Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}],"title":"Bilirubin Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Bilirubin Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"title":"Creatinine Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"9"}]}],"title":"Creatinine Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"}]}],"title":"Albumin Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Albumin Grade 3-4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"description":"NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:\\>1.0 to 2.5\\*ULN; Gr 2: \\>2.5 to 5.0\\*ULN; Gr 3: \\>5.0 to 20.0\\*ULN; Gr 4: \\>20.0\\*ULN. AST Gr 1: \\>1.0 to 2.5\\*ULN; Gr 2: \\>2.5 to 5.0\\*ULN; Gr 3: \\>5.0 to 20.0\\*ULN; Gr 4: \\>20.0\\*ULN. Total bilirubin Gr 1: \\>1.0 to 1.5\\*ULN; Gr 2: \\>1.5 to 3.0\\*ULN; Gr 3: \\>3.0 to 10..0\\*ULN; Gr 4: \\>10.0.0\\*ULN. ALP (U/L) Gr1:\\>1.0 to 2.5\\*ULN, Gr2:\\>2.5 to 5.0\\*ULN, Gr3:\\>5.0 to 20.0\\*ULN, Gr4:\\>20.0\\*ULN. Albumin (low) Gr 1:\\1 - 1.5\\*baseline (BL)to \\>ULN - 1.5\\*ULN; Gr 2: \\>1.5 - 3.0\\*BL to \\> 1.5 - 3.0\\*ULN; Gr 3: \\>3.0\\*BL to \\> 3.0 - 6.0\\*ULN; Gr 4: \\>6.0\\*ULN.","groups":[{"description":"LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. 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":"Elotuzumab + LD were 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 until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. 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":"Elotuzumab + LD were 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 until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. 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":"NUMBER","populationDescription":"All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.","reportingStatus":"POSTED","timeFrame":"From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)","title":"Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests","type":"SECONDARY","unitOfMeasure":"participants"}