{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"title":"Hemoglobin Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"}]}],"title":"Hemoglobin Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"}]}],"title":"Platelet Count Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}],"title":"Platelet Count Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}],"title":"Leukocytes Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}],"title":"Leukocytes Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}],"title":"Lymphocytes (Abs) Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"5"}]}],"title":"Lymphocytes (Abs) Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"}]}],"title":"Neutrophil Count (Abs) Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}],"title":"Neutrophil Count (Abs) Grade 3-4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"description":"National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:\\<LLN to 10.0 g/dL, Gr 2:\\<10.0 to 8.0 g/dL, Gr 3:\\<8.0 to 6.5 g/dL, Gr 4:\\<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: \\<1.5 to 0.8 \\*10\\^3 c/µL, Gr 2 \\<0.8 to 0.5 \\*10\\^3 c/µL, Gr 3: \\<0.5 to 0.2 \\*10\\^3 c/µL, Gr 4: \\<0.2\\*10\\^3 c/µL. Neutrophils abs: Gr 1:\\<LLN to 1.5\\*10\\^9/L, Gr 2:\\<1.5 to 1.0\\*10\\^9/L, Gr 3:\\<1.0 to 0.5\\*10\\^9/L, Gr 4:\\<0.5\\*10\\^9/L. Platelet count Gr 1:LLN to 75.0\\*10\\^9/L, Gr 2:\\<75.0 to 50.0\\*10\\^9/L, Gr 3:\\<50.0 to 25.0\\*10\\^9/L, Gr 4:\\<25.0 to 10\\^9/L. Leukocytes Gr 1:\\<LLN to 3.0 \\*10\\^3 c/µL, Gr 2; \\<3.0 to 2.0 \\*10\\^3 c/µL, Gr 3: \\<2.0 to 1.0 \\*10\\^3 c/µL, Gr 4: \\<1.0 \\*10\\^3 c/µL.","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 Hematology Laboratory Tests","type":"SECONDARY","unitOfMeasure":"participants"}