{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"Albumin Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Albumin Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"ALP Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"ALP Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"ALT Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"ALT Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"AST Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"AST Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Creatinine Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Creatinine Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Bilirubin Total Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Bilirubin Total Grade 3-4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"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). 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:\\<LLN to 3 grams per deciliter (g/dL); Gr 2: \\<3.0 - 2.0 g/L; Gr 3: \\< 2 g/dL. Creatinine 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":"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).","id":"OG000","title":"Elotuzumab 10 mg/kg"},{"description":"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent. Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion. On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).","id":"OG001","title":"Elotuzumab 20 mg/kg"}],"paramType":"NUMBER","populationDescription":"All participants who received at least one dose of study medication were summarized.","reportingStatus":"POSTED","timeFrame":"First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)","title":"Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests","type":"PRIMARY","unitOfMeasure":"participants"}