{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Potassium High, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Potassium High, Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Potassium Low, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Potassium Low, Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Sodium High, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Sodium High, Grade 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Sodium Low, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Sodium Low, Grade 3-4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:\\>ULN - 150; Gr 2: \\>150 - 155; Gr 3: \\>155 - 160; Gr 4: \\>160 mmol/L; Sodium low(L) Gr 1:\\<LLN - 130; Gr 3: \\<130 - 120; Gr 4: \\<120 mmol/L. Potassium (H) Gr 1: \\>ULN - 5.5; Gr 2: \\>5.5 - 6.0; Gr 3: \\> 6.0 - 7.0; Gr 4: \\>7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: \\<LLN - 3.0; Gr 3: \\< 3.0 - 2.5; Gr 4: \\<2.5 mmol/L.","groups":[{"description":"Elotuzumab 10 mg/kg was intravenously (IV) given 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. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).","id":"OG000","title":"Elotuzumab 10 mg/kg"},{"description":"Elotuzumab 20 mg/kg was intravenously (IV) given 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. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).","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 Chemistry Laboratory Tests","type":"PRIMARY","unitOfMeasure":"participants"}