{"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"Estimate value DL 3"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"description":"DLTs were grade 4 thrombocytopenia; grade 4 neutropenia lasting \\> 5 days or febrile neutropenia; grade 3 thrombocytopenia with bleeding or platelet transfusion; grade 3-4 hyperglycemia or a thrombotic/embolic event; or grade 3-4 non-hematologic toxicity (except grade 3 nausea, diarrhea, and vomiting), that were at least probably related to treatment, treatment delays ≥ 21 days for toxicity, and treatment-related death.","groups":[{"description":"Ibrutinib 560 mg on Days 1-28,\n\n\\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\n\n\\>\n\n\\> Every 28 days","id":"OG000","title":"Dose Level 1 (Starting DL)"},{"description":"Ibrutinib 560 mg on Days 1-28,\n\n\\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\n\n\\>\n\n\\> Every 28 days","id":"OG001","title":"Dose Level 2"},{"description":"Ibrutinib 840 mg on Days 1-28,\n\n\\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\n\n\\>\n\n\\> Every 28 days","id":"OG002","title":"Dose Level 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible patients who started protocol treatment were excluded from the determination of MTD if they failed to completed one cycle of treatments for reasons other than toxicity. Specifically. two patient assigned to DL3 were excluded from MTD determination: one developed COVID-19 infection and the other received 280 mg/day of IBR instead of the assigned 840 mg/day dose during cycle 1.","reportingStatus":"POSTED","timeFrame":"During cycle 1 (28-day cycle)","title":"Number of Participants With Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}