{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE/Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE/ Grade 3+4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE/Grade 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Atrial fibrillation/Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Atrial fibrillation/Grade 3+4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Atrial fibrillation/Grade 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Infection/Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Infection/Grade 3+4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Infection/Grade 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Neutropenia/Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Neutropenia/Grade 3+4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Neutropenia/Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications:\n\nNon-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting \\>5 days; Gr 3 fatigue persisting \\>7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug \\>7 days for toxicity.\n\nHematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC \\<500/mm\\^3) lasting for \\> 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (\\<25,000/mm\\^3) that persists for \\> 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug \\>7 days for hematologic toxicity.","groups":[{"description":"Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.","id":"OG000","title":"Safety Run-in: Increased TLS Risk at Baseline"},{"description":"Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.","id":"OG001","title":"Safety Run-in: Low TLS Risk at Baseline"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated safety run-in participants","reportingStatus":"POSTED","timeFrame":"After at least 3 months of treatment, with an overall median treatment duration of 20.0 months","title":"Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)","type":"PRIMARY","unitOfMeasure":"Participants"}