{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"TLS events are defined as follows:\n\n* Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions:\n\n  * For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine \\> 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS.\n  * In participants with renal dysfunction at baseline (CrCl \\< 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death.\n* Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management.","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 Tumor Lysis Syndrome (TLS) Events (Safety Run-in)","type":"PRIMARY","unitOfMeasure":"Participants"}