{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"}]}],"title":"Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}],"title":"Grades 3 and 4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"description":"Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).","groups":[{"description":"Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG000","title":"Randomization Phase: Ibrutinb + Venetoclax"},{"description":"Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG001","title":"Randomization Phase: Ibrutinib + Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized and treated participants","reportingStatus":"POSTED","timeFrame":"From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 months","title":"Number of Participants With TLS TEAEs (Randomization Phase)","type":"SECONDARY","unitOfMeasure":"Participants"}