{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"5"}]}],"title":"Any TEAE, Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"6"}]}],"title":"Any Venetoclax (V) Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}]}],"title":"Any V Related TEAE Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"}]}],"title":"Any Ibrutinib (I) Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"4"}]}],"title":"Any I Related TEAE Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (I only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (V only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (I Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (V Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"4"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (I Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (V Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"3"}]}],"title":"Any TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"2"}]}],"title":"Any TESAE, Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"1"}]}],"title":"Any TESAE, V Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"1"}]}],"title":"Any TESAE, I Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"1"}]}],"title":"Any TESAE, V or I Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Fatal TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Major Hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Major Hemorrhage, Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Major Hemorrhage, TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. 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. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5).","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":"From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 months","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)","type":"PRIMARY","unitOfMeasure":"Participants"}