{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"131"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"100"}]}],"title":"Any TEAE, Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"104"}]}],"title":"Any Venetoclax (V) Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"46"}]}],"title":"Any V Related TEAE Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"114"}]}],"title":"Any Ibrutinib (I) Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"58"}]}],"title":"Any I Related TEAE Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"48"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (I only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (V only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"30"}]}],"title":"Any TEAE Leading to Discontinuation of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"29"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"14"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (I Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"7"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (V Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"8"}]}],"title":"Any TEAE Leading to Dose Reduction of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"99"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (I or V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"18"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (I Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (V Only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"77"}]}],"title":"Any TEAE Leading to Dose Hold of Study Drug (Both I and V)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"80"}]}],"title":"Any TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"73"}]}],"title":"Any TESAE, Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"25"}]}],"title":"Any TESAE, V Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"37"}]}],"title":"Any TESAE, I Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"37"}]}],"title":"Any TESAE, V or I Related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"18"}]}],"title":"Fatal TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"8"}]}],"title":"Major Hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"7"}]}],"title":"Major Hemorrhage, Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"}]}],"title":"Major Hemorrhage, TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"132"}],"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 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 + 30 days, with an overall median treatment duration of 19.5 months","title":"Number of Participants With TEAEs (Randomization Phase)","type":"SECONDARY","unitOfMeasure":"Participants"}