{"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":"FG000","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":"FG001","title":"Safety Run-in: Low TLS Risk at Baseline"},{"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) once daily over a 5-week period 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":"FG002","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":"FG003","title":"Randomization Phase: Ibrutinib + Placebo"},{"description":"Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).","id":"FG004","title":"Treatment-naive Open-label Arm"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"67"},{"groupId":"FG003","numSubjects":"73"},{"groupId":"FG004","numSubjects":"18"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"}],"type":"Other, Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"134"},{"comment":"1 participant in this arm did not receive any dose of study drug.","groupId":"FG003","numSubjects":"133"},{"groupId":"FG004","numSubjects":"78"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"31"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"26"}],"type":"On Study Treatment at Study Closure"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"25"},{"groupId":"FG004","numSubjects":"25"}],"type":"Off Treatment and On Study Follow Up at Study Closure"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"53"},{"groupId":"FG003","numSubjects":"46"},{"groupId":"FG004","numSubjects":"51"}],"comment":"Completed=Participants followed for progression (if not progressed before treatment discontinuation), subsequent anticancer therapy, and survival status until study closure.\n\nNot Completed=Already off study at study closure.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"81"},{"groupId":"FG003","numSubjects":"87"},{"groupId":"FG004","numSubjects":"27"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}