{"groups":[{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 intravenous (IV) per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"FG000","title":"Ibrutinib + Rituximab"},{"description":"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"FG001","title":"Placebo + Rituximab"},{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.","id":"FG002","title":"Open-Label Substudy: Ibrutinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"8"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other, Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"75"},{"groupId":"FG002","numSubjects":"31"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"56"},{"groupId":"FG002","numSubjects":"21"}],"comment":"On-study until study termination by sponsor.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"10"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in a 1:1 ratio to receive ibrutinib + rituximab (Ibr+R) or placebo + rituximab (Pbo+R). Separately, participants refractory to treatment with rituximab were enrolled in an open-label ibrutinib monotherapy substudy to further investigate the safety and efficacy of ibrutinib.","recruitmentDetails":"This study was conducted in 48 sites (10 in the United States, 30 in Europe, 4 in Canada and 4 in Australia)."}