{"groups":[{"description":"Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).","id":"FG000","title":"Obinutuzumab + Chlorambucil (GClb)"},{"description":"Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.","id":"FG001","title":"Chlorambucil (Clb)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"16"}],"type":"Adverse Events or Intercurrent Illness"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrew Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative/Other"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Refused Treatment/Did Not Cooperate"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}],"type":"Insufficient Therapeutic Response"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Violation of Selection Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Did Not Receive Treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"238"},{"groupId":"FG001","numSubjects":"118"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"236"},{"groupId":"FG001","numSubjects":"116"}],"type":"Received Study Drug"},{"achievements":[{"comment":"Completed=Completed treatment.","groupId":"FG000","numSubjects":"190"},{"groupId":"FG001","numSubjects":"78"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"40"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 \\[NCT02053610\\]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) \\[NCT01998880\\] reported separately.","recruitmentDetails":"787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized."}