{"groups":[{"description":"Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\\^2 (for a total cycle dose of 1.5 mg/m\\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).","id":"FG000","title":"Inotuzumab Ozogamicin"},{"description":"Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.","id":"FG001","title":"Defined Investigator's Choice of Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}],"type":"Subject refused further follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"126"}],"type":"Death"}],"milestones":[{"achievements":[{"comment":"Treated (164 randomized)","groupId":"FG000","numSubjects":"164"},{"comment":"Treated (162 randomized)","groupId":"FG001","numSubjects":"143"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"10"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"133"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"164 participants were randomized to Inotuzumab Ozogamicin and 162 to Defined Investigator's Choice of Chemotherapy. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the intention-to-treat (ITT) population."}