{"analyses":[{"ciLowerLimit":"0.336","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"0.602","estimateComment":"Stratified HR, i.e., based on analysis stratified by randomization stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.450","statisticalMethod":"1-sided stratified log-rank p-value"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.9","upperLimit":"5.8","value":"5.0"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.1","value":"1.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"162"}],"units":"Participants"}],"description":"PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (\\>28 weeks if there was post-baseline disease assessment, or \\>12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.","dispersionType":"95% Confidence Interval","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":"OG000","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":"OG001","title":"Defined Investigator's Choice of Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.","reportingStatus":"POSTED","timeFrame":"Up to 2 years from randomization","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}