{"analyses":[{"ciLowerLimit":"38.4","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"64.3","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Rate difference","paramValue":"51.4","statisticalComment":"If any cell count was \\<5, p-value was based on Fisher's exact test","statisticalMethod":"1-sided p-value based on Chi-square test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.1","upperLimit":"87.7","value":"80.7"},{"groupId":"OG001","lowerLimit":"21.0","upperLimit":"38.8","value":"29.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"CR was the disappearance of leukemia indicated by less than (\\<) 5 percent (%) marrow blasts \\& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \\& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \\& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (\\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm \\& ≤1.5 cm in GTD at baseline must have regressed to \\<1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen \\& other previously enlarged organs must have regressed in size \\& must not be palpable) was required. CRi was defined as CR except ANC \\<1000/μL \\&/or platelets \\<100,000/μL.","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":"NUMBER","populationDescription":"ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants.","reportingStatus":"POSTED","timeFrame":"Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose","title":"Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}