{"analyses":[{"ciLowerLimit":"-0.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.07","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1710","paramType":"Mean Difference (Net)","paramValue":"0.03","statisticalComment":"Treatment, time, treatment-by-time interaction, and baseline included as covariate.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.02","value":"0.00"},{"groupId":"OG001","spread":"0.03","value":"0.02"}]}],"title":"Cycle 2, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.02","value":"0.01"},{"groupId":"OG001","spread":"0.08","value":"-0.08"}]}],"title":"Cycle 3, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.03","value":"0.04"},{"comment":"n=1","groupId":"OG001","spread":"NA","value":"0.00"}]}],"title":"Cycle 4, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.04","value":"0.04"},{"comment":"n=0","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Cycle 5, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.04","value":"0.03"},{"comment":"n=0","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Cycle 6, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.02","value":"-0.01"},{"groupId":"OG001","spread":"0.02","value":"-0.04"}]}],"title":"EoT"}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"162"}],"units":"Participants"}],"description":"The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting \"no problems\", \"some problems\", and \"extreme problems\". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).","dispersionType":"Standard Error","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":"MEAN","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":"Day 1 of each cycle prior to dosing and EoT","title":"Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score","type":"SECONDARY","unitOfMeasure":"Score on a scale"}