{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.162","statisticalComment":"Cochran-Mantel-Haenszel test stratified by age (18 - \\< 75, ≥ 75) and AML status (de novo, secondary).","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.277","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"7.9","value":"1.5"},{"groupId":"OG001","lowerLimit":"2.4","upperLimit":"10.7","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"description":"The percentage of participants with complete remission or complete remission with incomplete blood count recovery AND minimal residual disease (MRD) as assessed by the investigator. Response was based on the modified IWG response criteria for AML:\n\nCR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell (RBC) transfusion independence, and bone marrow with \\< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.\n\nCRi: All criteria as CR except for residual neutropenia \\< 10³/μL or thrombocytopenia \\< 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria are met.\n\nMRD response (at lowest-point MRD value) was defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow, per European LeukemiaNet (ELN) recommendations.\n\nParticipants who had no disease or MRD assessments were considered to be non-responders.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.","id":"OG000","title":"Placebo + Low Dose Cytarabine (LDAC)"},{"description":"Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.","id":"OG001","title":"Venetoclax + Low Dose Cytarabine (LDAC)"}],"paramType":"NUMBER","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.","title":"Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}