{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","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":"<0.001","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","upperLimit":"10.2","value":"2.9"},{"groupId":"OG001","lowerLimit":"26.5","upperLimit":"42.7","value":"34.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"description":"The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML:\n\nCR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell 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 for RBC transfusion independence, CRi criteria are met.\n\nParticipants who had no IWG disease 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":"Cycle 1, 28 days","title":"Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2","type":"SECONDARY","unitOfMeasure":"percentage of participants"}