{"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":"6.2","upperLimit":"23.6","value":"13.2"},{"groupId":"OG001","lowerLimit":"39.1","upperLimit":"56.1","value":"47.6"}]}]}],"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) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML:\n\nCR: No morphologic evidence of AML and absolute neutrophil count (ANC) ≥ 10³/μL (1,000/μL), platelets ≥ 10⁵/μL (100,000/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, the 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":"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)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}