{"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":"0.9","upperLimit":"12.4","value":"4.4"},{"groupId":"OG001","lowerLimit":"23.3","upperLimit":"39.0","value":"30.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"description":"The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) before initiation of Cycle 2 assessed by the investigator.\n\nCR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with \\< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.\n\nCRh is a derived response based on bone marrow blast and hematology lab values, achieved when when the following criteria are met:\n\n* Bone marrow with \\< 5% blasts and\n* Peripheral blood neutrophil count of \\> 0.5 × 10³/μL and\n* Peripheral blood platelet count of \\> 0.5 × 10⁵/μL and\n* A 1-week platelet transfusion-free period prior to the hematology lab collection.\n\nParticipants with no 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 and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2","type":"SECONDARY","unitOfMeasure":"percentage of participants"}