{"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":"7.3","upperLimit":"25.4","value":"14.7"},{"groupId":"OG001","lowerLimit":"38.5","upperLimit":"55.4","value":"46.9"}]}]}],"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) at any time point during the study 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 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":"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 Partial Hematologic Recovery (CR + CRh)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}