{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"}],"units":"Participants"}],"description":"ORR in patients with AML was also determined by ITT-PP analysis. ORR was defined by summarizing and calculating the number/percentage of patients with CR + CRi + Morphologic Leukemia-free State (MLFS), based on European LeukemiaNet (ELN) criteria. CR is defined as absolute neutrophil count (ANC) \\> 1000/microliter (mcL), platelets \\> 100,000/mcL, red cell transfusion independence, and bone marrow with \\< 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤ 1000/mcL or platelets ≤ 100,000/mcL. MLFS is defined as bone marrow blasts \\<5%; absence of blasts with Auer rods; and absence of extramedullary disease; no hematologic recovery required. Patients who have any response will be permitted to continue treatment until relapse or progression of disease. Results are summarized using basic descriptive statistics.","groups":[{"description":"Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ).\n\nVenetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle)\n\nDecitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)","id":"OG000","title":"Decitabine/Venetoclax (Single Arm)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"21 patients who comprised the Primary Outcome analysis were part of the AML cohort. Results for 2 of the 21 patients were not evaluable by ITT-PP analysis.","reportingStatus":"POSTED","timeFrame":"At the time of censoring of data, up to ~21 months","title":"Overall Response Rate in Patients With AML by Intention-to-treat Per Protocol (ITT-PP) Analysis","type":"POST_HOC","unitOfMeasure":"Participants"}