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This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"4 patients were part of the 'Other' cohort. This cohort was inclusive of patients with MDS/myeloproliferative neoplasm, chronic myelomonocytic leukemia, and myelofibrosis.","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"White"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"Black"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"Hispanic"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"Asian"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, 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The number of patients with each grade is summarized.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Clinical Oncology Group (ECOG) Performance Status (PS) Scale","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"ECOG PS = 0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"ECOG PS = 1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"ECOG PS = 2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"ECOG PS = 3"}],"description":"ECOG PS scale scores were summarized for the AML cohort. 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The number of AML patients with each grade is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"21 of the 31 patients were part of the AML cohort.","title":"ECOG PS Scale - AML Cohort","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"ECOG PS = 0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"ECOG PS = 1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"ECOG PS = 2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"ECOG PS = 3"}],"description":"ECOG PS scale scores were summarized for the HR-MDS cohort. ECOG PS scores describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. Grades range from 0-5. For this study only patients with an ECOG PS grade ≤ 3 are eligible. Brief ECOG PS grading is as follows: 0=fully active; 1=restricted in strenuous activity; 2=restricted in work activity but ambulatory and capable of self-care; 3=capable of limited self-care. Higher scores indicate increased levels of disability. Number of HR-MDS patients with each grade is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"6 of the 31 patients were part of the HR-MDS cohort.","title":"ECOG PS Scale - HR-MDS Cohort","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"4"}],"units":"Participants"}],"title":"ECOG PS = 0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"4"}],"units":"Participants"}],"title":"ECOG PS = 1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"4"}],"units":"Participants"}],"title":"ECOG PS = 2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"4"}],"units":"Participants"}],"title":"ECOG PS = 3"}],"description":"ECOG PS scale scores were summarized for the 'Other' cohort. ECOG PS scores describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. Grades range from 0-5. For this study only patients with an ECOG PS grade ≤ 3 are eligible. Brief ECOG PS grading is as follows: 0=fully active; 1=restricted in strenuous activity; 2=restricted in work activity but ambulatory and capable of self-care; 3=capable of limited self-care. Higher scores indicate increasing levels of disability. The number of patients with each grade is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"4 of the 31 patients were part of the 'Other' cohort.","title":"ECOG PS Scale - Other Cohort","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"IDH1 or IDH2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"NPM1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"FLT3 ITD"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"N/KRAS"},{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"31"}],"units":"Participants"}],"title":"TP53"}],"description":"Somatic mutations common in MDS and AML blood cancers were confirmed prior to treatment. 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The number/percentage of patients with each mutation is categorized by type.","paramType":"COUNT_OF_PARTICIPANTS","title":"Somatic mutations","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"IDH1 or IDH2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"NPM1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"FLT3 ITD"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"N/KRAS"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"TP53"}],"description":"Somatic mutations specific to AML were confirmed prior to treatment. 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The number/percentage of patients requiring either packed red blood cell (RBC) and/or platelet transfusions to manage MDS/AML symptoms at the start of a study or treatment is summarized.","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline Transfusion Dependence","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}]}],"description":"Patients with advanced myeloid malignancies often require frequent clinical visits and complete blood count (CBC) evaluation for supportive transfusions. 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The number/percentage of HR-MDS patients requiring either packed red blood cell (RBC) and/or platelet transfusions to manage their symptoms at the start of a study or treatment is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"6 of the 31 patients were part of the HR-MDS cohort.","title":"Baseline Transfusion Dependence - HR-MDS Cohort","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"4"}],"units":"Participants"}]}],"description":"Patients with advanced myeloid malignancies often require frequent clinical visits and CBC evaluation for supportive transfusions. The number/percentage of patients in the 'Other' cohort requiring either packed red blood cell (RBC) and/or platelet transfusions to manage their symptoms at the start of a study or treatment is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"4 of the 31 patients were part of the 'Other' cohort.","title":"Baseline Transfusion Dependence - Other Cohort","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"de novo"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"Secondary (or t-AML)"}],"description":"AML patients enrolled into the study were categorized as being of either de novo origin, or of Secondary or therapy-related AML (t-AML) origin. de novo AML arises spontaneously, while secondary AML develops from prior a hematologic disorder and t-AML develops as a complication of prior cytotoxic therapy. The number/percentage of patients within each category/type is summarized with Secondary and t-AML being grouped as a single category.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"21 of the 31 patients were part of the AML cohort.","title":"Acute Myeloid Leukemia (AML) Type","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"<30%"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"≥30%"}],"description":"In Myelodysplastic Syndromes (MDS), bone marrow blast counts are a key factor in diagnosis and risk stratification. The number/percentage of patients with bone marrow myeloblast counts \\< 30% and ≥30% was characterized prior to treatment to differentiate between high blast and low blast patients. A bone marrow myeloblast count in excess of 30% is a strong indicator of acute myeloid leukemia (AML) while patients with lower blast count AML (\\<30%) are able to access MDS therapy.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"21 of the 31 patients were part of the AML cohort.","title":"Bone Marrow Blast Count","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"Adverse Risk"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"Intermediate Risk"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"title":"Favorable Risk"}],"description":"ELN (2022) genetic risk stratification criteria were used to stratify AML patients into 3 risk strata based on genetic abnormalities prior to treatment. The 3 strata are Favorable Risk, Intermediate Risk, and Adverse Risk. The number/percentage of participants within each strata is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"21 of the 31 patients were part of the AML cohort.","title":"European Leukemia Net (ELN) Risk Stratification Criteria","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"Very low-risk: ≤1.5"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"Low-risk: 1.5 - 3"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"Intermediate-risk: 3 - 4.5"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"High-risk: 4.5 - 6"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"6"}],"units":"Participants"}],"title":"Very high-risk: >6"}],"description":"IPSS-R, a validated prognostic scheme, was used to classify patients with higher risk Myelodysplastic Syndrome (HR-MDS) into 1 of 5 risk categories based on how fast the disease is likely to progress, with risk categories corresponding to factors associated with increased mortality and an increased likelihood of the disease becoming AML. The categories of IPSS-R are determined based on a risk score: Very low-risk: ≤1.5; Low-risk: \\>1.5-3; Intermediate-risk: \\>3-4.5; High-risk: \\>4.5-6 and Very high-risk: \\>6. The number/percentage of HR-MDS patients within each category at baseline is summarized.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"6 of the 31 patients were part of the HR-MDS cohort.","title":"Revised International Prognostic Scoring System (IPSS-R) Risk Category","unitOfMeasure":"Participants"}],"populationDescription":"Baseline Analyses for initial group of 31 patients who comprised the Primary Outcome Measure."}