{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"46"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"36"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"46"}],"units":"Participants"}],"description":"A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).","groups":[{"description":"Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.","id":"OG000","title":"Phase 1: FT-2102 (Single Agent)"},{"description":"Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.","id":"OG001","title":"Phase 1: Total FT-2102 (Single Agent)"},{"description":"Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.","id":"OG002","title":"Phase 1: FT-2102 + Azacitidine (Combination Therapy)"},{"description":"Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.","id":"OG003","title":"Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (SAP).","reportingStatus":"POSTED","timeFrame":"Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)","title":"Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}