{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"19"},{"groupId":"OG004","value":"21"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"11"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"18"},{"groupId":"OG005","value":"13"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"9"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"21"},{"groupId":"OG005","value":"20"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"11"}],"units":"Participants"}],"description":"A TEAE was defined as an 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 SAE is defined as any untoward medical occur-rence 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.","groups":[{"description":"Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG000","title":"Phase 2: Cohort 1; FT-2102 (Single Agent)"},{"description":"Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG001","title":"Phase 2: Cohort 2; FT-2102 (Single Agent)"},{"description":"Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG002","title":"Phase 2: Cohort 3; FT-2102 (Single Agent)"},{"description":"Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\\^2 + FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG003","title":"Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)"},{"description":"Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\\^2 + FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG004","title":"Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)"},{"description":"Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.","id":"OG005","title":"Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)"},{"description":"Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG006","title":"Phase 2: Cohort 7; FT-2102 (Single Agent)"},{"description":"Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\\^2 + FT-2102 150 mg BID in continuous 28-day cycles.","id":"OG007","title":"Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).","reportingStatus":"POSTED","timeFrame":"Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)","title":"Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}