{"groups":[{"description":"Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m\\^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.","id":"FG000","title":"AG-120 + Azacitidine"},{"description":"Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.","id":"FG001","title":"Placebo + Azacitidine"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"46"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"23"}],"type":"Ongoing at Data Cut-off Date: 18 March 2021"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"74"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"71"},{"groupId":"FG001","numSubjects":"73"}],"comment":"Safety Analysis Set (SAS) included all participants who received at least 1 dose of the study treatment.","type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"74"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 146 participants with previously untreated isocitrate dehydrogenase 1 mutation-positive (IDH1m) acute myeloid leukemia (AML) were randomized into a 1:1 ratio to receive ivosidenib (AG-120) or AG-120 matched placebo in combination with azacitidine.","recruitmentDetails":"Participants took part in the study at 199 investigational sites from 19 March 2018 to 18 March 2021 (data cut off date). This study is ongoing. Results collected through data cut off date, 18 March 2021 are being reported."}