{"classes":[{"categories":[{"measurements":[{"comment":"Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.","groupId":"OG000","lowerLimit":"1.70","upperLimit":"NA","value":"3.60"},{"groupId":"OG001","lowerLimit":"0.90","upperLimit":"6.40","value":"2.90"},{"comment":"Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.","groupId":"OG002","lowerLimit":"3.20","upperLimit":"NA","value":"22.00"},{"comment":"Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.","groupId":"OG003","lowerLimit":"3.20","upperLimit":"NA","value":"22.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"22"}],"units":"Participants"}],"description":"Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.","dispersionType":"95% Confidence Interval","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 differ-ent 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":"MEDIAN","populationDescription":"FAS. N=participants with available data for this outcome measure. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD)were combined as prespecified in SAP.","reportingStatus":"POSTED","timeFrame":"Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)","title":"Phase 1: Duration of Overall Response for AML","type":"SECONDARY","unitOfMeasure":"Months"}