{"analyses":[{"ciLowerLimit":"0.441","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"0.734","estimateComment":"Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0020","pValueComment":"1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).","paramType":"Hazard Ratio (HR)","paramValue":"0.569","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.9","upperLimit":"9.9","value":"8.8"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"6.0","value":"4.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from time of randomization for each participant.","dispersionType":"80% Confidence Interval","groups":[{"description":"Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.","id":"OG000","title":"Phase 2 Unfit: Glasdegib 100 mg + LDAC"},{"description":"Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.","id":"OG001","title":"Phase 2 Unfit: LDAC Alone"}],"paramType":"MEDIAN","populationDescription":"Full analysis set: all randomized participants of Phase 2 Unfit arm.","reportingStatus":"POSTED","timeFrame":"Randomization to Follow-up (4 years)","title":"Overall Survival (OS) at Phase 2 Unfit","type":"PRIMARY","unitOfMeasure":"Months"}