{"analyses":[{"ciLowerLimit":"0.926","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"2.038","estimateComment":"Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1789","paramType":"Hazard Ratio (HR)","paramValue":"1.374","statisticalComment":"Stratified by squamous cell carcinoma versus non-squamous cell carcinoma","statisticalMethod":"Stratified Log-Rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.8","upperLimit":"4.0","value":"2.9"},{"groupId":"OG001","lowerLimit":"1.5","upperLimit":"8.0","value":"4.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"OG000","title":"CC-486 and Pembrolizumab (CC-486 + PBZ)"},{"description":"Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"OG001","title":"Placebo and Pembrolizumab (PBO + PBZ)"}],"paramType":"MEDIAN","populationDescription":"The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.","reportingStatus":"POSTED","timeFrame":"From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm","title":"Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology","type":"PRIMARY","unitOfMeasure":"months"}