{"analyses":[{"ciLowerLimit":"0.914","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"2.000","estimateComment":"Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1990","paramType":"Hazard Ratio (HR)","paramValue":"1.352","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":"7.0","value":"4.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"Progression-free survival was defined according to EMA methodology as the time 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 result, not including symptomatic deterioration) or death for (any cause) on or prior to the data cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the last known time that the participant was progression free. However, occasional missing observations or initiation of subsequent new anticancer therapy would not result in censoring for this analysis. Progressive disease is 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 European Medicines Agency Methodology","type":"PRIMARY","unitOfMeasure":"months"}