{"analyses":[{"ciLowerLimit":"0.830","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"2.276","estimateComment":"Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2968","paramType":"Hazard Ratio (HR)","paramValue":"1.375","statisticalComment":"Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit was not estimable as participants were still alive at the time of the clinical cut-off date","groupId":"OG000","lowerLimit":"7.2","upperLimit":"NA","value":"11.9"},{"comment":"Not estimable as participants were still alive at the time of the clinical cut-off date.","groupId":"OG001","lowerLimit":"11.0","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants received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.","reportingStatus":"POSTED","timeFrame":"From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo arm","title":"Kaplan Meier Estimate of Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}