{"analyses":[{"ciLowerLimit":"-11.5","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"21.3","estimateComment":"The 90% exact unconditional confidence interval was used for ORR difference.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Overall Response Rate (ORR) Difference","paramValue":"5.3"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.0","upperLimit":"31.0","value":"19.6"},{"groupId":"OG001","lowerLimit":"6.9","upperLimit":"25.2","value":"14.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment. RECIST v1.1 is defined as: - Complete response: disappearance of all target lesions - Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease - Progressive Disease (PD): 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":"NUMBER","populationDescription":"The Intent-to-Treat population includes all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBO","title":"Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}