{"analyses":[{"ciLowerLimit":"-29.0","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"3.5","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1572","paramType":"Disease Control Rate Difference","paramValue":"-13.3","statisticalComment":"Stratified by squamous cell carcinoma vs non-squamous cell carcinoma","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.8","upperLimit":"37.4","value":"25.5"},{"groupId":"OG001","lowerLimit":"27.1","upperLimit":"51.5","value":"38.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator. RECIST v 1.1 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. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization.","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, regardless of whether they received assigned treatment or not.","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 PBO +PBZ","title":"Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}