{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0634","paramType":"Log Rank Test Statistic","paramValue":"3.4471","statisticalMethod":"Log Rank"},{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.042","paramType":"Log-Rank Test Statistic","paramValue":"4.1362","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58.3","upperLimit":"76.5","value":"67.4"},{"groupId":"OG001","lowerLimit":"71.2","upperLimit":"86.4","value":"78.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"title":"Randomized patients"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.8","upperLimit":"74.3","value":"64.0"},{"groupId":"OG001","lowerLimit":"70.2","upperLimit":"87.2","value":"78.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"90"}],"units":"Participants"}],"title":"Randomized patients with INSS Stage 4 disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.","dispersionType":"95% Confidence Interval","groups":[{"description":"Randomized to Regimen A - RA Only","id":"OG000","title":"Regimen A"},{"description":"Randomized to Regimen B - RA + Immunotherapy","id":"OG001","title":"Regimen B"}],"paramType":"NUMBER","populationDescription":"Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.","reportingStatus":"POSTED","timeFrame":"Three years","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}