{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"The event-free 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":"0.1057","paramType":"Log Rank Test Statistic","paramValue":"2.6176","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.5","upperLimit":"53.8","value":"43.2"},{"groupId":"OG001","lowerLimit":"49.5","upperLimit":"69.9","value":"59.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"90"}],"units":"Participants"}],"title":"Randomized patients with INSS Stage 4 disease"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"19.8","upperLimit":"50.5","value":"35.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"Eligible patients with persistent disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.","dispersionType":"95% Confidence Interval","groups":[{"description":"Randomized to Regimen A - RA Only","id":"OG000","title":"Regimen A"},{"description":"Regimen B - RA + Immunotherapy","id":"OG001","title":"Regimen B"}],"paramType":"NUMBER","populationDescription":"Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.","reportingStatus":"POSTED","timeFrame":"Three years","title":"Event-Free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}