{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.44","paramType":"2 Year EFS","paramValue":"0.89","statisticalMethod":"2-year KM estimate"},{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.","groupIds":["OG001"],"nonInferiorityType":"OTHER","pValue":"0.40","paramType":"2 Year EFS","paramValue":"0.53","statisticalMethod":"2-year KM estimate"},{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.","groupIds":["OG002"],"nonInferiorityType":"OTHER","pValue":"0.00000853","paramType":"2 Year EFS","paramValue":"0.55","statisticalMethod":"2-year KM estimate"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.62","upperLimit":"0.95","value":"0.86"},{"groupId":"OG001","lowerLimit":"0.26","upperLimit":"0.74","value":"0.53"},{"groupId":"OG002","lowerLimit":"0.33","upperLimit":"0.66","value":"0.51"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"39"}],"units":"Participants"}],"description":"The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.","dispersionType":"95% Confidence Interval","groups":[{"description":"Stage I Disease (surgery, observation)","id":"OG000","title":"Stratum 1"},{"description":"Stage II Disease (surgery, observation)","id":"OG001","title":"Stratum 2"},{"description":"Stage III OR IV Disease (chemotherapy)","id":"OG002","title":"Stratum 3"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to five years after enrollment","title":"Five Year Event-free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"Estimated probability five year EFS"}