{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"80","ciUpperLimit":"1.9","groupDescription":"The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.","nonInferiorityType":"NON_INFERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.5"},{"ciNumSides":"ONE_SIDED","ciPctValue":"94","ciUpperLimit":"1.3","groupDescription":"The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.","groupIds":["OG002","OG003"],"nonInferiorityComment":"A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.","nonInferiorityType":"NON_INFERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"67.9","upperLimit":"84.7","value":"76.3"},{"groupId":"OG001","lowerLimit":"77.6","upperLimit":"92.2","value":"84.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"110"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"LDCSI vs SDCSI"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"81.1","upperLimit":"90.5","value":"85.8"},{"groupId":"OG003","lowerLimit":"81.1","upperLimit":"90.5","value":"85.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"227"},{"groupId":"OG003","value":"237"}],"units":"Participants"}],"title":"IFRT vs PFRT"}],"denoms":[{"counts":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"110"},{"groupId":"OG002","value":"227"},{"groupId":"OG003","value":"237"}],"units":"Participants"}],"description":"EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).","dispersionType":"95% Confidence Interval","groups":[{"description":"Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)","id":"OG000","title":"Low-dose Craniospinal Radiation (LDSCI)"},{"description":"Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)","id":"OG001","title":"Standard-dose Craniospinal Radiation (SDCSI)"},{"description":"Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).","id":"OG002","title":"Involved Field Radiation (IFRT)"},{"description":"Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).","id":"OG003","title":"Posterior Fossa Radiation (PFRT)"}],"paramType":"NUMBER","populationDescription":"Per protocol only eligible \\& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.","reportingStatus":"POSTED","timeFrame":"Assessed at 3 years","title":"Event-free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"probability of 3 year EFS"}