{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupDescription":"The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":".3212","paramType":"Log Rank Test Statistic","paramValue":".9841","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"35.9","upperLimit":"97.5","value":"66.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \\< 1 yrs of age.","dispersionType":"95% Confidence Interval","groups":[{"description":"4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.","id":"OG000","title":"Group 3 (Chemotherapy, Surgery)"},{"description":"8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \\< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.","id":"OG001","title":"Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)"}],"paramType":"NUMBER","populationDescription":"Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.","reportingStatus":"POSTED","timeFrame":"Up to 3 years","title":"Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961","type":"PRIMARY","unitOfMeasure":"percentage of 3 yr EFS rate"}