{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.31","groupDescription":"Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of anemia","paramValue":"0.2613"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.0449","groupDescription":"Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of nausea or hepatopathy","paramValue":"0.0270"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.1729","groupDescription":"Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of febrile neutropenia","paramValue":"0.1351"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.1577","groupDescription":"Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of platelet count decrease","paramValue":"0.1216"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.0623","groupDescription":"Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of vomiting","paramValue":"0.0405"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.3329","groupDescription":"Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of anemia","paramValue":"0.2798"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.0137","groupDescription":"Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of nausea or hepatopathy","paramValue":"0.0052"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.1216","groupDescription":"Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of febrile neutropenia","paramValue":"0.0881"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.3819","groupDescription":"Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of platelet count decrease","paramValue":"0.3264"},{"ciNumSides":"ONE_SIDED","ciPctValue":"95","ciUpperLimit":"0.0224","groupDescription":"Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"The incidence of vomiting","paramValue":"0.0104"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"54"}]}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"17"}]}],"title":"Febrile Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"1"}]}],"title":"Nausea or Hepatopathy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"63"}]}],"title":"Platelet Count Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}]}],"title":"Vomiting"}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"193"}],"units":"Participants"}],"description":"The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.","groups":[{"description":"Reporting period 1 (acute)","id":"OG000","title":"VAC (Weeks 1-15)"},{"description":"Reporting period 3 (late)","id":"OG001","title":"VAC (Weeks 31 - 43)"}],"paramType":"NUMBER","populationDescription":"Number of patients with specific adverse events.","reportingStatus":"POSTED","timeFrame":"Up to 43 weeks","title":"Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC","type":"SECONDARY","unitOfMeasure":"participants"}