{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"90","groupDescription":"In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValueComment":"The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.","paramType":"Binomial proportions","paramValue":"31.25"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.04","upperLimit":"47.21","value":"31.25"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"}],"units":"Participants"}],"description":"To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.","dispersionType":"90% Confidence Interval","groups":[{"description":"Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants receive 2 cycles of AEPA chemotherapy (brentuximab vedotin, etoposide, prednisone, doxorubicin)","id":"OG000","title":"AEPA Chemotherapy"}],"paramType":"NUMBER","populationDescription":"The first 32 evaluable participants enrolled was evaluated.","reportingStatus":"POSTED","timeFrame":"After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)","title":"Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control","type":"PRIMARY","unitOfMeasure":"percentage of participants"}