{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"90","groupDescription":"The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":".1","pValueComment":"The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.","paramType":"proportion","paramValue":"0.3","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.","groups":[{"description":"Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.","id":"OG000","title":"Nivolumab and EPOCH"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"up to 100 days post transplant","title":"Efficacy: Complete Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}