{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","pValueComment":"One sided P-value is calculated based on the null hypothesis ORR \\<= 50.2%","statisticalMethod":"Exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"68.2","upperLimit":"89.4","value":"80.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"}],"units":"Participants"}],"description":"Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.\n\nCR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.\n\nPR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.\n\nPET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \\> mediastinum but ≤ liver; 4- uptake moderately \\> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.","id":"OG000","title":"Lisocabtagene Maraleucel (JCAR017)"}],"paramType":"NUMBER","populationDescription":"All participants with PET positive disease who received at least one infusion of JCAR017","reportingStatus":"POSTED","timeFrame":"From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)","title":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"Percent of Participants"}