{"analyses":[{"ciLowerLimit":"46.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"90.3","estimateComment":"Exact (Clopper-Pearson) 95% confidence interval for complete response rate.","groupIds":["OG000"],"nonInferiorityType":"OTHER","paramType":"Proportion (percent)","paramValue":"75.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"Complete response rate (CR) of CC486-CHOP in PTCL by Lugano Criteria for target lesions, and the Deauville Criteria (5 point scale) assessed by PET or CT; CR (complete metabolic or radiologic response) defined as Deauville score of 1, 2 or 3 by PET or regression of all target lesions to \\< 1.5cm in longest diameter by CT.","groups":[{"description":"CC486 +CHOP\n\nCC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.\n\nCHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:\n\nCyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5","id":"OG000","title":"CC486 +CHOP"}],"paramType":"NUMBER","populationDescription":"3 of 21 participants did not complete treatment as outlined in the Participant Flow section; these subject were unevaluable and not included in analysis.","reportingStatus":"POSTED","timeFrame":"After Cycle 6 at 18 weeks","title":"Complete Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}