{"analyses":[{"ciLowerLimit":"-34.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.3","estimateComment":"Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7665","paramType":"Risk Difference (RD)","paramValue":"-7.6","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"Clinical Benefit Rate (CBR) was defined as the proportion of patients with a BOR of CR, PR, or SD \\>/= 6 months.","groups":[{"description":"rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \\[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \\[ET\\]\n\nrAd-IFN: Adenovirus-Delivered Interferon Alpha-2b\n\nCelecoxib Oral Product: 400 mg twice daily\n\nGemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination","id":"OG000","title":"Treatment Group"},{"description":"Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \\[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.\n\nCelecoxib Oral Product: 400 mg twice daily\n\nGemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination","id":"OG001","title":"Control Group"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).","reportingStatus":"POSTED","timeFrame":"4 years and 8 months","title":"Best Response: Clinical Benefit Rate (CBR)","type":"SECONDARY","unitOfMeasure":"Participants"}