{"analyses":[{"ciLowerLimit":"-17.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"24.3","estimateComment":"Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective 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":"1.0000","pValueComment":"2-sided","paramType":"Risk Difference (RD)","paramValue":"2.9","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"Best overall response (BOR) was defined as the best response designation, in the order of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE), for each patient that was recorded between the date of randomization and the date of documented disease progression per mRECIST or mRECIST version 1.1, or the date of subsequent anticancer therapy or cancer-related surgery (i.e., surgical resection of tumour), whichever occurred first. ORR was defined as the proportion of patients with a BOR of CR or PR.","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: Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Participants"}