{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"17"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"To evaluate the number of patients with Common Terminology Criteria for Adverse Events Grade 3 or 4.","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":"Safety Analysis Set","reportingStatus":"POSTED","timeFrame":"4 years and 8 months.","title":"Adverse Events Grade 3 or 4.","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}