{"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":"FG000","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":"FG001","title":"Control Group"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"26"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"22"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"22"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study opened to recruitment in January 2019 and was scheduled to complete recruitment by May 2021, with a target of approximately 300. 53 patients were randomized to treatment."}