{"denoms":[{"counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"53"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Control Group"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"43"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"8.84","value":"72.5"},{"groupId":"BG001","spread":"10.08","value":"69.3"},{"groupId":"BG002","spread":"9.51","value":"70.9"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"11"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"42"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"45"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}],"title":"Canada"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]}],"title":"Poland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"11"}]}],"title":"United Kingdom"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}],"title":"Australia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"15"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}],"title":"Germany"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}],"title":"Russia"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"53"}]}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Overall Number of Baseline Participants","unitOfMeasure":"Participants"}],"populationDescription":"Full Analysis Set: All patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine)."}