{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29","upperLimit":"100","value":"100"},{"groupId":"OG001","lowerLimit":"33","upperLimit":"62","value":"47"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"30","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"16"}],"units":"Participants"}],"description":"Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \\[RECIST V1.0\\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.","dispersionType":"95% Confidence Interval","groups":[{"description":"Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)\n\nGemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course\n\nALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course","id":"OG000","title":"ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine"},{"description":"Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)\n\nGemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course\n\nALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course","id":"OG001","title":"ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine"},{"description":"Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course\n\nALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course","id":"OG002","title":"ALT-801 0.06 mg/kg With Gemcitabine"}],"paramType":"NUMBER","populationDescription":"Intent to treat population","reportingStatus":"POSTED","timeFrame":"12 weeks","title":"Objective Response Rate in Treated Patients","type":"PRIMARY","unitOfMeasure":"percentage of participants"}