{"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"676"}],"units":"Participants"}],"groups":[{"description":"Patients receive either gemcitabine hydrochloride or \\[starting 06-28-2016\\] allowable combination chemotherapy per standard of care for 5 months.\n\nPatients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"BG000","title":"Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)"},{"description":"\\[Closed to accrual 2-28-2014.\\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"BG001","title":"Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)"},{"description":"Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"BG002","title":"Arm III (Chemotherapy)"},{"description":"Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"BG003","title":"Arm IV (Chemotherapy, Chemoradiotherapy)"},{"description":"Total of all reporting groups","id":"BG004","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"17"},{"groupId":"BG004","value":"35"}],"title":"≤ 49"},{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"37"},{"groupId":"BG004","value":"79"}],"title":"50 - 59"},{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"59"},{"groupId":"BG004","value":"116"}],"title":"60 - 69"},{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"41"},{"groupId":"BG004","value":"76"}],"title":"70 - 79"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"5"},{"groupId":"BG004","value":"16"}],"title":"≥ 80"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II Analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"33"}],"title":"≤ 49"},{"measurements":[{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"44"},{"groupId":"BG004","value":"88"}],"title":"50 - 59"},{"measurements":[{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"72"},{"groupId":"BG004","value":"135"}],"title":"60 - 69"},{"measurements":[{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"83"}],"title":"70 - 79"},{"measurements":[{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"15"}],"title":"≥ 80"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"63"},{"groupId":"BG004","value":"138"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"96"},{"groupId":"BG004","value":"184"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"85"},{"groupId":"BG004","value":"159"}],"title":"Female"},{"measurements":[{"groupId":"BG002","value":"100"},{"groupId":"BG003","value":"95"},{"groupId":"BG004","value":"195"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG004","value":"18"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"143"},{"groupId":"BG001","value":"143"},{"groupId":"BG004","value":"286"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG004","value":"18"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"24"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG002","value":"158"},{"groupId":"BG003","value":"162"},{"groupId":"BG004","value":"320"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"10"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG004","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG004","value":"8"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG004","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"22"},{"groupId":"BG004","value":"32"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"144"},{"groupId":"BG001","value":"129"},{"groupId":"BG004","value":"273"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG004","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG004","value":"7"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"12"}],"title":"Asian"},{"measurements":[{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"27"},{"groupId":"BG004","value":"46"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG002","value":"147"},{"groupId":"BG003","value":"139"},{"groupId":"BG004","value":"286"}],"title":"White"},{"measurements":[{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"6"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.0","upperLimit":"7.5","value":"3.0"},{"groupId":"BG001","lowerLimit":"1.0","upperLimit":"7.6","value":"3.0"},{"groupId":"BG004","lowerLimit":"1.0","upperLimit":"7.6","value":"3.0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","lowerLimit":"0.9","upperLimit":"7.9","value":"3.0"},{"groupId":"BG003","lowerLimit":"1.0","upperLimit":"6.5","value":"3.0"},{"groupId":"BG004","lowerLimit":"0.9","upperLimit":"7.9","value":"3.0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"From pathologic specimen.","dispersionType":"FULL_RANGE","paramType":"MEDIAN","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Tumor size largest dimension","unitOfMeasure":"centimeters"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"78"},{"groupId":"BG004","value":"143"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"98"},{"groupId":"BG001","value":"81"},{"groupId":"BG004","value":"179"}],"title":"1"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"72"},{"groupId":"BG003","value":"83"},{"groupId":"BG004","value":"155"}],"title":"0"},{"measurements":[{"groupId":"BG002","value":"102"},{"groupId":"BG003","value":"97"},{"groupId":"BG004","value":"199"}],"title":"1"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \\<50% in bed during the day; 3 = Symptomatic, \\>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Zubrod Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"154"},{"groupId":"BG001","value":"153"},{"groupId":"BG004","value":"307"}],"title":"Adenocarcinoma"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG004","value":"15"}],"title":"Intraductal papillary mucinous neoplasm with invasive adenocarcinoma"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"166"},{"groupId":"BG003","value":"172"},{"groupId":"BG004","value":"338"}],"title":"Adenocarcinoma"},{"measurements":[{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"16"}],"title":"Intraductal papillary mucinous neoplasm with invasive adenocarcinoma"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"A description of a tumor based on how the cancer cells and tissue look under a microscope.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Histologic Type","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG004","value":"15"}],"title":"T1"},{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"25"},{"groupId":"BG004","value":"55"}],"title":"T2"},{"measurements":[{"groupId":"BG000","value":"126"},{"groupId":"BG001","value":"126"},{"groupId":"BG004","value":"252"}],"title":"T3"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"14"}],"title":"T1"},{"measurements":[{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"52"}],"title":"T2"},{"measurements":[{"groupId":"BG002","value":"145"},{"groupId":"BG003","value":"143"},{"groupId":"BG004","value":"288"}],"title":"T3"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Pathologic T-Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"40"},{"groupId":"BG004","value":"85"}],"title":"N0"},{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"119"},{"groupId":"BG004","value":"237"}],"title":"N1"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"49"},{"groupId":"BG004","value":"91"}],"title":"N0"},{"measurements":[{"groupId":"BG002","value":"132"},{"groupId":"BG003","value":"131"},{"groupId":"BG004","value":"263"}],"title":"N1"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 6th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Pathologic N-Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"40"},{"groupId":"BG004","value":"85"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"78"},{"groupId":"BG004","value":"154"}],"title":"1-3"},{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"41"},{"groupId":"BG004","value":"83"}],"title":">3"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"49"},{"groupId":"BG004","value":"91"}],"title":"0"},{"measurements":[{"groupId":"BG002","value":"95"},{"groupId":"BG003","value":"79"},{"groupId":"BG004","value":"174"}],"title":"1-3"},{"measurements":[{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"52"},{"groupId":"BG004","value":"89"}],"title":">3"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II analysis and phase III analysis.","title":"Number of Positive Lymph Nodes","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"152"},{"groupId":"BG001","value":"148"},{"groupId":"BG004","value":"300"}],"title":"≤ 90"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG004","value":"22"}],"title":">90-180"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"163"},{"groupId":"BG003","value":"177"},{"groupId":"BG004","value":"340"}],"title":"≤ 90"},{"measurements":[{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"14"}],"title":">90-180"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"description":"CA 19-9 is a protein found on the surface of some cancer cells, and is also known as sialyl-Lewis A. It is a tumor marker that is commonly used to help diagnose, manage, and predict pancreatic ductal adenocarcinoma (PDAC). CA 19-9 levels are determined by a blood test and are often elevated in patients with advanced pancreatic cancer.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Carbohydrate antigen 19-9 (CA19-9) Level","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"26"},{"groupId":"BG004","value":"53"}],"title":"Positive"},{"measurements":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"133"},{"groupId":"BG004","value":"269"}],"title":"Negative"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"59"}],"title":"Positive"},{"measurements":[{"groupId":"BG002","value":"144"},{"groupId":"BG003","value":"151"},{"groupId":"BG004","value":"295"}],"title":"Negative"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Surgical margins","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"117"},{"groupId":"BG004","value":"240"}],"title":"Classic Pancreaticoduodenectomy (Whipple)"},{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG004","value":"80"}],"title":"Pylorus preserving pancreaticoduodenectomy"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG004","value":"2"}],"title":"Other"}],"denoms":[{"counts":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"159"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"322"}],"units":"Participants"}],"title":"Phase II analysis"},{"categories":[{"measurements":[{"groupId":"BG002","value":"121"},{"groupId":"BG003","value":"139"},{"groupId":"BG004","value":"260"}],"title":"Classic Pancreaticoduodenectomy (Whipple)"},{"measurements":[{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"41"},{"groupId":"BG004","value":"93"}],"title":"Pylorus preserving pancreaticoduodenectomy"},{"measurements":[{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}],"title":"Other"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}],"title":"Phase III analysis"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Baseline characteristics are reported separately for phase II and phase III components.","title":"Type of surgery (phase III only)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG002","value":"116"},{"groupId":"BG003","value":"120"},{"groupId":"BG004","value":"236"}],"title":"Gemcitabine alone"},{"measurements":[{"groupId":"BG002","value":"50"},{"groupId":"BG003","value":"50"},{"groupId":"BG004","value":"100"}],"title":"Gemcitabine + Erlotinib"},{"measurements":[{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"18"}],"title":"Non-oxaliplatin gemcitabine combinations"},{"measurements":[{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"FOLFIRINOX or mFOLFIRINOX"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"174"},{"groupId":"BG003","value":"180"},{"groupId":"BG004","value":"354"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Not reported for phase II analysis.","title":"Adjuvant Systemic Treatment (Phase III only)","unitOfMeasure":"Participants"}],"populationDescription":"Arm 1 and Arm 2: Phase II analysis population = eligible randomized Step 1 participants.\n\nArm 3 and Arm 4: Phase III analysis population = randomized Step 2 participants.\n\nPhase II and phase III components are reported separately for clarity and so that totals can be seen for each component. Note that 354 participants were in both components."}