{"analyses":[{"ciLowerLimit":"0.80","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.31","estimateComment":"Reference level = Arm I","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.02"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.8","upperLimit":"15.7","value":"12.7"},{"groupId":"OG001","lowerLimit":"9.7","upperLimit":"16.5","value":"12.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}],"units":"Participants"}],"description":"Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive either gemcitabine hydrochloride or \\[starting 06-28-2016\\] allowable combination chemotherapy per standard of care for 5 months. 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":"OG000","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":"OG001","title":"Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)"}],"paramType":"MEDIAN","populationDescription":"Eligible participants randomized at step 1.","reportingStatus":"POSTED","timeFrame":"From step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.","title":"Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]","type":"SECONDARY","unitOfMeasure":"months"}