{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.38","estimateComment":"Reference level = Arm I","groupDescription":"A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.62","pValueComment":"One-sided significance level = 0.15","paramType":"Hazard Ratio (HR)","paramValue":"1.04","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.7","upperLimit":"33.4","value":"29.9"},{"groupId":"OG001","lowerLimit":"20.7","upperLimit":"30.9","value":"28.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"159"}],"units":"Participants"}],"description":"Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from 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 6-28-2016\\] 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 2-28-14.\\] 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 step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.","title":"Overall Survival (Percentage of Participants Alive) [Phase II]","type":"PRIMARY","unitOfMeasure":"months"}