{"analyses":[{"ciLowerLimit":"0.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.64","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.42","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.9","upperLimit":"12.3","value":"9.4"},{"groupId":"OG001","lowerLimit":"4.4","upperLimit":"5.8","value":"5.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"87"}],"units":"Participants"}],"description":"The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)","dispersionType":"95% Confidence Interval","groups":[{"description":"Erlotinib (Tarceva)150 mg /day\n\nPatients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib\n\nErlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib","id":"OG000","title":"A: Erlotinib Group"},{"description":"4 cycles of Chemotherapy:\n\nCisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.\n\n3 week cycles of standard intravenous chemotherapy\n\n* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or\n* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8\n\nPatients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:\n\n* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or\n* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8\n\nPatients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.","id":"OG001","title":"B: Standard Chemotherapy Group"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the date of last follow up, assessed up to 24 months","title":"Progression Free-survival","type":"PRIMARY","unitOfMeasure":"months"}