{"analyses":[{"ciLowerLimit":"0.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.99","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.043","paramType":"Hazard Ratio (HR)","paramValue":"0.59","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"26.7","upperLimit":"39","value":"33.4"},{"groupId":"OG001","lowerLimit":"25","upperLimit":"32.1","value":"29.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"87"}],"units":"Participants"}],"description":"Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.","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":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}