{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.09","estimateComment":"Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.","groupDescription":"The results shown relate to Time to Deterioration in Coughing.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2562","pValueComment":"p-value calculated using log rank test stratified by race.","paramType":"Hazard Ratio (HR)","paramValue":"0.89","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.94","estimateComment":"Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.","groupDescription":"The results shown relate to Time to Deterioration in Dyspnoea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0078","pValueComment":"p-value calculated using log rank test stratified by race.","paramType":"Hazard Ratio (HR)","paramValue":"0.79","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.18","estimateComment":"Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.","groupDescription":"The results shown relate to Time to Deterioration in Pain","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8690","pValueComment":"p-value calculated using log rank test stratified by race","paramType":"Hazard Ratio (HR)","paramValue":"0.99","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.86","upperLimit":"4.93","value":"4.53"},{"groupId":"OG001","lowerLimit":"2.79","upperLimit":"4.66","value":"3.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"182"}],"units":"Participants"}],"title":"Time to Deterioration - Coughing"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.97","upperLimit":"2.86","value":"2.63"},{"groupId":"OG001","lowerLimit":"1.87","upperLimit":"2.33","value":"1.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"244"}],"units":"Participants"}],"title":"Time to Deterioration - Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.00","upperLimit":"2.79","value":"2.50"},{"groupId":"OG001","lowerLimit":"1.91","upperLimit":"2.76","value":"2.37"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"232"}],"units":"Participants"}],"title":"Time to Deterioration - Pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.","id":"OG000","title":"Afatinib"},{"description":"Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.","id":"OG001","title":"Erlotinib"}],"paramType":"MEDIAN","populationDescription":"RS","reportingStatus":"POSTED","timeFrame":"From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).","title":"Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.","type":"SECONDARY","unitOfMeasure":"Months"}