{"analyses":[{"ciLowerLimit":"-6.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.88","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.34","groupDescription":"The results shown relate to Change in scores over time for: Coughing.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0091","paramType":"Mean Difference (Final Values)","paramValue":"-3.5","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"-5.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.15","groupDescription":"The results shown relate to Change in scores over time for: Dyspnoea.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0024","paramType":"Mean Difference (Final Values)","paramValue":"-3.5","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"-5.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.32","groupDescription":"The results shown relate to Change in scores over time for: Pain.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0384","paramType":"Mean Difference (Final Values)","paramValue":"-2.7","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.40","value":"15.8"},{"groupId":"OG001","spread":"2.37","value":"19.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"333"}],"units":"Participants"}],"title":"Coughing"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.83","value":"11.4"},{"groupId":"OG001","spread":"1.85","value":"14.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"332"}],"units":"Participants"}],"title":"Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.13","value":"10.3"},{"groupId":"OG001","spread":"2.17","value":"13.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"334"}],"units":"Participants"}],"title":"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 change in score over time, adjusted for baseline score and race.\n\nQuestionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.\n\nThe change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.","dispersionType":"Standard Error","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":"LEAST_SQUARES_MEAN","populationDescription":"RS","reportingStatus":"POSTED","timeFrame":"From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).","title":"Change in Score Over Time in Coughing,Dyspnoea and Pain","type":"SECONDARY","unitOfMeasure":"Units on a scale"}