{"analyses":[{"ciLowerLimit":"0.307","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.529","estimateComment":"Based on stratified Cox regression model","groupDescription":"Comparison of dacomitinib vs gefitinib based on IRC review","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.403","statisticalMethod":"1-sided stratified log-rank test"},{"ciLowerLimit":"0.418","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.711","estimateComment":"Based on stratified Cox regression model","groupDescription":"Comparison of dacomitinib vs gefitinib based on Investigator assessment","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.545","statisticalMethod":"1-sided stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.0","upperLimit":"17.4","value":"14.8"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"9.2","value":"8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"170"},{"groupId":"OG001","value":"161"}],"units":"Participants"}],"title":"DoR: IRC review"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.8","upperLimit":"17.6","value":"15.9"},{"groupId":"OG001","lowerLimit":"8.2","upperLimit":"11.0","value":"9.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"158"}],"units":"Participants"}],"title":"DoR: Investigator assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"225"}],"units":"Participants"}],"description":"DoR was defined as time from first documentation of objective response(CR or PR, whichever occurred first)to date of PD/death from any cause, whichever occurred first. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to \\<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\\<10 mm short axis); PR:\\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:\\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \\>=5 mm, appearance of \\>=1 new lesions; unequivocal progression of existing non TLs. DoR was recorded based on IRC review and investigator's assessment and summarized for subgroup of participants with objective disease response.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"OG000","title":"Dacomitinib"},{"description":"Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"OG001","title":"Gefitinib"}],"paramType":"MEDIAN","populationDescription":"ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)","title":"Duration of Response (DoR)","type":"SECONDARY","unitOfMeasure":"months"}