{"analyses":[{"ciLowerLimit":"1.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.09","groupIds":["OG002","OG003"],"nonInferiorityComment":"The china cohort was not powered for superiority","nonInferiorityType":"OTHER","pValue":"0.0133","paramType":"Mean Difference (Final Values)","paramValue":"2.48","statisticalMethod":"Regression, Linear"},{"ciLowerLimit":"1.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.08","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Final Values)","paramValue":"2.27","statisticalMethod":"Regression, Linear"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.8","upperLimit":"22.0","value":"17.2"},{"groupId":"OG001","lowerLimit":"7.3","upperLimit":"9.8","value":"8.5"},{"comment":"NA-Upper limit is not calculable at this data cut-off.","groupId":"OG002","lowerLimit":"12.3","upperLimit":"NA","value":"16.4"},{"groupId":"OG003","lowerLimit":"8.3","upperLimit":"13.8","value":"10.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"277"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"65"}],"units":"Participants"}],"description":"Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Randomized participants received Osimertinib 80 mg orally once daily (QD)","id":"OG000","title":"Osimertinib 80 mg (Global Cohort)"},{"description":"Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.","id":"OG001","title":"SoC EGFR-TKI (Global Cohort)"},{"description":"Randomized participants received Osimertinib 80 mg orally once daily (QD)","id":"OG002","title":"Osimertinib 80 mg (China Cohort)"},{"description":"Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.","id":"OG003","title":"SoC EGFR-TKI (China Cohort)"}],"paramType":"MEDIAN","populationDescription":"The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.","reportingStatus":"POSTED","timeFrame":"At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression","title":"Duration of Response (DoR)","type":"SECONDARY","unitOfMeasure":"Months"}