{"analyses":[{"ciLowerLimit":"1.03","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.22","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.036","paramType":"Odds Ratio (OR)","paramValue":"1.51","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.61","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.84","groupIds":["OG002","OG003"],"nonInferiorityComment":"The china cohort was not powered for superiority","nonInferiorityType":"OTHER","pValue":"0.485","paramType":"Odds Ratio (OR)","paramValue":"1.31","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"71.29","upperLimit":"81.53","value":"76.7"},{"groupId":"OG001","lowerLimit":"63.14","upperLimit":"74.35","value":"69.0"},{"groupId":"OG002","lowerLimit":"64.5","upperLimit":"85.4","value":"76.1"},{"groupId":"OG003","lowerLimit":"58.2","upperLimit":"81.4","value":"70.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"277"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"65"}],"units":"Participants"}],"description":"ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment.","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":"NUMBER","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 relative to randomisation until progression","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}