{"analyses":[{"ciLowerLimit":"1.25","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.78","estimateComment":"An odds ratio \\> 1 favours osimertinib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0110","paramType":"Odds Ratio (OR)","paramValue":"2.78","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.98","estimateComment":"An odds ratio \\>1 favours osimertinib","groupIds":["OG002","OG003"],"nonInferiorityComment":"The china cohort was not powered for superiority","nonInferiorityType":"OTHER","pValue":"0.5772","paramType":"Odds Ratio (OR)","paramValue":"1.67","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"94.4","upperLimit":"98.8","value":"97.1"},{"groupId":"OG001","lowerLimit":"88.6","upperLimit":"95.2","value":"92.4"},{"groupId":"OG002","lowerLimit":"90.2","upperLimit":"99.7","value":"97.2"},{"groupId":"OG003","lowerLimit":"87.1","upperLimit":"99.0","value":"95.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"277"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"65"}],"units":"Participants"}],"description":"The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event 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":"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 until objective disease progression","title":"Disease Control Rate (DCR)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}