{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.24","estimateComment":"A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.","groupDescription":"The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.","pValue":"0.5238","paramType":"Hazard Ratio (HR)","paramValue":"0.90","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG000","lowerLimit":"31.9","upperLimit":"NA","value":"NA"},{"comment":"Median, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"Overall survival is defined as the time from the date of randomization until death due to any cause. Subjects not known to have died at the time of analysis are censored at the last recorded date on which the subject was known to be alive. Median overall Survival calculated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG000","title":"Randomized: AZD9291 + Chemo"},{"description":"Osimertinib (AZD9291) 80mg QD.","id":"OG001","title":"Randomized: AZD9291"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set, includes all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to approximately 33 months after the first patient is randomized (maximum follow up of 34.1 months)","title":"Overall Survival (OS) (Randomized Component)","type":"SECONDARY","unitOfMeasure":"Months"}