{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.79","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","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"24.7","upperLimit":"NA","value":"25.5"},{"groupId":"OG001","lowerLimit":"14.1","upperLimit":"21.3","value":"16.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"Progression-free survival (PFS) using Investigator assessment as defined by RECIST 1.1. Median progression free survival (months) calculated using the Kaplan-Meier method.\n\nProgression-free survival (PFS) is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.\n\nThe primary efficacy analysis of the investigator-assessed progression-free survival will be performed when approximately 278 PFS events and at least 16 months of follow-up after Last subject in, has occurred in the 556 randomized patients.","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 33.3 months)","title":"Progression-free Survival (PFS) (Randomized Component)","type":"PRIMARY","unitOfMeasure":"Months"}