{"analyses":[{"ciLowerLimit":"0.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.34","estimateComment":"A hazard ratio \\< 1 favours osimertinib","groupDescription":"Negative at screening","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.22","statisticalMethod":"Cox proportional hazard model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"EGFR mutation-positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"EGFR mutation-negative"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"EGFR mutation-unknown"}],"denoms":[{"counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"73"}],"units":"Participants"}],"description":"Number of PFS events (PFS is time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on blinded independent central review (BICR) assessment according to RECIST v1.1)","groups":[{"description":"80mg once daily tablet","id":"OG000","title":"Osimertinib"},{"description":"Matching Placebo","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months","title":"Number of Participants With Progression-free Survival (PFS) Events in Patients With EGFR Mutations Ex19del or L858R Detectable in Plasma-derived ctDNA","type":"SECONDARY","unitOfMeasure":"Participants"}