{"analyses":[{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.16","estimateComment":"HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.13499","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalComment":"One-sided p-value was based on the permutation test with multivariate Cox regression model.","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"47.8","upperLimit":"NA","value":"67.0"},{"comment":"NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"36.4","upperLimit":"NA","value":"47.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"165"}],"units":"Participants"}],"description":"DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received placebo, IV, every 3 weeks, for one year.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.","reportingStatus":"POSTED","timeFrame":"Up to approximately 84 months","title":"DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%","type":"PRIMARY","unitOfMeasure":"Months"}