{"analyses":[{"ciLowerLimit":"0.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.72","estimateComment":"Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\\>=50% versus \\<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.00001","pValueComment":"One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\\>=50% versus \\<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).","paramType":"Hazard Ratio (HR)","paramValue":"0.59","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Upper limit not reached at time of data cut-off","groupId":"OG000","lowerLimit":"32.9","upperLimit":"NA","value":"47.2"},{"groupId":"OG001","lowerLimit":"14.8","upperLimit":"22.1","value":"18.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"397"},{"groupId":"OG001","value":"400"}],"units":"Participants"}],"description":"EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).","dispersionType":"95% Confidence Interval","groups":[{"description":"Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \\[200 mg, intravenous (IV); given on cycle day 1\\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \\[75 mg/m\\^2, IV; given on cycle day 1\\] and either Gemcitabine \\[1000 mg/m\\^2, IV; given on cycle days 1 and 8\\] or Pemetrexed \\[500 mg/m\\^2, IV; given on cycle day 1\\].\n\nAdjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \\[200 mg, IV; given on cycle day 1\\].","id":"OG000","title":"NAC + Neoadjuvant/Adjuvant Pembrolizumab"},{"description":"Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \\[normal saline, IV; given on cycle day 1\\] in combination with platinum doublet NAC, consisting of cisplatin \\[75 mg/m\\^2, IV; given on cycle day 1\\] and either Gemcitabine \\[1000 mg/m\\^2, IV; given on cycle days 1 and 8\\] or Pemetrexed \\[500 mg/m\\^2, IV; given on cycle day 1\\].\n\nAdjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \\[normal saline, IV; given on cycle day 1\\].","id":"OG001","title":"NAC + Neoadjuvant/Adjuvant Placebo"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to approximately 5 years","title":"Event Free Survival (EFS)","type":"PRIMARY","unitOfMeasure":"Months"}