{"analyses":[{"ciLowerLimit":"39.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"56.5","estimateComment":"Arm C: EV+ Pembrolizumab +Surgery vs Arm B: Surgery Alone","groupDescription":"Based on Miettinen \\& Nurminen method stratified by cisplatin status (cisplatin-ineligible vs cisplatin-eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.000001","paramType":"Difference in Percentage","paramValue":"48.3","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"4.9","upperLimit":"13.8","value":"8.6"},{"groupId":"OG002","lowerLimit":"49.3","upperLimit":"64.6","value":"57.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"174"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blind independent central review (BICR).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.","id":"OG000","title":"Arm A: Pembrolizumab + Surgery"},{"description":"Participants receive standard of care surgery alone.","id":"OG001","title":"Arm B: Surgery Alone"},{"description":"Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.","id":"OG002","title":"Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery"}],"paramType":"NUMBER","populationDescription":"Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.","reportingStatus":"POSTED","timeFrame":"Up to approximately 53 monhts","title":"Pathologic Complete Response (pCR) Rate Between Arm C and Arm B","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}