{"analyses":[{"ciLowerLimit":"0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.57","groupDescription":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate 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":"<0.0001","pValueComment":"One-sided p-value based on log-rank test 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","paramType":"Hazard Ratio (HR)","paramValue":"0.40","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"10.3","upperLimit":"20.5","value":"15.7"},{"comment":"NA=median and upper limit not reached due to insufficient number of participants with an event","groupId":"OG002","lowerLimit":"37.3","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"174"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \\[MIBC\\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.","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":"MEDIAN","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 months","title":"Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone","type":"PRIMARY","unitOfMeasure":"Months"}