{"analyses":[{"ciLowerLimit":"44.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"61.2","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)","groupIds":["OG001","OG002"],"nonInferiorityType":"OTHER","pValue":"<0.000001","pValueComment":"p-value is nominal","paramType":"Difference in percentage","paramValue":"53.1","statisticalMethod":"Miettinen & Nurminen Method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"8.1","upperLimit":"18.5","value":"12.6"},{"groupId":"OG002","lowerLimit":"58.2","upperLimit":"73.0","value":"65.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"174"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"Pathologic downstaging (pDS) is defined as participants with a tumor classification of \\<pT2. The pathologic stage \\<pT2 includes pT0 (No residual primary tumor found in the tissue examined), pTis (carcinoma in situ; a flat, non-invasive cancer confined to the epithelial lining), pTa (Non-invasive papillary carcinoma limited to the urothelium) pT1 (tumor has invaded the connective tissue beneath the urothelium, but not the muscle layer) and N0 (No cancer found in the examined lymph nodes) in examined tissue from RC and PLND. The \\<pT2 category represents a better outcome than participants with residual muscle-invasive disease (pT2 or higher) and/or any nodal involvement (N1/N2). The percentage of participants with pDS is presented.","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 months","title":"Pathologic Downstaging {pDS) Rate Between Arm C and Arm B","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}