{"analyses":[{"ciLowerLimit":"0.377","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.538","estimateComment":"HR was calculated using stratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.00001","pValueComment":"P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.","paramType":"Hazard Ratio (HR)","paramValue":"0.450","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.4","upperLimit":"16.6","value":"12.5"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"6.5","value":"6.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"444"}],"units":"Participants"}],"description":"PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.","id":"OG000","title":"Enfortumab Vedotin + Pembrolizumab"},{"description":"Participants received gemcitabine at 1000 mg/m\\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.","id":"OG001","title":"Standard of Care"}],"paramType":"MEDIAN","populationDescription":"ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)","title":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)","type":"PRIMARY","unitOfMeasure":"Months"}