{"analyses":[{"ciLowerLimit":"0.376","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.582","estimateComment":"HR was calculated using stratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityComment":"P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.","nonInferiorityType":"SUPERIORITY","pValue":"<0.00001","paramType":"Hazard Ratio (HR)","paramValue":"0.468","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be estimated due to insufficient number of participants with event.","groupId":"OG000","lowerLimit":"25.4","upperLimit":"NA","value":"31.5"},{"groupId":"OG001","lowerLimit":"13.9","upperLimit":"18.3","value":"16.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"444"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. 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 randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}