{"analyses":[{"ciLowerLimit":"0.556","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.886","estimateComment":"Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00142","pValueComment":"Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.","paramType":"Stratified Hazard Ratio","paramValue":"0.702","statisticalMethod":"Stratified Log rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.58","upperLimit":"15.21","value":"12.88"},{"groupId":"OG001","lowerLimit":"8.05","upperLimit":"10.74","value":"8.97"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"307"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","id":"OG000","title":"Enfortumab Vedotin 1.25 mg/kg"},{"description":"Participants received either 75 mg/m\\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","id":"OG001","title":"Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"FAS Population","reportingStatus":"POSTED","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}