{"analyses":[{"ciLowerLimit":"0.505","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.748","estimateComment":"Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.00001","pValueComment":"Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.","paramType":"Stratified Hazard Ratio","paramValue":"0.615","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.32","upperLimit":"5.82","value":"5.55"},{"groupId":"OG001","lowerLimit":"3.52","upperLimit":"3.94","value":"3.71"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"307"}],"units":"Participants"}],"description":"PFS: time from date of randomization until date of documented radiological disease progression (PD) per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. PD: \\>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \\>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \\>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow-up for PFS was based on data cut-off \\& is same as median follow-up time for OS.","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":"Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)","type":"SECONDARY","unitOfMeasure":"months"}