{"groups":[{"description":"Participants received enfortumab vedotin at 1.25 milligram per kilogram (mg/kg) as an intravenous (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":"FG000","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 (area under curve \\[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":"FG001","title":"Standard of Care"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"73"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"62"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"28"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"24"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"11"}],"type":"Randomized but not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"144"},{"groupId":"FG001","numSubjects":"0"}],"type":"On-treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"442"},{"groupId":"FG001","numSubjects":"444"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"440"},{"groupId":"FG001","numSubjects":"433"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"244"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"434"},{"groupId":"FG001","numSubjects":"200"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Results are reported only for primary outcome measures at primary completion date (08-Aug-2023). Remaining secondary outcome measures whose analysis are not final, results would be reported at study completion date.","recruitmentDetails":"Participants with untreated locally advanced or metastatic urothelial cancer (UC) were enrolled in the study."}