{"description":"Serious/other AEs: Safety analysis set. All-cause mortality: ITT population (all randomized). The study was to evaluate efficacy of erdafitinib versus standard chemotherapy chosen at site level by investigators. Regardless of which chemotherapy was chosen by investigator (docetaxel/vinflunine), AEs were collected and analyzed collectively for chemotherapy arm (Vinflunine 320 mg/m\\^2 or Docetaxel 75 mg/m\\^2; Arm 1B). Per plan safety was analyzed per intervention.","eventGroups":[{"deathsNumAffected":91,"deathsNumAtRisk":143,"description":"Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\\[L\\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"EG000","otherNumAffected":141,"otherNumAtRisk":142,"seriousNumAffected":63,"seriousNumAtRisk":142,"title":"Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg"},{"deathsNumAffected":90,"deathsNumAtRisk":135,"description":"Participants with advanced urothelial cancer and selected FGFR aberrations who were previously treated with PD-(L)1 agent were randomized to receive chemotherapy (vinflunine 320 milligrams per meter square \\[mg/m\\^2\\] intravenous \\[IV\\] infusion or docetaxel 75 mg/m\\^2 IV infusion) on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment or end of treatment. The choice of chemotherapy regimen at each site was determined by the investigator. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"EG001","otherNumAffected":104,"otherNumAtRisk":117,"seriousNumAffected":50,"seriousNumAtRisk":117,"title":"Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)"},{"deathsNumAffected":141,"deathsNumAtRisk":175,"description":"Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"EG002","otherNumAffected":173,"otherNumAtRisk":173,"seriousNumAffected":69,"seriousNumAtRisk":173,"title":"Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg"},{"deathsNumAffected":131,"deathsNumAtRisk":176,"description":"Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with PD-(L)1 agent were randomized to receive pembrolizumab 200 mg IV infusion on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment or end of treatment. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"EG003","otherNumAffected":157,"otherNumAtRisk":173,"seriousNumAffected":81,"seriousNumAtRisk":173,"title":"Cohort 2: Arm 2B: Pembrolizumab 200 mg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 24.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":142},{"groupId":"EG001","numAffected":39,"numAtRisk":117},{"groupId":"EG002","numAffected":51,"numAtRisk":173},{"groupId":"EG003","numAffected":44,"numAtRisk":173}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 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Upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":142},{"groupId":"EG001","numAffected":32,"numAtRisk":117},{"groupId":"EG002","numAffected":40,"numAtRisk":173},{"groupId":"EG003","numAffected":38,"numAtRisk":173}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 24.1","stats":[{"groupId":"EG000","numAffected":90,"numAtRisk":142},{"groupId":"EG001","numAffected":22,"numAtRisk":117},{"groupId":"EG002","numAffected":92,"numAtRisk":173},{"groupId":"EG003","numAffected":23,"numAtRisk":173}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Aminotransferase Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 24.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":142},{"groupId":"EG001","numAffected":3,"numAtRisk":117},{"groupId":"EG002","numAffected":29,"numAtRisk":173},{"groupId":"EG003","numAffected":14,"numAtRisk":173}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 24.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":142},{"groupId":"EG001","numAffected":3,"numAtRisk":117},{"groupId":"EG002","numAffected":17,"numAtRisk":173},{"groupId":"EG003","numAffected":8,"numAtRisk":173}],"term":"Blood Alkaline Phosphatase Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 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