{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"24"}]}],"title":"Normal (BL) to Abnormal CS (post-BL)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"}]}],"title":"Normal (BL) to Abnormal NCS (post-BL)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}],"title":"Abnormal NCS (BL) to Abnormal CS (post-BL)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"165"}],"units":"Participants"}],"description":"Number of participants with shift from baseline to worst post-baseline in Amsler grid test was reported. Baseline and post-baseline visit findings included normal, abnormal CS (clinically significant) and abnormal NCS (not clinically significant). Clinical significance was determined by investigator's assessment. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening post-baseline measurement was reported.","groups":[{"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":"OG000","title":"Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg"},{"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":"OG001","title":"Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Analysis population set included participants from safety set (SS) with non-missing values for Amsler grid test (AGT) taken at baseline, at least 1 post-baseline visit, and at least 1 visit following the first worst post-baseline value. Due to change in planned analysis, data was collected and analyzed for only Cohort 1 and Cohort 2 Erdafitinib arms.","reportingStatus":"POSTED","timeFrame":"From baseline up to maximum of 51.7 months","title":"Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test","type":"SECONDARY","unitOfMeasure":"Participants"}