Trial Outcomes & Findings for A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (NCT NCT03390504)

NCT ID: NCT03390504

Last Updated: 2025-11-13

Results Overview

Overall survival was measured from the date of randomization to the date of the participant's death.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 629 participants
• Primary outcome timeframe: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)
• Results posted on: 2025-11-13

Participant Flow

With the implementation of Protocol Amendment 6 (20 January 2023), long term extension (LTE) phase was added in the study.

Participant milestones

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Overall Study STARTED	143	135	175	176
Overall Study Treated	142	117	173	173
Overall Study COMPLETED	137	114	168	167
Overall Study NOT COMPLETED	6	21	7	9

Reasons for withdrawal

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Overall Study Lost to Follow-up	2	4	0	1
Overall Study Withdrawal by Subject	3	15	5	2
Overall Study Other	1	2	2	6

Baseline Characteristics

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Baseline characteristics by cohort

Measure	Total n=629 Participants Total of all reporting groups	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=143 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=135 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Age, Categorical <=18 years	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	245 Participants n=44 Participants	61 Participants n=10 Participants	47 Participants n=10 Participants	67 Participants n=20 Participants	70 Participants n=45 Participants
Age, Categorical >=65 years	384 Participants n=44 Participants	82 Participants n=10 Participants	88 Participants n=10 Participants	108 Participants n=20 Participants	106 Participants n=45 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 9.55 • n=44 Participants	65.0 years STANDARD_DEVIATION 10.23 • n=10 Participants	67.9 years STANDARD_DEVIATION 9.07 • n=10 Participants	67.0 years STANDARD_DEVIATION 8.49 • n=20 Participants	65.9 years STANDARD_DEVIATION 10.20 • n=45 Participants
Sex: Female, Male Female	158 Participants n=44 Participants	43 Participants n=10 Participants	38 Participants n=10 Participants	33 Participants n=20 Participants	44 Participants n=45 Participants
Sex: Female, Male Male	471 Participants n=44 Participants	100 Participants n=10 Participants	97 Participants n=10 Participants	142 Participants n=20 Participants	132 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=44 Participants	3 Participants n=10 Participants	4 Participants n=10 Participants	5 Participants n=20 Participants	5 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	484 Participants n=44 Participants	119 Participants n=10 Participants	100 Participants n=10 Participants	126 Participants n=20 Participants	139 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	128 Participants n=44 Participants	21 Participants n=10 Participants	31 Participants n=10 Participants	44 Participants n=20 Participants	32 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	154 Participants n=44 Participants	39 Participants n=10 Participants	42 Participants n=10 Participants	37 Participants n=20 Participants	36 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	5 Participants n=44 Participants	0 Participants n=10 Participants	1 Participants n=10 Participants	4 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) White	357 Participants n=44 Participants	85 Participants n=10 Participants	66 Participants n=10 Participants	95 Participants n=20 Participants	111 Participants n=45 Participants
Race (NIH/OMB) More than one race	2 Participants n=44 Participants	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	111 Participants n=44 Participants	19 Participants n=10 Participants	25 Participants n=10 Participants	39 Participants n=20 Participants	28 Participants n=45 Participants
Region of Enrollment ARGENTINA	2 Participants n=44 Participants	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Region of Enrollment AUSTRALIA	14 Participants n=44 Participants	6 Participants n=10 Participants	2 Participants n=10 Participants	1 Participants n=20 Participants	5 Participants n=45 Participants
Region of Enrollment AUSTRIA	8 Participants n=44 Participants	2 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants	2 Participants n=45 Participants
Region of Enrollment BELGIUM	15 Participants n=44 Participants	5 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants	2 Participants n=45 Participants
Region of Enrollment BRAZIL	29 Participants n=44 Participants	4 Participants n=10 Participants	3 Participants n=10 Participants	11 Participants n=20 Participants	11 Participants n=45 Participants
Region of Enrollment CANADA	8 Participants n=44 Participants	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	4 Participants n=45 Participants
Region of Enrollment CHINA	44 Participants n=44 Participants	8 Participants n=10 Participants	11 Participants n=10 Participants	10 Participants n=20 Participants	15 Participants n=45 Participants
Region of Enrollment FRANCE	107 Participants n=44 Participants	20 Participants n=10 Participants	28 Participants n=10 Participants	34 Participants n=20 Participants	25 Participants n=45 Participants
Region of Enrollment GERMANY	26 Participants n=44 Participants	6 Participants n=10 Participants	10 Participants n=10 Participants	1 Participants n=20 Participants	9 Participants n=45 Participants
Region of Enrollment GREECE	19 Participants n=44 Participants	4 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=20 Participants	5 Participants n=45 Participants
Region of Enrollment HUNGARY	6 Participants n=44 Participants	2 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	2 Participants n=45 Participants
Region of Enrollment ISRAEL	7 Participants n=44 Participants	2 Participants n=10 Participants	3 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants
Region of Enrollment ITALY	55 Participants n=44 Participants	14 Participants n=10 Participants	11 Participants n=10 Participants	15 Participants n=20 Participants	15 Participants n=45 Participants
Region of Enrollment JAPAN	51 Participants n=44 Participants	15 Participants n=10 Participants	15 Participants n=10 Participants	11 Participants n=20 Participants	10 Participants n=45 Participants
Region of Enrollment NETHERLANDS	5 Participants n=44 Participants	4 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants
Region of Enrollment POLAND	1 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants
Region of Enrollment PORTUGAL	5 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	4 Participants n=20 Participants	1 Participants n=45 Participants
Region of Enrollment RUSSIAN FEDERATION	20 Participants n=44 Participants	2 Participants n=10 Participants	2 Participants n=10 Participants	7 Participants n=20 Participants	9 Participants n=45 Participants
Region of Enrollment SOUTH KOREA	41 Participants n=44 Participants	12 Participants n=10 Participants	13 Participants n=10 Participants	10 Participants n=20 Participants	6 Participants n=45 Participants
Region of Enrollment SPAIN	57 Participants n=44 Participants	14 Participants n=10 Participants	12 Participants n=10 Participants	15 Participants n=20 Participants	16 Participants n=45 Participants
Region of Enrollment TAIWAN	16 Participants n=44 Participants	4 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants	4 Participants n=45 Participants
Region of Enrollment TURKEY	36 Participants n=44 Participants	3 Participants n=10 Participants	1 Participants n=10 Participants	13 Participants n=20 Participants	19 Participants n=45 Participants
Region of Enrollment UKRAINE	16 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	9 Participants n=20 Participants	7 Participants n=45 Participants
Region of Enrollment UNITED KINGDOM	21 Participants n=44 Participants	6 Participants n=10 Participants	7 Participants n=10 Participants	2 Participants n=20 Participants	6 Participants n=45 Participants
Region of Enrollment UNITED STATES	19 Participants n=44 Participants	6 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=20 Participants	2 Participants n=45 Participants
Region of Enrollment Bulgaria	1 Participants n=44 Participants	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants

PRIMARY outcome

Timeframe: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)

Population: Intent-to-Treat (ITT) analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized.

Overall survival was measured from the date of randomization to the date of the participant's death.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=143 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=135 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Overall Survival (OS)	12.06 Months Interval 10.25 to 16.36	8.74 Months Interval 6.67 to 10.71	10.91 Months Interval 9.23 to 12.58	11.07 Months Interval 9.72 to 13.63

SECONDARY outcome

Timeframe: From randomization (3 days prior to Cycle 1 Day 1) until disease progression or relapse from CR or death (maximum up to 51.7 months)

Population: ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

PFS was defined as the time from the date of randomization to the date of disease progression or relapse from complete response (CR) based on investigator assessment using RECIST v 1.1, or death due to any cause, whichever occurred first. As per RECIST v 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). Progressive disease (PD) was defined as at least 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of greater than or equal to (>=) 5 mm or appearance of at least 1 new lesion.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=115 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=103 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=156 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=158 Participants 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.
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	5.39 Months Interval 4.37 to 5.62	2.73 Months Interval 2.1 to 4.17	4.44 Months Interval 4.07 to 5.49	2.69 Months Interval 1.64 to 3.02

SECONDARY outcome

Timeframe: From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months

Population: ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized.

ORR was defined as the percentage of participants who achieved CR or partial response (PR) as determined by investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=143 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=135 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Objective Response Rate (ORR) Per RECIST Version 1.1	46.9 Percentage of participants	12.6 Percentage of participants	40.0 Percentage of participants	21.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Cycle 11 (each cycle was of 21 days)

Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.

The FACT-Bl consisted of 39 items, with 5-point Likert scales, covering 5 primary domains: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns for participants with bladder cancer. The response options ranged from 0 to 4 where, 0='Not at all" and 4= "very much." FACT-Bl total score ranged from 0 (worst) to 156 (best). The higher the score, the better the quality of life (QOL). The baseline value was defined as the value collected at the time closest to but prior to the randomization.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=136 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=130 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)	-3.70 Score on scale Standard Error 2.365	-5.28 Score on scale Standard Error 2.746	-4.56 Score on scale Standard Error 1.946	-0.26 Score on scale Standard Error 1.980

SECONDARY outcome

Timeframe: Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months

Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.

Time until symptom deterioration was defined as the first time to increase in urinary bladder cancer symptoms score from the day of randomization beyond a meaningful change threshold compared to baseline. The urinary bladder cancer symptom score was subset of FACT-Bl which included 3 items related to urinary symptoms, 5-point Likert scale. Response options ranged from 0 to 4, 0 = Not at all, 1= A little bit, 2= Somewhat, 3=Quite a bit, 4 = Very much. A response of 0 indicated no symptoms and 4 indicated severe symptoms. Total sum scores ranged from 0 to 12, higher scores indicate relatively poor quality of life.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=136 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=130 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Time Until Symptom Deterioration	1.5 Months Interval 0.82 to 2.83	2.8 Months Interval 1.51 to 5.32	2.1 Months Interval 1.41 to 3.48	2.1 Months Interval 1.38 to 4.17

SECONDARY outcome

Timeframe: Baseline, 51.7 months

Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.

The PGI-S was a single item patient-reported measure assessing participants' impression of severity in bladder cancer symptoms. It uses a 4-point Likert scale as follows: symptoms are: 0-"absent (no symptoms)", 1-"mild", 2-"moderate", 3="severe" and 4= "very severe". Percentage of participants with shift from baseline in PGIS score were reported. A negative shift from baseline in PGIS score indicated Improvement and positive shift from baseline in PGIS score indicated Worsening. The baseline value was defined as the value collected at the time closest to but prior to the randomization.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=53 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=57 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=104 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=99 Participants 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.
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) -4 Improvement	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) -3	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) -2	5.7 Percentage of participants	8.8 Percentage of participants	3.8 Percentage of participants	4.0 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) -1	15.1 Percentage of participants	17.5 Percentage of participants	13.5 Percentage of participants	15.2 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) +1	30.2 Percentage of participants	26.3 Percentage of participants	20.2 Percentage of participants	17.2 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) +4 Worsening	0 Percentage of participants	0 Percentage of participants	1.9 Percentage of participants	1 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) 0 No Change	34.0 Percentage of participants	33.3 Percentage of participants	44.2 Percentage of participants	46.5 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) +2	7.5 Percentage of participants	10.5 Percentage of participants	11.5 Percentage of participants	13.1 Percentage of participants
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) +3	7.5 Percentage of participants	3.5 Percentage of participants	4.8 Percentage of participants	3.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Cycle 11 (each cycle was of 21 days)

Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.

The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ visual analog scale (VAS) recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=136 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=130 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	-0.06 Score on a scale Standard Error 0.023	-0.06 Score on a scale Standard Error 0.026	-0.04 Score on a scale Standard Error 0.023	-0.04 Score on a scale Standard Error 0.024

SECONDARY outcome

Timeframe: Baseline up to Cycle 11 (each cycle was of 21 days)

Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.

The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ VAS recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=136 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=130 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=175 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=176 Participants 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.
Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	-0.80 Score on a scale Standard Error 2.242	-0.29 Score on a scale Standard Error 2.626	-4.16 Score on a scale Standard Error 2.149	-2.28 Score on a scale Standard Error 2.198

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)

Population: ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

DOR was defined as time from the date of initial documentation of an overall response (CR or PR) to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experience CR) or death. As per RECIST Version 1.1: CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=67 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=17 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=70 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=38 Participants 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.
Duration of Response (DOR) as Per RECIST Version 1.1	4.86 Months Interval 3.84 to 6.9	5.62 Months Interval 2.79 to 6.01	4.67 Months Interval 3.68 to 6.9	15.21 Months Interval 7.39 to 27.79

SECONDARY outcome

Timeframe: From start of the treatment (Day 1 Cycle 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (maximum up to 51.7 months)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=142 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=117 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=173 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=173 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	142 Participants	114 Participants	173 Participants	167 Participants

SECONDARY outcome

Timeframe: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows.

Hematology parameters included: hemoglobin, platelet count, white blood cell (WBC) count, and absolute neutrophil count (ANC). According to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE and Grade 0= normal. In this outcome measure number of participants with shifts from baseline (BL) Grade <= 2 to Grade >=3 post-baseline in any of hematology parameters are reported. 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 those categories in which at least one participant had data were reported in this outcome measure.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=140 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=108 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=171 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=165 Participants 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.
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Anemia: Grade 0 (BL) to Grade 3 (Post BL)	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Anemia: Grade 1 (BL) to Grade 3 (Post BL)	5 Participants	6 Participants	9 Participants	10 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Anemia: Grade 2 (BL) to Grade 3 (Post BL)	10 Participants	4 Participants	4 Participants	5 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Hemoglobin Increased: Grade 0 (BL) to Grade 3 (Post BL)	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Neutrophil Count Decreased: Grade 0 (BL) to Grade 3 (Post BL)	2 Participants	9 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Neutrophil Count Decreased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	20 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Neutrophil Count Decreased: Grade 1 (BL) to Grade 4 (Post BL)	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Platelet Count Decreased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Platelet Count Decreased: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology White Blood Cell Decreased: Grade 0 (BL) to Grade 3 (Post BL)	0 Participants	10 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology White Blood Cell Decreased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	10 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology White Blood Cell Decreased: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology Platelet Count Decreased: Grade 0 (BL) to Grade 3 (Post BL)	2 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicates that no participant was available for the analysis in the respective arm.

Chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, bicarbonate, corrected calcium, magnesium, potassium, sodium, serum phosphate, serum parathyroid hormone. According to NCI-CTCAE version 4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE and Grade 0= normal. In this outcome measure number of participants with shifts from baseline (BL) Grade <= 2 to Grade >=3 post-baseline in any of chemistry parameters are reported. 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 those categories in which at least one participant had data were reported in this outcome measure.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=140 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=106 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=173 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=166 Participants 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.
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALT Increased: Grade 0 (BL) to Grade 3 (Post BL)	4 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALT Increased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALT Increased: Grade 1 (BL) to Grade 3 (Post BL)	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALP Increased: Grade 0 (BL) to Grade 3 (Post BL)	1 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALP Increased: Grade 1 (BL) to Grade 3 (Post BL)	5 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALP Increased: Grade 2 (BL) to Grade 3 (Post BL)	1 Participants	1 Participants	5 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry ALP Increased: Grade 2 (BL) to Grade 4 (Post BL)	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry AST Increased: Grade 0 (BL) to Grade 3 (Post BL)	3 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry AST Increased: Grade 0 (BL) to Grade 4 (Post BL)	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry AST Increased: Grade 1 (BL) to Grade 3 (Post BL)	1 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry AST Increased: Grade 2 (BL) to Grade 3 (Post BL)	—	—	—	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Blood Bilirubin Increased: Grade 0 (BL) to Grade 3 (Post BL)	1 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Blood Bilirubin Increased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Blood Bilirubin Increased: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	—	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Blood Bilirubin Increased: Grade 2 (BL) to Grade 3 (Post BL)	—	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Creatinine Increased: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Creatinine Increased: Grade 1 (BL) to Grade 3 (Post BL)	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Creatinine Increased: Grade 2 (BL) to Grade 3 (Post BL)	2 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypercalcemia (Corrected): Grade 0 (BL) to Grade 3 (Post BL)	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypercalcemia (Corrected): Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperkalemia: Grade 0 (BL) to Grade 3 (Post BL)	2 Participants	0 Participants	5 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypernatremia: Grade 0 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypermagnesemia: Grade 1 (BL) to Grade 3 (Post BL)	—	0 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperphosphatemia: Grade 0 (BL) to Grade 3 (Post BL)	6 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperphosphatemia: Grade 0 (BL) to Grade 4 (Post BL)	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypoalbuminemia: Grade 0 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypoalbuminemia: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypocalcemia (Corrected): Grade 0 (BL) to Grade 4 (Post BL)	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypocalcemia (Corrected): Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypokalemia: Grade 0 (BL) to Grade 3 (Post BL)	0 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypokalemia: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypokalemia: Grade 1 (BL) to Grade 3 (Post BL)	—	—	—	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypokalemia: Grade 2 (BL) to Grade 3 (Post BL)	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypomagnesemia: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypomagnesemia: Grade 2 (BL) to Grade 3 (Post BL)	—	—	—	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyponatremia: Grade 0 (BL) to Grade 3 (Post BL)	14 Participants	2 Participants	14 Participants	4 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyponatremia: Grade 0 (BL) to Grade 4 (Post BL)	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyponatremia: Grade 1 (BL) to Grade 3 (Post BL)	5 Participants	4 Participants	8 Participants	4 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyponatremia: Grade 1 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypophosphatemia: Grade 0 (BL) to Grade 3 (Post BL)	8 Participants	1 Participants	14 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypophosphatemia: Grade 1 (BL) to Grade 3 (Post BL)	1 Participants	—	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypophosphatemia: Grade 2 (BL) to Grade 3 (Post BL)	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Creatinine Increased: Grade 0 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypercalcemia (Corrected): Grade 1 (BL) to Grade 4 (Post BL)	1 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypercalcemia (Corrected): Grade 2 (BL) to Grade 3 (Post BL)	0 Participants	—	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperkalemia: Grade 0 (BL) to Grade 4 (Post BL)	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperkalemia: Grade 1 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hyperkalemia: Grade 2 (BL) to Grade 3 (Post BL)	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry Hypermagnesemia: Grade 0 (BL) to Grade 3 (Post BL)	3 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 of Cycle 2 and 4 (Each Cycle 21 days)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows.

Number of participants with abnormalities in ECG parameters were reported. The ECG variables included heart rate, RR interval, PR interval, QRS interval, QT interval and QT corrected according to Fridericia's formula (QTcF). ECG abnormality criteria include: Heart rate: Low <50 beats per minute (bpm); High > 100 bpm, RR interval: Low < 600 milliseconds (ms); High > 1000 ms, QT interval: High > 500 ms, QTc interval: High > (450 ms for males, 470 ms for females); increase to >500 ms.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=130 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=73 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=153 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=150 Participants 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.
Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters Cycle 4 Day 1	29 Participants	13 Participants	38 Participants	40 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters Cycle 2 Day 1	31 Participants	20 Participants	55 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline, 51.7 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

Changes from baseline in vital signs (weight) was reported. 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.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=76 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=79 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=120 Participants 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=115 Participants 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.
Change From Baseline in Vital Signs: Weight	-5.95 Kilograms Standard Deviation 6.183	-1.23 Kilograms Standard Deviation 3.580	-4.13 Kilograms Standard Deviation 5.531	-1.26 Kilograms Standard Deviation 4.334

SECONDARY outcome

Timeframe: From baseline up to maximum of 51.7 months

Population: 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.

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.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=126 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=165 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test Abnormal NCS (BL) to Abnormal CS (post-BL)	5 Participants	3 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test Normal (BL) to Abnormal CS (post-BL)	20 Participants	24 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test Normal (BL) to Abnormal NCS (post-BL)	9 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 51.7 months

Population: Analysis set: participants from SS with non-missing values for VA that were convertible to Snellen format taken at BL and at least 1 post BL visit that uses same method. Post BL ophthalmologic examinations were performed only when deemed clinically necessary based on findings of AGT and clinical assessment, or at regular intervals as deemed necessary by screening ophthalmologist. Due to change in planned analysis, data was collected and analyzed for only Cohort 1 and Cohort 2 Erdafitinib arms.

Number of participants with shift from baseline to worst post-baseline in visual acuity (VA) was reported. Worst post-baseline was defined as the visual acuity value that resulted in the largest change from baseline value for either eye. Baseline value was considered for the eye that reported the worst-post baseline value. Baseline and post-baseline visit visual acuity findings included: <= 20/30, >20/30 to <= 20/40, >20/40 to <= 20/80, >20/80 to <= 20/120, >20/120 to <= 20/160, >20/160 to <= 20/200, >20/200. 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 in visual acuity from baseline value to worst post-baseline measurement was reported.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=41 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=46 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/30 to <= 20/40 (Post BL)	10 Participants	11 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/40 to <= 20/80 (Post BL)	2 Participants	5 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/80 to <= 20/120 (Post BL)	2 Participants	1 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/120 to <= 20/160 (Post BL)	1 Participants	1 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/160 to <= 20/200 (Post BL)	5 Participants	1 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity <= 20/30 (BL) To >20/200 (post BL)	0 Participants	1 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity >20/30 to <= 20/40 (BL) To >20/40 to <= 20/80 (Post BL)	0 Participants	4 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity >20/30 to <= 20/40 (BL) To >20/160 to <= 20/200 (Post BL)	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 51.7 months

Population: Analysis population set: participants from safety set with non-missing values for the subretinal fluid at baseline and at least 1 post-baseline visit. Post-baseline ophthalmologic examinations were performed only when deemed clinically necessary based on the findings of the Amsler grid tests and clinical assessment, or at regular intervals as deemed necessary by the screening ophthalmologist. Due to change in planned analysis, data was collected and analyzed for Cohort 1 Erdafitinib arm only.

Number of participants with shift from baseline to worst post-baseline in optical coherence tomography for subretinal fluid was reported. At the baseline visit, findings may have been absent or present/visible. At all post-baseline visits, findings were compared to baseline and results may have been increased, decreased, stable or resolved. 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 category (shift from absent at baseline to increased at post-baseline) in which at least one participant had data for worsening post-baseline measurement was reported.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=39 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid	26 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 51.7 months

Population: Analysis population set: participants from safety set with non-missing values for the RPE elevation at baseline and at least 1 post-baseline visit. Post-baseline ophthalmologic examinations were performed only when deemed clinically necessary based on the findings of the Amsler grid tests and clinical assessment, or at regular intervals as deemed necessary by the screening ophthalmologist. Due to change in planned analysis, data was collected and analyzed for Cohort 1 Erdafitinib arm only.

Number of participants with shift from baseline to worst post-baseline in optical coherence tomography for RPE elevation was reported. At the baseline visit, findings may have been absent or present/visible. At all post-baseline visits, findings were compared to baseline and results may have been increased, decreased, stable or resolved. 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.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=38 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation Absent (BL) to Increased (Post BL)	4 Participants	—	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation Present/visible (BL) to Increased (Post BL)	2 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 51.7 months

Population: Analysis population set: participants from SS with non-missing values for retinal assessments at baseline and at least 1 post-baseline visit. Post-baseline ophthalmologic examinations were performed only when deemed clinically necessary based on the findings of the Amsler grid tests and clinical assessment, or at regular intervals as deemed necessary by screening ophthalmologist. Due to change in planned analysis, data was collected and analyzed for only Cohort 1 and Cohort 2 Erdafitinib arms.

Number of participants with shift from baseline to worst post-baseline in slit lamp biomicroscopy examination for retinal assessment was reported. Baseline and post-baseline visit findings included normal, abnormal CS and abnormal NCS. 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.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=39 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=47 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment Normal (BL) to Abnormal CS (post-BL)	3 Participants	4 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment Normal (BL) to Abnormal NCS (post-BL)	5 Participants	6 Participants	—	—
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment Abnormal NCS (BL) to Abnormal CS (post-BL)	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)

Population: Pharmacokinetic-evaluable analysis set included all randomized participants who received at least 1 dose of erdafitinib and had at least 1 evaluable pharmacokinetic sample obtained posttreatment. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=126 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=149 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Oral Clearance (CL/F) of Erdafitinib	NA Liter per hour Standard Deviation NA Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using non-compartmental analysis (NCA) method.	NA Liter per hour Standard Deviation NA Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using NCA method.	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days)

Population: Pharmacokinetic-evaluable analysis set included all randomized participants who received at least 1 dose of erdafitinib and had at least 1 evaluable pharmacokinetic sample obtained posttreatment. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

Area under the plasma concentration time-curve from time zero to the time t (AUC[0-t]) was reported.

Outcome measures

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=126 Participants 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=149 Participants 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib	NA Nanogram hour per milliliter Standard Deviation NA Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive AUC using NCA method.	NA Nanogram hour per milliliter Standard Deviation NA Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive AUC using NCA method.	—	—

Adverse Events

Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg

Serious events: 63 serious events

Other events: 141 other events

Deaths: 91 deaths

Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)

Serious events: 50 serious events

Other events: 104 other events

Deaths: 90 deaths

Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg

Serious events: 69 serious events

Other events: 173 other events

Deaths: 141 deaths

Cohort 2: Arm 2B: Pembrolizumab 200 mg

Serious events: 81 serious events

Other events: 157 other events

Deaths: 131 deaths

Serious adverse events

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=142 participants at risk 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=117 participants at risk 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=173 participants at risk 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=173 participants at risk 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.
Blood and lymphatic system disorders Anaemia	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Bone Marrow Failure	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Febrile Bone Marrow Aplasia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.4% 4/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.8% 8/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Acute Coronary Syndrome	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Acute Myocardial Infarction	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Angina Pectoris	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Atrial Fibrillation	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Cardiac Arrest	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Cardiac Tamponade	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Cardio-Respiratory Arrest	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Sinus Bradycardia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Stress Cardiomyopathy	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Ear and labyrinth disorders Vestibular Disorder	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Endocrine disorders Adrenal Insufficiency	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Cataract	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Detachment of Retinal Pigment Epithelium	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Keratitis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Serous Retinal Detachment	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Abdominal Pain	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Colo-Urethral Fistula	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Constipation	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Diarrhoea	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Dysphagia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Enterovesical Fistula	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastritis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastrointestinal Obstruction	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastrointestinal Perforation	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Ileus	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Inguinal Hernia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Intestinal Obstruction	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Mechanical Ileus	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Nausea	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Small Intestinal Obstruction	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Stomatitis	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Subileus	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Vomiting	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Asthenia	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Condition Aggravated	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Fatigue	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders General Physical Health Deterioration	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Malaise	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Multiple Organ Dysfunction Syndrome	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Non-Cardiac Chest Pain	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Pain	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Performance Status Decreased	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Precancerous Condition	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Pyrexia	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Sudden Death	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Biliary Obstruction	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Cholangitis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Cholecystitis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Hepatic Function Abnormal	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Hepatobiliary disorders Hepatobiliary Disease	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Abdominal Infection	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Abdominal Sepsis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Anal Abscess	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Appendicitis Perforated	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Atypical Pneumonia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Bacteraemia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Cellulitis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Clostridium Difficile Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Covid-19	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Covid-19 Pneumonia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Cystitis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Device Related Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Endocarditis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Kidney Infection	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Large Intestine Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Localised Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Lower Respiratory Tract Infection	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Perinephric Abscess	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pneumonia	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pneumonia Aspiration	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pneumonia Necrotising	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pyelonephritis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pyelonephritis Acute	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Pyelonephritis Chronic	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Respiratory Tract Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Sepsis	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Septic Shock	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Soft Tissue Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Upper Respiratory Tract Infection	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urinary Tract Candidiasis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urinary Tract Infection	4.9% 7/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urinary Tract Infection Enterococcal	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urinary Tract Infection Pseudomonal	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urosepsis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Viral Infection	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Compression Fracture	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Urinary Tract Stoma Complication	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Injury, poisoning and procedural complications Urostomy Complication	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Blood Creatinine Increased	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Urine Output Decreased	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Decreased Appetite	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Dehydration	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hypercalcaemia	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyponatraemia	2.1% 3/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Back Pain	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Osteitis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Cerebral Ischaemia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Cerebrovascular Accident	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Cognitive Disorder	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Dysarthria	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Headache	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Paralysis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Sciatica	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Seizure	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Spinal Cord Compression	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Product Issues Device Occlusion	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Psychiatric disorders Confusional State	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Acute Kidney Injury	2.1% 3/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Bladder Dysfunction	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Bladder Obstruction	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Bladder Perforation	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Haematuria	3.5% 5/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Hydronephrosis	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Micturition Urgency	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Nephrolithiasis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Pollakiuria	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Renal Colic	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Renal Failure	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Renal Impairment	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Ureteric Obstruction	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Ureteric Stenosis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Ureterolithiasis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Urethral Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Urinary Incontinence	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Urinary Retention	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Urinary Tract Obstruction	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Reproductive system and breast disorders Prostatitis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 3/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Dry Skin	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Nail Dystrophy	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Surgical and medical procedures Catheter Placement	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Deep Vein Thrombosis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Dry Gangrene	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Embolism	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Embolism Venous	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Extremity Necrosis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Hypotension	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Peripheral Artery Aneurysm	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Peripheral Ischaemia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Vascular Calcification	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Venous Thrombosis	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.

Other adverse events

Measure	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg n=142 participants at risk 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.	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) n=117 participants at risk 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.	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg n=173 participants at risk 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.	Cohort 2: Arm 2B: Pembrolizumab 200 mg n=173 participants at risk 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.
Blood and lymphatic system disorders Anaemia	28.2% 40/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	33.3% 39/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	29.5% 51/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	25.4% 44/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Leukopenia	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.8% 15/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	20.5% 24/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Blood and lymphatic system disorders Thrombocytopenia	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.7% 9/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.5% 13/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Endocrine disorders Hyperparathyroidism	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Endocrine disorders Hyperthyroidism	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Endocrine disorders Hypothyroidism	1.4% 2/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Chorioretinopathy	7.0% 10/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Detachment of Retinal Pigment Epithelium	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Dry Eye	19.7% 28/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.7% 22/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Keratitis	6.3% 9/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Lacrimation Increased	8.5% 12/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.8% 17/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Vision Blurred	9.9% 14/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.8% 10/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Visual Impairment	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Eye disorders Xerophthalmia	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Abdominal Pain	7.7% 11/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.8% 8/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.6% 20/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.8% 10/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Abdominal Pain Upper	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.4% 11/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Constipation	31.0% 44/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	27.4% 32/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	23.1% 40/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	22.0% 38/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Diarrhoea	63.4% 90/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	18.8% 22/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	53.2% 92/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	13.3% 23/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Dry Mouth	43.0% 61/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.4% 4/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	36.4% 63/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Dyspepsia	4.2% 6/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.4% 4/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Mouth Ulceration	6.3% 9/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Nausea	14.1% 20/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	23.1% 27/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.2% 28/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Stomatitis	52.1% 74/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	14.5% 17/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	48.0% 83/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Gastrointestinal disorders Vomiting	9.9% 14/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.8% 15/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	13.9% 24/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Asthenia	15.5% 22/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	24.8% 29/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	27.7% 48/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	21.4% 37/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Fatigue	15.5% 22/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	19.7% 23/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.8% 29/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	13.9% 24/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Oedema Peripheral	6.3% 9/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	14.5% 17/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.7% 15/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
General disorders Pyrexia	14.8% 21/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.8% 15/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.6% 20/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Conjunctivitis	9.9% 14/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.8% 17/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Covid-19	8.5% 12/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.1% 6/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Nail Infection	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Paronychia	14.1% 20/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Infections and infestations Urinary Tract Infection	9.2% 13/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.0% 7/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	17.9% 31/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Alanine Aminotransferase Increased	27.5% 39/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.3% 5/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.2% 28/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.5% 13/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Aspartate Aminotransferase Increased	21.8% 31/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.8% 29/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.1% 14/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Blood Alkaline Phosphatase Increased	12.7% 18/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.8% 17/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Blood Creatinine Increased	14.1% 20/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.7% 9/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	15.6% 27/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.9% 12/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Investigations Weight Decreased	23.2% 33/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.2% 28/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.0% 7/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Decreased Appetite	28.2% 40/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	21.4% 25/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	32.9% 57/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.1% 21/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hypercalcaemia	7.7% 11/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.0% 7/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyperkalaemia	6.3% 9/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.5% 13/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.0% 7/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyperphosphataemia	82.4% 117/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	77.5% 134/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hypoalbuminaemia	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.3% 5/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hypomagnesaemia	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Metabolism and nutrition disorders Hyponatraemia	12.0% 17/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	13.9% 24/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Arthralgia	12.0% 17/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.7% 9/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.1% 21/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.1% 14/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Back Pain	7.7% 11/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.4% 11/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.7% 22/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.4% 11/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Musculoskeletal and connective tissue disorders Pain in Extremity	9.9% 14/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.1% 6/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Dizziness	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.1% 6/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 3/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Dysgeusia	30.3% 43/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.8% 8/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	24.3% 42/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Headache	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.0% 7/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Nervous system disorders Peripheral Sensory Neuropathy	3.5% 5/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	7.7% 9/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Psychiatric disorders Insomnia	4.2% 6/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.8% 8/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Renal and urinary disorders Haematuria	10.6% 15/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.4% 11/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	12.7% 22/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.6% 20/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Cough	7.0% 10/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.5% 10/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.9% 5/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	9.8% 17/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.9% 7/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.0% 7/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.6% 8/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.7% 18/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.4% 4/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.0% 19/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	4.2% 6/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Alopecia	26.1% 37/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	23.9% 28/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	17.9% 31/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Dry Skin	23.9% 34/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.3% 5/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	24.9% 43/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Nail Discolouration	17.6% 25/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	16.8% 29/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Nail Disorder	14.1% 20/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	6.4% 11/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.2% 2/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Nail Dystrophy	10.6% 15/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	11.6% 20/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Nail Ridging	5.6% 8/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.58% 1/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Onycholysis	25.4% 36/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	24.3% 42/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Onychomadesis	20.4% 29/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.7% 15/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	31.0% 44/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	22.0% 38/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Pruritus	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	1.7% 2/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.0% 7/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	13.9% 24/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Rash	4.9% 7/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	4.3% 5/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	3.5% 6/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	8.7% 15/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Skin and subcutaneous tissue disorders Xeroderma	2.8% 4/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.85% 1/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	0.00% 0/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.
Vascular disorders Hypertension	0.70% 1/142 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.6% 3/117 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	2.3% 4/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.	5.2% 9/173 • All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months 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.

Additional Information

SR DIRECTOR ONCOLOGY CDTL

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER