NCT03390504 · OUTCOME
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity
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 · Source last updated 2026-07-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From baseline up to maximum of 51.7 months
What was measured
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.
Analysis 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.
Groups in this outcome
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 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 41 |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 46 |
|---|
Reported measurements
<= 20/30 (BL) To >20/30 to <= 20/40 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
<= 20/30 (BL) To >20/40 to <= 20/80 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
<= 20/30 (BL) To >20/80 to <= 20/120 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
<= 20/30 (BL) To >20/120 to <= 20/160 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
<= 20/30 (BL) To >20/160 to <= 20/200 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
<= 20/30 (BL) To >20/200 (post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
>20/30 to <= 20/40 (BL) To >20/40 to <= 20/80 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
>20/30 to <= 20/40 (BL) To >20/160 to <= 20/200 (Post BL)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- title
- <= 20/30 (BL) To >20/30 to <= 20/40 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- title
- <= 20/30 (BL) To >20/40 to <= 20/80 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- <= 20/30 (BL) To >20/80 to <= 20/120 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- <= 20/30 (BL) To >20/120 to <= 20/160 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- title
- <= 20/30 (BL) To >20/160 to <= 20/200 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- <= 20/30 (BL) To >20/200 (post BL)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- title
- >20/30 to <= 20/40 (BL) To >20/40 to <= 20/80 (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- >20/30 to <= 20/40 (BL) To >20/160 to <= 20/200 (Post BL)
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- 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.
- groups
- description
- Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\[L\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
- id
- OG000
- title
- Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg
- description
- Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
- id
- OG001
- title
- Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- From baseline up to maximum of 51.7 months
- title
- Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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