Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03390504 · OUTCOME

Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test

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 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.

Analysis 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.

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

GroupSource count
Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg126
Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg165

Reported measurements

Normal (BL) to Abnormal CS (post-BL)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg20Not reportedNot reportedNot reportedNot reported
Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg24Not reportedNot reportedNot reportedNot reported
Normal (BL) to Abnormal NCS (post-BL)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg9Not reportedNot reportedNot reportedNot reported
Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg11Not reportedNot reportedNot reportedNot reported
Abnormal NCS (BL) to Abnormal CS (post-BL)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg5Not reportedNot reportedNot reportedNot reported
Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        24
    title
    Normal (BL) to Abnormal CS (post-BL)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
    title
    Normal (BL) to Abnormal NCS (post-BL)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
    title
    Abnormal NCS (BL) to Abnormal CS (post-BL)
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      165
    units
    Participants
description
Number of participants with shift from baseline to worst post-baseline in Amsler grid test was reported. Baseline and post-baseline visit findings included normal, abnormal CS (clinically significant) and abnormal NCS (not clinically significant). Clinical significance was determined by investigator's assessment. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening post-baseline measurement was reported.
groups
  1. 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
  2. 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 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.
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: Amsler Grid Test
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice