TriangleNCT03390504 · OUTCOME
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation
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 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.
Analysis 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.
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.
| Group | Source count |
|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 38 |
Reported measurements
Absent (BL) to Increased (Post BL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 4 | Not reported | Not reported | Not reported | Not reported |
Present/visible (BL) to Increased (Post BL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Absent (BL) to Increased (Post BL)
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Present/visible (BL) to Increased (Post BL)
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- 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.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 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.
- 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: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice