Trial · NCT03390504
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months) | 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. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 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) | 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. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per RECIST Version 1.1 | From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months | ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl) | Baseline up to Cycle 11 (each cycle was of 21 days) | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time Until Symptom Deterioration | Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | Baseline, 51.7 months | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | Baseline up to Cycle 11 (each cycle was of 21 days) | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | Baseline up to Cycle 11 (each cycle was of 21 days) | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Response (DOR) as Per RECIST Version 1.1 | From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months) | 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. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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) | Safety analysis set included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Day 1 of Cycle 2 and 4 (Each Cycle 21 days) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Vital Signs: Weight | Baseline, 51.7 months | 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. | Kilograms | MEAN |
| SECONDARY | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test | From baseline up to maximum of 51.7 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity | From baseline up to maximum of 51.7 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid | From baseline up to maximum of 51.7 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation | From baseline up to maximum of 51.7 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment | From baseline up to maximum of 51.7 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Oral Clearance (CL/F) of Erdafitinib | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days) | 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. | Liter per hour | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03390504/outcomes