Urothelial Cancer
Conditions
Brief summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Detailed description
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.
Interventions
DRUGErdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
DRUGVinflunine
Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.
DRUGDocetaxel
Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.
DRUGPembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
DEVICEFibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than \[\<\] 50 percent \[%\] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable * Metastatic or surgically unresectable urothelial cancer * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at Screening (urine or serum) * Participants must meet appropriate molecular eligibility criteria * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 * Adequate bone marrow, liver, and renal function
Exclusion criteria
* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. * Symptomatic central nervous system metastases * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. * History of uncontrolled cardiovascular disease * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Overall survival was measured from the date of randomization to the date of the participant's death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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 | 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. |
| 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) | 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. |
| Time Until Symptom Deterioration | Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months | 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. |
| Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | Baseline, 51.7 months | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Day 1 of Cycle 2 and 4 (Each Cycle 21 days) | 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. |
| Change From Baseline in Vital Signs: Weight | Baseline, 51.7 months | 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. |
| 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 | 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. |
| Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity | From baseline up to maximum of 51.7 months | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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) | Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days) | Area under the plasma concentration time-curve from time zero to the time t (AUC\[0-t\]) was reported. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Participant flow
Recruitment details
With the implementation of Protocol Amendment 6 (20 January 2023), long term extension (LTE) phase was added in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 143 |
| 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. | 135 |
| 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. | 175 |
| 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. | 176 |
| Total | 629 |
Baseline characteristics
| Characteristic | Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Cohort 2: Arm 2B: Pembrolizumab 200 mg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 82 Participants | 88 Participants | 108 Participants | 106 Participants | 384 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 47 Participants | 67 Participants | 70 Participants | 245 Participants |
| Age, Continuous | 65.0 years STANDARD_DEVIATION 10.23 | 67.9 years STANDARD_DEVIATION 9.07 | 67.0 years STANDARD_DEVIATION 8.49 | 65.9 years STANDARD_DEVIATION 10.2 | 66.4 years STANDARD_DEVIATION 9.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 5 Participants | 5 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 100 Participants | 126 Participants | 139 Participants | 484 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 31 Participants | 44 Participants | 32 Participants | 128 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 42 Participants | 37 Participants | 36 Participants | 154 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 25 Participants | 39 Participants | 28 Participants | 111 Participants |
| Race (NIH/OMB) White | 85 Participants | 66 Participants | 95 Participants | 111 Participants | 357 Participants |
| Region of Enrollment ARGENTINA | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment AUSTRALIA | 6 Participants | 2 Participants | 1 Participants | 5 Participants | 14 Participants |
| Region of Enrollment AUSTRIA | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Region of Enrollment BELGIUM | 5 Participants | 2 Participants | 6 Participants | 2 Participants | 15 Participants |
| Region of Enrollment BRAZIL | 4 Participants | 3 Participants | 11 Participants | 11 Participants | 29 Participants |
| Region of Enrollment Bulgaria | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment CANADA | 2 Participants | 0 Participants | 2 Participants | 4 Participants | 8 Participants |
| Region of Enrollment CHINA | 8 Participants | 11 Participants | 10 Participants | 15 Participants | 44 Participants |
| Region of Enrollment FRANCE | 20 Participants | 28 Participants | 34 Participants | 25 Participants | 107 Participants |
| Region of Enrollment GERMANY | 6 Participants | 10 Participants | 1 Participants | 9 Participants | 26 Participants |
| Region of Enrollment GREECE | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 19 Participants |
| Region of Enrollment HUNGARY | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Region of Enrollment ISRAEL | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 7 Participants |
| Region of Enrollment ITALY | 14 Participants | 11 Participants | 15 Participants | 15 Participants | 55 Participants |
| Region of Enrollment JAPAN | 15 Participants | 15 Participants | 11 Participants | 10 Participants | 51 Participants |
| Region of Enrollment NETHERLANDS | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Region of Enrollment POLAND | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment PORTUGAL | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 2 Participants | 2 Participants | 7 Participants | 9 Participants | 20 Participants |
| Region of Enrollment SOUTH KOREA | 12 Participants | 13 Participants | 10 Participants | 6 Participants | 41 Participants |
| Region of Enrollment SPAIN | 14 Participants | 12 Participants | 15 Participants | 16 Participants | 57 Participants |
| Region of Enrollment TAIWAN | 4 Participants | 2 Participants | 6 Participants | 4 Participants | 16 Participants |
| Region of Enrollment TURKEY | 3 Participants | 1 Participants | 13 Participants | 19 Participants | 36 Participants |
| Region of Enrollment UKRAINE | 0 Participants | 0 Participants | 9 Participants | 7 Participants | 16 Participants |
| Region of Enrollment UNITED KINGDOM | 6 Participants | 7 Participants | 2 Participants | 6 Participants | 21 Participants |
| Region of Enrollment UNITED STATES | 6 Participants | 5 Participants | 6 Participants | 2 Participants | 19 Participants |
| Sex: Female, Male Female | 43 Participants | 38 Participants | 33 Participants | 44 Participants | 158 Participants |
| Sex: Female, Male Male | 100 Participants | 97 Participants | 142 Participants | 132 Participants | 471 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 91 / 143 | 90 / 135 | 141 / 175 | 131 / 176 |
| other Total, other adverse events | 141 / 142 | 104 / 117 | 173 / 173 | 157 / 173 |
| serious Total, serious adverse events | 63 / 142 | 50 / 117 | 69 / 173 | 81 / 173 |
Outcome results
Primary
Overall Survival (OS)
Overall survival was measured from the date of randomization to the date of the participant's death.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Overall Survival (OS) | 12.06 Months |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Overall Survival (OS) | 8.74 Months |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Overall Survival (OS) | 10.91 Months |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Overall Survival (OS) | 11.07 Months |
p-value: =0.003195% CI: [0.48, 0.86]Log Rank
p-value: =0.212195% CI: [0.92, 1.48]Stratified log-rank test
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib
Area under the plasma concentration time-curve from time zero to the time t (AUC\[0-t\]) was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib | NA Nanogram hour per milliliter |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib | NA Nanogram hour per milliliter |
Secondary
Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl) | -5.28 Score on scale | Standard Error 2.746 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl) | -4.56 Score on scale | Standard Error 1.946 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl) | -0.26 Score on scale | Standard Error 1.98 |
Secondary
Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 0.026 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | -0.04 Score on a scale | Standard Error 0.023 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | -0.04 Score on a scale | Standard Error 0.024 |
Secondary
Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | -0.29 Score on a scale | Standard Error 2.626 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | -4.16 Score on a scale | Standard Error 2.149 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) | -2.28 Score on a scale | Standard Error 2.198 |
Secondary
Change From Baseline in Vital Signs: Weight
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Change From Baseline in Vital Signs: Weight | -5.95 Kilograms | Standard Deviation 6.183 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Change From Baseline in Vital Signs: Weight | -1.23 Kilograms | Standard Deviation 3.58 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Change From Baseline in Vital Signs: Weight | -4.13 Kilograms | Standard Deviation 5.531 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Change From Baseline in Vital Signs: Weight | -1.26 Kilograms | Standard Deviation 4.334 |
Secondary
Duration of Response (DOR) as Per RECIST Version 1.1
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Duration of Response (DOR) as Per RECIST Version 1.1 | 4.86 Months |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Duration of Response (DOR) as Per RECIST Version 1.1 | 5.62 Months |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Duration of Response (DOR) as Per RECIST Version 1.1 | 4.67 Months |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Duration of Response (DOR) as Per RECIST Version 1.1 | 15.21 Months |
Secondary
Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 2 Day 1 | 31 Participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 4 Day 1 | 29 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 4 Day 1 | 13 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 2 Day 1 | 20 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 2 Day 1 | 55 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 4 Day 1 | 38 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 2 Day 1 | 47 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters | Cycle 4 Day 1 | 40 Participants |
Secondary
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 4 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 2 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 2 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 5 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 2 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 4 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 2 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 5 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 2 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 4 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 8 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 3 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 14 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 3 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 3 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 3 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 4 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 4 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 4 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 2 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 10 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 4 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 2 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 20 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 9 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 6 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 10 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 0 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 1 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 9 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 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) | 4 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 5 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 10 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 0 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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 |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 1 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | 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) | 2 Participants |
Secondary
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test | Normal (BL) to Abnormal CS (post-BL) | 24 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test | Normal (BL) to Abnormal NCS (post-BL) | 11 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test | Abnormal NCS (BL) to Abnormal CS (post-BL) | 3 Participants |
Secondary
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid | 26 Participants |
Secondary
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 4 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 6 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 0 Participants |
Secondary
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 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 |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 11 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 5 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 4 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity | <= 20/30 (BL) To >20/200 (post BL) | 1 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | 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 |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 142 Participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 114 Participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 173 Participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 167 Participants |
Secondary
Objective Response Rate (ORR) Per RECIST Version 1.1
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Objective Response Rate (ORR) Per RECIST Version 1.1 | 46.9 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Objective Response Rate (ORR) Per RECIST Version 1.1 | 12.6 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Objective Response Rate (ORR) Per RECIST Version 1.1 | 40.0 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Objective Response Rate (ORR) Per RECIST Version 1.1 | 21.6 Percentage of participants |
Secondary
Oral Clearance (CL/F) of Erdafitinib
Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Oral Clearance (CL/F) of Erdafitinib | NA Liter per hour |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Oral Clearance (CL/F) of Erdafitinib | NA Liter per hour |
Secondary
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS)
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.
Time frame: Baseline, 51.7 months
Population: Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +2 | 7.5 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +1 | 30.2 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +4 Worsening | 0 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -1 | 15.1 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -2 | 5.7 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -3 | 0 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +3 | 7.5 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | 0 No Change | 34.0 Percentage of participants |
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -4 Improvement | 0 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | 0 No Change | 33.3 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +2 | 10.5 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +1 | 26.3 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -3 | 0 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -4 Improvement | 0 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -2 | 8.8 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +4 Worsening | 0 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +3 | 3.5 Percentage of participants |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -1 | 17.5 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | 0 No Change | 44.2 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -4 Improvement | 0 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -3 | 0 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -2 | 3.8 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -1 | 13.5 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +1 | 20.2 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +2 | 11.5 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +3 | 4.8 Percentage of participants |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +4 Worsening | 1.9 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +2 | 13.1 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -1 | 15.2 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -2 | 4.0 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +4 Worsening | 1 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +3 | 3.0 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -3 | 0 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | +1 | 17.2 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | 0 No Change | 46.5 Percentage of participants |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS) | -4 Improvement | 0 Percentage of participants |
Secondary
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 5.39 Months |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 2.73 Months |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 4.44 Months |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 2.69 Months |
Secondary
Time Until Symptom Deterioration
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | Time Until Symptom Deterioration | 1.5 Months |
| Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2) | Time Until Symptom Deterioration | 2.8 Months |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | Time Until Symptom Deterioration | 2.1 Months |
| Cohort 2: Arm 2B: Pembrolizumab 200 mg | Time Until Symptom Deterioration | 2.1 Months |