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| ID | Type | Description | Link |
|---|---|---|---|
| 42756493BLC3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2017-002932-18 | EudraCT Number | ||
| 2023-510296-56-00 | Registry Identifier | EUCT number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Arm 1A): Erdafitinib | Experimental | Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]). Participants who enter in Long-term extension (LTE) phase will continue to receive the erdafitinib tablet as per investigator's decision. |
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| Cohort 1 (Arm 1B): Vinflunine or Docetaxel | Experimental | Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive Vinflunine or Docetaxel until the participant can commercially receive chemotherapy within the local healthcare system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdafitinib | Drug | Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was measured from the date of randomization to the date of the participant's death. | From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage | Alaska | 99503 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870920 | Derived | Loriot Y, Matsubara N, Park SH, Huddart RA, Burgess EF, Houede N, Banek S, Guadalupi V, Ku JH, Valderrama BP, Tran B, Triantos S, Kean Y, Akapame S, Deprince K, Mukhopadhyay S, Stone NL, Siefker-Radtke AO; THOR Cohort 1 Investigators. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2023 Nov 23;389(21):1961-1971. doi: 10.1056/NEJMoa2308849. Epub 2023 Oct 21. |
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With the implementation of Protocol Amendment 6 (20 January 2023), long term extension (LTE) phase was added in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2023 | Apr 28, 2025 |
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| Cohort 2 (Arm 2A): Erdafitinib |
| Experimental |
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs). Participants who enter in LTE phase will continue to receive the erdafitinib tablet as per investigator's decision. |
|
| Cohort 2 (Arm 2B): Pembrolizumab | Experimental | Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive the pembrolizumab until 2 years after the first dose of pembrolizumab (at start of study) or until the participant can commercially receive pembrolizumab within the local healthcare system, whichever comes first. |
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| Vinflunine | Drug | Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion. |
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| Docetaxel | Drug | Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion. |
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| Pembrolizumab | Drug | Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion. |
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| Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) | Device | FGFRi CTA will be used to determine molecular eligibility. |
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| 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) |
| 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. | From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months |
| 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. | Baseline up to Cycle 11 (each cycle was of 21 days) |
| 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. | Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months |
| 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. | Baseline, 51.7 months |
| 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. | Baseline up to Cycle 11 (each cycle was of 21 days) |
| 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. | Baseline up to Cycle 11 (each cycle was of 21 days) |
| 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. | From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months) |
| 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. | 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) |
| 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. | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) |
| 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. | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) |
| 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. | Day 1 of Cycle 2 and 4 (Each Cycle 21 days) |
| 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. | Baseline, 51.7 months |
| 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. | From baseline up to maximum of 51.7 months |
| 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. | From baseline up to maximum of 51.7 months |
| 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. | From baseline up to maximum of 51.7 months |
| 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. | From baseline up to maximum of 51.7 months |
| 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. | From baseline up to maximum of 51.7 months |
| 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. | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days) |
| 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. | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days) |
| University of Calif Davis Medical Center |
| Sacramento |
| California |
| 95817 |
| United States |
| St. Helena Hospital - Martin-O'Neil Cancer Center | St. Helena | California | 94574 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Mid Florida Hematology Oncology | Orange | Florida | 32763 | United States |
| Piedmont Cancer Institute | Atlanta | Georgia | 30318-0922 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Edward Hines Jr V A Hospital | Hines | Illinois | 60141 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Maryland Oncology Hematology, PA | Lanham | Maryland | 20706 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-5000 | United States |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89509 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Weill Cornell Medical College | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Levine Cancer Institute, Carolinas HealthCare System | Charlotte | North Carolina | 28204 | United States |
| W G Bill Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Texas Oncology-Memorial City | Houston | Texas | 77024 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology Tyler | Tyler | Texas | 75702 | United States |
| INOVA Dwiight &Martha Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| VA Puget Sound Healthcare System | Seattle | Washington | 98108 | United States |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | Buenos Aires | C1419AHN | Argentina |
| Centro Oncológico Korben | Buenos Aires | C1426AGE | Argentina |
| CEMIC Saavedra | Buenos Aires | C1431FWN | Argentina |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | C5000 | Argentina |
| Centro Urologico Profesor Bengio | Córdoba | X5000KPH | Argentina |
| Hospital Privado de Comunidad | Mar del Plata | B7602CBM | Argentina |
| Centro de Investigacion Pergamino SA | Pergamino | B2700CPM | Argentina |
| Clínica Viedma | Viedma | R8500ACE | Argentina |
| Chris O'Brien Lifehouse | Camperdown | 2050 | Australia |
| Peninsula & South Eastern Haematology and Oncology Group | Frankston | 3199 | Australia |
| St George Hospital | Kogarah | 2217 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | 3000 | Australia |
| Frankston Hospital | Melbourne | 3199 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| LKH-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | 4020 | Austria |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| Krankenhaus der Barmherzigen Brüder | Vienna | 1020 | Austria |
| Medical University Vienna MUV | Vienna | A-1090 | Austria |
| OLV Ziekenhuis Aalst | Aalst | 9300 | Belgium |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Clinique Notre Dame de Grâce | Charleroi | 6000 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CHC MontLegia | Liège | 4000 | Belgium |
| Sint-Augustinus AZ | Wilrijk | 2610 | Belgium |
| CHU UCL Namur - Site Godinne | Yvoir | 5530 | Belgium |
| Fundacao Pio XII | Barretos | 14784-400 | Brazil |
| Universidade Federal De Minas Gerais - Hospital das Clínicas | Belo Horizonte | 30130-100 | Brazil |
| Nucleo de Ensino e Pesquisa do Instituto Mario Penna | Belo Horizonte | 30380-472 | Brazil |
| Instituto de Oncologia do Parana | Curitiba | 80530-010 | Brazil |
| Liga Paranaense de Combate ao Cancer | Curitiba | 81520 060 | Brazil |
| Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge | Goiânia | 74605-070 | Brazil |
| Clínica de Neoplasias Litoral Ltda. | Itajaí | 88301-220 | Brazil |
| Fundacao Doutor Amaral Carvalho | Jaú | 17210 080 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Natal | 59075-740 | Brazil |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| Hospital Nossa Senhora da Conceicao S A | Porto Alegre | 91350 200 | Brazil |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | 20231 050 | Brazil |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | 22250 905 | Brazil |
| Hospital Sao Rafael | Salvador | 41253-190 | Brazil |
| CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia | Santo André | 09060-650 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto | 15090-000 | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes 1 | São Paulo | 01308 050 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia | São Paulo | 03102-002 | Brazil |
| Instituto D Or de Pesquisa e Ensino IDOR | São Paulo | 04502-001 | Brazil |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | 05652 900 | Brazil |
| Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas | Sorocaba | 18030-005 | Brazil |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | 5800 | Bulgaria |
| Complex Oncology Center - Plovdiv EOOD | Plovdiv | 4004 | Bulgaria |
| Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' | Sofia | 1407 | Bulgaria |
| UMHAT Sofia Med | Sofia | 1797 | Bulgaria |
| Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD | Varna | 9010 | Bulgaria |
| BC Cancer Agency - Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Cancercare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Princess Margaret Hospital- UHN | Toronto | Ontario | M5G 2M9 | Canada |
| Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Beijing Friendship Hospital | Beijing | 100050 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Beijing Hospital | Beijing | 100730 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| The First Bethune Hospital of Jilin University | Changchun | 130021 | China |
| Sichuan Provincial Peoples Hospital | Chengdu | 610000 | China |
| Sichuan University Huaxi Hospital | Chengdu | 610041 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | 510060 | China |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | 510120 | China |
| Guangzhou First Municipal People's Hospital | Guangzhou | 510180 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310020 | China |
| The First Affliated Hospital Of Nanchang University | Nanchang | 330006 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200127 | China |
| Huadong Hospital Affiliated to Fudan University | Shanghai | 200400 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110004 | China |
| Shenzhen university General Hospital | Shenzhen | 518055 | China |
| First Affiliated Hospital Of Wenzhou Medical College | Wenzhou | 325000 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| Institut de Cancerologie de l Ouest ICO | Angers | 49055 | France |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| Institut Bergonie | Bordeaux | 33000 | France |
| CHRU Brest - Hopital Morvan | Brest | 29609 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Georges-François Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Hôpital Privé Le Bois | Lille | 59000 | France |
| Groupe Hospitalier Bretagne Sud | Lorient | 56322 | France |
| Hopital de la Timone | Marseille | 13005 | France |
| Institut Regional du Cancer de Montpellier Val d'Aurelle | Montpellier | 34298 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut de Cancérologie du Gard | Nîmes | 30029 | France |
| Hopital Europeen Georges-Pompidou | Paris | 75015 | France |
| Hospital Saint-Louis | Paris | 75475 | France |
| Hospices Civils de Lyon HCL | Pierre-Bénite | 69495 | France |
| CHU De Poitiers | Poitiers | 86021 | France |
| Centre Eugene Marquis | Rennes | 35062 | France |
| Centre de radiothérapie et d'Oncologie médicale de l'Essonne | Ris-Orangis | 91130 | France |
| Institut de Cancérologie de Loire | Saint-Priest-en-Jarez | 42271 | France |
| Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre | Strasbourg | 67098 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Centre Les Dentellieres | Valenciennes | 59300 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Vivantes Klinikum Am Urban | Berlin | 10967 | Germany |
| Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie | Braunschweig | 38126 | Germany |
| Universitatsklinikum Carl Gustav Carcus Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | 40225 | Germany |
| Friedrich-Alexander Universitaet Urologische Universitaetskl | Erlangen | 91054 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitatsmedizin Gottingen | Göttingen | 37099 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitatsklinikum Schleswig Holstein Campus Lubeck | Lübeck | 23538 | Germany |
| Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim | 68167 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Studienpraxis Urologie Drs. Feyerabend | Nürtingen | 72622 | Germany |
| Caritas-Krankenhaus St. Josef | Regensburg | 93053 | Germany |
| Universitaetsmedizin Rostock | Rostock | 18057 | Germany |
| MVZ-Onkologie Velbert GbR | Velbert | 42551 | Germany |
| Kliniken Nordoberpfalz AG/Klinikum Weiden | Weiden | 92637 | Germany |
| University of Athens Medical School - Regional General Hospi | Athens | 115 28 | Greece |
| Errikos Dunant Hospital Center | Athens | 11526 | Greece |
| Athens Medical Center | Athens | 15125 | Greece |
| Metropolitan General A E | Athens | 15562 | Greece |
| University Hospital Of Larissa | Larissa | 41110 | Greece |
| University General Hospital of Rio Patras | Pátrai | 26504 | Greece |
| Interbalkan European Medical Center | Thessaloniki | 14564 | Greece |
| Euromedica General Clinic | Thessaloniki | 54645 | Greece |
| Papageorgiou General Hospital Of Thessaloniki | Thessaloniki | 56403 | Greece |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály | Budapest | 1122 | Hungary |
| Budapesti Uzsoki Utcai Korhaz | Budapest | H-1145 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 04400 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | 7624 | Hungary |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petach Tikvah | 49100 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Assaf Harofeh Medical Center | Tzrifin | 70300 | Israel |
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria | Alessandria | 15121 | Italy |
| Ospedale S. Donato - Asl 8 Arezzo | Arezzo | 52100 | Italy |
| CRO IRCCS Istituto Nazionale Tumori | Aviano | 33081 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili | Brescia | 25123 | Italy |
| Istituti Ospitalieri di Cremona, AO di Cremona | Cremona | 26100 | Italy |
| Oncologia Medica | Florence | 50139 | Italy |
| SPDC Villa Scassi | Genova | Italy |
| IRST Meldola Forli | Meldola | 47014 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| AOU Policlinico di Modena | Modena | 41124 | Italy |
| IRCCS-Fondazione Pascale | Naples | 80131 | Italy |
| Ospedale Maggiore della Carita | Novara | 28100 | Italy |
| Aou San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Istituto Oncologico Veneto Iov Irccs Padova | Padova | 35128 | Italy |
| AOU di Parma | Parma | 43126 | Italy |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo | Pavia | 27100 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST | Poggibonsi (SI) | 53100 | Italy |
| UOC Oncologia Ospedale Provinciale di Macerata | Province of Macerata | 62100 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Roma | 00168 | Italy |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Oncologia Medica-Città Della Salute E Della Scienza Di Torino | Torino | 10123 | Italy |
| Azienda Ospedaliero - Universitaria Ospedali Riuniti | Torrette Di Ancona | 60126 | Italy |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Hirosaki University Hospital | Hirosaki | 036-8563 | Japan |
| National Cancer Center Hospital East | Kashiwa | 277 8577 | Japan |
| Kagawa University Hospital | Kita Gun | 761 0793 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| Dokkyo Medical University Saitama Medical Center | Koshigaya | 343-8555 | Japan |
| Aso Co.,Ltd Iizuka Hospital | Matsuyama | 791-0280 | Japan |
| University of Miyazaki Hospital | Miyazaki | 889-1692 | Japan |
| Nagano Municipal Hospital | Nagano | 381-8551 | Japan |
| Aichi Cancer Center Hospital | Nagoya | 464 8681 | Japan |
| Osaka International Cancer Institute | Osaka | 541 8567 | Japan |
| Osaka City University Hospital | Osaka | 545 8586 | Japan |
| Kindai University Hospital | Ōsaka-sayama | 589-8511 | Japan |
| Gunma Prefectural Cancer Center | Ōta-ku | 373 8550 | Japan |
| Kitasato University Hospital | Sagamihara | 252-0375 | Japan |
| Toho University Sakura Medical Center | Sakura | 285-8741 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | 003-0804 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | 162-8666 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| The Cancer Institute Hospital of JFCR 1 | Tokyo | 135 8550 | Japan |
| University of Tsukuba Hospital | Tsukuba | 305 8576 | Japan |
| Yamaguchi University Hospital | Ube | 755-8505 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| Medicos Especialistas en Cancer, S.C. | Aguascalientes | 20230 | Mexico |
| Centro Estatal de Cancerología de Chihuahua | Chihuahua City | 31000 | Mexico |
| Oncologia Integral Satelite | Naucalpan | 53100 | Mexico |
| Antoni van Leeuwenhoek | Amsterdam | 1066 CX | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3430 EM | Netherlands |
| Haga ziekenhuis | The Hague | 2545 CH | Netherlands |
| Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy | Bydgoszcz | 85 796 | Poland |
| Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw | 02-507 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Uniwersytecki Szpital Kliniczny we Wroclawiu | Wroclaw | 50 556 | Poland |
| Champalimaud Foundation Champalimaud Centre | Lisbon | 1400-038 | Portugal |
| Hospital Lusíadas | Lisbon | 1500-458 | Portugal |
| H. Santa Maria - Centro Hospitalar de Lisboa Norte | Lisbon | 1649-035 | Portugal |
| Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos | Lisbon | G1R 2J6 | Portugal |
| Instituto Portugues de Oncologia | Porto | 4200072 | Portugal |
| Altai Regional Oncology Dispensary | Barnaul | 656049 | Russia |
| Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Chelyabinsk | 454087 | Russia |
| Irkutsk Regional Oncology Dispensary | Irkutsk | 664035 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Kostroma regional oncology dispensary | Kostroma | 156005 | Russia |
| Leningrad Regional Oncology Dispensary | Kuzmolovsky | 188663 | Russia |
| City Clinical Hospital n.a. D.D.Pletnev | Moscow | 105077 | Russia |
| FSBSI 'N. N. Blokhin Russian Cancer Research Center' | Moscow | 115478 | Russia |
| Russian Scientific Center of Roentgenoradiology | Moscow | 117997 | Russia |
| I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia |
| Hertzen Oncology Research Institute | Moscow | 125284 | Russia |
| City Clinical Hospital #1 | Nal'chik | 360017 | Russia |
| Privolzhsky District Medical Center under the Federal Medico-Biological Agency | Nizhny Novgorod | 603109 | Russia |
| Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| GBUZ of Stavropol region Pyatigorsk Oncological Dispensary | Pyatigorsk | 357502 | Russia |
| LLC 'Strategic Medical Systems' | Saint Petersburg | 192148 | Russia |
| Clinical hopital n/a Petra velikogo | Saint Petersburg | 195067 | Russia |
| Private Medical Institution Euromedservice | Saint Petersburg | 196603 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| Russian Scientific Center of Radiology and Surgical Technologies | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care | Saint Petersburg | 197758 | Russia |
| FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva | Saransk | 430032 | Russia |
| Saratov State Medical University | Saratov | 410000 | Russia |
| LLC Uromed | Smolensk | 214031 | Russia |
| GBUZ Oncology Centre #2 of Healthcare Department of Krasno | Sochi | 354057 | Russia |
| Multifunctional clinical medical center 'Medical city' | Tyumen | 625041 | Russia |
| Bashkiria State Medical University | Ufa | 450000 | Russia |
| Vologda Regional Oncological Dispensary | Vologda | 160012 | Russia |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| National Cancer Center | Goyang-si | 410-769 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Hosp. Univ. Infanta Cristina | Badajoz | 06006 | Spain |
| Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Hosp. San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hosp Reina Sofia | Córdoba | 14004 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Granada | 18014 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hosp. Univ. Insular de Gran Canaria | Las Palmas de Gran Canaria | 35016 | Spain |
| Hosp. Univ. Lucus Augusti | Lugo | 27003 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | 28220 | Spain |
| ALTHAIA, Xarxa Assistencial Universitària de Manresa | Manresa | 08243 | Spain |
| Hosp. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Gral. Univ. Valencia | Valencia | 46014 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Hosp. Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Chang Gung Medical Foundation | Niao-Sung Hsiang | 833 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| Chi Mei Medical Center Yong Kang | Tainan | 710 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 11259 | Taiwan |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | 333 | Taiwan |
| Baskent University Adana Practice and Research Center Kisla Health Campus | Adana | 01120 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 6100 | Turkey (Türkiye) |
| Bezmialem University Medical Faculty | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | 34098 | Turkey (Türkiye) |
| Bakirkoy Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Pendik Training and Research Hospital | Istanbul | 34890 | Turkey (Türkiye) |
| Ege University | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Fakultesi | Izmir | 35340 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari | Malatya | 44400 | Turkey (Türkiye) |
| Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Dnipro | 49100 | Ukraine |
| Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Dnipro | 49102 | Ukraine |
| MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | 76008 | Ukraine |
| Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Kharkiv | 61037 | Ukraine |
| Municipal non-profit enterprise 'Regional Center of Oncology' | Kharkiv | 61070 | Ukraine |
| National Cancer Institute | Kyiv | 03022 | Ukraine |
| State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Kyiv | 03115 | Ukraine |
| Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv | 79010 | Ukraine |
| Transkarpathian Regional University Oncology Clinic | Uzhhorod | 88000 | Ukraine |
| Podilskiy Regional Center of Oncology | Vinnitsa | 21029 | Ukraine |
| Zaokod | Zaporizhzhia | 69040 | Ukraine |
| Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital | Zaporizhzhia | 69600 | Ukraine |
| University Hospitals Bristol - Bristol Haematology & Oncolog | Bristol | BS2 8ED | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Derriford Hospital-Department of Medical Oncology | Plymouth | PL6 8QH | United Kingdom |
| University of Sheffield | Sheffield | S10 2 RX | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5NG | United Kingdom |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Treated |
|
| COMPLETED | Participants who died were considered to have completed the study as per protocol. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival was measured from the date of randomization to the date of the participant's death. | 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. | Posted | Median | 95% Confidence Interval | Months | From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
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| 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. | ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. | Posted | Number | Percentage of participants | From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months |
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| 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. | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline up to Cycle 11 (each cycle was of 21 days) |
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| 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. | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months |
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| 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. | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Posted | Number | Percentage of participants | Baseline, 51.7 months |
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| 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. | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Cycle 11 (each cycle was of 21 days) |
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| 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. | Analysis population set included in ITT (all randomized) participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Cycle 11 (each cycle was of 21 days) |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months) |
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| 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. | Safety analysis set included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months) |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 of Cycle 2 and 4 (Each Cycle 21 days) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 51.7 months |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to maximum of 51.7 months |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to maximum of 51.7 months |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to maximum of 51.7 months |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to maximum of 51.7 months |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to maximum of 51.7 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | Liter per hour | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Nanogram hour per milliliter | Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days) |
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All-cause mortality: From randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months; serious AEs and other AEs: From Day 1 Cycle 1 up to maximum of 51.7 months
Serious/other AEs: Safety analysis set. All-cause mortality: ITT population (all randomized). The study was to evaluate efficacy of erdafitinib versus standard chemotherapy chosen at site level by investigators. Regardless of which chemotherapy was chosen by investigator (docetaxel/vinflunine), AEs were collected and analyzed collectively for chemotherapy arm (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2; Arm 1B). Per plan safety was analyzed per intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 91 | 143 | 63 | 142 | 141 | 142 |
| EG001 | 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. | 90 | 135 | 50 | 117 | 104 | 117 |
| EG002 | 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. | 141 | 175 | 69 | 173 | 173 | 173 |
| EG003 | 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. | 131 | 176 | 81 | 173 | 157 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Bone Marrow Failure | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Myelosuppression | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Stress Cardiomyopathy | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Vestibular Disorder | Ear and labyrinth disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Adrenal Insufficiency | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Detachment of Retinal Pigment Epithelium | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Serous Retinal Detachment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Colo-Urethral Fistula | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Enterovesical Fistula | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Gastrointestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Intestinal Perforation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Large Intestine Perforation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Mechanical Ileus | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Condition Aggravated | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Precancerous Condition | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Biliary Obstruction | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatobiliary Disease | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Large Intestine Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Perinephric Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Necrotising | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis Chronic | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Candidiasis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection Pseudomonal | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Stoma Complication | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urostomy Complication | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bladder Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bladder Dysfunction | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bladder Obstruction | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bladder Perforation | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ureteric Stenosis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urethral Haemorrhage | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Dystrophy | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toxic Skin Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Catheter Placement | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Gangrene | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Embolism Venous | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Extremity Necrosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Peripheral Artery Aneurysm | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vascular Calcification | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Detachment of Retinal Pigment Epithelium | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Dystrophy | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Ridging | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SR DIRECTOR ONCOLOGY CDTL | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2023 | Apr 28, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000604580 | erdafitinib |
| C111217 | vinflunine |
| D000077143 | Docetaxel |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AUSTRALIA |
|
| AUSTRIA |
|
| BELGIUM |
|
| BRAZIL |
|
| CANADA |
|
| CHINA |
|
| FRANCE |
|
| GERMANY |
|
| GREECE |
|
| HUNGARY |
|
| ISRAEL |
|
| ITALY |
|
| JAPAN |
|
| NETHERLANDS |
|
| POLAND |
|
| PORTUGAL |
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| RUSSIAN FEDERATION |
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| SOUTH KOREA |
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| SPAIN |
|
| TAIWAN |
|
| TURKEY |
|
| UKRAINE |
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| UNITED KINGDOM |
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| UNITED STATES |
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| Bulgaria |
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| Hazard Ratio (HR) |
| 1.16 |
| 2-Sided |
| 95 |
| 0.92 |
| 1.48 |
| Superiority |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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