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| ID | Type | Description | Link |
|---|---|---|---|
| NCT04822350 | Registry Identifier | ClinicalTrials.gov |
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| Name | Class |
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| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally advanced or metastatic urothelial carcinoma patients treated with avelumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | As provided in real world practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Overall | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
| OS: by Histology Group | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| OS From Initiation of First-Line Chemotherapy: Overall | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to consider the participant 'immortality' time before avelumab initiation. |
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Inclusion Criteria:
Patient ≥ 18 years of age
Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.
Patient benefiting from a social security scheme according to local regulations
Exclusion Criteria:
For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
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Patients with advanced or metastatic Urothelial Carcinoma treated with avelumab as a maintenance treatment
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Charles Nicolle | Rouen | Haute-normandie | 76031 | France | ||
| CHU Nantes |
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| Label | URL |
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| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This was a multicenter ambispective (retrospective and prospective) non-interventional study which collected data from participants with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with adv/mUC who in real world practice initiated avelumab were included in this non-interventional observational study. No intervention was administered under the protocol of this 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 | Nov 21, 2022 | Dec 22, 2025 |
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| From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) |
| OS From Initiation of First-Line Chemotherapy: by Histology Group | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. OS from initiation of first line chemotherapy according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to take into account the participant 'immortality' time before avelumab initiation. | From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Overall | PFS: time between first injection of avelumab and the date of disease progression (PD) or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
| PFS 1 According to RECIST 1.1: by Histology Group | PFS:time between first injection of avelumab and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group:pure urothelial carcinoma,pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
| PFS During the Second Line of Treatment Post-Avelumab (PFS 2) According to RECIST 1.1: Overall | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of second line of post-avelumab treatment during the study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) |
| PFS 2 According to RECIST 1.1: by Histology Group | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of 2nd line of post-avelumab treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) |
| Overall Response Rate (ORR) According to RECIST 1.1: Overall | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) |
| ORR According to RECIST 1.1: by Histology Group | ORR was defined as the percentage of participants with a CR or PR as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) |
| Duration of Response (DOR): Overall | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| DOR: by Histology Group | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. DOR according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Duration of Treatment (DOT): Overall | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) |
| DOT: by Histology Group | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. DOT according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) |
| Number of Participants Classified Per Progression Type: Overall | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) |
| Number of Participants Classified Per Progression Type: by Histology Group | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. Number of participants classified per progression type according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) |
| Duration of Subsequent Treatment: Overall | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) |
| Duration of Subsequent Treatment: by Histology Group | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Duration of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) |
| PFS of Subsequent Treatment: Overall | PFS of subsequent treatment was defined as time between first injection of subsequent treatment and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) |
| PFS of Subsequent Treatment: by Histology Group | PFS: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) |
| ORR of Subsequent Treatment: Overall | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) |
| ORR of Subsequent Treatment: by Histology Group | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR of subsequent therapy according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) |
| OS of Subsequent Treatment: Overall | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) |
| OS of Subsequent Treatment by Histology Group | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) |
| Number of Participants With Adverse Events (AEs): Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both serious AEs (SAEs) and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With AEs: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With Grade 3, 4 or 5 AEs: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE, Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With Grade 3, 4 or 5 AEs: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE and Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With AEs Leading to Death: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death are reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants With AEs Leading to Death: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
| Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: Overall | Number of participants who received at least one premedication with paracetamol among all avelumab injections were reported in this outcome measure. | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
| Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: by Histology Group | Number of participants who received at least one premedication with paracetamol among all avelumab injections according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
| Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: Overall | Number of participants who received at least one premedication with antihistamines among all avelumab injections were reported in this outcome measure. | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
| Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: by Histology Group | Number of participants who received at least one premedication with antihistamines among all avelumab injections according to histology group: pure urothelial carcinoma (UC), pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
| Change From Baseline in National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy -Bladder Symptom Index-18 (FACT FBlSI-18) at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The NCCN/FACT FBlSI-18 was a self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. The response to each of the 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline was defined as the time of avelumab initiation. | Baseline; at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in NCCN/FACT FBlSI-18 at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | NCCN/FACT FBlSI-18: self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Response to each of 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline=time of avelumab initiation. Change from Baseline in NCCN/FACT FBlSI-18 according to histology group: pure UC, pure variant and UC variant were reported. | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the visual analogue scale (VAS). The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in EQ-5D-5L Index Score at Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L Index Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in EQ-5D-5L-VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in EQ-5D-5L- VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L- VAS Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Nantes |
| Pays de la Loire Region |
| 44093 |
| France |
| Centre Hospitalier du Pays d AIX | Aix-en-Provence | 13100 | France |
| CHU Amiens-Picardie | Amiens | 80054 | France |
| Centre Hospitalier Victor Dupouy | Argenteuil | 95107 | France |
| Centre Hospitalier Auxerre | Auxerre | 89000 | France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Centre Hospitalier de la cote Basque | Bayonne | 64100 | France |
| Chru Besancon | Besançon | 25030 | France |
| Clinique Tivoli-Ducos | Bordeaux | 33000 | France |
| CHU de Bordeaux - Hopital Saint Andre | Bordeaux | 33075 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Hospitalier de Boulogne Sur Mer | Boulogne-sur-Mer | 62321 | France |
| Centre Hospitalier Regional Universitaire de Brest | Brest | 29200 | France |
| Clinique Pasteur - Lanroze | Brest | 29200 | France |
| Hopital Louis Pradel | Bron | 69677 | France |
| CENTRE HOSPITALIER Dr Jean-Eric TECHER | Calais | 62107 | France |
| Medipole de Savoie | Challes-les-Eaux | 73190 | France |
| Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Hospitalier Universitaire Gabriel Montpied | Clermont-Ferrand | 63011 | France |
| Pole Sante Republique | Clermont-Ferrand | 63050 | France |
| Polyclinique Saint Come | Compiègne | 60200 | France |
| Clinique de Flandre | Coudekerque-Branche | 59210 | France |
| Centre Hospitalier Intercommunal de Creteil | Créteil | 94010 | France |
| Centre Leonard de Vinci | Dechy | 59187 | France |
| Clinique Clement Drevon | Dijon | 21000 | France |
| Centre Hospitalier Intercommunal Louviers | Elbeuf | 76503 | France |
| Centre Hospitalier Annecy Genevois | Epargny METZ Tessy | 74370 | France |
| Clinique Du Mousseau | Évry | 91035 | France |
| Chi Frejus - Saint Raphael | Fréjus | 83608 | France |
| Chi Alpes Du Sud | Gap | 5000 | France |
| Centre Hospitalier de Grenoble | Greboble | 38043 | France |
| Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard | Grenoble | 38000 | France |
| Centre Hospitalier Haguenau | Haguenau | 67500 | France |
| Polyclinique de Blois | La Chaussée-Saint-Victor | 41260 | France |
| La Roche Sur Yon - Centre Hospitalier Departemetal Vendee | La Roche-sur-Yon | 85960 | France |
| Groupe Hospitalier La Rochelle - Re - Aunis | La Rochelle | 17019 | France |
| Clinique Victor Hugo | Le Mans | 72015 | France |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | 43000 | France |
| Polyclinique Du Bois | Lille | 59004 | France |
| Clinique de la Louvière | Lille | 59042 | France |
| Chu Dupuytren Service Oncologie | Limoges | 87000 | France |
| Polyclinique de LIMOGE-Clinique François CHENIEUX | Limoges | 87039 | France |
| Centre Hospitalier Jura Sud | Lons-le-Saunier | 39000 | France |
| Centre Hospitalier Bretagne Sud | Lorient | 56322 | France |
| Clinique de la Sauvegarde | Lyon | 69337 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Europeen | Marseille | 13003 | France |
| Hopital de La Timone | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | 34295 | France |
| Hopital prive Arnault Tzanck | Mougins | 06254 | France |
| Centre D'Oncologie de Gentilly | Nancy | 54100 | France |
| Hopital prive du Confluent S.A.S | Nantes | 44277 | France |
| Clinique Saint Georges | Nice | 06105 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut de Cancerologie Du Gard | Nîmes | 30900 | France |
| ONCOGARD | Nîmes | 30900 | France |
| Hopital Prive Sainte Marie | Osny | 95520 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Hopital Pitie Salpetriere | Paris | 75013 | France |
| Hopital Cochin/Unité de Cancerologie | Paris | 75014 | France |
| Groupe Hospitalier Diaconesse La Croix Saint Simon | Paris | 75020 | France |
| Hopital Europeen Georges Pompidou | Paris | 75908 | France |
| Polyclinique Marzet | Pau | 64001 | France |
| Centre Hospitalier de Cornouaille | Quimper | 29107 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Hopistalier Roanne | Roanne | 42300 | France |
| Ch Roubais | Roubaix | 59100 | France |
| Clinique Mathilde | Rouen | 76100 | France |
| Centre Hospitalier Prive Saint Gregoire | Saint-Grégoire | 35768 | France |
| Hia Begin | Saint-Mandé | 94160 | France |
| Clinique mutualiste de l Estuaire | Saint-Nazaire | 44606 | France |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Centre Hospitalier de Soissons | Soissons | 02200 | France |
| Clinique Sainte Anne | Strasbourg | 67000 | France |
| ICANS - Institut de cancerologie Strasbourg Europe | Strasbourg | 67200 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Hia Sainte Anne | Toulon | 83041 | France |
| IUCT - Oncopole | Toulouse | 31059 | France |
| Centre Alexis VAUTRIN | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Full Analysis Set (FAS) | FAS was defined as all enrolled participants who met the eligibility criteria and received at least one injection of avelumab. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety analysis set (SAS) was defined as all participants who received at least one injection of avelumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with adv/mUC who in real world practice initiated avelumab were included in this non-interventional observational study. No intervention was administered under the protocol of this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Here "Number Analyzed" signifies number of participants evaluable for the specified baseline characteristics. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Primary | OS: by Histology Group | OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
|
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| Secondary | OS From Initiation of First-Line Chemotherapy: Overall | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to consider the participant 'immortality' time before avelumab initiation. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) |
|
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| Secondary | OS From Initiation of First-Line Chemotherapy: by Histology Group | OS from initiation of first-line chemotherapy was defined as the time from the date of first injection of the chemotherapy used in first line (before avelumab initiation) as reported in medical history to death due to any cause. Participants last known to be alive or lost to follow up were censored at date of last contact. OS from initiation of first line chemotherapy according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method with left truncature and right censoring to take into account the participant 'immortality' time before avelumab initiation. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of first line chemotherapy to the date of death due to any cause or censoring date, whichever occurred first (maximum duration of 95 months) |
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| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Overall | PFS: time between first injection of avelumab and the date of disease progression (PD) or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | PFS 1 According to RECIST 1.1: by Histology Group | PFS:time between first injection of avelumab and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group:pure urothelial carcinoma,pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab and the date of progression or death from any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | PFS During the Second Line of Treatment Post-Avelumab (PFS 2) According to RECIST 1.1: Overall | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of second line of post-avelumab treatment during the study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants from FAS population with a subsequent treatment since avelumab initiation. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) |
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| Secondary | PFS 2 According to RECIST 1.1: by Histology Group | PFS2: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of 2nd line of post-avelumab treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression, death or 2nd line of post-avelumab treatment discontinuation were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab to the date of progression or death from any cause during the second line of treatment post-avelumab or censoring date (for a maximum of 62.3 months follow-up) |
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| Secondary | Overall Response Rate (ORR) According to RECIST 1.1: Overall | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) |
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| Secondary | ORR According to RECIST 1.1: by Histology Group | ORR was defined as the percentage of participants with a CR or PR as a best response during the avelumab treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose of avelumab until documented disease progression, death or start of new anticancer therapy (for a maximum of 62.3 months follow-up) |
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| Secondary | Duration of Response (DOR): Overall | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies number of participants with response evaluable for this outcome measure. Participants with missing date of response were excluded from analysis. | Posted | Median | 95% Confidence Interval | Months | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | DOR: by Histology Group | DOR: time between beginning of response (CR or PR) and PD or death from any cause, whichever occurred first. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. Any pathological lymph nodes (target or non-target) must have reduction in short axis to<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study. In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions or appearance of any new unequivocal malignant lesion was also considered PD. DOR according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information. Participants with missing date of response were excluded from analysis. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From the beginning of the response to progression or death from any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Duration of Treatment (DOT): Overall | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. | Posted | Median | 95% Confidence Interval | Months | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) |
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| Secondary | DOT: by Histology Group | DOT was defined as the time between the first and last dose of avelumab. DOT was evaluated using survival analysis where first dose date was considered as date of first study treatment intake until permanent discontinuation of treatment or death due to any cause. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. DOT according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From the first dose of avelumab to the last dose of avelumab or death or censoring date, whichever occurred earlier (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants Classified Per Progression Type: Overall | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure who had documented progression. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) |
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| Secondary | Number of Participants Classified Per Progression Type: by Histology Group | The number of participants classified per progression type (new lesions; pre-existing lesions progression; pre-existing lesions progression and new lesions; undefined) were reported in this outcome measure. Number of participants classified per progression type according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure who had documented progression and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of progression (for a maximum duration of 62.3 months) |
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| Secondary | Duration of Subsequent Treatment: Overall | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment. | Posted | Median | 95% Confidence Interval | Months | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) |
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| Secondary | Duration of Subsequent Treatment: by Histology Group | Duration of subsequent treatment was defined as the time from the first to last dose of subsequent treatment to avelumab. Participants without permanent discontinuation reported at the end of study or who were lost to follow-up or had early permanent study discontinuation without stopping treatment were censored at the last contact date. Duration of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From the first dose of subsequent treatment to last dose of subsequent treatment or censoring date (up to approximately 24 months) |
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| Secondary | PFS of Subsequent Treatment: Overall | PFS of subsequent treatment was defined as time between first injection of subsequent treatment and the date of PD or death from any cause, whichever occurred first. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment. | Posted | Median | 95% Confidence Interval | Months | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) |
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| Secondary | PFS of Subsequent Treatment: by Histology Group | PFS: time between first injection and date of PD or death from any cause, whichever occurred first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study including baseline sum if that was smallest on study). In addition to relative increase of 20%,sum must have also demonstrated an absolute increase of at least 5mm. Unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy was also considered PD. Appearance of any new unequivocal malignant lesion was also considered PD. Participants with final discontinuation of treatment during study before any progression or death or who were lost to follow-up or had early study discontinuation without progression or death were censored at last contact date. PFS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported. Kaplan-Meier method was used. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of subsequent treatment to the date of progression or death from any cause or censoring date, whichever occurred first (up to approximately 24 months) |
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| Secondary | ORR of Subsequent Treatment: Overall | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment and evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) |
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| Secondary | ORR of Subsequent Treatment: by Histology Group | ORR of subsequent therapy was defined as the percentage of participants with a CR or PR as a best response during the subsequent treatment. Responses to treatment were defined according to RECIST 1.1. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. ORR of subsequent therapy according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment and evaluable for this outcome measure; "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first dose of subsequent therapy until documented disease progression, death or start of new anticancer therapy (up to approximately 24 months) |
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| Secondary | OS of Subsequent Treatment: Overall | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) |
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| Secondary | OS of Subsequent Treatment by Histology Group | OS of subsequent treatment was defined as the time from the date of first injection of subsequent treatment to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS of subsequent treatment according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, 'Overall Number of Participants Analyzed' signifies number of participants who received subsequent treatment evaluable for this outcome measure with non-missing histology information and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From first injection of avelumab subsequent treatment to the date of death due to any cause or censoring date, whichever occurred first (up to approximately 24 months) |
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| Secondary | Number of Participants With Adverse Events (AEs): Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both serious AEs (SAEs) and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. | SAS was defined as all participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With AEs: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. SAE was defined as any untoward medical occurrence at any dose that met 1 or more of following criteria: resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other important medical events. AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With Grade 3, 4 or 5 AEs: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE, Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With Grade 3, 4 or 5 AEs: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Severity of AEs were graded as according to NCI CTCAE v5.0 as: Grade 3= severe AE and Grade 4= life-threatening and Grade 5= death. Number of participants with any Grade 3, 4 or 5 AEs according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants With AEs leading to temporary/permanent discontinuation of avelumab according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With AEs Leading to Death: Overall | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death are reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants With AEs Leading to Death: by Histology Group | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs leading to death according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | SAS was defined as all participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up) |
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| Secondary | Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: Overall | Number of participants who received at least one premedication with paracetamol among all avelumab injections were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
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| Secondary | Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: by Histology Group | Number of participants who received at least one premedication with paracetamol among all avelumab injections according to histology group: pure urothelial carcinoma, pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
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| Secondary | Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: Overall | Number of participants who received at least one premedication with antihistamines among all avelumab injections were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. | Posted | Count of Participants | Participants | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
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| Secondary | Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: by Histology Group | Number of participants who received at least one premedication with antihistamines among all avelumab injections according to histology group: pure urothelial carcinoma (UC), pure variant, urothelial carcinoma variant and missing were reported in this outcome measure. | FAS was defined as all enrolled participants who received at least one injection of avelumab. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From date of first dose of avelumab until 30 days after last dose or day before start of new anti-cancer drug therapy, whichever occurred first (maximum avelumab treatment duration: up to 44.5 months) |
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| Secondary | Change From Baseline in National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy -Bladder Symptom Index-18 (FACT FBlSI-18) at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The NCCN/FACT FBlSI-18 was a self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. The response to each of the 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline was defined as the time of avelumab initiation. | Prospective participants from FAS were analyzed. FAS included all enrolled participants who received at least one injection of avelumab. Here "Overall Number of Participants Analyzed (N)" signifies participants evaluable for this outcome measure and "Number Analyzed (n)" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in NCCN/FACT FBlSI-18 at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | NCCN/FACT FBlSI-18: self-administered questionnaire to assess participant's bladder cancer-specific symptoms using a 'core' set of 18 questions. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Response to each of 18 questions was evaluated using a 5-point scale ranging from 0='not at all' to 4='very much'. For items negatively framed, scores were reversed for analysis so that higher scores indicated a higher degree of bladder symptoms. Total score ranged from 0 to 72, where higher scores indicated a higher degree of bladder symptoms. This outcome measure was planned to be evaluated only in prospectively included participants. Baseline=time of avelumab initiation. Change from Baseline in NCCN/FACT FBlSI-18 according to histology group: pure UC, pure variant and UC variant were reported. | Prospective participants from FAS were analyzed. FAS=all enrolled participants who received at least one injection of avelumab. Here "N"=participants evaluable for this outcome measure with non-missing data; "n"=participants evaluable for specified rows. None of pure variant participants reached Month (M)15; hence, no participants were analyzed at M15,18,21,24; UC variant participants data could not be calculated for M15,18,21,24 as only participant who reached M15 did not have a baseline score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the visual analogue scale (VAS). The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. | Prospective participants from FAS were analyzed. FAS included all enrolled participants who received at least one injection of avelumab. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in EQ-5D-5L Index Score at Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The index score measures health across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five severity levels from 1= no problems to 5= extreme problems. These responses form a five-digit health state score ranging from 11111 (no problems) to 55555 (extreme problems), which was then converted into a single utility EQ-5D-5L index score between 0 (death) and 1 (perfect health) using a weighted formula from the EQ-5D official website, where higher EQ-5D-5L scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L Index Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. | Prospective participants from FAS were analyzed. FAS=all enrolled participants who received at least one injection of avelumab. Here "N"=participants evaluable for this outcome measure with non-missing data; "n"=participants evaluable for specified rows. None of pure variant participants reached Month (M)15; hence, no participants were analyzed at M15,18,21,24; UC variant participants data could not be calculated for M15,18,21,24 as only participant who reached M15 did not have a baseline score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in EQ-5D-5L-VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. | Prospective participants from FAS were analyzed. FAS included all enrolled participants who received at least one injection of avelumab. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in EQ-5D-5L- VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group | The EQ-5D-5L was a participant-completed questionnaire with two parts: the EQ-5D index score and the VAS. The EQ VAS records participants' self-rated health on a vertical scale ranging from 0= worst health you can imagine to 100= best health you can imagine, where higher scores signified better health. Baseline was defined as the time of avelumab initiation. Change from Baseline in EQ-5D-5L- VAS Score according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. | Prospective participants from FAS were analyzed. FAS=all enrolled participants who received at least one injection of avelumab. Here "N"=participants evaluable for this outcome measure with non-missing data; "n"=participants evaluable for specified rows. None of pure variant participants reached Month (M)15; hence, no participants were analyzed at M15,18,21,24; UC variant participants data could not be calculated for M15,18,21,24 as only participant who reached M15 did not have a baseline score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24 |
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From first injection of avelumab to the date of death due to any cause, whichever occurred first (for a maximum of 62.3 months follow-up)
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set was defined as all participants who received at least one injection of avelumab.
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 | All Participants | Participants with adv/mUC who in real world practice initiated avelumab were included in this non-interventional observational study. No intervention was administered under the protocol of this study. | 369 | 596 | 345 | 596 | 427 | 596 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neoplasm Recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cachexia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Genitourinary Tract Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Laryngeal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Metastases To Bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Febrile Bone Marrow Aplasia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal Cord Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Device Related Bacteraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bladder Mass | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bladder Disorder | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bladder Hypertrophy | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bladder Perforation | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatorenal Syndrome | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nephropathy Toxic | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Uraemic Encephalopathy | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ureteric Dilatation | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ureteric Stenosis | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary Bladder Polyp | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Appendicitis Perforated | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Chemical Peritonitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hernial Eventration | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pancreatic Toxicity | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peritoneal Disorder | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Wound Evisceration | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Immune-Mediated Myocarditis | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Motor Dysfunction | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute Generalised Exanthematous Pustulosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis Bullous | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis Exfoliative Generalised | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Female Genital Tract Fistula | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skin Oedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Steroid Diabetes | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arterial Stenosis | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Coronary Artery Stenosis | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peripheral Artery Aneurysm | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Shock Haemorrhagic | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Superficial Vein Thrombosis | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Autoimmune Hepatitis | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Autoimmune Myocarditis | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Giant Cell Arteritis | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Immune-Mediated Adverse Reaction | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vitiligo | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Implant Site Necrosis | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Transurethral Bladder Resection | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ureterectomy | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lung Lobectomy | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pelvic Operation | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal Laminectomy | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urostomy | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Thyroid Disorder | Endocrine disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatitis Acute | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood Glucose Fluctuation | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| N-Terminal Prohormone Brain Natriuretic Peptide Increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vascular Dementia | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Intentional Product Misuse | Injury, poisoning and procedural complications | MedDRA25.0 | Non-systematic Assessment |
| |
| Inappropriate Schedule Of Product Administration | Injury, poisoning and procedural complications | MedDRA25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA25.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov.Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2022 | Dec 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
Not provided
Not provided
Not provided
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Participants with adv/mUC who in real world practice initiated avelumab were included in this non-interventional observational study. No intervention was administered under the protocol of this study.
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