| Primary | Real-World Overall Survival | Real-World Overall Survival is the time from participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring, inclusive of start and end date. Analysis was performed using Kaplan-Meier method. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | 95% Confidence Interval | months | | From participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis | Time from First Diagnosis to Locally Advanced or Metastatic Diagnosis is the time between date of first diagnosis and date of locally advanced or metastatic diagnosis. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | weeks | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Participant's Age at Locally Advanced or Metastatic Diagnosis | Age (in years) at date of locally advanced or metastatic cancer diagnosis. Calculated as the number of years between date of birth and date of locally advanced or metastatic diagnosis, rounded down to the nearest whole year of age was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | years | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis | The Stage of UC of participants at Locally Advanced or Metastatic Diagnosis was reported as recorded in eCRF Q13: Stage IIIA, Stage IIIB, Stage IVA or Stage IVB. Urothelial cancer stages III to IVB indicate progressive spread of the disease. In Stage IIIA, the cancer has invaded nearby tissues like the prostate, uterus, or vagina, or has reached one lymph node in the pelvis. Stage IIIB involves spread to two or more lymph nodes in that region. In Stage IVA, the cancer extends further to nearby organs such as the pelvic or abdominal wall, or to distant lymph nodes. Stage IVB represents the most advanced stage, where the cancer has metastasized to distant organs like the lungs, liver, or bones. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis | Participant's Histology at Locally Advanced or Metastatic Diagnosis was reported. Number of participants with histology of Pure urothelial cancer, mixed urothelial with component of another pathology, or other were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis | Number of participants with de novo disease or newly relapsed at locally advanced or metastatic diagnosis was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Participant's Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis | Participants PD-L1 tumour assessment immune cell (IC) test result at Locally Advanced or Metastatic Diagnosis was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | cubic/millimeter (mm) 3 | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 | ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Participants Site of Metastases | Participants site of metastases: Lymph nodes, Bone, Lung, Liver, Peritoneum or other was reported. Participants could have one or more sites of metastases. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis | The number of participants with prior radical treatment of primary UC at Locally Advanced or Metastatic Diagnosis were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis | The number of participants with prior adjuvant or neoadjuvant system therapy at Locally Advanced or Metastatic Diagnosis were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Age of Participants at Avelumab Initiation | The age of participants at avelumab initiation was reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | years | | At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF. | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Real-World Progression-Free Survival (Rw-PFS) | Rw-PFS is the time from the start date of avelumab treatment to the first date of either: any evidence of progression or date of death. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | months | | From participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date | Number of participants who received type of First SACT regimen received were reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received | Number of first line SACT cycles received by participants was reported as treatment characteristics. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | cycles | | From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies | Number of participants switching between different platinum-based chemotherapies were reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab | Time from completion of first line SACT to start of avelumab was reported. Calculated as the number of days from the end date of the last first line SACT cycle to the start date of avelumab, inclusive of the start and end dates of this period. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | weeks | | From date of the last record of first line SACT to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Response to First Line Therapy | Response to first line therapy was reported. Response to first line SACT as reported in eCRF included: Complete Response (CR), Partial Response (PR) and Stable disease. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence | Response to First Line therapy based on CT scan evidence was reported. Response to first line SACT was judged based on CT scan evidence after the last cycle of first line SACT, as reported in eCRF. Reported as Yes or No. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Patterns: Duration of Treatment With Avelumab | Duration was derived based on the date of avelumab initiation and the last date of avelumab treatment. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | weeks | | From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) to end date of avelumab, or date of censoring (whichever is first), assessed upto 24 months after avelumab initiation | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF | Number of participants who received second-line therapy were reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) and end of follow-up (upto 24 months after avelumab initiation) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy | Time interval was derived using the dates of avelumab initiation and initiation of first regimen of second line therapy. This parameter was calculated only among participants who go on to receive second-line therapy after avelumab initiation. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | weeks | | From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF)to start of second-line therapy assessed upto 24 months after avelumab initiation. | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy | Number of participants who received Systematic Anti-Cancer Therapy Regimen as Second Line Therapy was reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Treatment Patterns: High Dose Systemic Steroid Use | Number of participants with high dose systemic steroid use was reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population | The number of separate AEs recorded per participants (with explicit linkage in the medical notes to avelumab) will be calculated using data from eCRF (each reported event on the eCRF counts as a separate AE). | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Count of Participants | | Participants | | From participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits | The number of accident and emergency visits recorded per participant as reported on the eCRF was used to calculate the rate of events per participant per year of follow-up time. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | number of accident&emergency visits/year | | From participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations | The number of hospital admissions recorded per participant as reported on the eCRF was used to calculate the rate of events per participant per year of follow-up time | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Mean | Standard Deviation | rate of hospitalization per year | | From participant electronic case report form (eCRF) index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation | Duration of Hospitalisation was reported. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | Full Range | days | | Time from the start date of platinum-basedchemotherapeutic treatment to the earliest of date of death or date of censoring,as reported on the eCRF assessed up to 24 months from avelumab initiation (index date) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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| Secondary | Real-World Overall Survival | Real world overall suvival was the time from the start date of platinum-based chemotherapeutic treatment to the earliest of date of death or date of censoring, as reported on the eCRF. | The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria. | Posted | | Median | 95% Confidence Interval | months | | From participant electronic case report form (eCRF) index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment) | | | | ID | Title | Description |
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| OG000 | Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) | Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts. |
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