Trial Outcomes & Findings for A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy (NCT NCT05366725)

NCT ID: NCT05366725

Last Updated: 2025-12-02

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: 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)
• Results posted on: 2025-12-02

Participant Flow

Participant milestones

Measure	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 participants medical records and hospital charts.
Overall Study STARTED	106
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Baseline characteristics by cohort

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Age, Continuous	65.5 years STANDARD_DEVIATION 12.33 • n=121 Participants
Sex: Female, Male Female	28 Participants n=121 Participants
Sex: Female, Male Male	78 Participants n=121 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	106 Participants n=121 Participants

PRIMARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Real-World Overall Survival

16.8 months Interval 11.6 to 23.4

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis

67.4 weeks Interval 0.0 to 621.4

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Clinical Characteristics: Participant's Age at Locally Advanced or Metastatic Diagnosis

68.5 years Standard Deviation 11.46

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis Stage IIIA	13 Participants
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis Stage IIIB	8 Participants
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis Stage IVA	20 Participants
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis Stage IVB	55 Participants
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis Unknown	10 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis Pure urothelial cancer (transitional cell carcinoma)	86 Participants
Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis Mixed urothelial with component of another pathology	11 Participants
Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis Other	9 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis De novo disease	59 Participants
Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis Newly relapsed	46 Participants
Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis Unknown	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Clinical Characteristics: Participant's Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis

2.0 cubic/millimeter (mm) 3 Standard Deviation 2.45

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 0	35 Participants
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 1	36 Participants
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 2, 3, or 4	5 Participants
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 Not recorded	30 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Participants Site of Metastases Lymph nodes	64 Participants
Clinical Characteristics: Participants Site of Metastases Bone	21 Participants
Clinical Characteristics: Participants Site of Metastases Lung	32 Participants
Clinical Characteristics: Participants Site of Metastases Liver	18 Participants
Clinical Characteristics: Participants Site of Metastases Other	19 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis Unknown	2 Participants
Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis Yes	47 Participants
Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis No	57 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis Yes	35 Participants
Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis No	69 Participants
Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis Unknown	2 Participants

SECONDARY outcome

Timeframe: At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

The age of participants at avelumab initiation was reported.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Age of Participants at Avelumab Initiation

69.3 years Standard Deviation 11.41

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Real-World Progression-Free Survival (Rw-PFS)

8.7 months Interval 7.1 to 14.2

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of participants who received type of First SACT regimen received were reported.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date Cisplatin/gemcitabine	49 Participants
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date Carboplatin/gemcitabine	55 Participants
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date Unknown	2 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of first line SACT cycles received by participants was reported as treatment characteristics.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received

5.3 cycles Standard Deviation 1.16

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of participants switching between different platinum-based chemotherapies were reported.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies Yes	7 Participants
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies No	99 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab

8.5 weeks Interval 0.43 to 26.1

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Treatment Characteristics: Response to First Line Therapy Complete response	9 Participants
Treatment Characteristics: Response to First Line Therapy Partial response	54 Participants
Treatment Characteristics: Response to First Line Therapy Stable disease	42 Participants
Treatment Characteristics: Response to First Line Therapy Unknown	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence Yes	101 Participants
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence No	5 Participants

SECONDARY outcome

Timeframe: 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

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Duration was derived based on the date of avelumab initiation and the last date of avelumab treatment.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Patterns: Duration of Treatment With Avelumab

34.2 weeks Interval 0.14 to 104.6

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of participants who received second-line therapy were reported.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF

15 Participants

SECONDARY outcome

Timeframe: 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.

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy

38.7 weeks Interval 9.1 to 92.0

SECONDARY outcome

Timeframe: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of participants who received Systematic Anti-Cancer Therapy Regimen as Second Line Therapy was reported.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy

5 Participants Interval 9.1 to 92.0

SECONDARY outcome

Timeframe: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Number of participants with high dose systemic steroid use was reported.

Outcome measures

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.
Treatment Patterns: High Dose Systemic Steroid Use Yes	24 Participants
Treatment Patterns: High Dose Systemic Steroid Use No	80 Participants
Treatment Patterns: High Dose Systemic Steroid Use Unknown	2 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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).

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population

80 Participants

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits

1.9 number of accident&emergency visits/year Standard Deviation 1.67

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations

2.7 rate of hospitalization per year Standard Deviation 3.81

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Duration of Hospitalisation was reported.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation

14.5 days Interval 0.5 to 172.3

SECONDARY outcome

Timeframe: 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)

Population: The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

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.

Outcome measures

Measure

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 Participants 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.

Real-World Overall Survival

21.8 months Interval 17.0 to 28.9

Adverse Events

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC)

Serious events: 34 serious events

Other events: 78 other events

Deaths: 66 deaths

Serious adverse events

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 participants at risk 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.
General disorders Disease progression	10.4% 11/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Infections and infestations Pneumonitis	2.8% 3/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Dermatitis	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Infusion reaction	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Endocrine disorders Diabetes Mellitus	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Nervous system disorders Sub-dural Hemorrhage	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Pain	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Nervous system disorders Immunotherapy induced Encephalitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Renal and urinary disorders Incidental acute kidney injury	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Skin reaction	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Immune system disorders Hypersensitivity	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Hepatobiliary disorders Deranged Liver Function Tests	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Lack of efficacy	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Musculoskeletal and connective tissue disorders Myositis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Nervous system disorders Vestibular neuritis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Left Flank Pain	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Blood and lymphatic system disorders Febrile Neutropenia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Investigations Hypophosphatemia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Spinal Cord Compression	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Metastases	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Other adverse events

Measure	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) n=106 participants at risk 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.
General disorders Disease progression	26.4% 28/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Lack of efficacy	13.2% 14/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Fatigue	10.4% 11/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Rash	7.5% 8/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Renal and urinary disorders Nephritis	4.7% 5/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Endocrine disorders Hypothyroidism	8.5% 9/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Hepatobiliary disorders Transaminitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Pruritus	3.8% 4/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Toxicity	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Diarrhea	3.8% 4/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Vomiting	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Musculoskeletal and connective tissue disorders Myositis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Constipation	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Endocrine disorders Hyperthyroidism	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Hepatobiliary disorders Hepatitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Dermatitis	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Lichenoid drug eruption	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Itch and macular rash	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Infusion reaction	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Rash and balanitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Palmar-plantar erythema	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Loss of appetite	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Itch and maculopustular rash	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Endocrine disorders Low Cortisol	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Endocrine disorders Adrenal insufficiency	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Urticaria	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Skin rash in forehead	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Itch scalp	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone metastases	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Nervous system disorders Residual neuropathy	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Papular rash on legs	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Fevers and chills	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Hepatobiliary disorders ALT increased	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
General disorders Sequelae	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Psychiatric disorders Anorexia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Renal and urinary disorders Acute Kidney Injury	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Renal and urinary disorders Creatinine Increased	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Infections and infestations Urinary Tract Infection	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Infections and infestations Pneumonitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Immune system disorders Hypersensitivity reaction	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Colitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Abdominal Pain	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Investigations Hypomagnesemia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Investigations Hypocalcemia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Investigations Neutropenia	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Pelvic Pain	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Renal and urinary disorders Urinary Symptoms	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Nausea	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Nervous system disorders Neuropathy	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Gastrointestinal disorders Sore mouth	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Itchy skin	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Folliculitis	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Vascular disorders Peripheral oedema	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Itching	1.9% 2/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Skin and subcutaneous tissue disorders Maculopapular Rash	2.8% 3/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.
Hepatobiliary disorders Immune related transaminitis	0.94% 1/106 • Up to 24-months from initiation of avelumab treatment The Full Analysis Set comprised of participants who met the inclusion criteria and did not meet the exclusion criteria.

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49 06151725200

Email: service@emdgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place