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

November 17, 2025 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy.

This study is seeking participants who:

  1. Have UC that cannot be operated on or has spread to other parts of the body
  2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
  3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
  4. Are 18 years or older on the date that they start taking Avelumab

All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.

The secondary objectives are:

  1. To describe the clinical and demographic characteristics of the study population
  2. To estimate real-world progression-free survival (rwPFS)
  3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
  4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
  5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
  6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS1 3NU
        • University Hospitals Bristol
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed who are progression-free following completion of platinum-based chemotherapy.

Description

Inclusion Criteria:

  1. Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
  2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
  3. Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy
  4. Patients aged ≥18 years on the date that they commenced avelumab -

Exclusion Criteria:

  1. Patients whose hospital records are not available for review
  2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with locally advanced or metastatic urothelial cancer
Drug: Avelumab
As provided in real world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-World Overall Survival
Time Frame: 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)
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Participant's Age at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Participant's Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4
Time Frame: 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)
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.
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)
Clinical Characteristics: Participants Site of Metastases
Time Frame: 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)
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.
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)
Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis
Time Frame: 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)
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.
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)
Age of Participants at Avelumab Initiation
Time Frame: At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.
The age of participants at avelumab initiation was reported.
At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.
Real-World Progression-Free Survival (Rw-PFS)
Time Frame: 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)
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.
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)
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date
Time Frame: 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)
Number of participants who received type of First SACT regimen received were reported.
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)
Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received
Time Frame: 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)
Number of first line SACT cycles received by participants was reported as treatment characteristics.
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)
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies
Time Frame: 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)
Number of participants switching between different platinum-based chemotherapies were reported.
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)
Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab
Time Frame: 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)
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.
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)
Treatment Characteristics: Response to First Line Therapy
Time Frame: 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)
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.
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)
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence
Time Frame: 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)
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.
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)
Treatment Patterns: Duration of Treatment With Avelumab
Time Frame: 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
Duration was derived based on the date of avelumab initiation and the last date of avelumab treatment.
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
Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF
Time Frame: 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)
Number of participants who received second-line therapy were reported.
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)
Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy
Time Frame: 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.
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.
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.
Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy
Time Frame: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation
Number of participants who received Systematic Anti-Cancer Therapy Regimen as Second Line Therapy was reported.
From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation
Treatment Patterns: High Dose Systemic Steroid Use
Time Frame: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation
Number of participants with high dose systemic steroid use was reported.
From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation
Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population
Time Frame: 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)
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).
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)
Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits
Time Frame: 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)
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.
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)
Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations
Time Frame: 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)
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
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)
Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation
Time Frame: 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)
Duration of Hospitalisation was reported.
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)
Real-World Overall Survival
Time Frame: 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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

June 27, 2024

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B9991047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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