A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Study Overview
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Brief Summary
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Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer. People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only. This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study. Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.

Official Title
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Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Conditions
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Urothelial Cancer

Intervention / Treatment
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* Drug: Enfortumab Vedotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive treatment with PADCEV Injection, according to the approved local label. Exclusion Criteria: Patients with any contraindication for PADCEV Injection, according to the approved local label. Patients who receive or are going to receive any investigational medicine during the observation period.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PADCEV<br>Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization. | Drug: Enfortumab Vedotin<br>* Intravenous<br>* Other names: ASG-22CE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with an Adverse Event | Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with an adverse drug reaction (ADR) | An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with a serious AE (SAE) | An AE is considered serious if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with a serious ADR (SADR) | An ADR is considered serious if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with an unexpected AE (UAE) | An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with an unexpected ADR (UADR) | An UADR is defined as an unexpected adverse drug reaction. | Up to 48 weeks after the first administration of PADCEV | 
| Number of patients with an important risk | An important risk is classified as an important identified risk and an important potential risk. An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug.Important Identified Risks are identified risks that have the potential to affect the risk-benefit balance of a product. An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug.Important Potential Risks are potential risks that have the potential to affect the risk-benefit balance of a product. | Up to 48 weeks after the first administration of PADCEV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival (OS) is defined as time from start of PADCEV to death. | Up to 48 weeks after the first administration of PADCEV | 
| Progression free survival | Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first. | Up to 48 weeks after the first administration of PADCEV | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urothelial Cancer, Bladder Cancer, enfortumab vedotin, PADCEV