Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 31
- 主要终点
- Number of patients with an Adverse Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive treatment with PADCEV Injection, according to the approved local label.
排除标准
- •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.
研究组 & 干预措施
PADCEV
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.
干预措施: Enfortumab Vedotin (Drug)
结局指标
主要结局
Number of patients with an Adverse Event
时间窗: Up to 48 weeks after the first administration of PADCEV
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.
Number of patients with an adverse drug reaction (ADR)
时间窗: Up to 48 weeks after the first administration of PADCEV
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.
Number of patients with a serious AE (SAE)
时间窗: Up to 48 weeks after the first administration of PADCEV
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.
Number of patients with a serious ADR (SADR)
时间窗: Up to 48 weeks after the first administration of PADCEV
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.
Number of patients with an unexpected AE (UAE)
时间窗: Up to 48 weeks after the first administration of PADCEV
An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.
Number of patients with an unexpected ADR (UADR)
时间窗: Up to 48 weeks after the first administration of PADCEV
An UADR is defined as an unexpected adverse drug reaction.
Number of patients with an important risk
时间窗: Up to 48 weeks after the first administration of PADCEV
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.
次要结局
- Overall survival(Up to 48 weeks after the first administration of PADCEV)
- Progression free survival(Up to 48 weeks after the first administration of PADCEV)