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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 48 weeks after the first administration of PADCEV