A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

Number of patients with an adverse event (AE)

Adverse events (AEs) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient 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 54 Weeks after the first administration of VYLOY

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 54 Weeks after the first administration of VYLOY

Number of patients with a serious AE (SAE)

An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

Time frame: Up to 54 Weeks after the first administration of VYLOY

Number of patients with a serious ADR (SADR)

An ADR considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

Time frame: Up to 54 Weeks after the first administration of VYLOY

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 Precautions in Use Section of approved Korean label.

Time frame: Up to 54 Weeks after the first administration of VYLOY

Number of patients with an unexpected ADR (UADR)

An UADR is defined as an unexpected adverse drug reaction.

Time frame: Up to 54 Weeks after the first administration of VYLOY

Number of patients who died during the study

Time frame: Up to 54 Weeks after the first administration of VYLOY

Number patients with an AE leading to death

Time frame: Up to 54 Weeks after the first administration of VYLOY

Number of patients with an important risk compared to number of patients evaluated

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 54 Weeks after the first administration of VYLOY