1.2 Adverse event (AE): An AE is an

1.2 Adverse event (AE): An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily 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 temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Kết quả (Anh) 1:

1.2 Adverse event (AE): any untoward medical occurrence is An AE in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily 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 temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Kết quả (Anh) 2:

1.2 Adverse event (AE): An AE is any untoward medical occurrence in a patient or subject Clinical Investigation Administered a pharmaceutical product and không necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (an abnormal laboratory finding gồm), symptom, or disease temporally associated with the use of a medicinal (investigational) product, or not related to the nếu medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).