How to Report?
All information that pertains to a Reportable Event must be directed to Zeta for review and analysis as appropriate. Report Reportable Events related to any Zeta product to Zeta by:
Adverse Events (AE)
An AE is any untoward medical occurrence in a patient administered an Zeta product and which is not necessarily caused by the Zeta product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:
- Any clinically significant worsening of a pre-existing condition; or
- An AE that has been associated with the discontinuation of the use of a product.