Adverse Event Reporting

Part of Zeta's mission to serve patients includes collecting, reviewing and reporting all Adverse Events (AEs), Other Safety Findings (OSFs), and Product Complaints (PCs) information associated with the use of Zeta's investigational and marketed products.

It is Zeta's policy to comply with all regulations and laws worldwide relating to reporting Adverse Events, Other Safety Findings and Product Complaints (collectively known as Reportable Events). Individuals subject to this policy are required to report all Reportable Events within one business day of learning of it.

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:

Hotline: 17053

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.