What are adverse events?

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

A Serious Adverse Event (SAE) is any adverse drug event (experience) occurring at any dose that, in the opinion of either the investigator or sponsor, results in any of the following outcomes:

Death.
Life-threatening adverse drug experience.
Inpatient hospitalization or prolongation of existing hospitalization (for > 24 hours).
Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Congenital anomaly/birth defect.
Important Medical Event (IME) that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Serious adverse events must be reported to regulatory authorities. Based on your company policies and trial design, you may also have non-serious adverse events that are determined to be of significant medical interest that should also be reported to regulatory authorities.

AEs of all types are documented in InForm, along with information about the event, such as medications taken and current status of the AE. You can collect AEs and serious events data on a single Adverse Event form. This approach can be used when there is a one-to-one relationship between an adverse event that is marked as serious or reportable and a case in Argus Safety, or if additional adverse events will be sent based on date ranges you configure.

You can also collect AE and serious events data on separate, standalone Adverse Event and Safety Case forms. This approach can be used regardless of the number of adverse events that should be associated with a case in Argus Safety. However, separate Adverse Event and Safety Case Forms are required if your study design calls for sites to choose multiple AEs that should be associated with one Argus case.