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AE/SAE summary

With the Study Analytics dashboard, you can view various kinds of charts that display the current data of the ongoing EDC processes, such as sites with enrolled/not enrolled subjects, opened/answered queries, and so on. One of the charts displayed in the dashboard is the AE/SAE Summary pie chart. This chart displays data about the total subjects identified with adverse events (AEs) and the count of subjects identified with serious adverse events (SAEs) and non-serious adverse events.

Whenever you record the adverse event information for a subject, then based on the data provided, the count for adverse event (AE) or serious adverse event (SAE) is updated in the AE/SAE Summary pie chart.

AE/SAE summary pie chart
Figure 1. AE/SAE summary pie chart

In the preceding figure, the blue color in the pie chart signifies the Serious AEs, and the yellow color signifies the Non Serious AEs.

Tip

If you want to know the exact number of subjects identified with AE or SAE, hover over the required color in the pie chart to view the required information. For example, as shown in the following figure, out of a total of 54 reported adverse events, 35 are non-serious adverse events.

Viewing count of non-serious AEs
Figure 2. Viewing count of non-serious AEs

In this section:

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any 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.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.