Adverse Event Distribution

Note : JMP Clinical is shipped with a simulated data set of 10,000 Cases. Generally, each Case represents one single event for which one single drug is listed. However, there are two single-event Cases with multiple drugs listed - one with four drugs and one with three drugs for a total of 10,005 records.

The Adverse Event Distribution section contains the following elements:

•	One or more Distribution s.

JMP Clinical determines event uniqueness based on the variables supplied for analysis such as Case ID ; the event name and classification, which could refer to MedDRA preferred terms and system organ class ; the onset date of the event; or, any variables used for stratification, such as event severity.

The total sample size represents the number of unique events. Typically, Histogram s and summary statistics are provided for event name, classification (if provided), categorical and continuous strata variables (if provided), and event location (if provided).

•

One Map.

If an event location is provided, a Geographical Map colored by the frequency of events is provided. The map is determined based on the type of location variable provided (for example, Country versus U.S. state).

•	One Data Filter .

By default, it includes the event and event classification (if provided). Other analysis variables can be added.