Users can interact with an AE timeline in the following ways:

This drop-down menu is used to filter serious events in the data set. The default is set to include all events, but can be manipulated to include events that are only marked as serious or events that are only marked as non-serious. An open-ended black circle marks serious events so they can be viewed in the timeline at a glance.

This drop-down menu displays a listing of the adverse event severity levels in the data set. The default is to display all severity levels. The current severity levels captured are mild, moderate, and severe, which are color coded and displayed in a legend above the timeline.

This drop-down menu displays a list of all of the subject identifiers included in the data set. Each participant is assigned a unique identifier that is associated with their adverse event data. Filtering to view a particular subject ID will only show data for that subject. The default for this filter is set to show data for all subjects.

The chart can be configured to have any number of data filters. Each specified filter has a drop-down menu that is used to filter the visit data that is displayed in the chart.

This drop-down menu can sort the subject IDs included in the timeline data set. This option can sort the data by the participants with the earliest occurring adverse event(s) or the participants that appear first alphabetically in descending order. This option defaults to the earliest occurring events and their related participants.

Displayed in the top right corner of the page, this statement provides the total number of participants in the data set in integers as well as the percentage of participants shown to one decimal place. In the default view, all participant data is included in the chart, or 100%, unless the project team requests otherwise. When filters are used, the data shown in the histogram is manipulated and the number of participant records shown at the top of the page may increase or decrease, depending on the variable selected.

By moving a mouse cursor over a bar in the chart, users can display metadata for some variables. Hovering the cursor over a particular bar will display the reported term of an event, the day the event started, and the day the event stopped. More information about the event can be accessed by clicking on the Subject ID.

Clicking on the Subject ID seen to the left of the bar will load a more detailed view. This view displays the raw data for a participant's adverse events. This view shows the sequence number for the event, the day the event started, the day the event stopped, the reported term, the event's severity/intensity, and if the event is classified as serious or not.

The Back button is only visible if users have clicked on the detailed view for a given participant. Clicking on this button returns users to the default AE Timelines view.

• Confirm that selecting a filter manipulates the visible events
• Confirm that selecting a filter changes the ratio and percentage of affected participants
• Confirm that sorting subject IDs changes the order of the results as expected
• Confirm that hovering over event lines shows adverse event information (reported term, start day, stop day) for a participant
• Confirm that the date of an adverse event doesn't end in a circle
• Confirm that a serious AE is notated by a different mark than a normal AE
• Confirm that plot points marked as queried appear as a different color than other plot points and when clicked, display a message detailing the event and query
• Confirm that clicking on a participant ID takes the user to the detail view
• Confirm that Search works to filter the data displayed in the listing
• Confirm that Sort works in the listing by clicking on column headers
• Confirm that you can export the displayed data to a csv via via the Export: CSV button
• Confirm that clicking the Back button takes the user to the timelines chart screen
• Confirm that the population annotation (n of N participants...) is italicized.