Output Overview Descriptions | Clinical | AE Incidence Screen

AE Incidence Screen
Running this process using the Nicardipine sample setting with the following modifications:
Group Level set to Body System or Organ Class, and
Trial Time Windows of [1,6][7,12]
generates the tabbed Results window shown below. Refer to the AE Incidence Screen process description for more information. Output from the process is organized into tabs. Each tab contains one or more plots, data panels, data filters, and other features to facilitate your analysis.
The Results window contains the following panes:
Tab Viewer
This pane provides you with a space to view individual tabs within the Results window. Use the tabs to access and view the output plots and associated data sets.
The following tabs are generated by this process:
Body System or Organ Class Results: This tab presents a Volcano Plot with the adverse events summarized at the selected Group Level. Note that the name of this tab reflects whatever term is selected as Group Level and is presented only if Perform Double FDR Adjustment is selected.
Dictionary-Derived Term Results: This tab contains a Bubble Plot for each event defined at the Term Level for each statistically significant group and time window (if present) that appears on the Body System or Organ Class Results tab if Perform Double FDR Adjustment is checked. If Perform Double FDR Adjustment is not checked, all adverse events at the Term Level are presented. Note that the name of this tab reflects whatever term is selected as Term Level.
Body System or Organ Class Exploding Volcano: Contains an animation across the time windows of the results included on the Body System or Organ Class Results tab. Note that the name of this tab reflects whatever is selected as Group Level and is presented only if Trial Time Windows are provided and Perform Double FDR Adjustment is selected.
Dictionary-Derived Term Exploding Volcano: Contains an animation across the time windows of the results included on the Dictionary-Derived Term Results tab, which presents a separate bubble for each term or time window. Note that the name of this tab reflects whatever term is selected as Term Level and is presented only if Trial Time Windows are provided.
Drill Down Buttons
Drill down buttons provide you with an easy way to drill down into your data. The following drill down buttons are generated by this process:
Dot Plot: Click Dot Plot to create a dot plot for selected terms or for all terms that fall under selected groups, with rates of adverse events by treatment, the relative risk, the risk difference, and the odds ratio presented.
Relative Risk Plot: Click Relative Risk Plot to create a relative risk plot and table for selected terms or for all terms that fall under selected groups, with rates of adverse events by treatment, the log2(relative risk) and unadjusted 95% confidence intervals (Multiple Testing Method is not applied) presented.
Odds Ratio Plot: Click Odds Ratio Plot to create a plot that shows the ratio of the odds for exhibiting a selected event/intervention to the odds for those who do not exhibit the event/intervention and it can be used to estimate the relative risk when the probability of positive response is small.
Contingency Analysis: Click Contingency Analysis to create the typical treatment by event contingency table for selected terms or for all terms that fall under selected groups.
Venn Diagram: Click Venn Diagram to create a Venn diagram for up to five selected terms or for terms that fall under selected groups, to show the co-occurrence of adverse events within study subject.
Tabulate: Click Tabulate to create a table for selected terms or for all terms that fall under selected groups, showing the co-occurrence of adverse events within study subject. You can further modify the tables to show additional summary statistics.
General
Click View Data to view the associated data table. Refer to View Data for more information.
Click Reopen Dialog to reopen the completed process dialog used to generate this output.
Click Create Report to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected tabs.
Click Add Notes to take notes, and store them in a central location. Refer to Add Notes for more information.
Click View Notes to read user-generated notes. Refer to View Notes for more information.
Click Close All to close all graphics windows and underlying data sets associated with the output.