AE Severity ANOVA

The AE Severity ANOVA process screens all adverse events by performing a mixed-model analysis of variance , with average ranked severity score as the dependent variable and customizable fixed and random effects . A separate ANOVA is fit for each distinct adverse event. Volcano plots and other output enable efficient screening of adverse event severities that differ between treatment groups. If a patient has multiple instances of a particular adverse event, then those scores are averaged to form a single score for analysis.

Running this process for Nicardipine using default settings generates the report shown below.

The Results window contains the following elements:

Results Section

This pane enables you to access and view the output plots and associated data sets on each tab. Use the drop-down menu to view the section in the Results pane or remove the section and its contents from the Results pane.

The following sections are generated by this process:

•	Results : This tab shows the primary results from the analysis, including Volcano Plot s and various analyses on least squares means.

•	Variability Estimates (AE Severity ANOVA) : This tab shows the analyses on variance component estimates from the ANOVA model fits.

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:

•	Fit Model and Plot LS Means : Select points or rows and click to select variable (s) that uniquely define wide column names. Selected Findings tests are analyzed in the JMP Fit Model platform to view detailed fitting results and plots. Attention : Read the warning found in the link.

•	Construct One-way Plots : Click to plot the original data in one-way format using treatment variables of your choice.

Output Data

This pane provides links to the following output data sets:

•	Significant Differences Data Set : This output data set contains a complete list of the adverse events significant by one or more criteria. This data set is indicated by the _sig suffix. Click Open to view the data set.

•	Stacked Significant Differences Data Set : This output data set contains a complete list of all adverse events for all subjects. It is typically very tall.

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Experimental Design Data Set : This is a SAS data set that provides information about the columns of a tall data set. It describes relevant experimental variables such as treatment conditions and covariates as well as a variable named ColumnName. Refer to Sample Case Studies for more information. Click Open to view the data set.

For detailed information about the files and data sets used or created by JMP Life Sciences software, see Files and Data Sets .

General

•	Click to view the associated data tables. Refer to View Data for more information.

•	Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

•	Click to take notes, and store them in a central location. Refer to Add Notes for more information.

•	Click to read user-generated notes. Refer to View Notes for more information.

•	Click the Options arrow to reopen the completed process dialog used to generate this output.

Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to Determining If an Event Is a Treatment Emergent Adverse Event .