The AE Incidence Screen report screens all adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event incidence and treatment arm. Output one or more volcano plots of risk differences when using default settings. However, plots of relative risks or odds ratios can be generated depending on the selected option for the x-Axis for Volcano Plot. If Study ID varies among the subjects for analysis, the test is stratified by Study ID.
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Perform Double FDR Adjustment checked,
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Group Level set to Body System or Organ Class, and
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Trial Time Windows of [1,6][7,12]
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generates the report shown below. Refer to the AE Incidence Screen requirements description for more information.
The Report contains the following sections:
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Body System or Organ Class Results: This tab presents a data filter and 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.
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Dictionary-Derived Term Results: This tab contains a data filter and 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.
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Body System or Organ Class Exploding Volcano: Contains a data filter and 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.
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Dictionary-Derived Term Exploding Volcano: Contains a data filter and 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.
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Dot Plot: Click
 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. |
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Relative Risk Plot: Click
 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. |
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Odds Ratio Plot: Click
 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. |
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Contingency Analysis: Click
 to create the typical treatment by event contingency table for selected terms or for all terms that fall under selected groups. |
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Venn Diagram: Click
 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. |
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Tabulate: Click
 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. |
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Click
 to view the associated data tables. Refer to View Data for more information. |
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Click
 to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections. |
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Click
 to take notes, and store them in a central location. Refer to Add Notes for more information. |
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Click
 to read user-generated notes. Refer to View Notes for more information. |
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Click the arrow to reopen the completed process dialog used to generate this output.
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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.