AE Resolution Screen

This process screens all adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event resolution and treatment arm . Resolution is computed directly from the end time of an adverse event and the end time of the trial, or from a resolution time window that you specify.

Refer to the AE Incidence Screen report description, keeping in mind the following important process differences in contrast with the example:

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:

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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 log 2 (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 generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

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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 .