Reports
| AE Incidence Screen

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 .

• Perform Double FDR Adjustment checked,

• Group Level set to Body System or Organ Class , and

• Trial Time Windows of [1,6][7,12]generates the report shown below. Refer to the AE Incidence Screen requirements description for more information.The Report contains the following elements:Presents a Data Filter and a Volcano Plot with the adverse events summarized at the selected Group Level . .Note : The name of this section reflects whatever term is selected as Group Level and is presented only if Perform Double FDR Adjustment is checked.The Body System or Organ Class Results section contains the following elements:

• This Volcano Plot displays adverse events summarized at the selected Group Level by Trial Time Windows (if specified). The X axis is chosen from X-Axis for Volcano Plot . In this example, the plot uses the difference in proportions between the treatments ( Risk Difference ). Other options include the log 2 (Relative Risk ), which represents a doubling of the event rate for every one unit of change on the X axis, or the log 2 (Odds Ratio ), which represents a doubling of the odds of an event for every one unit of change on the X axis.In short, the smaller the p -value, the larger the number on the Y axis ( Y can be thought of as the number of decimal places or number of zeros). Adverse events that are considered statistically significant while adjusting for multiple comparisons are above the dashed red line. This line is determined based on the selected Multiple Testing Method . The testing method considers the adverse event Group Level if Perform Double FDR Adjustment is checked. p -Value is from a Cochran-Mantel-Haenszel exact test . If Study ID varies among the subjects for analysis, the test is stratified by Study ID .Bubble size is an indicator of the total number of subjects experiencing the event. Because numerous adverse events could be represented at the Group Level , the most statistically significant individual term defined at the Term Level within each Group Level by Trial Time s (if specified) is presented on this tab. Because Trial Time s are defined, a Group Level bubble is presented separately for each time .

• One Data Filter .Note the following section-specific properties of the Action Buttons located at the top of the Report :

• Dot Plot : Click to display several statistics used to describe binary outcomes. For all terms that fall under selected groups (here, Vascular Disorders and Renal and Urinary Disorders), a dot plot that presents the rates of adverse events by treatment, the relative risk, the risk difference, and odds ratio, is created. The figure can be sorted based on the magnitudes of a particular statistic and is another way of ordering events by severity.

• Relative Risk Plot : Click to create a relative risk plot and relative risk table for selected terms or for all terms that fall under selected groups (here, Vascular Disorders and Renal and Urinary Disorders). In the plot, rates of adverse events by treatment, the log 2 (relative risk) and unadjusted 95% confidence intervals are presented. (Confidence intervals do not account for the Multiple Testing Method .) The table presents an alternate view, listing the subject counts experiencing an event and the respective percent of subjects ( in parentheses ) on each treatment arm , as well as the relative risk and 95% confidence interval ( in parentheses ) for selected terms (or those terms falling under selected groups).Relative Risk Table Example : For the Dictionary-Derived Term with Time Phlebitis [7,12] , NIC .15 Count (%) is listed as 96 (21.5%) , Placebo Count (%) is listed as 20 (4.4%) , and Relative Risk (95% CI) is listed as 4.9 (3.1, 7.8) . This means that in Days 7 to 12 of the study, 96 subjects on the Nicardipine arm (which is 21.5% of all subjects on Nicardipine), and 20 subjects on the Placebo arm (which is 4.4% of all subjects on Placebo) experienced Phlebitis, with those in the Nicardipine arm 4.9 times more likely than those in the Placebo arm to experience it (with a 95% confidence interval between 3.1 and 7.8 more likely).

• Contingency Analysis : Click to create the usual treatment by event contingency table for selected terms or for all terms that fall under selected groups (here, Vascular Disorders, though only Hypotension is presented). Tests do not account for the Multiple Testing Method .

• Venn Diagram : Click to create a Venn diagram for up to five selected terms or for terms that fall under selected groups (here, Renal and Urinary Disorders), to show the co-occurrence of adverse events within study subject. Here, we can identify 61 subjects who had Isosthenuria events from days [1,6] and days [7,12].

• Tabulate : Click to create a table for selected terms or for all terms that fall under selected groups (here, Vascular Disorders and Renal and Urinary Disorders), showing the co-occurrence of adverse events within study subject. You can further modify the tables to show additional summary statistics. The default view is shown below.Contains a data filter and a Bubble Plot for each event defined at the Term Level for each statistically significant group and time (if present) that appears on the Body System or Organ Class Results section 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 section reflects whatever term is selected as Term Level .Note : The name of this section reflects whatever term is selected as Term Level . If Perform Double FDR Adjustment is checked, the terms for each statistically significant group and time (if present) that appear on the Body System or Organ Class Results section are presented. If Perform Double FDR Adjustment is not checked, all adverse events at the Term Level are presented.The Dictionary-Derived Term Results section contains the following elements:

• This Volcano Plot displays adverse events summarized at the selected Group Level by Trial Time Windows (if specified). The X axis is chosen from X-Axis for Volcano Plot . In this example, the plot uses the difference in proportions between the treatments ( Risk Difference ). Other options include the log 2 (Relative Risk ), which represents a doubling of the event rate for every one unit of change on the X axis, or the log 2 (Odds Ratio ), which represents a doubling of the odds of an event for every one unit of change on the X axis.In short, the smaller the p -value, the larger the number on the Y axis ( y can be thought of as the number of decimal places or number of zeros). Adverse events that are considered statistically significant while adjusting for multiple comparisons are above the dashed red line. This line is determined based on the selected Multiple Testing Method . The testing method considers the adverse event Group Level if Perform Double FDR Adjustment is checked. The p -value is from a Cochran-Mantel-Haenszel exact test . If Study ID varies among the subjects for analysis, the test is stratified by Study ID .Bubble size is an indicator of the total number of subjects experiencing the event. Because numerous adverse events could be represented at the Group Level , the most statistically significant individual term defined at the Term Level within each Group Level by Trial Time s (if specified) is presented on this tab. Because Trial Time s are defined, a Group Level bubble is presented separately for each time .

• One Data Filter .Contains a data filter and an animation across the time s of the results included on the Body System or Organ Class Results section.Note : The name of this section reflects whatever term is selected as Group Level and is presented only if Trial Time Windows are provided and Perform Double FDR Adjustment is selected.The Body System or Organ Class Exploding Volcano section contains the following elements:

• This figure is animated and shows how the incidence of adverse events between the treatments changes over the course of the specified Trial Time Windows .

• One Days slider ( ).

• One Speed slider ( ).

• One Circle Size slider ( ).Contains a data filter and an animation across the time s of the results included on the Dictionary-Derived Term Results tab, which presents a separate bubble for each term or time .Note : The name of this section reflects whatever term is selected as Term Level and is presented only if Trial Time Windows are provided.The Dictionary-Derived Term Exploding Volcano section contains the following elements:

• This figure is animated and shows how the incidence of adverse events between the treatments changes over the course of the specified Trial Time Windows .

• One Days slider ( ).

• One Speed slider ( ).

• One Circle Size slider ( ).

• 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.

• 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.

• 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.

• Contingency Analysis : Click to create the typical treatment by event contingency table for selected terms or for all terms that fall under selected groups.

• 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.

• 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.

• 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 arrow to reopen the completed report dialog used to generate this output.

• Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information.Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event? .Subject Filter^{ 1 }

Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.

For more information about how to specify a filter using this option, see The SAS WHERE Expression .