Body System or Organ Class Results

Note : The name of this tab 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 tab contains the following elements:

•	One Bubble Plot of -log 10 (Raw p-value) by Risk Difference .

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.

The y -axis represents the -log 10 (Raw p-value ). To interpret this axis, consider that

1. a p -value of 1 equals 0 on the -log 10 scale,

2. a p -value of 0.1 equals 1 on the -log 10 scale,

3. a p -value of 0.01 equals 2 on the -log 10 scale,

4. a p -value of 0.001 equals 3 on the -log 10 scale,

5. a p -value of 0.0001 equals 4 on the -log 10 scale.

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 Windows (if specified) is presented on this tab. Because Trial Time Windows are defined, a Group Level bubble is presented separately for each time window.

•	One Data Filter .

By default, Group Level and Trial Time Windows (if specified) are presented.

Note the following tab-specific properties of the Drill Down Buttons located at the top of the Report :

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Dot Plot : Click Dot Plot 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.

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Relative Risk Plot : Click Relative Risk Plot 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 Window 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 Contingency Analysis 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 .

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Venn Diagram : Click Venn Diagram 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].

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Tabulate : Click Tabulate 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.