The
Dictionary-Derived Term Results
tab 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.

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. 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 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.