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 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 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
.