This report 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 that you specify.
Refer to the
AE Incidence Screen
report description, keeping in mind the following important report differences in contrast with the example:
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output (including section names) reflects
adverse event
resolution
(resolution status is determined by
Determine Resolved / Not Resolved Status using:
), rather than incidence
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Time s for Start of AE
replaces
Trial Time Windows
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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 report dialog used to generate this output.
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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.
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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?
.
Include serious adverse events only
,
Event Type
,
Ignore available treatment emergent flags
,
Offset for End of Dosing
,
Determine Resolved / Not Resolved Status using:
,
Reference Value or Day
Additional Filter to Include Subjects
2
Merge supplemental domain
,
Filter to Include Adverse Events
,
Select the population to include in the analysis
,
By Variables
Treatment Control Level
,
Time Scale
,
Time s for Start of AE
,
Stratification Variables
,
Perform Double FDR Adjustment
,
Group Level
,
Multiple Testing Method
,
Alpha
,
-l
og
10
(p-Value) Cutoff
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
.