This report screens Standard
MedDRA
Query terms by performing a
Cochran-Mantel-Haenszel exact test
on all 2 x 2 tables constructed from event incidence and treatment
arm
. Output is a table of multiplicity-adjusted
p-values
, an accompanying
volcano plot
of relative risk and a SAS data set of indicator
variables
that can be used as input for other reports.
Running
Standardized MedDRA Queries Incidence Screen
for the
Nicardipine
study using
MedDRA
Version 16.0 files generates the report shown below.
Note
: Your output might vary depending on which version of MedDRA you provide (in terms of the location of the *.
asc
files).
The
Report
contains the following elements:
Provides one or more
Volcano Plot
s to summarize the incidence of
SMQs
between pairs of treatments. For the selected set of
SMQs
from the study
dialog
using
Perform incidence analysis using the following SMQs:
, one or more
volcano plots
are generated summarizing the difference in incidence between pairs of treatments.
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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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Include serious adverse events only
,
Event Type
,
Ignore available treatment emergent flags
,
Offset for End of Dosing
Additional Filter to Include Subjects
2
,
Merge supplemental domain
,
Filter to Include Adverse Events
,
Select the population to include in the analysis
,
By Variables
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
.