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. Refer to the Standardized MedDRA Queries Incidence Screen requirements description for more information. 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:
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Name of Standardized MedDRA Queries Results: Provides one or more Volcano Plots to summarize the incidence of SMQs 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 log2(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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