Summary Counts
The Total Counts for All Cases (Initial + Follow-up) and Studies summary count table displays various counts for all cases (Initial + Follow-up) from all studies. It appears once for each tabulation, that is, once for the Main Summary tabulation, once for Fatal Summary Tabulation, and so on.
This count table has fixed columns that print the total of all event terms, cases and patients for IMP treatments, Comparator treatments, Blinded, Placebo and No Study Drug Given columns from the DSUR tabulation.
The system uses the following labels for these counts:
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Total Number of Events: Displays the sum of all events terms corresponding to IMP Treatment, Comparator Treatment, Blinded, Placebo and No Study Drug Given for each column. These totals are based on Main, Fatal, and Cumulative tabulations.
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Total Number of Distinct Cases: Displays the count of distinct cases for all summary columns.
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Total Number of Distinct Patient IDs: Displays the count of distinct patient IDs configured for cases that are part of the respective tabulation. Any case where patient ID is not configured is not counted in this column, that is, only those patients are counted where patient ID is configured. If the same patient ID is configured in multiple cases or the same patient is part of multiple cases from this tabulation, that patient ID is counted only once.
Parent topic: Summary Tabulations of Serious Adverse Events