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The "Common Safety Displays" reporting event contains the specifications for 5 commonly used safety displays and the analyses required to generate the results represented in the displays; the "FDA Standard Safety Tables and Figures" reporting event contains similar information for the summary of demographics and clinical characteristics display ("Table 2"), which is one of the safety tables defined in the FDA's Standard Safety Tables and Figures: Integrated Guide document.
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Using example data generated for the CDISC pilot study, analysis results for each of the 6 outputs have been generated according to the analysis specifications recorded in the example reporting events. The analysis results are also represented in the example reporting events, and each result value is associated with sufficient metadata to relate it to the metadata describing the analysis which generated the result value.
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