Example Reporting Events

Two example reporting events have been created to show the use of the ARS Model to represent

• prospective analysis definition metadata,
• analysis results with accompanying contextualizing metadata, and
• metadata describing the layout of output displays.

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.

• Common Safety Displays
  • Summary of Demographics
  • Overall Summary of Treatment-Emergent Adverse Events
  • Summary of TEAE by System Organ Class and Preferred Term
  • Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
  • Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs <Vertical Layout>
• FDA Standard Safety Tables and Figures
  • Table 2: Baseline Demographic and Clinical Characteristics, Safety Population

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.

All metadata describing the outputs and analyses in each of the example reporting events, as well as all of the analysis results, are available for download from the ARS GitHub repository (https://github.com/cdisc-org/analysis-results-standard).

Each of the following sections contains an image of 1 of the example output displays and a list of the details of the specifications both for the output and for each of the analyses that have been defined to generate the results for each output display. The lists of output and analysis details have been derived by programmatically extracting and reformatting the details of each of the outputs and analyses referenced in the mainListOfContents attribute for each of the reporting events.