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changes.mady.by.user Richard Marshall

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changes.mady.by.user Richard Marshall

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  • display within the displays attribute: refer to the OutputDisplay section for a full example of a display specification.
  • categoryIds: refer to the AnalysisOutputCategorization section for examples of the categorization of outputs.
  • documentRefs: refer to the DocumentReference section for examples of informational documentation document references specified for an output.
  • programmingCode: refer to the AnalysisOutputProgrammingCode section for examples of the representation of programming code for analyses and outputs.
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Lines 2-30:

Show the definition of the "Summary of Demographics" output, in which:

  • Lines 5-9: Show that the results for the output are represented in a single PDF file, which the sponsor labeled as "t14-1-1-demog". The file (t14-1-1-demog.pdf) is located in the "outputs" sub-folder of the folder that contains the reporting event file.
  • Lines 10-24: Show that the sponsor chose to represent summary statistics for male and female subjects in 2 separate displays within the output.
Lines 31-58:

Show the definition of the "Overall Summary of Treatment-Emergent Adverse Events" output, in which:

  • Lines 34-44: Show that the results for the output are represented in 2 files (1 in RTF format and 1 in PDF format), which the sponsor labeled as "t14-3-1-1-teae-summ (RTF)" and "t14-3-1-1-teae-summ (PDF)". Both files are located in the "outputs" sub-folder of the folder that contains the reporting event file. For both files, the sponsor also used the style attribute to record a formatting element that was meaningful to their implementation system.
  • Lines 45-52: Show that the sponsor chose to represent all results for the output in a single display.

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