Page History

In this example, the sponsor defined a top-level "Analysis Data Class" categorization, with one or more sub-categorizations for each of the data class categories. In this list, categorization labels are shown in bold and category labels are shown in italics.:

• Analysis Data Class
  • Subject-level
    • Subject-level Data Type (sub-categorization of "Subject-level")
      • Demographics
  • Events
    • Events Data Type (sub-categorization of "Events")
      • Adverse Events
      • Clinical Events
      • Disposition
    • Events Analysis Type (sub-categorization of "Events")
      • Occurrence
      • Time-to-Event
  • Findings
    • Findings Data Type (sub-categorization of "Findings")
      • Vital Signs
      • Laboratory Tests
    • Findings Analysis Type (sub-categorization of "Findings")
      • Change from Baseline
      • Shift Table

This categorization and its sub-categorizations are represented—with identifier values assigned form both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:

In the same reporting event, both analyses and outputs were categorized by specifying one or more of the defined category identifier values in the categoryIds attribute:

• The "Summary of Age by Treatment" analysis was categorized as:
  • "Population Description" (Analysis Data Class) and
  • "Demographics" (Subject-level Data Type).
• The "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as:
  • "Findings" (Analysis Data Class),
  • "Vital Signs" (Findings Data Type), and
  • "Shift Table" (Findings Analysis Type).