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Model Documentation

Class: AnalysisOutputCategorization

The AnalysisOutputCategorization class can be used to create sponsor-defined categorizations, where a categorization is a set categories with a common topic. Defined categorizations are stored in the reporting event's analysisOutputCategorizations attribute. In its simplest form, a categorization is a list of categories, each of which is a label with an associated identifier value. However, it is possible to define one or more sub-categorizations for any category. Each sub-categorization is another instance of the AnalysisOutputCategorization class, with its own list of categories (each of which may again have sub-categorizations).

ER Diagram: AnalysisOutputCategorization

The categories within any categorization (or sub-categorization) may be used to categorize any analysis or output. Each analysis or output may be assigned to one or more categories by including the identifier value of the category in the categoryIds attribute of the analysis or output.

Example

In this example, the sponsor defined 2 categorizations, which are represented—with identifier values assigned for both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute:

Lines 2-10:

Show the "Group of Analyses" categorization with 3 categories:

  • Population Description
  • Safety
  • Efficacy
Lines 12-19:

Show the "Estimand Analysis Type" categorization with 3 categories:

  • Primary Estimator
  • Sensitivity Analysis
  • Supplemental Analysis

YAML Example
analysisOutputCategorizations:
- id: Catn_01_Grp
  label: Group of Analyses
  categories:
  - id: Catn_01_Grp_1_Pop
    label: Population Description
  - id: Catn_01_Grp_2_Saf
    label: Safety
  - id: Catn_01_Grp_3_Eff
    label: Efficacy
- id: Catn_02_Est
  label: Estimand Analysis Type
  categories:
  - id: Catn_02_Est_1_Prim
    label: Primary Estimator
  - id: Catn_02_Est_2_Sens
    label: Sensitivity Analysis
  - id: Catn_02_Est_3_Supp
    label: Supplementary Analysis

These categorization and category definitions could be represented in tabular form as shown in the following table where:

  • Each instance of the AnalysisOutputCategory class is shown on a separate line, with values for the id and label attributes shown in the category_id and category_label columns, respectively.
  • Attribute values each instance of the AnalysisOutputCategorization class are represented on each of the rows for the categories in the categorization.

$titleHtml
idlabelcategory_idcategory_label
Catn_01_GrpGroup of AnalysesCatn_01_Grp_1_PopPopulation Description
Catn_01_GrpGroup of AnalysesCatn_01_Grp_2_SafSafety
Catn_01_GrpGroup of AnalysesCatn_01_Grp_3_EffEfficacy
Catn_02_EstEstimand Analysis TypeCatn_02_Est_1_PrimPrimary Estimator
Catn_02_EstEstimand Analysis TypeCatn_02_Est_2_SensSensitivity Analysis
Catn_02_EstEstimand Analysis TypeCatn_02_Est_3_SuppSupplementary Analysis
$warningHtml
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:
Lines 5, 18:

Show that both the "Summary of Subjects by Treatment" analysis and the "Summary of Demographics" output were categorized as "Population Description".

Lines 10-11:

Show that the "Comparison of Change in Clinical Characteristic X by Treatment" analysis was categorized as both "Efficacy" and "Primary Estimand".

Line 23:

Shows that the "Change in Clinical Characteristic X" output was categorized as "Efficacy".

YAML Example
analyses:
- id: An01_05_SAF_Summ_ByTrt
  name: Summary of Subjects by Treatment
  categoryIds:
  - Catn_01_Grp_1_Pop
  ...
- id: An02_03_SAF_Summ_ByTrt
  name: Comparison of Change in Clinical Characteristic X by Treatment
  categoryIds:
  - Catn_01_Grp_3_Eff
  - Catn_02_Est_1_Prim
  ...
...
outputs:
- id: Out14-1-5
  name: Summary of Demographics
  categoryIds:
  - Catn_01_Grp_1_Pop
  ...
- id: Out14-2-3
  name: Change in Clinical Characteristic X
  categoryIds:
  - Catn_01_Grp_3_Eff
  ...

Example

In this example, the sponsor had a specific operational need to categorize analyses and outputs according to the class and type of data included in each analysis or output. They therefore defined a top-level "Data Class" categorization with a "Data Type" subcategorization for each of the data class categories. This categorization and its subcategorizations are represented—with identifier values assigned for both categorizations and categories—in the reporting event's analysisOutputCategorizations attribute.

The categorization and category names represented here are only examples of ways in which a sponsor might choose to categorize, and subcategorize, the analyses or outputs included in a reporting event. While the categorizations chosen for this example are similar to Study Data Tabulation Model (SDTM) general observation classes and domains, this does not imply that analyses or outputs should be categorized by data class or data type as shown here.

In these line captions, categorization labels are shown in bold and category labels are shown in italics.:

Lines 2-4:
  • Data Class (categorization)
Lines 5-7:
    • Subject-level (category of "Data Class")
Lines 8-10:
      • Subject-level Data Type (sub-categorization of "Subject-level")
Lines 11-12:
        • Demographics (category of "Subject-level Data Type")
Lines 13-15:
    • Events (category of "Data Class")
Lines 16-18:
      • Events Data Type (sub-categorization of "Events")
Lines 19-20:
        • Adverse Events (category of "Events Data Type")
Lines 21-22:
        • Clinical Events (category of "Events Data Type")
Lines 23-24:
        • Disposition (category of "Events Data Type")
Lines 25-27:
    • Findings (category of "Data Class")
Lines 28-30:
      • Findings Data Type (sub-categorization of "Findings")
Lines 31-32:
        • Vital Signs (category of "Findings Data Type")
Lines 33-34:
        • Laboratory Tests (category of "Findings Data Type")

YAML Example
analysisOutputCategorizations:
- id: Catn_02_DClass
  label: Data Class
  categories:
  - id: Catn_02_Dclass_1_Sbj
    label: Subject-level
    subCategorizations:
    - id: Catn_03_SbjDType
      label: Subject-level Data Type
      categories:
      - id: Catn_03_SbjDType_1_Dm
        label: Demographics
  - id: Catn_02_Dclass_2_Evt
    label: Events
    subCategorizations:
    - id: Catn_04_EvtDType
      label: Events Data Type
      categories:
      - id: Catn_04_EvtDType_1_Ae
        label: Adverse Events
      - id: Catn_04_EvtDType_2_Ce
        label: Clinical Events
      - id: Catn_04_EvtDType_3_Ds
        label: Disposition
  - id: Catn_02_Dclass_3_Fnd
    label: Findings
    subCategorizations:
    - id: Catn_06_FndDType
      label: Findings Data Type
      categories:
      - id: Catn_06_FndDType_1_Vs
        label: Vital Signs
      - id: Catn_06_FndDType_2_Lb
        label: Laboratory Tests

These categorization and category definitions could be represented in tabular form as shown in the following table where:

  • Each instance of the AnalysisOutputCategory class is shown on a separate line, with values for the id and label attributes shown in the "category_id" and "category_label" columns, respectively.
  • Attribute values each instance of the AnalysisOutputCategorization class are represented on each of the rows for the categories in the categorization.
  • For subcategorizations, the id value of the parent category is shown in the "parent_category_id" column.

$titleHtml
idlabelparent_category_idcategory_idcategory_label
Catn_02_DClassData Class
Catn_02_Dclass_1_SbjSubject-level
Catn_02_DClassData Class
Catn_02_Dclass_2_EvtEvents
Catn_02_DClassData Class
Catn_02_Dclass_3_FndFindings
Catn_03_SbjDTypeSubject-level Data TypeCatn_02_Dclass_1_SbjCatn_03_SbjDType_1_DmDemographics
Catn_04_EvtDTypeEvents Data TypeCatn_02_Dclass_2_EvtCatn_04_EvtDType_1_AeAdverse Events
Catn_04_EvtDTypeEvents Data TypeCatn_02_Dclass_2_EvtCatn_04_EvtDType_2_CeClinical Events
Catn_04_EvtDTypeEvents Data TypeCatn_02_Dclass_2_EvtCatn_04_EvtDType_3_DsDisposition
Catn_06_FndDTypeFindings Data TypeCatn_02_Dclass_3_FndCatn_06_FndDType_1_VsVital Signs
Catn_06_FndDTypeFindings Data TypeCatn_02_Dclass_3_FndCatn_06_FndDType_2_LbLaboratory Tests
$warningHtml
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:
Lines 4-6:Show that the "Summary of Age by Treatment" analysis was categorized as:
  • Subject-level (category of "Data Class")
  • Demographics (category of "Subject-level Data Type") 
Lines 12-15:

Show the "Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs" output was categorized as:

  • Findings (category of "Data Class")
  • Vital Signs (category of "Findings Data Type")

YAML Example
analyses:
- id: An03_01_Age_Summ_ByTrt
  name: Summary of Age by Treatment
  categoryIds:
  - Catn_02_Dclass_1_Sbj
  - Catn_03_SbjDType_1_Dm
  ...
...
outputs:
- id: Out14-3-3-1a
  name: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
  categoryIds:
  - Catn_02_Dclass_3_Fnd
  - Catn_06_FndDType_1_Vs
  ...

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