This example shows the definitions for 2 analyses. To illustrate the structure of an analysis specification, all attributes in the Analysis class are represented for both analyses but, for brevity, some or all of the details have been omitted for some of the attributes, including:

In the following line captions, a label is shown in parentheses next to each referenced identifier value. These labels were obtained from the definition of each of the referenced components even though these definitions are not included in the example.

Lines 2-30:

Show the definition of the "Comparison of Height by Treatment" analysis, in which:

  • Lines 7-8: Show that the rationale for the performing the analysis was that it was specified in the SAP.
  • Lines 9-10: Show that the purpose of the analysis was that it was a primary outcome measure.
  • Lines 15-16: Show that the analysis variable was the HEIGHTBL variable in the ADSL dataset.
  • Line 17: Shows that the analysis was performed for the analysis set identified as "AnalysisSet_02_SAF" ("Safety Population").
  • Lines 20-23: Show that a single grouping factor identified as "AnlsGrouping_01_Trt" ("Treatment") was referenced in the analysis and results were not expected to be generated for each of the groups in the grouping factor (resultsByGroup = false on line 22).
  • Line 24: Shows the analysis method used for the analysis is identified as "Mth04_ContVar_Comp_Anova" ("ANOVA group comparison for continuous variable").
Lines 31-62:

Show the definition of the "Comparison of Height by Treatment" analysis, in which:

  • Lines 36-37: Show that the rationale for the performing the analysis was that it was specified in the SAP.
  • Lines 38-39: Show that the purpose of the analysis was that it was a primary outcome measure.
  • Lines 44-45: Show that the analysis variable was the AVAL variable in the ADVS dataset.
  • Line 46: Shows that the analysis was performed for the analysis set identified as "AnalysisSet_02_SAF" ("Safety Population").
  • Line 47: Shows that the data subset identified as "Dss09_VS_AnRec" ("Vital Signs Analysis Records") was used to restrict the data records that were included in the analysis.
  • Lines 48-47: Show that 3 grouping factors were referenced in the analysis and results were expected to be generated for each of the groups in all 3 of the grouping factors (resultsByGroup = true on lines 50, 53, and 36). The 3 grouping factors were identified as:
    • "AnlsGrouping_01_Trt" ("Treatment")
    • "AnlsGrouping_08_Param" ("Parameter")
    • "AnlsGrouping_09_Visit" ("Visit")
  • Line 24: Shows the analysis method used for the analysis is identified as "Mth02_ContVar_Summ_ByGrp" ("Summary by group of a continuous variable").
analyses:
- id: An03_06_Height_Comp_ByTrt
  version: 1
  name: Comparison of Height by Treatment
  description:
    ...
  reason:
    controlledTerm: SPECIFIED IN SAP
  purpose:
    controlledTerm: PRIMARY OUTCOME MEASURE
  documentRefs:
    ...
  categoryIds:
    ...
  dataset: ADSL
  variable: HEIGHTBL
  analysisSetId: AnalysisSet_02_SAF
  dataSubsetId:
    ...
  orderedGroupings:
  - order: 1
    resultsByGroup: false
    groupingId: AnlsGrouping_01_Trt
  methodId: Mth04_ContVar_Comp_Anova
  referencedAnalysisOperations:
    ...
  programmingCode:
    ...
  results:
    ...
- id: An08_01_Obs_Summ_ByTrt
  version: 1
  name: Summary of Observed Value by Treatment, Parameter and Visit
  description:
    ...
  reason:
    controlledTerm: SPECIFIED IN SAP
  purpose:
    controlledTerm: PRIMARY OUTCOME MEASURE
  documentRefs:
    ...
  categoryIds:
    ...
  dataset: ADVS
  variable: AVAL
  analysisSetId: AnalysisSet_02_SAF
  dataSubsetId: Dss09_VS_AnRec
  orderedGroupings:
  - order: 1
    resultsByGroup: true
    groupingId: AnlsGrouping_01_Trt
  - order: 2
    resultsByGroup: true
    groupingId: AnlsGrouping_08_Param
  - order: 3
    resultsByGroup: true
    groupingId: AnlsGrouping_09_Visit
  methodId: Mth02_ContVar_Summ_ByGrp
  programmingCode:
    ...
  results:
    ...
...