Versions Compared

Old Version 2

changes.mady.by.user Richard Marshall

Saved on

compared with

New Version Current

changes.mady.by.user Richard Marshall

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Corrected typo: removed duplicate "the"

...

Xfancy
classrowcaps
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 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").

...