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Comment: Output from updated example and list program

Excerpt Include
Vitals Obs ChgBaseline Table Shell
Vitals Obs ChgBaseline Table Shell
nopaneltrue

...

4. Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs (Horizontal)
  Output: Out14-3-3-1a - Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs Horizontal
    Categories:
      > Safety
      > Vital Signs
    Output File(s):
      > RTF Format: t14-3-3-1-vitals-chgbl (RTF) (./t14-3-3-1-vitals-chgbl.rtf)
      > PDF Format: t14-3-3-1-vitals-chgbl (PDF) (./t14-3-3-1-vitals-chgbl.pdf)
    Displays:
      1. Disp14-3-3-1a - Vitals Change from Baseline (Vitals_ChgBl)
        Display Title: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs

...


        Sections:
          > Header:
            1. Study - CDISC 360
            2. Page x of y
          > Title:
            1. Table 14.3.3.1a
            2. Summary of Observed and Change from Baseline by Scheduled Visits – Vital Signs
            3. Safety Population
          > Legend:
            1. Note: Baseline is defined as the last assessment that is non-missing prior to first dose of investigational product.
          > Footer:
            1. Source dataset: advs, Generated on: DDMONYYYY:HH:MM
            2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
          > Rowlabel Header:
            1. Parameter (Units)
            2. Visit
  4.1. Summary of Subjects by Treatment

...

    Analysis: An01_05_SAF_Summ_ByTrt - Summary of Subjects by Treatment
      Documentation:
        Reason: SPECIFIED IN SAP
        Purpose: PRIMARY OUTCOME MEASURE
        See:
          > Statistical Analysis Plan (./sap.pdf)
            - Page 9 [6. ANALYSIS POPULATIONS]
      Categories:
        > Population Description
        > Subject-level
        > Demographics
      Population: AnalysisSet_02_SAF - Safety Population (SAF)
        Selection Criteria: ADSL.SAFFL EQ 'Y'
      Groupings:
        1. AnlsGrouping_01_Trt - Treatment
          Grouping Variable: ADSL.TRT01A
          Groups [Results per group: Y]:
            1. AnlsGrouping_01_Trt_1 - Placebo
               Selection Criteria: ADSL.TRT01A EQ 'Placebo'
            2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
            3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
      Analysis Variable: ADSL.USUBJID
      Method: Mth01_CatVar_Count_ByGrp - Count by group for a categorical variable (Grouped count for categorical variable)
              Count across groups for a categorical variable, based on subject occurrence
        Operations:
          1. Mth01_CatVar_Count_ByGrp_1_n - Count of subjects (n)
  4.2. Summary of Observed Value by Treatment, Parameter and Visit

...

    Analysis: An08_01_Obs_Summ_ByTrt - Summary of Observed Value by Treatment, Parameter and Visit
      Documentation:
        Reason: SPECIFIED IN SAP
        Purpose: PRIMARY OUTCOME MEASURE
        See:
          > Statistical Analysis Plan (./sap.pdf)
            - Pages 9 and 17 [Sections 7 (General Considerations) and 11.6 (Other Safety Measures)]
      Categories:
        > Safety
        > Findings
        > Vital Signs
        > Change from Baseline
      Population: AnalysisSet_02_SAF - Safety Population (SAF)
        Selection Criteria: ADSL.SAFFL EQ 'Y'
      Data Subset: Dss09_VS_AnRec - Vital Signs Analysis Records
        Selection Criteria: ADVS.ANL01FL EQ 'Y'
      Groupings:
        1. AnlsGrouping_01_Trt - Treatment
          Grouping Variable: ADSL.TRT01A
          Groups [Results per group: Y]:
            1. AnlsGrouping_01_Trt_1 - Placebo
               Selection Criteria: ADSL.TRT01A EQ 'Placebo'
            2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
            3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
        2. AnlsGrouping_08_Param - Parameter
          Grouping Variable: ADVS.PARAMCD
          Groups [Results per group: Y]:
            1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg)
               Selection Criteria: ADVS.PARAMCD EQ 'SYSBP'
            2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg)
               Selection Criteria: ADVS.PARAMCD EQ 'DIABP'
            3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min)
               Selection Criteria: ADVS.PARAMCD EQ 'PULSE'
            4. AnlsGrouping_08_Param_4 - Temperature (C)
               Selection Criteria: ADVS.PARAMCD EQ 'TEMP'
        3. AnlsGrouping_09_Visit - Visit
          Grouping Variable: ADVS.AVISIT
          Groups [Results per group: Y]:
            1. AnlsGrouping_09_Visit_01 - Baseline
               Selection Criteria: ADVS.AVISIT EQ 'Baseline'
            2. AnlsGrouping_09_Visit_02 - Week 2
               Selection Criteria: ADVS.AVISIT EQ 'Week 2'
            3. AnlsGrouping_09_Visit_03 - Week 4
               Selection Criteria: ADVS.AVISIT EQ 'Week 4'
            4. AnlsGrouping_09_Visit_04 - Week 6
               Selection Criteria: ADVS.AVISIT EQ 'Week 6'
            5. AnlsGrouping_09_Visit_05 - Week 8
               Selection Criteria: ADVS.AVISIT EQ 'Week 8'
            6. AnlsGrouping_09_Visit_06 - Week 12
               Selection Criteria: ADVS.AVISIT EQ 'Week 12'
            7. AnlsGrouping_09_Visit_07 - Week 16
               Selection Criteria: ADVS.AVISIT EQ 'Week 16'
            8. AnlsGrouping_09_Visit_08 - Week 20
               Selection Criteria: ADVS.AVISIT EQ 'Week 20'
            9. AnlsGrouping_09_Visit_09 - Week 24
               Selection Criteria: ADVS.AVISIT EQ 'Week 24'
            10. AnlsGrouping_09_Visit_10 - Week 26
               Selection Criteria: ADVS.AVISIT EQ 'Week 26'
            11. AnlsGrouping_09_Visit_11 - End of Treatment
               Selection Criteria: ADVS.AVISIT EQ 'End of Treatment'
      Analysis Variable: ADVS.AVAL
      Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
              Descriptive summary statistics across groups for a continuous variable
        Operations:
          1. Mth02_ContVar_Summ_ByGrp_1_n - Count of non-missing values (n)
          2. Mth02_ContVar_Summ_ByGrp_2_Mean - Mean (Mean)
          3. Mth02_ContVar_Summ_ByGrp_3_SD - Standard deviation (SD)
          4. Mth02_ContVar_Summ_ByGrp_4_Median - Median (Median)
          5. Mth02_ContVar_Summ_ByGrp_5_Q1 - First quartile (Q1)
          6. Mth02_ContVar_Summ_ByGrp_6_Q3 - Third quartile (Q3)
          7. Mth02_ContVar_Summ_ByGrp_7_Min - Minimum (Min)
          8. Mth02_ContVar_Summ_ByGrp_8_Max - Maximum (Max)
  4.3. Summary of Change from Baseline by Treatment, Parameter and Visit

...

    Analysis: An08_02_ChgBl_Summ_ByTrt - Summary of Change from Baseline by Treatment, Parameter and Visit
      Documentation:
        Reason: SPECIFIED IN SAP
        Purpose: PRIMARY OUTCOME MEASURE
        See:
          > Statistical Analysis Plan (./sap.pdf)
            - Page 9 [Sections 7 (General Considerations)]
            - Page 17 [11.6 (Other Safety Measures)]
          > Clinical Study Report (./csr-cdiscpilot01.pdf)
            - Section "Table 14-7.02"
      Categories:
        > Safety
        > Findings
        > Vital Signs
        > Change from Baseline
      Population: AnalysisSet_02_SAF - Safety Population (SAF)
        Selection Criteria: ADSL.SAFFL EQ 'Y'
      Data Subset: Dss10_VS_NonBl_AnRec - Vital Signs Non-baseline Analysis Records
        Selection Criteria: (ADVS.ANL01FL EQ 'Y' AND ADVS.AVISIT NE 'Baseline')
      Groupings:
        1. AnlsGrouping_01_Trt - Treatment
          Grouping Variable: ADSL.TRT01A
          Groups [Results per group: Y]:
            1. AnlsGrouping_01_Trt_1 - Placebo
               Selection Criteria: ADSL.TRT01A EQ 'Placebo'
            2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
            3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
        2. AnlsGrouping_08_Param - Parameter
          Grouping Variable: ADVS.PARAMCD
          Groups [Results per group: Y]:
            1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg)
               Selection Criteria: ADVS.PARAMCD EQ 'SYSBP'
            2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg)
               Selection Criteria: ADVS.PARAMCD EQ 'DIABP'
            3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min)
               Selection Criteria: ADVS.PARAMCD EQ 'PULSE'
            4. AnlsGrouping_08_Param_4 - Temperature (C)
               Selection Criteria: ADVS.PARAMCD EQ 'TEMP'
        3. AnlsGrouping_09_Visit - Visit
          Grouping Variable: ADVS.AVISIT
          Groups [Results per group: Y]:
            1. AnlsGrouping_09_Visit_01 - Baseline
               Selection Criteria: ADVS.AVISIT EQ 'Baseline'
            2. AnlsGrouping_09_Visit_02 - Week 2
               Selection Criteria: ADVS.AVISIT EQ 'Week 2'
            3. AnlsGrouping_09_Visit_03 - Week 4
               Selection Criteria: ADVS.AVISIT EQ 'Week 4'
            4. AnlsGrouping_09_Visit_04 - Week 6
               Selection Criteria: ADVS.AVISIT EQ 'Week 6'
            5. AnlsGrouping_09_Visit_05 - Week 8
               Selection Criteria: ADVS.AVISIT EQ 'Week 8'
            6. AnlsGrouping_09_Visit_06 - Week 12
               Selection Criteria: ADVS.AVISIT EQ 'Week 12'
            7. AnlsGrouping_09_Visit_07 - Week 16
               Selection Criteria: ADVS.AVISIT EQ 'Week 16'
            8. AnlsGrouping_09_Visit_08 - Week 20
               Selection Criteria: ADVS.AVISIT EQ 'Week 20'
            9. AnlsGrouping_09_Visit_09 - Week 24
               Selection Criteria: ADVS.AVISIT EQ 'Week 24'
            10. AnlsGrouping_09_Visit_10 - Week 26
               Selection Criteria: ADVS.AVISIT EQ 'Week 26'
            11. AnlsGrouping_09_Visit_11 - End of Treatment
               Selection Criteria: ADVS.AVISIT EQ 'End of Treatment'
      Analysis Variable: ADVS.CHG
      Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
              Descriptive summary statistics across groups for a continuous variable
        Operations:
          1. Mth02_ContVar_Summ_ByGrp_1_n - Count of non-missing values (n)
          2. Mth02_ContVar_Summ_ByGrp_2_Mean - Mean (Mean)
          3. Mth02_ContVar_Summ_ByGrp_3_SD - Standard deviation (SD)
          4. Mth02_ContVar_Summ_ByGrp_4_Median - Median (Median)
          5. Mth02_ContVar_Summ_ByGrp_5_Q1 - First quartile (Q1)
          6. Mth02_ContVar_Summ_ByGrp_6_Q3 - Third quartile (Q3)
          7. Mth02_ContVar_Summ_ByGrp_7_Min - Minimum (Min)
          8. Mth02_ContVar_Summ_ByGrp_8_Max - Maximum (Max)

Pagenav