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5. Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs (Vertical)

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  Output: Out14-3-3-1b

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  5.1. Summary of Subjects by Treatment

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    Analysis: An01_05_SAF_Summ_ByTrt
      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: Safety Population [ADSL.SAFFL EQ 'Y']
      Groupings:
        1. Treatment [Results per group: Y]:
           1. Placebo [ADSL.TRT01A EQ 'Placebo']
           2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
           3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
      Analysis Variable: ADSL.USUBJID
      Method: Count by group for a categorical variable
        Operations:
          > Mth01_CatVar_Count_ByGrp_1_n: Count of subjects (n)
  5.2

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. Summary of Observed Value by Treatment, Parameter and Visit

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    Analysis: An08_01_Obs_Summ_ByTrt
      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: Safety Population [ADSL.SAFFL EQ 'Y']
      Data Subset: Vital Signs Analysis Records [ADVS.ANL01FL EQ 'Y']
      Groupings:
        1. Treatment [Results per group: Y]:
           1. Placebo [ADSL.TRT01A EQ 'Placebo']
           2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
           3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
        2. Parameter [Results per group: Y]:
           1. Systolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'SYSBP']
           2. Diastolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'DIABP']
           3. Pulse Rate (beats/min) [ADVS.PARAMCD EQ 'PULSE']
           4. Temperature (C) [ADVS.PARAMCD EQ 'TEMP']
        3. Visit [Results per group: Y]:
           1. Baseline [ADVS.AVISIT EQ 'Baseline']
           2. Week 2 [ADVS.AVISIT EQ 'Week 2']
           3. Week 4 [ADVS.AVISIT EQ 'Week 4']
           4. Week 6 [ADVS.AVISIT EQ 'Week 6']
           5. Week 8 [ADVS.AVISIT EQ 'Week 8']
           6. Week 12 [ADVS.AVISIT EQ 'Week 12']
           7. Week 16 [ADVS.AVISIT EQ 'Week 16']
           8. Week 20 [ADVS.AVISIT EQ 'Week 20']
           9. Week 24 [ADVS.AVISIT EQ 'Week 24']
           10. Week 26 [ADVS.AVISIT EQ 'Week 26']
           11. End of Treatment [ADVS.AVISIT EQ 'End of Treatment']
      Analysis Variable: ADVS.AVAL
      Method: Summary by group of a continuous variable
        Operations:
          > Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
          > Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
          > Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
          > Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
          > Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
          > Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
          > Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
          > Mth02_ContVar_Summ_ByGrp_8_Max: Maximum (Max)
  5.3. Summary of Change from Baseline by Treatment, Parameter and Visit

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    Analysis: An08_02_ChgBl_Summ_ByTrt
      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: Safety Population [ADSL.SAFFL EQ 'Y']
      Data Subset: Vital Signs Non-baseline Analysis Records [(ADVS.ANL01FL EQ 'Y' AND ADVS.AVISIT NE 'Baseline')]
      Groupings:
        1. Treatment [Results per group: Y]:
           1. Placebo [ADSL.TRT01A EQ 'Placebo']
           2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
           3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
        2. Parameter [Results per group: Y]:
           1. Systolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'SYSBP']
           2. Diastolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'DIABP']
           3. Pulse Rate (beats/min) [ADVS.PARAMCD EQ 'PULSE']
           4. Temperature (C) [ADVS.PARAMCD EQ 'TEMP']
        3. Visit [Results per group: Y]:
           1. Baseline [ADVS.AVISIT EQ 'Baseline']
           2. Week 2 [ADVS.AVISIT EQ 'Week 2']
           3. Week 4 [ADVS.AVISIT EQ 'Week 4']
           4. Week 6 [ADVS.AVISIT EQ 'Week 6']
           5. Week 8 [ADVS.AVISIT EQ 'Week 8']
           6. Week 12 [ADVS.AVISIT EQ 'Week 12']
           7. Week 16 [ADVS.AVISIT EQ 'Week 16']
           8. Week 20 [ADVS.AVISIT EQ 'Week 20']
           9. Week 24 [ADVS.AVISIT EQ 'Week 24']
           10. Week 26 [ADVS.AVISIT EQ 'Week 26']
           11. End of Treatment [ADVS.AVISIT EQ 'End of Treatment']
      Analysis Variable: ADVS.CHG
      Method: Summary by group of a continuous variable
        Operations:
          > Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
          > Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
          > Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
          > Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
          > Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
          > Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
          > Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
          > Mth02_ContVar_Summ_ByGrp_8_Max: Maximum (Max)