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32. Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events
  Output: Out14-3-21-1 (Summary of TEAE by System Organ Class and Preferred Term)- Overall Summary of Treatment-Emergent Adverse Events
    Documentation:
      > Statistical Analysis Plan AE Summary Table Shell (./sapAE_Summary_Table_Shell.pdf)
    Categories:
      - Page 32 [Template 13]> Safety
      > Clinical Study Report (./csr-cdiscpilot01.pdf)
          - Pages 63-78 [Table 14-5.01]
    Categories:
      > Safety
      > Adverse Events
    Adverse Events
    Output File(s):
      > RTF Format: t14-3-21-1-teae-socpt summ (RTF) (./t14-3-1-1-teae-summ.rtf)
      > PDF Format: t14-3-21-1-teae-socpt (.summ (PDF) (./t14-3-1-1-teae-summ.pdf)
    Displays:
      1. Disp14-3-21-1 - AE Summary (AE_SOC_PTSumm)
        Display Title: Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events
        Sections:
          > TitleHeader:
            1. Table 14.3.1.1Study - CDISC 360
            2. Summary of TEAE by System Organ Class and Preferred TermPage x of y
            3. > Title:
            1. Table 14.3.1.<x>.<y>
            2. Overall Summary of Treatment-Emergent Adverse Events
            3. Safety Population
          > Abbreviation:
            1. NotesNote: TEAE=Treatment-Emergent Adverse Events.
          > LegendFootnote:
            1. [a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
         Subjects are counted once within each system organ class and preferred term.
            2. [a] All investigators adverse events were coded using MedDRA version xx.x.
          > Footnote> Footer:
            1. Source dataset: adae, Generated on: DDMONYYYY:HH:MM
            2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
          > Rowlabel Header:
            1. System Organ Class
            2.     Preferred Term [a]Categories, n (%)
  32.1. 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: Safety 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. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
               Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
           3.   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)
        Operations:
          > Mth01_CatVar_Count_Count across groups for a categorical variable, based on subject occurrence
        Operations:
          1. Mth01_CatVar_Count_ByGrp_1_n : - Count of subjects (n)
  32.2. Number of subjects with at least one event
    32.2.1. Summary of Subjects by TreatmentTEAE
      Analysis: An07_01_TEAE_Summ_ByTrt (- Summary of Subjects with At Least One TEAE, by Treatment (TEAE)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Data Subset: Dss01_TEAE - Treatment-Emergent Adverse Events [
          Selection Criteria: ADAE.TRTEMFL EQ 'Y']
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
             1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2. Xanomeline Low Dose [  2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
        Analysis Variable: ADAE.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
          Operations:
            > Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
            1. Mth01_CatVar_Summ_ByGrp_1_n : - Count of subjects (n)
            > 2. Mth01_CatVar_Summ_ByGrp_2_pct : - Percent of subjects (%)
                - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    32.2.2. Comparison of Subjects by Treatment - Placebo vs Low DoseRelated TEAE
      Analysis: An07_0102_TEAERelTEAE_CompSumm_ByTrt _PlacLow (Comparison - Summary of Subjects with TEAEs by Treatment - Placebo vs Low DoseAt Least One Related TEAE, by Treatment (Related TEAE)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Data Subset: Dss02_Related_TEAE - Related Treatment-Emergent Adverse Events for Placebo and Low Active Dose [
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSLADAE.TRT01A AEREL IN ('PlaceboPOSSIBLE', 'Xanomeline Low DosePROBABLE'))]
        Groupings:
          1. Treatment [Results per group: N]:AnlsGrouping_01_Trt - Treatment
             1. Placebo [Grouping Variable: ADSL.TRT01A EQ 'Placebo']

            Groups [Results per group: Y]:
               2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']1. AnlsGrouping_01_Trt_1 - Placebo
             3. Xanomeline High Dose [     Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High DosePlacebo']
        Analysis Variable: ADAE.USUBJID
        Method: Fisher's exact test group comparison for a categorical variable      2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
          Operations:       Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
            > Mth03_CatVar_Comp_FishEx_1_pval: P-value (p-value)
    3.2.3. Comparison of Subjects by Treatment - Placebo vs High Dose  3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
        Analysis : An07_01_TEAE_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment - Placebo vs High Dose)
        Documentation:
          Reason: ADDITIONAL EXAMPLEVariable: ADAE.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          PurposeOperations: SECONDARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf  1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
              - Pages 15-16 [11.2. Adverse Events]2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
        Categories:
          > Safety
          > Events
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
              > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events for Placebo and High Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))]
        Groupings:
          1. Treatment [Results per group: N]:
             1. Placebo [ADSL.TRT01A EQ 'Placebo']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']  - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    2.2.3. Serious TEAE
      Analysis: An07_03_SerTEAE_Summ_ByTrt - Summary of Subjects with At Least One Serious TEAE, by Treatment (Serious TEAE)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss03_Serious_TEAE - Serious Treatment-Emergent Adverse Events
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESER 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: ADAE.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
        Analysis Variable: ADAE.USUBJID    2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
        Method: Fisher's exact test group comparison for a categorical variable        - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
          Operations:
            > Mth03- Denominator: result of operation Mth01_CatVar_CompCount_FishExByGrp_1_pval: P-value (p-value)
  3.3. System Organ Class
    3.3.1. Summary of Subjects by Treatment and System Organ Class_n for analysis An01_05_SAF_Summ_ByTrt
    2.2.4. Related Serious TEAE
      Analysis: An07_0904_SocRelSerTEAE_Summ_ByTrt (- Summary of Subjects with TEAEs by Treatment and System Organ Classwith At Least One Related Serious TEAE, by Treatment (Related Serious TEAE)
        Documentation:
          Reason: SPECIFIED IN SAPADDITIONAL EXAMPLE
          Purpose: PRIMARY SECONDARY OUTCOME MEASURE
          See:Categories:
          > Safety
          > Events
  > Statistical Analysis Plan (./sap.pdf)        > Adverse Events
          > Occurrence
        - Pages 15-16 [11.2. Adverse Events]
Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Categories:Selection Criteria: ADSL.SAFFL EQ 'Y'
          > SafetyData Subset: Dss04_RelSer_TEAE - Related Serious Treatment-Emergent Adverse Events
          > EventsSelection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE') AND ADAE.AESER EQ 'Y')
          > Adverse EventsGroupings:
          > Occurrence
1. AnlsGrouping_01_Trt - Treatment
          Population: Safety Population [ADSL.SAFFL EQ 'Y']
  Grouping Variable: ADSL.TRT01A
            Data Subset: Treatment-Emergent Adverse Events [ADAE.TRTEMFL EQ 'Y']Groups [Results per group: Y]:
        Groupings:
          1. Treatment [Results per group: Y]:
      1. AnlsGrouping_01_Trt_1 - Placebo
                 1. Placebo [ Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2.   2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3. Xanomeline High Dose [  3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. System Organ Class [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variablecategorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
            > 1. Mth01_CatVar_Summ_ByGrp_1_n : - Count of subjects (n)
            > 2. Mth01_CatVar_Summ_ByGrp_2_pct : - Percent of subjects (%)
                - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    32.32.2. Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low Dose5. TEAE Leading to Death
      Analysis: An07_0905_SocTEAELd2Dth_CompSumm_ByTrt _PlacLow (Comparison - Summary of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low DoseAt Least One TEAE Leading to Death, by Treatment (TEAE Leading to Death)
        Documentation:
          Reason: SPECIFIED IN SAPADDITIONAL EXAMPLE
          Purpose: PRIMARY SECONDARY OUTCOME MEASURE
          SeeCategories:
            > Statistical Analysis Plan (./sap.pdf)Safety
              - Pages 15-16 [11.2. Adverse Events]
        Categories:> Events
          > SafetyAdverse Events
          > EventsOccurrence
          > Adverse EventsPopulation: AnalysisSet_02_SAF - Safety Population (SAF)
          > Occurrence
        Population: Safety Population [Selection Criteria: ADSL.SAFFL EQ 'Y']
        Data Subset: Dss05_TEAE_Ld2Dth - Treatment-Emergent Adverse Events for Placebo and Low Active Dose [Leading to Death
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))]
ADAE.AESDTH EQ 'Y')
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
          Groupings:
  Grouping Variable: ADSL.TRT01A
            1. Treatment Groups [Results per group: NY]:
               1. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2. Xanomeline Low Dose [  2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. System Organ Class [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJID
        Method: Fisher's exact test group comparison for Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
          Operations:
      Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
      > Mth03_CatVar_Comp_FishEx_1_pval: P-value (p-value)
    3.3.3. Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs High Dose    Operations:
      Analysis: An07_09_Soc_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs High Dose      1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
        Documentation:
          Reason: SPECIFIED IN SAP    2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
          Purpose: PRIMARY OUTCOME MEASURE
          See:- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
            > Statistical Analysis Plan (./sap.pdf)
              - Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events    - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    2.2.6. Related TEAE Leading to Death
      Analysis: An07_06_RelTEAELd2Dth_Summ_ByTrt - Summary of Subjects with At Least One Related TEAE Leading to Death, by Treatment (Related TEAE Leading to Death)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          > OccurrencePurpose: SECONDARY OUTCOME MEASURE
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events for Placebo and High Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))]
Categories:
          > Safety
          Groupings:> Events
          1. Treatment [Results per group: N]:> Adverse Events
             1. Placebo [ADSL.TRT01A EQ 'Placebo']> Occurrence
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']Population: AnalysisSet_02_SAF - Safety Population (SAF)
             3. Xanomeline High Dose [Selection Criteria: ADSL.TRT01A SAFFL EQ 'Xanomeline High DoseY']
          2. System Organ Class [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJIDData Subset: Dss06_Rel_TEAE_Ld2Dth - Related Treatment-Emergent Adverse Events Leading to Death
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH EQ 'Y' AND (ADAE.AEREL EQ 'POSSIBLE' OR ADAE.AEREL EQ 'PROBABLE'))
        Method: Fisher's exact test group comparison for a categorical variableGroupings:
          Operations:1. AnlsGrouping_01_Trt - Treatment
            > Mth03_CatVar_Comp_FishEx_1_pval: P-value (p-value)
  3.4. Preferred Term
    3.4.1. Summary of Subjects by Treatment, System Organ Class and Preferred Term
      Analysis: An07_10_SocPt_Summ_ByTrt (Summary of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term)
        Documentation:Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
              1. AnlsGrouping_01_Trt_1 - Placebo
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE Selection Criteria: ADSL.TRT01A EQ 'Placebo'
          See:
            > Statistical Analysis Plan (./sap.pdf)2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
              - Pages 15-16 [11.2. Adverse Events]   Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
        Categories:
      3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
      > Safety
          > Events Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          > Adverse EventsAnalysis Variable: ADAE.USUBJID
          > OccurrenceMethod: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events [ADAE.TRTEMFL EQ 'Y']Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
        Groupings  Operations:
            1. Treatment [Results per group: Y]:Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
             1. Placebo [ADSL.TRT01A EQ 'Placebo']2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']    - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. System Organ Class [Results per group: Y]: [Data-driven]
          3. Preferred Term [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJID
        Method: Summary by group of a categorical variable    - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    2.2.7. TEAE Leading to Dose Modification
      Analysis: An07_07_TEAELd2DoseMod_Summ_ByTrt - Summary of Subjects with At Least One TEAE Leading to Dose Modification, by Treatment (TEAE Leading to Dose Modification [a])
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          OperationsPurpose: SECONDARY OUTCOME MEASURE
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)Categories:
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)> Safety
              - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
> Events
          > Adverse Events
          > Occurrence
      - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    3.4.2. Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low Dose
      Analysis: An07_10_SocPt_Comp_ByTrt_PlacLow (Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low Dose  Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss07_TEAE_Ld2DoseMod - Treatment-Emergent Adverse Events Leading to Dose Modification
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN IN ('DOSE REDUCED', 'DRUG INTERRUPTED'))
        Documentation:Groupings:
          1. AnlsGrouping_01_Trt - Treatment
          Reason: SPECIFIED IN SAP
  Grouping Variable: ADSL.TRT01A
            Purpose: PRIMARY OUTCOME MEASUREGroups [Results per group: Y]:
              1. AnlsGrouping_01_Trt_1 - Placebo
      See:
            > Statistical Analysis Plan (./sap.pdf) Selection Criteria: ADSL.TRT01A EQ 'Placebo'
              - Pages 15-16 [11.2. Adverse Events]2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
        Categories:
          > Safety
          > Events Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
          > Adverse Events
          > Occurrence    3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND  Selection Criteria: ADSL.TRT01A IN ('Placebo', EQ 'Xanomeline Low High Dose'))]
        GroupingsAnalysis Variable: ADAE.USUBJID
          1. Treatment [Results per group: N]:
Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                 1. Placebo [ADSL.TRT01A EQ 'Placebo']Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']Operations:
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. System Organ Class [Results per group: Y]: [Data-driven]
1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
            3. Preferred Term [Results per group: Y]: [Data-driven]2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
        Analysis Variable: ADAE.USUBJID
        Method: Fisher's exact test group comparison for a categorical variable- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
          Operations:
            > Mth03- Denominator: result of operation Mth01_CatVar_CompCount_FishExByGrp_1_pval: P-value (p-value)_n for analysis An01_05_SAF_Summ_ByTrt
    32.42.3. Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs High Dose8. TEAE Leading to Treatment Discontinuation
      Analysis: An07_1008_SocPtTEAELd2TrtDsc_CompSumm_ByTrt _PlacHigh (Comparison - Summary of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs High Dose)At Least One TEAE Leading to Treatment Discontinuation, by Treatment (TEAE Leading to Treatment Discontinuation)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE
        DocumentationCategories:
          Reason: SPECIFIED IN SAP> Safety
          Purpose: PRIMARY OUTCOME MEASURE> Events
          See:> Adverse Events
          > Occurrence
        > Statistical Analysis Plan (./sap.pdfPopulation: AnalysisSet_02_SAF - Safety Population (SAF)
              - Pages 15-16 [11.2. Adverse Events]Selection Criteria: ADSL.SAFFL EQ 'Y'
        Categories:Data Subset: Dss08_AE_Ld2TrtDsc - Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
          > SafetySelection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN EQ 'DRUG WITHDRAWN')
          > EventsGroupings:
          > Adverse Events1. AnlsGrouping_01_Trt - Treatment
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
  Grouping Variable: ADSL.TRT01A
          Data Subset: Treatment-Emergent Adverse Events for Placebo and High Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))]  Groups [Results per group: Y]:
        Groupings:
          1. Treatment [Results per group: N]:
      1. AnlsGrouping_01_Trt_1 - Placebo
                 1. Placebo [ Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2.   2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
        Analysis Variable: ADAE.USUBJID
        2. System Organ Class [Results per group: Y]: [Data-driven]Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
          3. Preferred Term [Results per group: Y]: [Data-driven]
  1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
            Analysis Variable: ADAE.USUBJID
        Method: Fisher's exact test group comparison for a categorical variable
2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
                Operations:
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
              > Mth03  - Denominator: result of operation Mth01_CatVar_CompCount_FishExByGrp_1_pval: P-value (p-value)n for analysis An01_05_SAF_Summ_ByTrt