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23. Overall Summary of Treatment-Emergent Adverse EventsTEAE by System Organ Class and Preferred Term
  Output: Out14-3-12-1 (Overall Summary of Treatment-Emergent Adverse EventsTEAE by System Organ Class and Preferred Term)
    Documentation:
      > AE Summary Table Shell Statistical Analysis Plan (./AE_Summary_Table_Shellsap.pdf)
    Categories:
      > Safety- Page 32 [Template 13]
      > Adverse Events
    Clinical Study Report (./csr-cdiscpilot01.pdf)
          - Pages 63-78 [Table 14-5.01]
    Categories:
      > Safety
      > Adverse Events
    Output File(s):
      > RTF Format: t14-3-12-1-teae-summ socpt (.)
      > PDF Format: t14-3-12-1-teae-summ socpt (.)
    Displays:
      1. Disp14-3-12-1 (AE_SOC_SummPT)
        Display Title: Overall Summary of Treatment-Emergent Adverse EventsTEAE by System Organ Class and Preferred Term
        Sections:
          > Title:
            1. Table 14.3.1.<x>.<y>1
            2. Overall Summary of Treatment-Emergent Adverse EventsTEAE by System Organ Class and Preferred Term
            3. Safety Population
          > Abbreviation:
            1. NoteNotes: TEAE=Treatment-Emergent Adverse Events.
          > Legend:
            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:
            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. CategoriesSystem Organ Class
            2.     Preferred Term [a], n (%)
  23.1. 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 [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)
  23.2. Number of subjects with at least one event
    23.2.1. TEAESummary of Subjects by Treatment
      Analysis: An07_01_TEAE_Summ_ByTrt (Summary of Subjects with At Least One TEAE, by Treatment)
        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 [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events [ADAE.TRTEMFL 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: ADAE.USUBJID
        Method: Summary by group of a categorical variable
          Operations:
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
            > 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
    23.2.2. Related TEAE
Comparison of Subjects by Treatment - Placebo vs Low Dose
      Analysis: An07_0201_RelTEAETEAE_SummComp_ByTrt_PlacLow (Summary Comparison of Subjects with At Least One Related TEAE, TEAEs by Treatment - Placebo vs Low Dose)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE
          CategoriesSee:
          > Safety
  > Statistical Analysis Plan (./sap.pdf)
              > Events- Pages 15-16 [11.2. Adverse Events]
          > Adverse EventsCategories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Related Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADAEADSL.AEREL TRT01A IN ('POSSIBLEPlacebo', 'PROBABLEXanomeline Low Dose'))]
        Groupings:
          1. Treatment [Results per group: YN]:
             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: ADAE.USUBJID
        Method: Summary by group of Fisher's exact test group comparison for a categorical variable
          Operations:
            > Mth01Mth03_CatVar_SummComp_ByGrpFishEx_1_n: Count of subjects (npval: P-value (p-value)
    3.2.3. Comparison of Subjects by Treatment - Placebo vs High Dose
        > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
    Analysis: An07_01_TEAE_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment - Placebo vs High Dose)
        Documentation:
          - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
    Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE
          - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrtSee:
    2.2.3. Serious TEAE
      Analysis: An07_03_SerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Serious TEAE, by Treatment  > Statistical Analysis Plan (./sap.pdf)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE- Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Serious Treatment-Emergent Adverse Events for Placebo and High Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AESER EQ 'Y'ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))]
        Groupings:
          1. Treatment [Results per group: YN]:
             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: ADAE.USUBJID
        Method: Summary by group of Fisher's exact test group comparison for a categorical variable
          Operations:
            > Mth01Mth03_CatVar_SummComp_ByGrpFishEx_1_n: Count of subjects (npval: P-value (p-value)
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
    3.3. System Organ Class
    3.3.1. Summary of Subjects by Treatment and System Organ Class
      Analysis: An07_09_Soc_Summ_ByTrt (Summary of Subjects with TEAEs by Treatment and System Organ Class)
        Documentation:
          - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
      Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    2.2.4. Related Serious TEAE
See:
            Analysis: An07_04_RelSerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Related Serious TEAE, by Treatment> Statistical Analysis Plan (./sap.pdf)
        Documentation:
          Reason: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE- Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Related Serious Treatment-Emergent Adverse Events [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE') AND ADAE.AESER 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. System Organ Class [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJID
        Method: Summary by group of a categorical variable
          Operations:
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
            > 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
    23.3.2. 5. TEAE Leading to Death
Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low Dose
      Analysis: An07_0509_TEAELd2DthSoc_SummComp_ByTrt_PlacLow (Summary Comparison of Subjects with At Least One TEAE Leading to Death, by TreatmentTEAEs by Treatment and System Organ Class - Placebo vs Low Dose)
        Documentation:
          Reason: ADDITIONAL EXAMPLESPECIFIED IN SAP
          Purpose: SECONDARY PRIMARY OUTCOME MEASURE
          CategoriesSee:
            > Safety
  Statistical Analysis Plan (./sap.pdf)
        > Events
      - Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events Leading to Death for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH EQ 'Y'ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))]
        Groupings:
          1. Treatment [Results per group: YN]:
             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. System Organ Class [Results per group: Y]: [Data-driven]
        Analysis Variable: ADAE.USUBJID
        Method: Summary by group of Fisher's exact test group comparison for a categorical variable
          Operations:
            > Mth01Mth03_CatVar_SummComp_ByGrpFishEx_1_n: Count of subjects (n)
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
    pval: P-value (p-value)
    3.3.3. Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs High Dose
      Analysis: An07_09_Soc_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs High Dose)
        Documentation:
          - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisReason: SPECIFIED IN SAP
              - 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)
        Documentation:Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Pages 15-16 [11.2. Adverse Events]
          ReasonCategories: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE> Safety
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Related Treatment-Emergent Adverse Events Leading to Death for Placebo and High Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH EQ 'Y' AND (ADAE.AEREL EQ 'POSSIBLE' OR ADAE.AEREL EQ 'PROBABLEADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))]
        Groupings:
          1. Treatment [Results per group: YN]:
             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: ADAE.USUBJID
2. System Organ Class [Results per group: Y]: [Data-driven]
        Method: Summary by group of Analysis Variable: ADAE.USUBJID
        Method: Fisher's exact test group comparison for a categorical variable
          Operations:
            > Mth01Mth03_CatVar_SummComp_ByGrpFishEx_1_n: Count of subjects (npval: P-value (p-value)
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
    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:
          - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisReason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          - 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)
        Documentation:See:
            > Statistical Analysis Plan (./sap.pdf)
              - Pages 15-16 [11.2. Adverse Events]
          ReasonCategories: ADDITIONAL EXAMPLE
          Purpose: SECONDARY OUTCOME MEASURE> Safety
        Categories:
          > Safety
          >   > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events Leading to Dose Modification [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN IN ('DOSE REDUCED', 'DRUG INTERRUPTED'))]
        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: ADAE.USUBJID
        Method: 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
          Operations:
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
            > 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
    23.4.2. 8. TEAE Leading to Treatment DiscontinuationComparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low Dose
      Analysis: An07_0810_TEAELd2TrtDscSocPt_SummComp_ByTrt_PlacLow (Summary Comparison of Subjects with At Least One TEAE Leading to Treatment Discontinuation, by TreatmentTEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low Dose)
        Documentation:
          Reason: ADDITIONAL EXAMPLESPECIFIED IN SAP
          Purpose: SECONDARY PRIMARY OUTCOME MEASURE
          CategoriesSee:
          > Safety
          > Events
    Statistical Analysis Plan (./sap.pdf)
      > Adverse Events
        - Pages 15-16 [11.2. Adverse Events]
        Categories:
          > Safety
          > Events
          > Adverse Events
          > Occurrence
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Data Subset: Treatment-Emergent Adverse Events Leading to Treatment Discontinuation for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN EQ 'DRUG WITHDRAWN')ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))]
        Groupings:
          1. Treatment [Results per group: YN]:
             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: ADAE.USUBJID
        Method: Summary by group of a categorical variable2. System Organ Class [Results per group: Y]: [Data-driven]
          Operations:3. Preferred Term [Results per group: Y]: [Data-driven]
            > 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
          Operations:
            > Mth01Mth03_CatVar_SummComp_ByGrpFishEx_21_pct: Percent of subjects (%)pval: P-value (p-value)
    3.4.3. Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs High Dose
      Analysis: An07_10_SocPt_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs High Dose)
        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 [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']
             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: Fisher's exact test group comparison for a categorical variable
              - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisOperations:
              - Denominator: result of operation Mth01> Mth03_CatVar_CountComp_ByGrpFishEx_1_n for analysis An01_05_SAF_Summ_ByTrtpval: P-value (p-value)