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3. Summary of TEAE by System Organ Class and Preferred Term
  Output: Out14-3-2-1 - Summary of TEAE by System Organ Class and Preferred Term
    Documentation:
      > Statistical Analysis Plan (./sap.pdf)
        - Page 32 [Template 13]
      > Clinical Study Report (./csr-cdiscpilot01.pdf)
        - Pages 63-78 [Table 14-5.01]
    Categories:
      > Safety
      > Adverse Events
    Output File(s):
      > RTF Format: t14-3-2-1-teae-socpt (RTF) (./t14-3-2-1-teae-socpt.rtf)
      > PDF Format: t14-3-2-1-teae-socpt (PDF) (./t14-3-2-1-teae-socpt.pdf)
    Displays:
      1. Disp14-3-2-1 - AE SOCPT Summary (AE_SOC_PT)
        Display Title: Summary of TEAE by System Organ Class and Preferred Term
        Sections:
          > Header:
            1. Study - CDISC 360
            2. Page x of y
          > Title:
            1. Table 14.3.1.1
            2. Summary of TEAE by System Organ Class and Preferred Term
            3. Safety Population
          > Abbreviation:
            1. Notes: TEAE=Treatment-Emergent Adverse Events.
          > Legend:
            1.        Subjects are counted once within each system organ class and preferred term.
          > Footnote:
            1. [a] All investigators adverse events were coded using MedDRA version xx.x.
            2. [b] P-values are based on Fisher's Exact test for the comparison of placebo versus each active treatment group. An asterisk is appended to p-values that are less than 0.15.
          > 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], n (%)
  3.1. 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)
  3.2. Number of subjects with at least one event
    3.2.1. Summary of Subjects by Treatment
      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: 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. 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:
            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
    3.2.2. Comparison of Subjects by Treatment - Placebo vs Low Dose
      Analysis: An07_01_TEAE_Comp_ByTrt_PlacLow - Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose
        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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss11_TEAE_PlacLow - Treatment-Emergent Adverse Events for Placebo and Low Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_FishEx_1_pval - P-value (p-value)
    3.2.3. Comparison of Subjects by Treatment - Placebo vs High Dose
      Analysis: An07_01_TEAE_Comp_ByTrt_PlacHigh - Comparison of Subjects with TEAEs by Treatment - Placebo vs High Dose
        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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss12_TEAE_PlacHigh - Treatment-Emergent Adverse Events for Placebo and High Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_FishEx_1_pval - P-value (p-value)
  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:
          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: 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. 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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
        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:
            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
    3.3.2. Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low Dose
      Analysis: An07_09_Soc_Comp_ByTrt_PlacLow - Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low 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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss11_TEAE_PlacLow - Treatment-Emergent Adverse Events for Placebo and Low Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
        Analysis Variable: ADAE.USUBJID
        Method: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. 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
      Analysis: An07_09_Soc_Comp_ByTrt_PlacHigh - Comparison of Subjects with TEAEs by Treatment and System Organ Class - 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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss12_TEAE_PlacHigh - Treatment-Emergent Adverse Events for Placebo and High Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
        Analysis Variable: ADAE.USUBJID
        Method: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. 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:
          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: 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. 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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
          3. AnlsGrouping_07_Pt - Preferred Term
            Grouping Variable: ADAE.AEDECOD
            Data-driven [Results per group: Y]
        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:
            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
    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
        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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss11_TEAE_PlacLow - Treatment-Emergent Adverse Events for Placebo and Low Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
          3. AnlsGrouping_07_Pt - Preferred Term
            Grouping Variable: ADAE.AEDECOD
            Data-driven [Results per group: Y]
        Analysis Variable: ADAE.USUBJID
        Method: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_FishEx_1_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: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Data Subset: Dss12_TEAE_PlacHigh - Treatment-Emergent Adverse Events for Placebo and High Active Dose
          Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              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_06_Soc - System Organ Class
            Grouping Variable: ADAE.AESOC
            Data-driven [Results per group: Y]
          3. AnlsGrouping_07_Pt - Preferred Term
            Grouping Variable: ADAE.AEDECOD
            Data-driven [Results per group: Y]
        Analysis Variable: ADAE.USUBJID
        Method: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
                Comparison of groups by Fisher's exact test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_FishEx_1_pval - P-value (p-value)