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)