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 (.)
> PDF Format: t14-3-2-1-teae-socpt (.)
Displays:
1. Disp14-3-2-1 (AE_SOC_PT)
Display Title: Summary of TEAE by System Organ Class and Preferred Term
Sections:
> 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.
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. 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: 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)
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)
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
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: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low 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']
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable
Operations:
> 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: 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']
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable
Operations:
> 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: 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']
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
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: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low 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]
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable
Operations:
> 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: 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]
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable
Operations:
> 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: 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']
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
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: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low 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
Operations:
> 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: 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
Operations:
> Mth03_CatVar_Comp_FishEx_1_pval: P-value (p-value)