...
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:
> 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 14.3.1.1
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:
2 1. [a] All investigators adverse events were coded using MedDRA version xx.x.
> Footnote:
1. Source dataset: adae, Generated on: 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: Safety Population [ADSL.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 [ADSL.TRT01A EQ 'Placebo']
1. AnlsGrouping_01_Trt_1 - Placebo
2. Xanomeline Low Dose [ Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low DosePlacebo']
3. Xanomeline High Dose [ 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: 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. Treatment [Results 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. Xanomeline High 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: Safety 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. Treatment [Results per group: N]:AnlsGrouping_01_Trt - Treatment
1. Placebo [Grouping Variable: ADSL.TRT01A EQ 'Placebo']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']Groups [Results per group: N]:
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'] 1. AnlsGrouping_01_Trt_1 - Placebo
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable Selection Criteria: ADSL.TRT01A EQ 'Placebo'
Operations:
> Mth03_CatVar_Comp_FishEx_1_pval: P-value (p-value)
3.2.3. Comparison of Subjects by Treatment - Placebo vs High 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Analysis: An07_01_TEAE_Comp_ByTrt_PlacHigh (Comparison of Subjects with TEAEs by Treatment - Placebo vs High Dose)
Documentation: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
Reason: ADDITIONAL EXAMPLE
3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
Purpose: SECONDARY OUTCOME MEASURE
See: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
> Statistical Analysis Plan (./sap.pdf)Analysis Variable: ADAE.USUBJID
- Pages 15-16 [11.2. Adverse Events]Method: Mth05_CatVar_Comp_FishEx - Fisher's exact test group comparison for a categorical variable (Fisher's exact test group comparison for categorical variable)
Categories:
> SafetyComparison of groups by Fisher's exact test for a categorical variable
> EventsOperations:
> Adverse Events
> Occurrence 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
Population: Safety Population [ADSL.SAFFL EQ 'Y']Documentation:
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: Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
1. Treatment [Results per group: N]:See:
1. Placebo [ADSL.TRT01A EQ 'Placebo']> Statistical Analysis Plan (./sap.pdf)
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose' - Pages 15-16 [11.2. Adverse Events]
Categories:
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
Analysis Variable: ADAE.USUBJID
> Safety
Method: Fisher's exact test group comparison for a categorical variable> Events
Operations:> Adverse Events
> 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)> 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
Documentation:
Reason: SPECIFIED IN SAP Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose'))
PurposeGroupings: PRIMARY OUTCOME MEASURE
See:1. AnlsGrouping_01_Trt - Treatment
> Statistical Analysis Plan (./sap.pdf)Grouping Variable: ADSL.TRT01A
- Pages 15-16 [11.2. Adverse Events]Groups [Results per group: N]:
Categories:
> Safety1. AnlsGrouping_01_Trt_1 - Placebo
> Events
> Adverse Events Selection Criteria: ADSL.TRT01A EQ 'Placebo'
> Occurrence
Population: Safety Population [ADSL.SAFFL EQ 'Y']
2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Data Subset: Treatment-Emergent Adverse Events [ADAE.TRTEMFL EQ 'Y'] Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
Groupings:
1. Treatment [Results per group: Y]:3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
1. Placebo [ADSL.TRT01A EQ 'Placebo']
2. Xanomeline Low Dose [ Selection Criteria: 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 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:
> Mth011. Mth03_CatVar_SummComp_ByGrpFishEx_1_n: Count of subjects (npval - P-value (p-value)
3.3. System Organ Class
3.3.1. Summary of Subjects by Treatment and System Organ Class
> Mth01_CatVarAnalysis: An07_09_Soc_Summ_ByGrp_2_pct: Percent of subjects (%)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
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 DoseSee:
> Statistical Analysis Plan (./sap.pdf)
Documentation: - Pages 15-16 [11.2. Adverse Events]
ReasonCategories: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE> Safety
See:> Events
> Statistical Analysis Plan (./sap.pdf> Adverse Events
> Occurrence
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
- Pages 15-16 [11.2. Adverse Events] Data Subset: Dss01_TEAE - Treatment-Emergent Adverse Events
Categories: Selection Criteria: ADAE.TRTEMFL EQ 'Y'
> SafetyGroupings:
> Events
1. AnlsGrouping_01_Trt - Treatment
Grouping Variable: ADSL.TRT01A
> Adverse Events
Groups [Results per group: Y]:
> Occurrence 1. AnlsGrouping_01_Trt_1 - Placebo
Population: Safety Population [ Selection Criteria: ADSL.SAFFL TRT01A EQ 'YPlacebo']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))] 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Groupings:
1. Treatment [Results per group: N]:
1. Placebo [ Selection Criteria: ADSL.TRT01A EQ 'PlaceboXanomeline Low Dose']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
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]: [Data-driven]
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison 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:
> Mth031. Mth01_CatVar_CompSumm_FishExByGrp_1_pval: P-value (p-valuen - Count of subjects (n)
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) 2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Documentation:
- 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: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Dss01_TEAE - 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
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 a categorical variableAnlsGrouping_06_Soc - System Organ Class
Operations: Grouping Variable: ADAE.AESOC
> 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)Data-driven [Results per group: Y]
3. AnlsGrouping_07_Pt - Preferred Term
Grouping Variable: ADAE.AEDECOD
Data-driven [Results per group: Y]
DocumentationAnalysis Variable: ADAE.USUBJID
Reason: SPECIFIED IN SAPMethod: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
Purpose: PRIMARY OUTCOME MEASURE
See:Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
> Statistical Analysis Plan (./sap.pdf)Operations:
- Pages 15-16 [11.2. Adverse Events]
Categories:1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
> Safety
> Events 2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
> Adverse Events
> Occurrence
Population: Safety Population [ADSL.SAFFL EQ 'Y']- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
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- 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]:
> Statistical Analysis Plan (./sap.pdf)
1. AnlsGrouping_01_Trt_1 - Placebo
- Pages 15-16 [11.2. Adverse Events]
Selection Criteria: ADSL.TRT01A EQ 'Placebo'
Categories:2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
> Safety
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
> Events
> Adverse Events
3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
> Occurrence
Population Selection Criteria: Safety Population [ ADSL.SAFFL TRT01A EQ 'YXanomeline High Dose']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))]2. AnlsGrouping_06_Soc - System Organ Class
Groupings: Grouping Variable: ADAE.AESOC
1. Treatment Data-driven [Results per group: NY]:
1. Placebo [ADSL.TRT01A EQ 'Placebo']3. AnlsGrouping_07_Pt - Preferred Term
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']Grouping Variable: ADAE.AEDECOD
2. System Organ Class [Results per group: Y]: [ Data-driven ]
3. Preferred Term [Results per group: Y]: [Data-driven]
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)
Method: Comparison of groups by Fisher's exact test group comparison 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: Safety 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'))]High Dose'))
Groupings:
1. AnlsGrouping_01_Trt - Treatment
Groupings: Grouping Variable: ADSL.TRT01A
1. Treatment Groups [Results per group: N]:
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']
2. AnlsGrouping_06_Soc - System Organ Class
Grouping Variable: ADAE.AESOC
Data-driven [Results per group: Y]: [Data-driven]]
3. AnlsGrouping_07_Pt - Preferred Term
Grouping Variable: ADAE.AEDECOD
3. Preferred Term Data-driven [Results per group: Y]: [Data-driven]
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)
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