| Excerpt Include |
|---|
| AE Summary Table Shell |
|---|
| AE Summary Table Shell |
|---|
| nopanel | true |
|---|
|
32. Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events
Output: Out14-3-21-1 (Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events)
Documentation:
> Statistical Analysis Plan AE Summary Table Shell (./sapAE_Summary_Table_Shell.pdf)
Categories:
- Page 32 [Template 13]> Safety
> Clinical Study Report (./csr-cdiscpilot01.pdf)
- Pages 63-78 [Table 14-5.01]
Categories:
> Safety
> Adverse Events
Adverse Events
Output File(s):
> RTF Format: t14-3-21-1-teae-socpt summ (.)
> PDF Format: t14-3-21-1-teae-socpt summ (.)
Displays:
1. Disp14-3-21-1 (AE_SOC_PTSumm)
Display Title: Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events
Sections:
> Title:
1. Table 14.3.1.<x>.1<y>
2. Overall Summary of TEAE by System Organ Class and Preferred TermTreatment-Emergent Adverse Events
3. Safety Population
> Abbreviation:
1. NotesNote: TEAE=Treatment-Emergent Adverse Events.
> Legend:
1. Subjects are counted once within each system organ class and preferred term[a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
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]Categories, n (%)
32.1. 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)
32.2. Number of subjects with at least one event
32.2.1. Summary of Subjects by TreatmentTEAE
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
32.2.2. Comparison of Subjects by Treatment - Placebo vs Low Dose
Related TEAE
Analysis: An07_0102_TEAERelTEAE_CompSumm_ByTrt _PlacLow (Comparison Summary of Subjects with TEAEs At Least One Related TEAE, by Treatment - Placebo vs Low Dose)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
SeeCategories:
> Statistical Analysis Plan (./sap.pdf)
Safety
> Events
- Pages 15-16 [11.2. > Adverse Events]
Categories:
> 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 ADSLADAE.TRT01A AEREL IN ('PlaceboPOSSIBLE', 'Xanomeline Low DosePROBABLE'))]
Groupings:
1. Treatment [Results per group: NY]:
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 Summary by group of a categorical variable
Operations:
> Mth03Mth01_CatVar_CompSumm_FishExByGrp_1_pval: P-value (p-valuen: Count of subjects (n)
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> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
Documentation:
Reason: ADDITIONAL EXAMPLE- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Purpose: SECONDARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf- Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
2.2.3. Serious TEAE
Analysis: An07_03_SerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Serious TEAE, by Treatment)
- Pages 15-16 [11.2. Adverse Events]
Documentation:
CategoriesReason: ADDITIONAL EXAMPLE
> Purpose: SECONDARY OUTCOME MEASURE
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 ADSL.TRT01A IN ('Placebo', 'Xanomeline High Dose')ADAE.AESER EQ 'Y')]
Groupings:
1. Treatment [Results per group: NY]:
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 Summary by group of a categorical variable
Operations:
> Mth03Mth01_CatVar_CompSumm_FishExByGrp_1_pval: P-value (p-valuen: Count of subjects (n)
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:
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
See:
> Statistical Analysis Plan (./sap.pdf- Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
2.2.4. Related Serious TEAE
Analysis: An07_04_RelSerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Related Serious TEAE, by Treatment)
- Pages 15-16 [11.2. Adverse Events]
Documentation:
CategoriesReason: ADDITIONAL EXAMPLE
> Purpose: SECONDARY OUTCOME MEASURE
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']
Analysis Variable: ADAE.USUBJID
2. System Organ Class [Results per group: Y]: [Data-driven]
Analysis Variable: ADAE.USUBJID
Method: Summary by 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
32.32.2. Comparison of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low Dose5. TEAE Leading to Death
Analysis: An07_0905_SocTEAELd2Dth_CompSumm_ByTrt _PlacLow (Comparison Summary of Subjects with TEAEs by Treatment and System Organ Class - Placebo vs Low DoseAt Least One TEAE Leading to Death, by Treatment)
Documentation:
Reason: SPECIFIED IN SAPADDITIONAL EXAMPLE
Purpose: PRIMARY SECONDARY OUTCOME MEASURE
SeeCategories:
> Statistical Analysis Plan (./sap.pdf)Safety
- Pages 15-16 [11.2. Adverse Events]
> Events
Categories:> Adverse Events
> SafetyOccurrence
> Events
> Adverse Events
> Occurrence
Population: Population: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Treatment-Emergent Adverse Events for Placebo and Low Active Dose Leading to Death [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose')ADAE.AESDTH EQ 'Y')]
Groupings:
1. Treatment [Results per group: NY]:
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 Analysis Variable: ADAE.USUBJID
Method: Summary by group of a categorical variable
Operations:
> Mth03Mth01_CatVar_CompSumm_FishExByGrp_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 Dosen: Count of subjects (n)
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
Documentation:
Reason: SPECIFIED IN SAP
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf- 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)
- Pages 15-16 [11.2. Adverse Events]
Documentation:
CategoriesReason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Related Treatment-Emergent Adverse Events for Placebo and High Active Dose Leading to Death [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline High DoseADAE.AESDTH EQ 'Y' AND (ADAE.AEREL EQ 'POSSIBLE' OR ADAE.AEREL EQ 'PROBABLE'))]
Groupings:
1. Treatment [Results per group: NY]:
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 Analysis Variable: ADAE.USUBJID
Method: Summary by group of a categorical variable
Operations:
> Mth03Mth01_CatVar_CompSumm_FishExByGrp_1_pval: P-value (p-valuen: Count of subjects (n)
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:
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)
Reason: SPECIFIED IN SAP- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Pages 15-16 [11.2. Adverse Events] - 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:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
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
2. System Organ Class [Results per group: Y]: [Data-driven]
Method: Summary by group of a categorical variable
Operations:
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
32.42.2. Comparison of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low Dose8. TEAE Leading to Treatment Discontinuation
Analysis: An07_1008_SocPtTEAELd2TrtDsc_CompSumm_ByTrt _PlacLow (Comparison Summary of Subjects with TEAEs by Treatment, System Organ Class and Preferred Term - Placebo vs Low DoseAt Least One TEAE Leading to Treatment Discontinuation, by Treatment)
Documentation:
Reason: SPECIFIED IN SAPADDITIONAL EXAMPLE
Purpose: PRIMARY SECONDARY OUTCOME MEASURE
SeeCategories:
> Statistical Analysis Plan (./sap.pdf)
> Safety
- 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 Leading to Treatment Discontinuation [(ADAE.TRTEMFL EQ 'Y' AND ADSL.TRT01A IN ('Placebo', 'Xanomeline Low Dose'))ADAE.AEACN EQ 'DRUG WITHDRAWN')]
Groupings:
1. Treatment [Results per group: NY]:
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
3. Preferred Term [Results per group: Y]: [Data-driven]
Operations:
Analysis Variable: ADAE.USUBJID
Method: Fisher's exact test group comparison for a categorical variable
Operations: > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
> Mth03Mth01_CatVar_CompSumm_FishExByGrp_12_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)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