...
2. Overall Summary of Treatment-Emergent Adverse Events
Output: Out14-3-1-1
2.1. - Overall Summary of Subjects by Treatment-Emergent Adverse Events
Analysis: An01_05_SAF_Summ_ByTrt
DocumentationDocumentation:
> AE Summary Table Shell (./AE_Summary_Table_Shell.pdf)
Categories:
Reason: SPECIFIED IN SAP
> Safety
> Adverse Events
Purpose: PRIMARY OUTCOME MEASUREOutput File(s):
See:
> Statistical Analysis Plan (./sap.pdf> RTF Format: t14-3-1-1-teae-summ (RTF) (./t14-3-1-1-teae-summ.rtf)
- Page 9 [6. ANALYSIS POPULATIONS]
Categories:
> Population Description> PDF Format: t14-3-1-1-teae-summ (PDF) (./t14-3-1-1-teae-summ.pdf)
Displays:
1. Disp14-3-1-1 - AE Summary (AE_Summ)
> Subject-levelDisplay Title: Overall Summary of Treatment-Emergent Adverse Events
> DemographicsSections:
Population: Safety Population [ADSL.SAFFL EQ 'Y']> Header:
1. Study - CDISC 360
Groupings:
2. Page x of y
1. Treatment [Results per group: Y]> Title:
1. Placebo [ADSL.TRT01A EQ 'Placebo']
1. Table 14.3.1.<x>.<y>
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']2. Overall Summary of Treatment-Emergent Adverse Events
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'] 3. Safety Population
Analysis Variable: ADSL.USUBJID
Method: Count by group for a categorical variable> Abbreviation:
Operations:
> Mth01_CatVar_Count_ByGrp_1_n: Count of subjects (n)
2.2. Number of subjects with at least one event
2.2.1. TEAE
Analysis: An07_01_TEAE_Summ_ByTrt 1. Note: TEAE=Treatment-Emergent Adverse Events.
> Footnote:
Documentation:
Reason: SPECIFIED IN SAP 1. [a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
Purpose> Footer: PRIMARY OUTCOME MEASURE
See:1. Source dataset: adae, Generated on: DDMONYYYY:HH:MM
> Statistical Analysis Plan (./sap.pdf)
- Pages 15-16 [11.2. Adverse Events]
Categories:2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
> SafetyRowlabel Header:
> Events
> Adverse Events
> Occurrence 1. Categories, n (%)
2.1. Summary of Subjects by Treatment
Analysis: An01_05_SAF_Summ_ByTrt - Summary of Subjects by Treatment
Documentation:
Population: Safety Population [ADSL.SAFFL EQ 'Y']Reason: SPECIFIED IN SAP
Data Subset: Treatment-Emergent Adverse Events [ADAE.TRTEMFL EQ 'Y']Purpose: PRIMARY OUTCOME MEASURE
GroupingsSee:
1. Treatment [Results per group: Y]:> Statistical Analysis Plan (./sap.pdf)
1. Placebo [ADSL.TRT01A EQ 'Placebo']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']- Page 9 [6. ANALYSIS POPULATIONS]
Categories:
> Population Description
> Subject-level
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']> Demographics
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Analysis Variable: ADAE.USUBJIDGroupings:
Method: Summary by group of a categorical variable1. AnlsGrouping_01_Trt - Treatment
OperationsGrouping Variable: ADSL.TRT01A
> Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)Groups [Results per group: Y]:
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)1. AnlsGrouping_01_Trt_1 - Placebo
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Selection Criteria: ADSL.TRT01A EQ 'Placebo'
- Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
2.2.2. Related TEAE
Analysis: An07_02_RelTEAE_Summ_ByTrt
2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Documentation:
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
Reason: ADDITIONAL EXAMPLE3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
Purpose: SECONDARY OUTCOME MEASURE
Categories: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
> SafetyAnalysis Variable: ADSL.USUBJID
> EventsMethod: Mth01_CatVar_Count_ByGrp - Count by group for a categorical variable (Grouped count for categorical variable)
> Adverse Events
> Occurrence Count across groups for a categorical variable, based on subject occurrence
Population: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Related Treatment-Emergent Adverse Events [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE'))]
Groupings:
1. Treatment [Results per group: Y]:
1. Placebo [ADSL.TRT01A EQ 'Placebo']Operations:
1. Mth01_CatVar_Count_ByGrp_1_n - Count of subjects (n)
2.2. Number of subjects with at least one event
2.2.1. TEAE
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
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
See:
> Statistical Analysis Plan (./sap.pdf)
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'- Pages 15-16 [11.2. Adverse Events]
Analysis VariableCategories: ADAE.USUBJID
Method: Summary by group of a categorical variable> Safety
> Events
Operations:> Adverse Events
> Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)Occurrence
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%Population: AnalysisSet_02_SAF - Safety Population (SAF)
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisSelection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss01_TEAE - Treatment-Emergent Adverse Events
Selection Criteria: ADAE.TRTEMFL EQ 'Y'
- 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
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety 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'
> Events
> Adverse Events 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
> Occurrence
Population: Safety Population [ Selection Criteria: ADSL.SAFFL TRT01A EQ 'Y']Xanomeline Low Dose'
3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
Data Subset: Serious Treatment-Emergent Adverse Events [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AESER EQ 'Y')] Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
GroupingsAnalysis Variable: ADAE.USUBJID
1. Treatment [Results per group: Y]:
Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
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: 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
2.2.42. Related Serious TEAE
Analysis: An07_0402_RelSerTEAERelTEAE_Summ_ByTrt
- Summary of Subjects with At Least One Related TEAE, by Treatment (Related TEAE)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Related Serious Dss02_Related_TEAE - Related Treatment-Emergent Adverse Events [
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', 'PROBABLE') AND ADAE.AESER EQ 'Y')]
Groupings:
1. Treatment [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: ADAE.USUBJID
Method: Summary 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
2.2.53. Serious TEAE Leading to Death
Analysis: An07_0503_TEAELd2DthSerTEAE_Summ_ByTrt
- Summary of Subjects with At Least One Serious TEAE, by Treatment (Serious TEAE)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Dss03_Serious_TEAE - Serious Treatment-Emergent Adverse Events Leading to Death [
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH AESER EQ 'Y')]
Groupings:
1. 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. Xanomeline Low Dose [ADSL.TRT01A EQ '2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose']
3. Xanomeline High 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)
Operations:
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
2.2.64. Related Serious TEAE Leading to Death
Analysis: An07_0604_RelTEAELd2DthRelSerTEAE_Summ_ByTrt - Summary of Subjects with At Least One Related Serious TEAE, by Treatment (Related Serious TEAE)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Dss04_RelSer_TEAE - Related Serious Treatment-Emergent Adverse Events Leading to Death [
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH EQ 'Y' AND (ADAE.AEREL EQ 'POSSIBLE' OR ADAE.AEREL EQ 'PROBABLE'))]
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
2.2.7. TEAE Leading to Dose Modification
Analysis: An07_07_TEAELd2DoseMod_Summ_ByTrt
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
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
2.2.8. TEAE Leading to Treatment Discontinuation
Analysis: An07_08_TEAELd2TrtDsc_Summ_ByTrt
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 Treatment Discontinuation [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN EQ 'DRUG WITHDRAWN')]
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']AEREL IN ('POSSIBLE', 'PROBABLE') AND ADAE.AESER 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
2.2.5. TEAE Leading to Death
Analysis: An07_05_TEAELd2Dth_Summ_ByTrt - Summary of Subjects with At Least One TEAE Leading to Death, by Treatment (TEAE Leading to Death)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss05_TEAE_Ld2Dth - Treatment-Emergent Adverse Events Leading to Death
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH 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
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 (Related TEAE Leading to Death)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss06_Rel_TEAE_Ld2Dth - Related Treatment-Emergent Adverse Events Leading to Death
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH EQ 'Y' AND (ADAE.AEREL EQ 'POSSIBLE' OR ADAE.AEREL EQ 'PROBABLE'))
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
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 (TEAE Leading to Dose Modification [a])
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss07_TEAE_Ld2DoseMod - Treatment-Emergent Adverse Events Leading to Dose Modification
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN IN ('DOSE REDUCED', 'DRUG INTERRUPTED'))
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
2.2.8. TEAE Leading to Treatment Discontinuation
Analysis: An07_08_TEAELd2TrtDsc_Summ_ByTrt - Summary of Subjects with At Least One TEAE Leading to Treatment Discontinuation, by Treatment (TEAE Leading to Treatment Discontinuation)
Documentation:
Reason: ADDITIONAL EXAMPLE
Purpose: SECONDARY OUTCOME MEASURE
Categories:
> Safety
> Events
> Adverse Events
> Occurrence
Population: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss08_AE_Ld2TrtDsc - Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEACN EQ 'DRUG WITHDRAWN')
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
...