2. Overall Summary of Treatment-Emergent Adverse Events
Output: Out14-3-1-1 - Overall Summary of Treatment-Emergent Adverse Events
Documentation:
> AE Summary Table Shell (./AE_Summary_Table_Shell.pdf)
Categories:
> Safety
> Adverse Events
Output File(s):
> RTF Format: t14-3-1-1-teae-summ (RTF) (./t14-3-1-1-teae-summ.rtf)
> 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)
Display Title: Overall Summary of Treatment-Emergent Adverse Events
Sections:
> Header:
1. Study - CDISC 360
2. Page x of y
> Title:
1. Table 14.3.1.<x>.<y>
2. Overall Summary of Treatment-Emergent Adverse Events
3. Safety Population
> Abbreviation:
1. Note: TEAE=Treatment-Emergent Adverse Events.
> Footnote:
1. [a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
> 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. Categories, n (%)
2.1. 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)
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
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
2.2.2. Related TEAE
Analysis: An07_02_RelTEAE_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: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss02_Related_TEAE - Related Treatment-Emergent Adverse Events
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.AEREL IN ('POSSIBLE', '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
2.2.3. Serious TEAE
Analysis: An07_03_SerTEAE_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: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss03_Serious_TEAE - Serious Treatment-Emergent Adverse Events
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' 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
2.2.4. Related Serious TEAE
Analysis: An07_04_RelSerTEAE_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: AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y'
Data Subset: Dss04_RelSer_TEAE - Related Serious Treatment-Emergent Adverse Events
Selection Criteria: (ADAE.TRTEMFL EQ 'Y' AND ADAE.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