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 (.)
> PDF Format: t14-3-1-1-teae-summ (.)
Displays:
1. Disp14-3-1-1 (AE_Summ)
Display Title: Overall Summary of Treatment-Emergent Adverse Events
Sections:
> 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.
> Legend:
1. [a] Dose Modification includes Dose Reduced; Drug Interrupted in the AE action taken with study treatment.
> 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. 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: 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)
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)
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
2.2.2. Related TEAE
Analysis: An07_02_RelTEAE_Summ_ByTrt (Summary of Subjects with At Least One Related TEAE, 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: 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']
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
2.2.3. Serious TEAE
Analysis: An07_03_SerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Serious TEAE, 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: Serious Treatment-Emergent Adverse Events [(ADAE.TRTEMFL EQ 'Y' 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
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
2.2.4. Related Serious TEAE
Analysis: An07_04_RelSerTEAE_Summ_ByTrt (Summary of Subjects with At Least One Related Serious TEAE, 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: 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
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
2.2.5. TEAE Leading to Death
Analysis: An07_05_TEAELd2Dth_Summ_ByTrt (Summary of Subjects with At Least One TEAE Leading to Death, 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 Death [(ADAE.TRTEMFL EQ 'Y' AND ADAE.AESDTH 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
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)
Documentation:
Reason: 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 Leading to Death [(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 (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
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 (Summary of Subjects with At Least One TEAE Leading to Treatment Discontinuation, 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 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']
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