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1. Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
Output: O_T2
1.1. Summary of Subjects by Treatment- Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
Analysis: A_SAF_SUM_USUBJID_TRTDocumentation:
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap> Standard Safety Tables and Figures: Integrated Guide (https://downloads.regulations.gov/FDA-2022-N-1961-0046/attachment_1.pdf)
- Pages 12-13 [Table 2]
Output File(s):
> RTF Format: t2-demog (RTF) (./t2-demog.rtf)
> PDF Format: t2-demog (PDF) (./t2-demog.pdf)
Displays:
- Page 9 [6. ANALYSIS POPULATIONS]1. D_T2 - Table 2
Population: Safety Population [ADSL.SAFFL EQ 'Y'] Display Title: Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
Groupings Sections:
1. Treatment [Results per group: Y]: > Title:
1. Placebo [ADSL.TRT01A EQ 'Placebo'] 1. Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']> Footer:
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
Analysis Variable: ADSL.USUBJID
Method: Count by group for a categorical variable
Operations: 1. Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
> Rowlabel Header:
1. Characteristic
> M_GRP_CNT_1_N: Count of subjects (n)
1.2. Sex
Abbreviation:
1. 2.N, number of patients in treatment arm
2. n, number of patients with given characteristic
3. SD, standard deviation
1.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT _SEX- Summary of Subjects by Treatment
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 9 [9.2. Demographic and Baseline Characteristics6. ANALYSIS POPULATIONS]
Population: AS_SAF - Safety Population [
Selection Criteria: ADSL.SAFFL EQ 'Y']
Groupings:
1. AG_TRT - Treatment
Grouping Variable: ADSL.TRT01A
Groups [Results per group: Y]:
1. Placebo [1. AG_TRT_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AG_TRT_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. 3. AG_TRT_3 - Xanomeline High Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
2. Gender [Results per group: Y]:Analysis Variable: ADSL.USUBJID
1. Male [ADSL.SEX EQ 'M']
Method: M_GRP_CNT - Count by group for a categorical variable (Grouped count for categorical variable)
2. Female [ADSL.SEX EQ 'F']
Analysis Variable: ADSL.USUBJID
Method: Summary by group of a categorical variable
Count across groups for a categorical variable, based on subject occurrence
Operations:
> 1. M_GRP_SUM_CATEGCNT_1_N : - Count of subjects (n)
> M_GRP1.2. Sex
1.2.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_CATEGUSUBJID_2_PCT: Percent of subjects (%)TRT_SEX - Summary of Subjects by Treatment and Sex
Documentation:
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
1.3. Age
1.3.1. Summary of Age by Treatment
Analysis: A_SAF_SUM_AGE_TRT
Documentation: See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Reason: SPECIFIED IN SAPPopulation: AS_SAF - Safety Population
Purpose: PRIMARY OUTCOME MEASURESelection Criteria: ADSL.SAFFL EQ 'Y'
SeeGroupings:
> Statistical Analysis Plan (./sap.pdf)1. AG_TRT - Treatment
- Page 13 [9.2. Demographic and Baseline Characteristics]
Grouping Variable: ADSL.TRT01A
Population: Safety Population [ADSL.SAFFL EQ 'Y']Groups [Results per group: Y]:
Groupings:
1. Treatment [Results per group: Y]:
1. AG_TRT_1 - Placebo
1. Placebo [ Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. Xanomeline Low Dose [ADSL.TRT01A 2. AG_TRT_2 - Xanomeline Low Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. 3. AG_TRT_3 - Xanomeline High Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
2. AG_SEX - Gender
Analysis Grouping Variable: ADSL.AGESEX
Method: Summary by group of a continuous variable Groups [Results per group: Y]:
Operations: 1. AG_SEX_1 - Male
> M_GRP_SUM_CONTIN_1_MEAN: Mean (Mean) Selection Criteria: ADSL.SEX EQ 'M'
> M_GRP_SUM_CONTIN_2_SD: Standard deviation (SD)
2. AG_SEX_2 - Female
> M_GRP_SUM_CONTIN_3_MEDIAN: Median (Median)
Selection Criteria: ADSL.SEX EQ 'F'
Analysis Variable: ADSL.USUBJID
> Method: M_GRP_SUM_CONTIN_4_MIN: Minimum (min)
CATEG - Summary by group of a categorical variable (Grouped summary of categorical variable)
> M_GRP_SUM_CONTIN_5_MAX: Maximum (max)
1.4. Age groups
1.4.1. Summary of Subjects by Treatment Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
Analysis: A_SAF Operations:
1. M_GRP_SUM_USUBJIDCATEG_TRT_AGEGRP
Documentation:
Reason: SPECIFIED IN SAP1_N - Count of subjects (n)
2. M_GRP_SUM_CATEG_2_PCT - Percent of subjects (%)
Purpose: PRIMARY OUTCOME MEASURE
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
1.3. Age
1.3.1. Summary of Age by Treatment
Analysis: A_SAF_SUM_AGE_TRT - Summary of Age by Treatment
Population: Safety Population [ADSL.SAFFL EQ 'Y']
Documentation:
GroupingsReason: SPECIFIED IN SAP
1. Treatment [Results per group: Y]:Purpose: PRIMARY OUTCOME MEASURE
1. Placebo [ADSL.TRT01A EQ 'Placebo']See:
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
> Statistical Analysis Plan (./sap.pdf)
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'- Page 13 [9.2. Demographic and Baseline Characteristics]
2. Age groups [Results per group: Y]:Population: AS_SAF - Safety Population
1. < 65 [Selection Criteria: ADSL.AGEGR2 SAFFL EQ '<65Y']
2. ≥ 65 [ADSL.AGEGR2 EQ '65+']Groupings:
3. Age sub-groups [Results per group: Y]:1. AG_TRT - Treatment
1. ≥17 to <65 [ADSL.AGEGR3 EQ '17-<65']Grouping Variable: ADSL.TRT01A
2. ≥ 65 to <75 [ADSL.AGEGR3 EQ '65-<75']Groups [Results per group: Y]:
3. ≥ 75 [ADSL.AGEGR3 EQ '75+'] 1. AG_TRT_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo'
Analysis Variable: ADSL.USUBJID 2. AG_TRT_2 - Xanomeline Low Dose
Method: Summary by group of a categorical variable
Operations: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
> M_GRP_SUM_CATEG_1_N: Count of subjects (n) 3. AG_TRT_3 - Xanomeline High Dose
> M_GRP_SUM_CATEG_2_PCT: Percent of subjects (%) Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
Analysis Variable: ADSL.AGE
- Numerator: result of operation Method: M_GRP_SUM_CATEG_1_N for this analysis
CONTIN - Summary by group of a continuous variable (Grouped summary of continuous variable)
- Denominator: result of operation Descriptive summary statistics across groups for a continuous variable
Operations:
1. M_GRP_CNTSUM_CONTIN_1_N for analysis A_SAFMEAN - Mean (Mean)
2. M_GRP_SUM_USUBJID_TRT
1.5. Race
1.5.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_RACECONTIN_2_SD - Standard deviation (SD)
3. M_GRP_SUM_CONTIN_3_MEDIAN - Median (Median)
Documentation:
Reason: SPECIFIED IN SAP
4. M_GRP_SUM_CONTIN_4_MIN - Minimum (min)
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]5. M_GRP_SUM_CONTIN_5_MAX - Maximum (max)
1.4. Age groups
1.4.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_AGEGRP - Summary of Subjects by Treatment and Age Group
Documentation:
Population: Safety Population [ADSL.SAFFL EQ 'Y']
Reason: SPECIFIED IN SAP
GroupingsPurpose: PRIMARY OUTCOME MEASURE
1. Treatment [Results per group: Y]See:
1. Placebo [ADSL.TRT01A EQ 'Placebo']
> Statistical Analysis Plan (./sap.pdf)
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose'- Page 13 [9.2. Demographic and Baseline Characteristics]
Population: AS_SAF - Safety Population
3. Xanomeline High Dose [ Selection Criteria: ADSL.TRT01A SAFFL EQ 'Xanomeline High Dose']Y'
Groupings:
2. Race 1. AG_TRT - Treatment
Grouping Variable: ADSL.TRT01A
Groups [Results per group: Y]:
1. American Indian or Alaska Native [ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'] 1. AG_TRT_1 - Placebo
2. Black or African American [ Selection Criteria: ADSL.RACE TRT01A EQ 'BLACK OR AFRICAN AMERICANPlacebo']
3. Native Hawaiian or Other Pacific Islander [ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
2. AG_TRT_2 - Xanomeline Low Dose
4. White [ADSL.RACE EQ 'WHITE']
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
5. Other [ADSL.RACE NOTIN ('AMERICAN INDIAN OR ALASKA NATIVE', 'BLACK OR AFRICAN AMERICAN', 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'WHITE')]
Analysis Variable: ADSL.USUBJID
Method: Summary by group of a categorical variable
Operations:
> M_GRP_SUM_CATEG_1_N: Count of subjects (n)
> M_GRP_SUM_CATEG_2_PCT: Percent of subjects (%)
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
1.6. Ethnicity
1.6.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_ETHNIC
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
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']
2. Ethnicity 3. AG_TRT_3 - Xanomeline High Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
2. AG_AGEGR2 - Age groups
Grouping Variable: ADSL.AGEGR2
Groups [Results per group: Y]:
1. AG_AGEGR2_1 - < 65
Selection Criteria: ADSL.AGEGR2 EQ '<65'
2. AG_AGEGR2_2 - ≥ 65
Selection Criteria: ADSL.AGEGR2 EQ '65+'
3. AG_AGEGR3 - Age sub-groups
Grouping Variable: ADSL.AGEGR3
Groups [Results per group: Y]:
1. AG_AGEGR3_1 - ≥17 to <65
Selection Criteria: ADSL.AGEGR3 EQ '17-<65'
2. AG_AGEGR3_2 - ≥ 65 to <75
Selection Criteria: ADSL.AGEGR3 EQ '65-<75'
3. AG_AGEGR3_3 - ≥ 75
Selection Criteria: ADSL.AGEGR3 EQ '75+'
Analysis Variable: ADSL.USUBJID
Method: M_GRP_SUM_CATEG - 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. M_GRP_SUM_CATEG_1_N - Count of subjects (n)
2. M_GRP_SUM_CATEG_2_PCT - Percent of subjects (%)
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
1.5. Race
1.5.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_RACE - Summary of Subjects by Treatment and Race
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Population: AS_SAF - Safety Population
Selection Criteria: ADSL.SAFFL EQ 'Y'
Groupings:
1. AG_TRT - Treatment
Grouping Variable: ADSL.TRT01A
Groups [Results per group: Y]:
1. AG_TRT_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo'
2. AG_TRT_2 - Xanomeline Low Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
3. AG_TRT_3 - Xanomeline High Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
2. AG_RACE - Race
Grouping Variable: ADSL.RACE
Groups [Results per group: Y]:
1. AG_RACE_1 - American Indian or Alaska Native
Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'
2. AG_RACE_2 - Black or African American
Selection Criteria: ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN'
3. AG_RACE_3 - Native Hawaiian or Other Pacific Islander
Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'
4. AG_RACE_4 - White
Selection Criteria: ADSL.RACE EQ 'WHITE'
5. AG_RACE_5 - Other
Selection Criteria: ADSL.RACE NOTIN ('AMERICAN INDIAN OR ALASKA NATIVE', 'BLACK OR AFRICAN AMERICAN', 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'WHITE')
Analysis Variable: ADSL.USUBJID
Method: M_GRP_SUM_CATEG - 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. M_GRP_SUM_CATEG_1_N - Count of subjects (n)
2. M_GRP_SUM_CATEG_2_PCT - Percent of subjects (%)
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
1.6. Ethnicity
1.6.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_ETHNIC - Summary of Subjects by Treatment and Ethnicity
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Population: AS_SAF - Safety Population
Selection Criteria: ADSL.SAFFL EQ 'Y'
Groupings:
1. AG_TRT - Treatment
Grouping Variable: ADSL.TRT01A
Groups [Results per group: Y]:
1. AG_TRT_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo'
2. AG_TRT_2 - Xanomeline Low Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
3. AG_TRT_3 - Xanomeline High Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
2. AG_ETHNIC - Ethnicity
Grouping Variable: ADSL.ETHNIC
Groups [Results per group: Y]:
1. 1. AG_ETHNIC_1 - Hispanic or Latino [
Selection Criteria: ADSL.ETHNIC EQ 'HISPANIC OR LATINO']
2. Not Hispanic or Latino [2. AG_ETHNIC_2 - Not Hispanic or Latino
Selection Criteria: ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
Analysis Variable: ADSL.USUBJID
Method: M_GRP_SUM_CATEG - 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. M_GRP_SUM_CATEG_1_N : - Count of subjects (n)
> 2. M_GRP_SUM_CATEG_2_PCT : - Percent of subjects (%)
- Numerator: result of operation M_GRP_SUM_CATEG_1_N for this analysis
- Denominator: result of operation M_GRP_CNT_1_N for analysis A_SAF_SUM_USUBJID_TRT
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