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1. Summary of Demographics
Output: Out14-1-1 (Summary of Demographics)
Documentation:
> Clinical Study Report (./csr-cdiscpilot01.pdf)
- Pages 46-48 [Table 14-2.01]
Categories:
> Population Description
> Demographics
Output File(s):
> RTF Format: t14-1-1-demog (.)
> PDF Format: t14-1-1-demog (.)
Displays:
1. Disp14-1-1 (Demog)
Display Title: Summary of Demographics
Sections:
> Title:
1. Table 14.1.1
2. Summary of Demographics
3. Safety Population
> Footnote:
1. Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
> Rowlabel Header:
1. Characteristics
1.1. 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)
1.2. Age
1.2.1. Summary by Treatment
Analysis: An03_01_Age_Summ_ByTrt (Summary of Age by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
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.AGE
Method: Summary by group of a continuous variable
Operations:
> Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
> Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
> Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
> Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
> Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
> Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
> Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
> Mth02_ContVar_Summ_ByGrp_8_Max: Maximum (Max)
1.2.2. Comparison by Treatment
Analysis: An03_01_Age_Comp_ByTrt (Comparison of Age by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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']
Analysis Variable: ADSL.AGE
Method: Analysis of variance group comparison for a continuous variable
Operations:
> Mth04_ContVar_Comp_Anova_1_pval: P-value (p-value)
1.3. Age Group
1.3.1. Summary of Subjects by Treatment
Analysis: An03_02_AgeGrp_Summ_ByTrt_Summ_ByTrt (Summary of Subjects by Treatment and Age Group)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
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']
2. Age Group [Results per group: Y]:
1. < 65 years [ADSL.AGEGR1 EQ '<65']
2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]
Analysis Variable: ADSL.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
1.3.2. Comparison of Subjects by Treatment
Analysis: An03_02_AgeGrp_Comp_ByTrt (Comparison of Age Group by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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. Age Group [Results per group: N]:
1. < 65 years [ADSL.AGEGR1 EQ '<65']
2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]
Analysis Variable: ADSL.USUBJID
Method: Pearson's chi-square test group comparison for a categorical variable
Operations:
> Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
1.4. Sex
1.4.1. Summary of Subjects by Treatment
Analysis: An03_03_Sex_Summ_ByTrt (Summary of Subjects by Treatment and Sex)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
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']
2. Gender [Results per group: Y]:
1. Male [ADSL.SEX EQ 'M']
2. Female [ADSL.SEX EQ 'F']
Analysis Variable: ADSL.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
1.4.2. Comparison of Subjects by Treatment
Analysis: An03_03_Sex_Comp_ByTrt (Comparison of Sex by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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. Gender [Results per group: N]:
1. Male [ADSL.SEX EQ 'M']
2. Female [ADSL.SEX EQ 'F']
Analysis Variable: ADSL.USUBJID
Method: Pearson's chi-square test group comparison for a categorical variable
Operations:
> Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
1.5. Ethnicity
1.5.1. Summary of Subjects by Treatment
Analysis: An03_04_Ethnic_Summ_ByTrt (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]
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']
2. Ethnicity [Results per group: Y]:
1. Hispanic or Latino [ADSL.ETHNIC EQ 'HISPANIC OR LATINO']
2. Not Hispanic or Latino [ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
Analysis Variable: ADSL.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
1.5.2. Comparison of Subjects by Treatment
Analysis: An03_04_Ethnic_Comp_ByTrt (Comparison of Ethnicity by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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. Ethnicity [Results per group: N]:
1. Hispanic or Latino [ADSL.ETHNIC EQ 'HISPANIC OR LATINO']
2. Not Hispanic or Latino [ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
Analysis Variable: ADSL.USUBJID
Method: Pearson's chi-square test group comparison for a categorical variable
Operations:
> Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
1.6. Race
1.6.1. Summary of Subjects by Treatment
Analysis: An03_05_Race_Summ_ByTrt (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]
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']
2. Primary Race [Results per group: Y]:
1. American Indian or Alaska Native [ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE']
2. Asian [ADSL.RACE EQ 'ASIAN']
3. Black or African American [ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']
4. Native Hawaiian or Other Pacific Islander [ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
5. White [ADSL.RACE EQ 'WHITE']
6. Multiple [ADSL.RACE EQ 'MULTIPLE']
7. Not Reported [ADSL.RACE EQ 'NOT REPORTED']
8. Unknown [ADSL.RACE EQ 'UNKNOWN']
9. Other [ADSL.RACE EQ 'OTHER']
Analysis Variable: ADSL.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
1.6.2. Comparison of Subjects by Treatment
Analysis: An03_05_Race_Comp_ByTrt (Comparison of Race by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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. Primary Race [Results per group: N]:
1. American Indian or Alaska Native [ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE']
2. Asian [ADSL.RACE EQ 'ASIAN']
3. Black or African American [ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']
4. Native Hawaiian or Other Pacific Islander [ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
5. White [ADSL.RACE EQ 'WHITE']
6. Multiple [ADSL.RACE EQ 'MULTIPLE']
7. Not Reported [ADSL.RACE EQ 'NOT REPORTED']
8. Unknown [ADSL.RACE EQ 'UNKNOWN']
9. Other [ADSL.RACE EQ 'OTHER']
Analysis Variable: ADSL.USUBJID
Method: Pearson's chi-square test group comparison for a categorical variable
Operations:
> Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
1.7. Height
1.7.1. Summary by Treatment
Analysis: An03_06_Height_Summ_ByTrt (Summary of Height by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
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.HEIGHTBL
Method: Summary by group of a continuous variable
Operations:
> Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
> Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
> Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
> Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
> Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
> Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
> Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
> Mth02_ContVar_Summ_ByGrp_8_Max: Maximum (Max)
1.7.2. Comparison by Treatment
Analysis: An03_06_Height_Comp_ByTrt (Comparison of Height by Treatment)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 13 [9.2. Demographic and Baseline Characteristics]
Categories:
> Population Description
> Subject-level
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y']
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']
Analysis Variable: ADSL.HEIGHTBL
Method: Analysis of variance group comparison for a continuous variable
Operations:
> Mth04_ContVar_Comp_Anova_1_pval: P-value (p-value)
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