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 (RTF) (./t14-1-1-demog.rtf)
> PDF Format: t14-1-1-demog (PDF) (./t14-1-1-demog.pdf)
Displays:
1. Disp14-1-1 - Demographics (Demog)
Display Title: Summary of Demographics
Sections:
> Header:
1. Study - CDISC 360
2. Page x of y
> Title:
1. Table 14.1.1
2. Summary of Demographics
3. Safety Population
> Footer:
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: 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)
1.2. Age
1.2.1. Summary by Treatment
Analysis: An03_01_Age_Summ_ByTrt - Summary of Age by Treatment (Age)
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: 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.AGE
Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
Descriptive summary statistics across groups for a continuous variable
Operations:
1. Mth02_ContVar_Summ_ByGrp_1_n - Count of non-missing values (n)
2. Mth02_ContVar_Summ_ByGrp_2_Mean - Mean (Mean)
3. Mth02_ContVar_Summ_ByGrp_3_SD - Standard deviation (SD)
4. Mth02_ContVar_Summ_ByGrp_4_Median - Median (Median)
5. Mth02_ContVar_Summ_ByGrp_5_Q1 - First quartile (Q1)
6. Mth02_ContVar_Summ_ByGrp_6_Q3 - Third quartile (Q3)
7. Mth02_ContVar_Summ_ByGrp_7_Min - Minimum (Min)
8. 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 (Age)
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: 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: N]:
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.AGE
Method: Mth04_ContVar_Comp_Anova - Analysis of variance group comparison for a continuous variable (ANOVA group comparison for continuous variable)
Comparison of groups by analysis of variance (ANOVA) for a continuous variable
Operations:
1. 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 - Summary of Subjects by Treatment and Age Group (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: 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'
2. AnlsGrouping_03_AgeGp - Age Group
Grouping Variable: ADSL.AGEGR1
Groups [Results per group: Y]:
1. AnlsGrouping_03_AgeGp_1 - < 65 years
Selection Criteria: ADSL.AGEGR1 EQ '<65'
2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
Selection Criteria: ADSL.AGEGR1 IN ('65-80', '>80')
Analysis Variable: ADSL.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
1.3.2. Comparison of Subjects by Treatment
Analysis: An03_02_AgeGrp_Comp_ByTrt - Comparison of Age Group by Treatment (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: 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: N]:
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'
2. AnlsGrouping_03_AgeGp - Age Group
Grouping Variable: ADSL.AGEGR1
Groups [Results per group: N]:
1. AnlsGrouping_03_AgeGp_1 - < 65 years
Selection Criteria: ADSL.AGEGR1 EQ '<65'
2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
Selection Criteria: ADSL.AGEGR1 IN ('65-80', '>80')
Analysis Variable: ADSL.USUBJID
Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
Comparison of groups by Pearson's chi-square test for a categorical variable
Operations:
1. 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 (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: 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'
2. AnlsGrouping_02_Sex - Gender
Grouping Variable: ADSL.SEX
Groups [Results per group: Y]:
1. AnlsGrouping_02_Sex_1 - Male
Selection Criteria: ADSL.SEX EQ 'M'
2. AnlsGrouping_02_Sex_2 - Female
Selection Criteria: ADSL.SEX EQ 'F'
Analysis Variable: ADSL.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
1.4.2. Comparison of Subjects by Treatment
Analysis: An03_03_Sex_Comp_ByTrt - Comparison of Sex by Treatment (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: 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: N]:
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'
2. AnlsGrouping_02_Sex - Gender
Grouping Variable: ADSL.SEX
Groups [Results per group: N]:
1. AnlsGrouping_02_Sex_1 - Male
Selection Criteria: ADSL.SEX EQ 'M'
2. AnlsGrouping_02_Sex_2 - Female
Selection Criteria: ADSL.SEX EQ 'F'
Analysis Variable: ADSL.USUBJID
Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
Comparison of groups by Pearson's chi-square test for a categorical variable
Operations:
1. 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 (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: 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'
2. AnlsGrouping_05_Ethnic - Ethnicity
Grouping Variable: ADSL.ETHNIC
Groups [Results per group: Y]:
1. AnlsGrouping_05_Ethnic_1 - Hispanic or Latino
Selection Criteria: ADSL.ETHNIC EQ 'HISPANIC OR LATINO'
2. AnlsGrouping_05_Ethnic_2 - Not Hispanic or Latino
Selection Criteria: ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO'
Analysis Variable: ADSL.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
1.5.2. Comparison of Subjects by Treatment
Analysis: An03_04_Ethnic_Comp_ByTrt - Comparison of Ethnicity by Treatment (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: 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: N]:
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'
2. AnlsGrouping_05_Ethnic - Ethnicity
Grouping Variable: ADSL.ETHNIC
Groups [Results per group: N]:
1. AnlsGrouping_05_Ethnic_1 - Hispanic or Latino
Selection Criteria: ADSL.ETHNIC EQ 'HISPANIC OR LATINO'
2. AnlsGrouping_05_Ethnic_2 - Not Hispanic or Latino
Selection Criteria: ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO'
Analysis Variable: ADSL.USUBJID
Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
Comparison of groups by Pearson's chi-square test for a categorical variable
Operations:
1. 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 (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: 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'
2. AnlsGrouping_04_Race - Primary Race
Grouping Variable: ADSL.RACE
Groups [Results per group: Y]:
1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native
Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'
2. AnlsGrouping_04_Race_2 - Asian
Selection Criteria: ADSL.RACE EQ 'ASIAN'
3. AnlsGrouping_04_Race_3 - Black or African American
Selection Criteria: ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN'
4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander
Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'
5. AnlsGrouping_04_Race_5 - White
Selection Criteria: ADSL.RACE EQ 'WHITE'
6. AnlsGrouping_04_Race_6 - Multiple
Selection Criteria: ADSL.RACE EQ 'MULTIPLE'
7. AnlsGrouping_04_Race_7 - Not Reported
Selection Criteria: ADSL.RACE EQ 'NOT REPORTED'
8. AnlsGrouping_04_Race_8 - Unknown
Selection Criteria: ADSL.RACE EQ 'UNKNOWN'
9. AnlsGrouping_04_Race_9 - Other
Selection Criteria: ADSL.RACE EQ 'OTHER'
Analysis Variable: ADSL.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
1.6.2. Comparison of Subjects by Treatment
Analysis: An03_05_Race_Comp_ByTrt - Comparison of Race by Treatment (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: 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: N]:
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'
2. AnlsGrouping_04_Race - Primary Race
Grouping Variable: ADSL.RACE
Groups [Results per group: N]:
1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native
Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'
2. AnlsGrouping_04_Race_2 - Asian
Selection Criteria: ADSL.RACE EQ 'ASIAN'
3. AnlsGrouping_04_Race_3 - Black or African American
Selection Criteria: ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN'
4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander
Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'
5. AnlsGrouping_04_Race_5 - White
Selection Criteria: ADSL.RACE EQ 'WHITE'
6. AnlsGrouping_04_Race_6 - Multiple
Selection Criteria: ADSL.RACE EQ 'MULTIPLE'
7. AnlsGrouping_04_Race_7 - Not Reported
Selection Criteria: ADSL.RACE EQ 'NOT REPORTED'
8. AnlsGrouping_04_Race_8 - Unknown
Selection Criteria: ADSL.RACE EQ 'UNKNOWN'
9. AnlsGrouping_04_Race_9 - Other
Selection Criteria: ADSL.RACE EQ 'OTHER'
Analysis Variable: ADSL.USUBJID
Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
Comparison of groups by Pearson's chi-square test for a categorical variable
Operations:
1. 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 (Height)
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: 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.HEIGHTBL
Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
Descriptive summary statistics across groups for a continuous variable
Operations:
1. Mth02_ContVar_Summ_ByGrp_1_n - Count of non-missing values (n)
2. Mth02_ContVar_Summ_ByGrp_2_Mean - Mean (Mean)
3. Mth02_ContVar_Summ_ByGrp_3_SD - Standard deviation (SD)
4. Mth02_ContVar_Summ_ByGrp_4_Median - Median (Median)
5. Mth02_ContVar_Summ_ByGrp_5_Q1 - First quartile (Q1)
6. Mth02_ContVar_Summ_ByGrp_6_Q3 - Third quartile (Q3)
7. Mth02_ContVar_Summ_ByGrp_7_Min - Minimum (Min)
8. 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 (Height)
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: 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: N]:
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.HEIGHTBL
Method: Mth04_ContVar_Comp_Anova - Analysis of variance group comparison for a continuous variable (ANOVA group comparison for continuous variable)
Comparison of groups by analysis of variance (ANOVA) for a continuous variable
Operations:
1. Mth04_ContVar_Comp_Anova_1_pval - P-value (p-value)