...
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
> FootnoteFooter:
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.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. Placebo [ 1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. 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: Safety 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. Placebo [ 1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. Xanomeline High 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: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Groupings:
1. Treatment [Results per group: N]:AnlsGrouping_01_Trt - Treatment
1. Placebo [Grouping Variable: ADSL.TRT01A EQ 'Placebo']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']Groups [Results per group: N]:
3. Xanomeline High Dose [ 1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High DosePlacebo']
Analysis Variable: ADSL.AGE 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Method: Analysis of variance group comparison for a continuous variable
Operations: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
> 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)
Documentation: 3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
Reason: SPECIFIED IN SAPAnalysis Variable: ADSL.AGE
Purpose: PRIMARY OUTCOME MEASUREMethod: Mth04_ContVar_Comp_Anova - Analysis of variance group comparison for a continuous variable (ANOVA group comparison for continuous variable)
See:
> Statistical Analysis Plan (./sap.pdf)Comparison of groups by analysis of variance (ANOVA) for a continuous variable
- Page 13 [9.2. Demographic and Baseline Characteristics]
CategoriesOperations:
> Population Description
> Subject-level
> Demographics1. Mth04_ContVar_Comp_Anova_1_pval - P-value (p-value)
1.3. Age Group
1.3.1. Summary of Subjects by Treatment
Population: Safety Population [ADSL.SAFFL EQ 'Y']Analysis: An03_02_AgeGrp_Summ_ByTrt - Summary of Subjects by Treatment and Age Group (Age Group)
GroupingsDocumentation:
1. Treatment [Results per group: Y]:Reason: SPECIFIED IN SAP
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 Group [Results per group: Y]Categories:
1. < 65 years [ADSL.AGEGR1 EQ '<65']> Population Description
2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]> Subject-level
Analysis Variable: ADSL.USUBJID > Demographics
Method: Summary by group of a categorical variablePopulation: AnalysisSet_02_SAF - Safety Population (SAF)
Operations:Selection Criteria: ADSL.SAFFL EQ 'Y'
> Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)Groupings:
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)1. AnlsGrouping_01_Trt - Treatment
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisGrouping Variable: ADSL.TRT01A
- 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)Groups [Results per group: Y]:
1. AnlsGrouping_01_Trt_1 - Placebo
Documentation:
Reason: SPECIFIED IN SAP Selection Criteria: ADSL.TRT01A EQ 'Placebo'
Purpose: PRIMARY OUTCOME MEASURE
2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
See:
> Statistical Analysis Plan (./sap.pdf) Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
- Page 13 [9.2. Demographic and Baseline Characteristics]3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
Categories: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
> Population Description
2. AnlsGrouping_03_AgeGp - Age Group
> Subject-levelGrouping Variable: ADSL.AGEGR1
> Demographics
Population: Safety Population [ADSL.SAFFL EQ 'Y'] Groups [Results per group: Y]:
Groupings:
1. Treatment [Results per group: N]:1. AnlsGrouping_03_AgeGp_1 - < 65 years
1. Placebo [ Selection Criteria: ADSL.TRT01A AGEGR1 EQ 'Placebo<65']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose'] 2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'] Selection Criteria: ADSL.AGEGR1 IN '65-80 | >80'
2. Age Group [Results per group: N]:Analysis Variable: ADSL.USUBJID
1. < 65 years [ADSL.AGEGR1 EQ '<65']
2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
Analysis Variable: ADSL.USUBJID
Method: Pearson's chi-square test group comparison Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
Operations:
> Mth031. Mth01_CatVar_CompSumm_PChiSqByGrp_1_pval: P-value (p-valuen - Count of subjects (n)
1.4. Sex
1.4.1. Summary of Subjects by Treatment
Analysis: An03_03_Sex_Summ_ByTrt (Summary of Subjects by Treatment and Sex)
2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
Documentation: - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
Reason: - 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: Safety 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: YN]:
1. Placebo [ADSL.TRT01A EQ 'Placebo'] 1. AnlsGrouping_01_Trt_1 - Placebo
2. Xanomeline Low Dose [ Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low DosePlacebo']
3. Xanomeline High Dose [ 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Low Dose']
2. Gender [Results per group: Y]: 3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
1. Male [ Selection Criteria: ADSL.SEX TRT01A EQ 'MXanomeline High Dose']
2. Female [ADSL.SEX EQ 'F']2. AnlsGrouping_03_AgeGp - Age Group
Analysis Grouping Variable: ADSL.USUBJIDAGEGR1
Method: Summary by group of a categorical variableGroups [Results per group: N]:
Operations:
1. AnlsGrouping_03_AgeGp_1 - < 65 years
> Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n) Selection Criteria: ADSL.AGEGR1 EQ '<65'
> Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%) 2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis Selection Criteria: ADSL.AGEGR1 IN '65-80 | >80'
Analysis Variable: ADSL.USUBJID
- Denominator: result of operation Mth01 Method: Mth03_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)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
Documentation:
Reason: SPECIFIED IN SAP Operations:
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 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_SummComp_ByTrt (Summary - Comparison of Subjects Ethnicity 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 [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Groupings:
1. AnlsGrouping_01_Trt - Treatment
GroupingsGrouping Variable: ADSL.TRT01A
1. Treatment Groups [Results per group: YN]:
1. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. Xanomeline High 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: YN]:
1. 1. AnlsGrouping_05_Ethnic_1 - Hispanic or Latino [
Selection Criteria: ADSL.ETHNIC EQ 'HISPANIC OR LATINO']
2. 2. AnlsGrouping_05_Ethnic_2 - Not Hispanic or Latino [
Selection Criteria: 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 (%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)
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis Comparison of groups by Pearson's chi-square test for a categorical variable
- Denominator: result of operation Mth01Operations:
1. Mth03_CatVar_CountComp_ByGrpPChiSq_1_n for analysis An01_05_SAF_Summ_ByTrtpval - P-value (p-value)
1.6. Race
1.56.21. Comparison Summary of Subjects by Treatment
Analysis: An03_0405_EthnicRace_CompSumm_ByTrt (Comparison - Summary of Ethnicity 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: Safety Population [ADSL.SAFFL EQ 'Y']
Groupings:
1. Treatment [Results per group: N]Categories:
1. Placebo [ADSL.TRT01A EQ 'Placebo']> Population Description
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']> Subject-level
3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']> Demographics
2. Ethnicity [Results per group: N]:Population: AnalysisSet_02_SAF - Safety Population (SAF)
1. Hispanic or Latino [Selection Criteria: ADSL.ETHNIC SAFFL EQ 'HISPANIC OR LATINOY']
Groupings:
2. Not Hispanic or Latino [ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
1. AnlsGrouping_01_Trt - Treatment
Analysis Grouping Variable: ADSL.USUBJIDTRT01A
Method: Pearson's chi-square test group comparison for a categorical variable
Operations Groups [Results per group: Y]:
> 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 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
Purpose: PRIMARY OUTCOME MEASURE Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
See:2. AnlsGrouping_04_Race - Primary Race
> Statistical Analysis Plan (./sap.pdf)Grouping Variable: ADSL.RACE
- Page 13 [9.2. Demographic and Baseline Characteristics]Groups [Results per group: Y]:
Categories: 1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native
> Population Description Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'
> Subject-level 2. AnlsGrouping_04_Race_2 - Asian
> Demographics
Population: Safety Population [ Selection Criteria: ADSL.SAFFL RACE EQ 'YASIAN']
Groupings:
1. Treatment [Results per group: Y]:
3. AnlsGrouping_04_Race_3 - Black or African American
1. Placebo [ Selection Criteria: ADSL.TRT01A RACE EQ 'PlaceboBLACK OR AFRICAN AMERICAN']
2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander
3. Xanomeline High Dose [ Selection Criteria: ADSL.TRT01A RACE EQ 'Xanomeline High Dose']NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'
2. Primary Race [Results per group: Y]: 5. AnlsGrouping_04_Race_5 - White
1. American Indian or Alaska Native [ Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVEWHITE']
2. Asian [ 6. AnlsGrouping_04_Race_6 - Multiple
Selection Criteria: ADSL.RACE EQ 'ASIANMULTIPLE']
3. Black or African American [ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN'] 7. AnlsGrouping_04_Race_7 - Not Reported
4. Native Hawaiian or Other Pacific Islander [ Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
NOT REPORTED'
5. White [ADSL.RACE EQ 'WHITE']
8. AnlsGrouping_04_Race_8 - Unknown
6. Multiple [ Selection Criteria: ADSL.RACE EQ 'MULTIPLEUNKNOWN']
7. Not Reported [ADSL.RACE EQ 'NOT REPORTED'] 9. AnlsGrouping_04_Race_9 - Other
8. Unknown [ Selection Criteria: ADSL.RACE EQ 'UNKNOWNOTHER']
9. Other [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)
Analysis Variable: ADSL.USUBJID
Method: Summary by group of 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: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Groupings:
1. AnlsGrouping_01_Trt - Treatment
Groupings: Grouping Variable: ADSL.TRT01A
1. Treatment Groups [Results per group: N]:
1. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'Xanomeline Low Dose']
3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
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. 1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native [
Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE']ALASKA NATIVE'
2. AnlsGrouping_04_Race_2 - Asian
2. Asian [ Selection Criteria: ADSL.RACE EQ 'ASIAN']
3. 3. AnlsGrouping_04_Race_3 - Black or African American [
Selection Criteria: ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']
4. 4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander [
Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']PACIFIC ISLANDER'
5. AnlsGrouping_04_Race_5 - White
5. White [ Selection Criteria: ADSL.RACE EQ 'WHITE']
6. Multiple [ 6. AnlsGrouping_04_Race_6 - Multiple
Selection Criteria: ADSL.RACE EQ 'MULTIPLE']
7. Not Reported [ 7. AnlsGrouping_04_Race_7 - Not Reported
Selection Criteria: ADSL.RACE EQ 'NOT REPORTED']
8. AnlsGrouping_04_Race_8 - Unknown
8. Unknown [ Selection Criteria: ADSL.RACE EQ 'UNKNOWN']
9. Other [9. AnlsGrouping_04_Race_9 - Other
Selection Criteria: ADSL.RACE EQ 'OTHER']
Analysis Variable: ADSL.USUBJID
Method: 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 group comparison 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: Safety 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. Placebo [ 1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']
2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. 3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
Analysis Variable: ADSL.HEIGHTBL
HEIGHTBL
Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
Method: Summary by group of 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)
> Demographics
Population: Safety Population [Selection Criteria: ADSL.SAFFL EQ 'Y']
Groupings:
1. AnlsGrouping_01_Trt - Treatment
Grouping Variable: ADSL.TRT01A
Groups [Results per group: N]:
1. Placebo [ 1. AnlsGrouping_01_Trt_1 - Placebo
Selection Criteria: ADSL.TRT01A EQ 'Placebo']'
2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
2. Xanomeline Low Dose [ Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
3. 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)
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