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1. Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
Output: O_T2 (Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01)
Documentation:
> Standard Safety Tables and Figures: Integrated Guide (https://downloadswww.regulations.gov/document/FDA-2022-N-1961-0046/attachment_1.pdf)
- Pages 12-13 [Table 2]
Output File(s):
> RTF Format: t2-demog (.)
> PDF Format: t2-demog (.)
Displays:
1. D_T2 (Table 2)
Display Title: Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
Sections:
> Title:
1. Table 2. Baseline Demographic and Clinical Characteristics, Safety Population, Trial CDISCPILOT01
> Footnote:
1. Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
> Rowlabel Header:
1. Characteristic
> Abbreviation:
1. 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 (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]
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:
> M_GRP_CNT_1_N: Count of subjects (n)
1.2. Sex
1.2.1. Summary of Subjects by Treatment
Analysis: A_SAF_SUM_USUBJID_TRT_SEX (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]
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:
> 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
1.3. Age
1.3.1. Summary of Age by Treatment
Analysis: A_SAF_SUM_AGE_TRT (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]
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:
> M_GRP_SUM_CONTIN_1_MEAN: Mean (Mean)
> M_GRP_SUM_CONTIN_2_SD: Standard deviation (SD)
> M_GRP_SUM_CONTIN_3_MEDIAN: Median (Median)
> M_GRP_SUM_CONTIN_4_MIN: Minimum (min)
> 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:
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. Age groups [Results per group: Y]:
1. < 65 [ADSL.AGEGR2 EQ '<65']
2. ≥ 65 [ADSL.AGEGR2 EQ '65+']
3. Age sub-groups [Results per group: Y]:
1. ≥17 to <65 [ADSL.AGEGR3 EQ '17-<65']
2. ≥ 65 to <75 [ADSL.AGEGR3 EQ '65-<75']
3. ≥ 75 [ADSL.AGEGR3 EQ '75+']
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
1.5. 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: 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. Race [Results per group: Y]:
1. American Indian or Alaska Native [ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE']
2. Black or African American [ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']
3. Native Hawaiian or Other Pacific Islander [ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
4. White [ADSL.RACE EQ 'WHITE']
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 (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: 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:
> 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
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