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4. Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs (Horizontal)
Output: Out14-3-3-1a (- Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs Horizontal)
Categories:
> Safety
> Vital Signs
Output File(s):
> RTF Format: t14-3-3-1-vitals-chgbl (RTF) (./t14-3-3-1-vitals-chgbl.rtf)
> PDF Format: t14-3-3-1-vitals-chgbl (PDF) (./t14-3-3-1-vitals-chgbl.pdf)
Displays:
1. Disp14-3-3-1a - Vitals Change from Baseline (Vitals_ChgBl)
Display Title: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
Sections:
> Header:
1. Study - CDISC 360
2. Page x of y
> Title:
1. Table 14.3.3.1a
2. Summary of Observed and Change from Baseline by Scheduled Visits – Vital Signs
3. Safety Population
> Legend:
1. Note: Baseline is defined as the last assessment that is non-missing prior to first dose of investigational product.
> FootnoteFooter:
1. Source dataset: advs, Generated on: DDMONYYYY:HH:MM
2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
> Rowlabel Header:
1. Parameter (Units)
2. Visit
4.1. 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. 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)
4.2. Summary of Observed Value by Treatment, Parameter and Visit
Analysis: An08_01_Obs_Summ_ByTrt (- Summary of Observed Value by Treatment, Parameter and Visit)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Pages 9 and 17 [Sections 7 (General Considerations) and 11.6 (Other Safety Measures)]
Categories:
> Safety
> Findings
> Vital Signs
> Change from Baseline
Population: AnalysisSet_02_SAF - Safety Population [(SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Dss09_VS_AnRec - Vital Signs Analysis Records [
Selection Criteria: ADVS.ANL01FL 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']
2. AnlsGrouping_08_Param - Parameter
Grouping Variable: ADVS.PARAMCD
Groups [Results per group: Y]:
1. 1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg) [
Selection Criteria: ADVS.PARAMCD EQ 'SYSBP']
2. 2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg) [
Selection Criteria: ADVS.PARAMCD EQ 'DIABP']
3. 3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min) [
Selection Criteria: ADVS.PARAMCD EQ 'PULSE']
4. 4. AnlsGrouping_08_Param_4 - Temperature (C) [
Selection Criteria: ADVS.PARAMCD EQ 'TEMP']
3. AnlsGrouping_09_Visit - Visit
Grouping Variable: ADVS.AVISIT
Groups [Results per group: Y]:
1. Baseline [ 1. AnlsGrouping_09_Visit_01 - Baseline
Selection Criteria: ADVS.AVISIT EQ 'Baseline']
2. Week 2 [ 2. AnlsGrouping_09_Visit_02 - Week 2
Selection Criteria: ADVS.AVISIT EQ 'Week 2']
3. Week 4 [3. AnlsGrouping_09_Visit_03 - Week 4
Selection Criteria: ADVS.AVISIT EQ 'Week 4']
4. Week 6 [4. AnlsGrouping_09_Visit_04 - Week 6
Selection Criteria: ADVS.AVISIT EQ 'Week 6']
5. Week 8 [ 5. AnlsGrouping_09_Visit_05 - Week 8
Selection Criteria: ADVS.AVISIT EQ 'Week 8']
6. Week 12 [ 6. AnlsGrouping_09_Visit_06 - Week 12
Selection Criteria: ADVS.AVISIT EQ 'Week 12']
7. Week 16 [ 7. AnlsGrouping_09_Visit_07 - Week 16
Selection Criteria: ADVS.AVISIT EQ 'Week 16']
8. Week 20 [ 8. AnlsGrouping_09_Visit_08 - Week 20
Selection Criteria: ADVS.AVISIT EQ 'Week 20']
9. Week 24 [ 9. AnlsGrouping_09_Visit_09 - Week 24
Selection Criteria: ADVS.AVISIT EQ 'Week 24']
10. Week 26 [ 10. AnlsGrouping_09_Visit_10 - Week 26
Selection Criteria: ADVS.AVISIT EQ 'Week 26']
11. 11. AnlsGrouping_09_Visit_11 - End of Treatment [
Selection Criteria: ADVS.AVISIT EQ 'End of Treatment']
Analysis Variable: ADVS.AVAL
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)
4.3. Summary of Change from Baseline by Treatment, Parameter and Visit
Analysis: An08_02_ChgBl_Summ_ByTrt (- Summary of Change from Baseline by Treatment, Parameter and Visit)
Documentation:
Reason: SPECIFIED IN SAP
Purpose: PRIMARY OUTCOME MEASURE
See:
> Statistical Analysis Plan (./sap.pdf)
- Page 9 [Sections 7 (General Considerations)]
- Page 17 [11.6 (Other Safety Measures)]
> Clinical Study Report (./csr-cdiscpilot01.pdf)
- Section "Table 14-7.02"
Categories:
> Safety
> Findings
> Vital Signs
> Change from Baseline
Population: AnalysisSet_02_SAF - Safety Population [(SAF)
Selection Criteria: ADSL.SAFFL EQ 'Y']
Data Subset: Dss10_VS_NonBl_AnRec - Vital Signs Non-baseline Analysis Records [
Selection Criteria: (ADVS.ANL01FL EQ 'Y' AND ADVS.AVISIT NE 'Baseline')]
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']
2. AnlsGrouping_08_Param - Parameter
Grouping Variable: ADVS.PARAMCD
Groups [Results per group: Y]:
1. 1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg) [
Selection Criteria: ADVS.PARAMCD EQ 'SYSBP']
2. 2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg) [
Selection Criteria: ADVS.PARAMCD EQ 'DIABP']
3. 3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min) [
Selection Criteria: ADVS.PARAMCD EQ 'PULSE']
4. 4. AnlsGrouping_08_Param_4 - Temperature (C) [
Selection Criteria: ADVS.PARAMCD EQ 'TEMP']
3. AnlsGrouping_09_Visit - Visit
Grouping Variable: ADVS.AVISIT
Groups [Results per group: Y]:
1. Baseline [1. AnlsGrouping_09_Visit_01 - Baseline
Selection Criteria: ADVS.AVISIT EQ 'Baseline']
2. Week 2 [ 2. AnlsGrouping_09_Visit_02 - Week 2
Selection Criteria: ADVS.AVISIT EQ 'Week 2']
3. Week 4 [ 3. AnlsGrouping_09_Visit_03 - Week 4
Selection Criteria: ADVS.AVISIT EQ 'Week 4']
4. Week 6 [ 4. AnlsGrouping_09_Visit_04 - Week 6
Selection Criteria: ADVS.AVISIT EQ 'Week 6']
5. Week 8 [ 5. AnlsGrouping_09_Visit_05 - Week 8
Selection Criteria: ADVS.AVISIT EQ 'Week 8']
6. Week 12 [6. AnlsGrouping_09_Visit_06 - Week 12
Selection Criteria: ADVS.AVISIT EQ 'Week 12']
7. Week 16 [7. AnlsGrouping_09_Visit_07 - Week 16
Selection Criteria: ADVS.AVISIT EQ 'Week 16']
8. Week 20 [ 8. AnlsGrouping_09_Visit_08 - Week 20
Selection Criteria: ADVS.AVISIT EQ 'Week 20']
9. Week 24 [ 9. AnlsGrouping_09_Visit_09 - Week 24
Selection Criteria: ADVS.AVISIT EQ 'Week 24']
10. Week 26 [ 10. AnlsGrouping_09_Visit_10 - Week 26
Selection Criteria: ADVS.AVISIT EQ 'Week 26']
11. 11. AnlsGrouping_09_Visit_11 - End of Treatment [
Selection Criteria: ADVS.AVISIT EQ 'End of Treatment']
Analysis Variable: ADVS.CHG
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)
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