5. Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs (Vertical)
Output: Out14-3-3-1b - Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs Vertical
Categories:
> Safety
> Vital Signs
Output File(s):
> RTF Format: t14-3-3-1-vitals-chgbl-vert (RTF) (./t14-3-3-1-vitals-chgbl-vert.rtf)
> PDF Format: t14-3-3-1-vitals-chgbl-vert (PDF) (./t14-3-3-1-vitals-chgbl-vert.pdf)
Displays:
1. Disp14-3-3-1b - Vitals Change from Baseline - Vertical (Vitals_ChgBl_Vert)
Display Title: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs <Vertical Layout>
Sections:
> Header:
1. Study - CDISC 360
2. Page x of y
> Title:
1. Table 14.3.3.1b
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.
> Footer:
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
5.1. 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)
5.2. 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. 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_08_Param - Parameter
Grouping Variable: ADVS.PARAMCD
Groups [Results per group: Y]:
1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg)
Selection Criteria: ADVS.PARAMCD EQ 'SYSBP'
2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg)
Selection Criteria: ADVS.PARAMCD EQ 'DIABP'
3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min)
Selection Criteria: ADVS.PARAMCD EQ 'PULSE'
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. AnlsGrouping_09_Visit_01 - Baseline
Selection Criteria: ADVS.AVISIT EQ 'Baseline'
2. AnlsGrouping_09_Visit_02 - Week 2
Selection Criteria: ADVS.AVISIT EQ 'Week 2'
3. AnlsGrouping_09_Visit_03 - Week 4
Selection Criteria: ADVS.AVISIT EQ 'Week 4'
4. AnlsGrouping_09_Visit_04 - Week 6
Selection Criteria: ADVS.AVISIT EQ 'Week 6'
5. AnlsGrouping_09_Visit_05 - Week 8
Selection Criteria: ADVS.AVISIT EQ 'Week 8'
6. AnlsGrouping_09_Visit_06 - Week 12
Selection Criteria: ADVS.AVISIT EQ 'Week 12'
7. AnlsGrouping_09_Visit_07 - Week 16
Selection Criteria: ADVS.AVISIT EQ 'Week 16'
8. AnlsGrouping_09_Visit_08 - Week 20
Selection Criteria: ADVS.AVISIT EQ 'Week 20'
9. AnlsGrouping_09_Visit_09 - Week 24
Selection Criteria: ADVS.AVISIT EQ 'Week 24'
10. AnlsGrouping_09_Visit_10 - Week 26
Selection Criteria: ADVS.AVISIT EQ 'Week 26'
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)
5.3. 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. 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_08_Param - Parameter
Grouping Variable: ADVS.PARAMCD
Groups [Results per group: Y]:
1. AnlsGrouping_08_Param_1 - Systolic Blood Pressure (mmHg)
Selection Criteria: ADVS.PARAMCD EQ 'SYSBP'
2. AnlsGrouping_08_Param_2 - Diastolic Blood Pressure (mmHg)
Selection Criteria: ADVS.PARAMCD EQ 'DIABP'
3. AnlsGrouping_08_Param_3 - Pulse Rate (beats/min)
Selection Criteria: ADVS.PARAMCD EQ 'PULSE'
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. AnlsGrouping_09_Visit_01 - Baseline
Selection Criteria: ADVS.AVISIT EQ 'Baseline'
2. AnlsGrouping_09_Visit_02 - Week 2
Selection Criteria: ADVS.AVISIT EQ 'Week 2'
3. AnlsGrouping_09_Visit_03 - Week 4
Selection Criteria: ADVS.AVISIT EQ 'Week 4'
4. AnlsGrouping_09_Visit_04 - Week 6
Selection Criteria: ADVS.AVISIT EQ 'Week 6'
5. AnlsGrouping_09_Visit_05 - Week 8
Selection Criteria: ADVS.AVISIT EQ 'Week 8'
6. AnlsGrouping_09_Visit_06 - Week 12
Selection Criteria: ADVS.AVISIT EQ 'Week 12'
7. AnlsGrouping_09_Visit_07 - Week 16
Selection Criteria: ADVS.AVISIT EQ 'Week 16'
8. AnlsGrouping_09_Visit_08 - Week 20
Selection Criteria: ADVS.AVISIT EQ 'Week 20'
9. AnlsGrouping_09_Visit_09 - Week 24
Selection Criteria: ADVS.AVISIT EQ 'Week 24'
10. AnlsGrouping_09_Visit_10 - Week 26
Selection Criteria: ADVS.AVISIT EQ 'Week 26'
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)