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 (.)
> PDF Format: t14-3-3-1-vitals-chgbl (.)
Displays:
1. Disp14-3-3-1a (Vitals_ChgBl)
Display Title: Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs
Sections:
> 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.
> Footnote:
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: 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:
> 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: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Vital Signs Analysis Records [ADVS.ANL01FL 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. Parameter [Results per group: Y]:
1. Systolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'SYSBP']
2. Diastolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'DIABP']
3. Pulse Rate (beats/min) [ADVS.PARAMCD EQ 'PULSE']
4. Temperature (C) [ADVS.PARAMCD EQ 'TEMP']
3. Visit [Results per group: Y]:
1. Baseline [ADVS.AVISIT EQ 'Baseline']
2. Week 2 [ADVS.AVISIT EQ 'Week 2']
3. Week 4 [ADVS.AVISIT EQ 'Week 4']
4. Week 6 [ADVS.AVISIT EQ 'Week 6']
5. Week 8 [ADVS.AVISIT EQ 'Week 8']
6. Week 12 [ADVS.AVISIT EQ 'Week 12']
7. Week 16 [ADVS.AVISIT EQ 'Week 16']
8. Week 20 [ADVS.AVISIT EQ 'Week 20']
9. Week 24 [ADVS.AVISIT EQ 'Week 24']
10. Week 26 [ADVS.AVISIT EQ 'Week 26']
11. End of Treatment [ADVS.AVISIT EQ 'End of Treatment']
Analysis Variable: ADVS.AVAL
Method: Summary by group of a continuous variable
Operations:
> Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
> Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
> Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
> Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
> Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
> Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
> Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
> 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: Safety Population [ADSL.SAFFL EQ 'Y']
Data Subset: Vital Signs Non-baseline Analysis Records [(ADVS.ANL01FL EQ 'Y' AND ADVS.AVISIT NE 'Baseline')]
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. Parameter [Results per group: Y]:
1. Systolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'SYSBP']
2. Diastolic Blood Pressure (mmHg) [ADVS.PARAMCD EQ 'DIABP']
3. Pulse Rate (beats/min) [ADVS.PARAMCD EQ 'PULSE']
4. Temperature (C) [ADVS.PARAMCD EQ 'TEMP']
3. Visit [Results per group: Y]:
1. Baseline [ADVS.AVISIT EQ 'Baseline']
2. Week 2 [ADVS.AVISIT EQ 'Week 2']
3. Week 4 [ADVS.AVISIT EQ 'Week 4']
4. Week 6 [ADVS.AVISIT EQ 'Week 6']
5. Week 8 [ADVS.AVISIT EQ 'Week 8']
6. Week 12 [ADVS.AVISIT EQ 'Week 12']
7. Week 16 [ADVS.AVISIT EQ 'Week 16']
8. Week 20 [ADVS.AVISIT EQ 'Week 20']
9. Week 24 [ADVS.AVISIT EQ 'Week 24']
10. Week 26 [ADVS.AVISIT EQ 'Week 26']
11. End of Treatment [ADVS.AVISIT EQ 'End of Treatment']
Analysis Variable: ADVS.CHG
Method: Summary by group of a continuous variable
Operations:
> Mth02_ContVar_Summ_ByGrp_1_n: Count of non-missing values (n)
> Mth02_ContVar_Summ_ByGrp_2_Mean: Mean (Mean)
> Mth02_ContVar_Summ_ByGrp_3_SD: Standard deviation (SD)
> Mth02_ContVar_Summ_ByGrp_4_Median: Median (Median)
> Mth02_ContVar_Summ_ByGrp_5_Q1: First quartile (Q1)
> Mth02_ContVar_Summ_ByGrp_6_Q3: Third quartile (Q3)
> Mth02_ContVar_Summ_ByGrp_7_Min: Minimum (Min)
> Mth02_ContVar_Summ_ByGrp_8_Max: Maximum (Max)