VST01 · Table

Summary of Vital Signs at Baseline and End of Treatment

Blood pressure and pulse in three positions, at baseline, Week 24 and end of treatment, by planned treatment.

Slug: t-vitals
Regulatory ID: VST01
Type: Table
E3 position: §14.3.5
Status: evidenced
Current iteration: v001
Datasets: advs, adsl
Evidence: 6/6 passing
Requirements: DSP-AE-001 DSP-AE-002 DSP-AE-003 DSP-AE-004 DSP-AE-005 DSP-ALL-001 DSP-ALL-002 DSP-CM-001 DSP-CM-002 DSP-CM-003 DSP-DEMO-001 DSP-DEMO-002 DSP-DISP-001 DSP-DISP-002 DSP-EXP-001 DSP-EXP-002 DSP-SAE-001 DSP-VS-001 DSP-VS-002 DSP-VSC-001 DSP-VWC-001 DSP-VWC-002 DSP-WT-001
Used in: Clinical Study Report Table 14.3.5.1
Post-Text Display Package Table 14.3.5.1

Generated by the same pipeline run that wrote the ARD and the HTML above, from the same rendered cells; the short hash is the manifest's record of the file.

t-vitals · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Vital Signs at Baseline and End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Systolic Blood Pressure (mmHg)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	138.6 (16.75)	138.8 (16.55)	140.1 (17.82)
Median	140.0	138.0	141.0
Min, Max	90.0, 180.0	100.0, 178.0	100.0, 188.0
Week 24
n	59	27	30
Mean (SD)	135.8 (17.30)	134.1 (16.74)	132.2 (18.18)
Median	131.0	136.0	130.0
Min, Max	100.0, 180.0	100.0, 173.0	101.0, 178.0
End of treatment
n	84	84	82
Mean (SD)	136.7 (18.30)	135.7 (17.17)	134.0 (17.86)
Median	134.0	134.0	130.0
Min, Max	100.0, 180.0	100.0, 190.0	101.0, 178.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	135.3 (17.89)	135.6 (18.04)	137.3 (19.71)
Median	134.0	136.0	138.0
Min, Max	90.0, 180.0	100.0, 186.0	100.0, 194.0
Week 24
n	59	27	30
Mean (SD)	133.5 (19.23)	131.0 (17.82)	130.4 (20.83)
Median	130.0	130.0	128.0
Min, Max	90.0, 199.0	92.0, 168.0	96.0, 198.0
End of treatment
n	84	84	82
Mean (SD)	133.9 (18.68)	132.8 (17.53)	130.4 (20.37)
Median	130.5	130.0	128.0
Min, Max	90.0, 199.0	92.0, 180.0	90.0, 198.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	136.5 (18.77)	136.4 (18.11)	138.8 (18.75)
Median	136.0	134.5	138.0
Min, Max	80.0, 184.0	104.0, 182.0	100.0, 186.0
Week 24
n	59	27	30
Mean (SD)	134.8 (17.35)	131.0 (17.92)	129.2 (16.95)
Median	131.0	130.0	126.0
Min, Max	100.0, 190.0	100.0, 168.0	90.0, 172.0
End of treatment
n	84	83	81
Mean (SD)	134.1 (18.01)	133.1 (17.80)	130.4 (17.77)
Median	130.0	130.0	130.0
Min, Max	90.0, 190.0	98.0, 200.0	88.0, 184.0
Diastolic Blood Pressure (mmHg)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	75.7 (11.09)	76.3 (9.77)	77.2 (9.80)
Median	76.0	76.0	78.0
Min, Max	40.0, 99.0	57.0, 100.0	51.0, 98.0
Week 24
n	59	27	30
Mean (SD)	72.9 (11.32)	76.1 (9.14)	73.9 (9.23)
Median	74.0	76.0	74.0
Min, Max	44.0, 109.0	60.0, 90.0	60.0, 92.0
End of treatment
n	84	84	82
Mean (SD)	74.5 (11.11)	74.3 (8.88)	74.1 (9.27)
Median	76.0	74.0	74.0
Min, Max	44.0, 109.0	45.0, 90.0	56.0, 94.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	77.9 (10.63)	76.2 (10.14)	78.1 (10.77)
Median	78.0	78.0	78.0
Min, Max	51.0, 104.0	54.0, 98.0	56.0, 108.0
Week 24
n	59	27	30
Mean (SD)	74.2 (12.89)	76.3 (10.28)	74.9 (11.00)
Median	74.0	78.0	76.0
Min, Max	45.0, 117.0	60.0, 98.0	50.0, 97.0
End of treatment
n	84	84	82
Mean (SD)	74.9 (12.16)	75.0 (9.34)	75.9 (11.77)
Median	76.0	75.0	76.5
Min, Max	45.0, 117.0	51.0, 98.0	48.0, 112.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	77.7 (11.00)	76.6 (10.93)	79.6 (10.19)
Median	78.0	76.0	80.0
Min, Max	46.0, 110.0	48.0, 108.0	51.0, 104.0
Week 24
n	59	27	30
Mean (SD)	74.3 (11.38)	76.2 (10.18)	76.0 (10.63)
Median	74.0	76.0	78.5
Min, Max	51.0, 110.0	57.0, 98.0	50.0, 98.0
End of treatment
n	84	83	81
Mean (SD)	75.0 (11.19)	74.9 (9.66)	76.8 (11.71)
Median	74.5	74.0	78.0
Min, Max	51.0, 110.0	57.0, 102.0	50.0, 118.0
Pulse (beats/min)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	70.4 (10.46)	68.8 (9.52)	70.1 (9.27)
Median	70.0	68.0	68.0
Min, Max	51.0, 100.0	50.0, 88.0	52.0, 98.0
Week 24
n	59	27	30
Mean (SD)	69.1 (9.46)	68.1 (9.28)	69.3 (11.88)
Median	68.0	68.0	68.0
Min, Max	50.0, 92.0	52.0, 90.0	47.0, 96.0
End of treatment
n	84	84	82
Mean (SD)	69.3 (9.42)	67.8 (10.55)	68.1 (11.27)
Median	68.5	68.0	68.0
Min, Max	50.0, 92.0	48.0, 100.0	47.0, 100.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	75.5 (12.68)	73.5 (10.59)	75.0 (10.89)
Median	76.0	72.0	72.0
Min, Max	56.0, 133.0	53.0, 100.0	56.0, 104.0
Week 24
n	59	27	30
Mean (SD)	72.8 (8.98)	72.1 (9.53)	73.4 (11.93)
Median	74.0	74.0	72.0
Min, Max	52.0, 88.0	52.0, 88.0	54.0, 98.0
End of treatment
n	84	84	82
Mean (SD)	73.5 (9.09)	73.0 (10.84)	72.6 (11.11)
Median	74.0	73.0	71.0
Min, Max	52.0, 96.0	51.0, 104.0	52.0, 100.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	74.6 (11.94)	72.3 (10.99)	74.0 (10.76)
Median	74.0	70.0	72.0
Min, Max	54.0, 134.0	51.0, 104.0	52.0, 100.0
Week 24
n	59	27	30
Mean (SD)	72.8 (8.73)	70.7 (10.78)	72.4 (11.92)
Median	74.0	72.0	71.5
Min, Max	56.0, 88.0	52.0, 96.0	54.0, 96.0
End of treatment
n	84	83	81
Mean (SD)	73.4 (9.08)	71.6 (10.42)	71.8 (10.76)
Median	74.0	72.0	70.0
Min, Max	56.0, 98.0	52.0, 97.0	54.0, 106.0
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Blood pressure and pulse are measured in three positions and each position is summarised as its own series: a subject's baseline after standing for three minutes is not the baseline for their supine measurement.
End of treatment is the last observed measurement of that parameter in that position, at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set.
Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-vitals (post_text variant); generated from the committed ARD.

Rendered from outputs/t-vitals/v001/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	n	n	—	—	86
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	N	N	—	—	86
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	p	%	—	—	1
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	n	n	—	—	84
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	N	N	—	—	84
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	p	%	—	—	1
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	n	n	—	—	84
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	N	N	—	—	84
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	p	%	—	—	1
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	85
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	138.635294117647
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	16.7537110734874
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	140
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	129
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	180
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	138.797619047619
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	16.5476892150883
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	138
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	129.5
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	178
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	140.142857142857
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.8245416691225
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	141
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	129
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	188
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	135.779661016949
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	17.2956719686928
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	131
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	124
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	145
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	180
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	27
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	134.111111111111
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	16.7362649388256
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	136
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	124
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	146
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	173
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	30
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	132.233333333333
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	18.1804808808093
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	118
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	142
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	101
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	178
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	136.666666666667
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	18.3002622493115
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	134
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	124.5
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	148
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	180
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	135.666666666667
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.1677291362247
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	134
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	124.5
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	146
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	190
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	82
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	134.036585365854
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.8605331663545
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	146
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	101
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	178
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	85
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	135.305882352941
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	17.8918866485102
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	134
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	122
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand1_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	180
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	135.571428571429
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	18.0449810892921
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	136
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	121
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_stand1_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	186
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	137.345238095238
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	19.7071903259962
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	138
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	123
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	147
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_stand1_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	194
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	133.491525423729
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	19.2312361585179
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	143
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand1_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	199
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	27
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	131
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.8217671574787
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	92
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	168
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	30
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	130.433333333333
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	20.8271761016182
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	128
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	96
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	198
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	133.916666666667
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	18.6826434066123
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	130.5
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	144
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand1_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	199
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	132.785714285714
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.5328067214534
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	92
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	180
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	82
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	130.378048780488
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	20.3746636684518
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	128
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	116
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	198
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	85
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	136.482352941176
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	18.7683952714244
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	136
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	124
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	80
sbp_stand3_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	184
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	136.357142857143
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	18.1092021187278
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	134.5
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120.5
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	104
sbp_stand3_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	182
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	138.833333333333
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	18.7480654959214
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	138
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	124
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	150
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_stand3_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	186
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	134.762711864407
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	17.3516758437899
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	131
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	122
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	145
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_stand3_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	190
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	27
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	130.962962962963
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.9175064402678
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	142
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	168
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	30
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	129.2
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	16.9469761314519
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	126
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	172
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	84
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	134.130952380952
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	18.0085520259124
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	121
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	144.5
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	90
sbp_stand3_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	190
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	83
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	133.060240963855
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.8033632048735
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	122
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	144
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	98
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	200
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	81
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	130.395061728395
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.7677228509633
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	130
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	120
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	140
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	88
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	184
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	85
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	75.6941176470588
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	11.0884147278351
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	76
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	70
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	84
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	40
dbp_lying_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	99
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	76.2738095238095
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	9.76883560963644
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	76
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	70
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	82.5
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	57
dbp_lying_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	100
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	84
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	77.1547619047619
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	9.80471247358206
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	78
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	70
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	84
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	51
dbp_lying_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	98
dbp_lying_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59

Showing the first 250 of 657 rows — the full ARD is committed beside the display.

Schema: opencsr/ard/v1
Generated: 2026-08-27T04:06:01Z
Spec hash: sha256:2aeb25861d2864c68dec7cb56a37435df974e048d036e1a3a1b256a5604d4290
Display hash: sha256:faa409af7dbd05b5409f52ae6c23560eb497e6a4db308db4647ba54ad93b9ef7
ARD file: outputs/t-vitals/v001/ard.json
ARD hash: sha256:88e8ee0b9d51761c4bafa4a2b13ee72b699117f76d08849535d26674ecf8e961

Source datasets

Dataset	Rows	Package	Hash
adsl	254	pharmaverseadam 1.1.0	sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918
advs	65032	pharmaverseadam 1.1.0	sha256:7be440388501966144aa18f3d460cc9e4bb783eb8312df196aa6dfb7502e685b

Environment

R 4.3.3 · Darwin 23.6.0 · cards 0.6.1 · cardx 0.2.5 · gtsummary 2.3.0 · gt 1.0.0 · dplyr 1.1.4 · pharmaverseadam 1.1.0 · jsonlite 2.0.0 · yaml 2.3.10 · digest 0.6.37

library/tfl/t-vitals/analysis.yaml

# ------------------------------------------------------------------------------
# t-vitals — Summary of Vital Signs at Baseline and End of Treatment
# ------------------------------------------------------------------------------
# Target: Table 14-7.01 of the CDISCPILOT01 clinical study report (27 June 2006).
#
# Twenty-seven summaries: three measures (systolic and diastolic blood pressure,
# pulse) x three positions x three time points. Each is its own `analyses` entry
# because v0 supports one grouping variable, which the treatment column uses;
# measure, position and visit are therefore selection, not grouping, and each
# combination gets an addressable name of its own (`sbp_lying_bl`, ...).
#
# The reference table puts treatment in the rows and n / Mean / SD / Median /
# Min / Max in the columns. This one transposes that: treatment is the column, as
# it is everywhere else in this library, and the six statistics become four rows
# under a Measure -> Position -> Visit heading stack. The statistics are the same
# statistics; only the axis they are laid out on differs.
#
# Temperature, height, BMI, body surface area and mean arterial pressure are
# collected in ADVS and are NOT summarised here: the reference report's vital
# signs display covers blood pressure and pulse only, and Section 12.5 of its
# narrative says so.
# ------------------------------------------------------------------------------
id: t-vitals
title: "Summary of Vital Signs at Baseline and End of Treatment"
regulatory_id: VST01
type: table
dataset: advs
analysis_set: safety
denominator: adsl
group:
  - TRT01P
total: false
analyses:
  # Supplies the column denominators (N = subjects in the safety analysis set).
  # Every other analysis here reports n, the number of subjects contributing a
  # measurement at that visit, which is smaller and means something different.
  - name: population
    method: subject_count
    label: "Subjects in the safety analysis set"
    variable: POPFL

  - name: sbp_lying_bl
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After lying down for 5 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_lying_wk24
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After lying down for 5 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_lying_eot
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After lying down for 5 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

  - name: sbp_stand1_bl
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 1 minute — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_stand1_wk24
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 1 minute — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_stand1_eot
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 1 minute — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & EOTFL == "Y" & !is.na(AVAL)'

  - name: sbp_stand3_bl
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 3 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_stand3_wk24
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 3 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: sbp_stand3_eot
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After standing for 3 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

  - name: dbp_lying_bl
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After lying down for 5 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_lying_wk24
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After lying down for 5 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_lying_eot
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After lying down for 5 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

  - name: dbp_stand1_bl
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 1 minute — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_stand1_wk24
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 1 minute — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_stand1_eot
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 1 minute — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 1 MINUTE" & EOTFL == "Y" & !is.na(AVAL)'

  - name: dbp_stand3_bl
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 3 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_stand3_wk24
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 3 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: dbp_stand3_eot
    method: continuous
    label: "Diastolic Blood Pressure (mmHg) — After standing for 3 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "DIABP" & ATPT == "AFTER STANDING FOR 3 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

  - name: pulse_lying_bl
    method: continuous
    label: "Pulse (beats/min) — After lying down for 5 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_lying_wk24
    method: continuous
    label: "Pulse (beats/min) — After lying down for 5 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_lying_eot
    method: continuous
    label: "Pulse (beats/min) — After lying down for 5 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

  - name: pulse_stand1_bl
    method: continuous
    label: "Pulse (beats/min) — After standing for 1 minute — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_stand1_wk24
    method: continuous
    label: "Pulse (beats/min) — After standing for 1 minute — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 1 MINUTE" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_stand1_eot
    method: continuous
    label: "Pulse (beats/min) — After standing for 1 minute — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 1 MINUTE" & EOTFL == "Y" & !is.na(AVAL)'

  - name: pulse_stand3_bl
    method: continuous
    label: "Pulse (beats/min) — After standing for 3 minutes — Baseline"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_stand3_wk24
    method: continuous
    label: "Pulse (beats/min) — After standing for 3 minutes — Week 24"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 3 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'

  - name: pulse_stand3_eot
    method: continuous
    label: "Pulse (beats/min) — After standing for 3 minutes — End of treatment"
    variables: [AVAL]
    filter: 'PARAMCD == "PULSE" & ATPT == "AFTER STANDING FOR 3 MINUTES" & EOTFL == "Y" & !is.na(AVAL)'

library/tfl/t-vitals/display.yaml

id: t-vitals
title: "Summary of Vital Signs at Baseline and End of Treatment"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01."
footnotes:
  - "Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72."
  - "Blood pressure and pulse are measured in three positions and each position is summarised as its own series: a subject's baseline after standing for three minutes is not the baseline for their supine measurement."
  - "End of treatment is the last observed measurement of that parameter in that position, at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected."
  - "n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose"]
format:
  digits:
    # `N:` and `n:` are deliberately absent. R's YAML reader resolves BOTH bare
    # `N` and bare `n` to the boolean FALSE, so declaring the two together is a
    # duplicate-key parse error and declaring either alone silently keys the digit
    # plan under "FALSE". Counts default to zero decimals, which is what is wanted.
    p: 1
    mean: 1
    sd: 2
    median: 1
    min: 1
    max: 1
rows:
  - { label: "Systolic Blood Pressure (mmHg)", section: true }
  - { label: "After lying down for 5 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: sbp_lying_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_lying_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_lying_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_lying_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: sbp_lying_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: sbp_lying_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_lying_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_lying_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_lying_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 1 minute", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: sbp_stand1_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand1_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand1_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand1_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: sbp_stand1_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand1_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand1_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand1_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: sbp_stand1_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand1_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand1_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand1_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 3 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: sbp_stand3_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand3_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand3_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand3_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: sbp_stand3_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: sbp_stand3_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "Diastolic Blood Pressure (mmHg)", section: true }
  - { label: "After lying down for 5 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: dbp_lying_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_lying_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_lying_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_lying_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: dbp_lying_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: dbp_lying_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_lying_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_lying_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_lying_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 1 minute", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: dbp_stand1_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand1_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand1_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand1_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: dbp_stand1_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand1_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand1_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand1_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: dbp_stand1_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand1_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand1_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand1_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 3 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: dbp_stand3_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand3_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand3_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand3_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: dbp_stand3_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: dbp_stand3_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "Pulse (beats/min)", section: true }
  - { label: "After lying down for 5 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: pulse_lying_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_lying_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_lying_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_lying_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: pulse_lying_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: pulse_lying_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_lying_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_lying_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_lying_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 1 minute", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: pulse_stand1_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand1_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand1_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand1_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: pulse_stand1_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand1_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand1_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand1_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: pulse_stand1_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand1_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand1_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand1_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

  - { label: "After standing for 3 minutes", section: true, indent: 1 }
  - { label: "Baseline", section: true, indent: 2 }
  - { analysis: pulse_stand3_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand3_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand3_bl, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand3_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: pulse_stand3_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand3_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand3_wk24, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand3_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: pulse_stand3_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_stand3_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_stand3_eot, variable: AVAL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_stand3_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 3 }

variants:
  post_text: {}

Every iteration is kept: outputs/t-vitals/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.