Summary of Vital Signs Change from Baseline at End of Treatment

The same measurements as a change from each subject's own observed Week 0 value.

Slug: t-vitals-change
Regulatory ID: VST02
Type: Table
E3 position: §14.3.5
Status: evidenced
Current iteration: v001
Datasets: advs, adsl
Evidence: 5/5 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 14.3.5.2
Post-Text Display Package Table 14.3.5.2

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-change · 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 Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Systolic Blood Pressure (mmHg)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-2.1 (14.73)	-0.3 (17.19)	-5.6 (17.18)
Median	-4.0	2.0	-7.0
Min, Max	-28.0, 50.0	-48.0, 30.0	-36.0, 26.0
End of treatment
n	83	84	82
Mean (SD)	-2.0 (16.76)	-3.1 (16.57)	-5.8 (14.48)
Median	-4.0	-2.0	-8.0
Min, Max	-32.0, 50.0	-48.0, 34.0	-36.0, 29.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-1.7 (16.87)	-0.1 (17.73)	-6.3 (19.49)
Median	0.0	-1.0	-9.0
Min, Max	-32.0, 40.0	-30.0, 48.0	-36.0, 42.0
End of treatment
n	83	84	82
Mean (SD)	-1.6 (17.76)	-2.8 (17.40)	-6.7 (16.98)
Median	0.0	-1.5	-8.0
Min, Max	-46.0, 48.0	-52.0, 48.0	-44.0, 42.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-1.0 (15.80)	-0.1 (16.20)	-9.0 (16.88)
Median	-3.5	0.0	-8.0
Min, Max	-36.0, 38.0	-30.0, 30.0	-40.0, 30.0
End of treatment
n	83	83	81
Mean (SD)	-2.5 (16.61)	-3.5 (16.51)	-8.3 (15.21)
Median	-4.0	-4.0	-8.0
Min, Max	-40.0, 48.0	-52.0, 60.0	-40.0, 30.0
Diastolic Blood Pressure (mmHg)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-0.8 (10.82)	-0.9 (7.71)	-2.2 (9.20)
Median	-0.5	-2.0	-1.0
Min, Max	-18.0, 41.0	-20.0, 16.0	-20.0, 21.0
End of treatment
n	83	84	82
Mean (SD)	-1.0 (10.99)	-2.0 (8.80)	-3.1 (8.79)
Median	0.0	-2.0	-4.0
Min, Max	-34.0, 41.0	-30.0, 18.0	-24.0, 21.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-2.3 (10.08)	1.0 (7.30)	-2.3 (10.85)
Median	-4.0	2.0	-7.0
Min, Max	-23.0, 24.0	-20.0, 18.0	-18.0, 22.0
End of treatment
n	83	84	82
Mean (SD)	-2.8 (10.17)	-1.2 (8.93)	-2.1 (12.10)
Median	-2.0	0.0	-2.0
Min, Max	-34.0, 24.0	-30.0, 20.0	-34.0, 28.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-2.3 (9.56)	-1.6 (8.29)	-2.1 (9.77)
Median	-3.5	0.0	-3.5
Min, Max	-22.0, 20.0	-20.0, 10.0	-20.0, 16.0
End of treatment
n	83	83	81
Mean (SD)	-2.7 (9.36)	-1.8 (9.69)	-2.6 (10.81)
Median	-2.0	-1.0	-2.0
Min, Max	-30.0, 20.0	-24.0, 38.0	-40.0, 27.0
Pulse (beats/min)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-0.3 (8.77)	-1.6 (10.53)	-2.0 (11.16)
Median	-1.0	0.0	-2.0
Min, Max	-24.0, 24.0	-24.0, 25.0	-34.0, 20.0
End of treatment
n	83	84	82
Mean (SD)	-0.9 (8.69)	-1.0 (11.12)	-1.7 (8.95)
Median	-1.0	-0.5	-2.0
Min, Max	-24.0, 24.0	-24.0, 32.0	-34.0, 20.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-1.7 (11.72)	-1.3 (9.05)	-1.8 (13.41)
Median	0.5	0.0	-3.0
Min, Max	-53.0, 18.0	-20.0, 12.0	-36.0, 20.0
End of treatment
n	83	84	82
Mean (SD)	-1.8 (11.05)	-0.5 (11.69)	-2.1 (10.43)
Median	-1.0	0.0	-1.5
Min, Max	-53.0, 20.0	-24.0, 34.0	-36.0, 22.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-1.5 (10.47)	-2.1 (8.77)	-2.7 (11.12)
Median	0.0	-2.0	-2.0
Min, Max	-46.0, 14.0	-20.0, 16.0	-40.0, 14.0
End of treatment
n	83	83	81
Mean (SD)	-1.0 (9.89)	-0.7 (10.73)	-1.9 (9.49)
Median	0.0	-1.0	-1.0
Min, Max	-46.0, 18.0	-22.0, 29.0	-40.0, 20.0
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.
Change from baseline is the subject's value minus that subject's own observed Week 0 value in the same position. A subject with no Week 0 measurement contributes to no row here, so n can be one below the corresponding n in the vital signs summary.
n is the number of subjects contributing a change; 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-change (post_text variant); generated from the committed ARD.

Rendered from outputs/t-vitals-change/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_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.12068965517241
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	14.732798576713
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-4
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	8
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-28
sbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	50
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.259259259259259
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	17.190320605129
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	2
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-8
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-48
sbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	30
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-5.6
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	17.1797796140174
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-7
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-16
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	8
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-36
sbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	26
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	83
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.01204819277108
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	16.7619589459277
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-4
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-14
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	8
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-32
sbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	50
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	84
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-3.13095238095238
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	16.5716987385736
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-2
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-13
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-48
sbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	34
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	82
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-5.80487804878048
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	14.4764082445874
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-8
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-15
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	5
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-36
sbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	29
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-1.68965517241379
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	16.8712429440009
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	0
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-14
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-32
sbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	40
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.148148148148148
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	17.7280822506243
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-1
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-11
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-30
sbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	48
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-6.33333333333333
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	19.4906402529846
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-9
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-20
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-36
sbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	42
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	83
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-1.63855421686747
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	17.7589402515981
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	0
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-12
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-46
sbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	48
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	84
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.78571428571429
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	17.3982906157794
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-1.5
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-12
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	7
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-52
sbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	48
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	82
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-6.65853658536586
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	16.9779955717525
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-8
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-20
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-44
sbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	42
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.982758620689655
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	15.8030547561199
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-3.5
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-12
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	7
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-36
sbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	38
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.148148148148148
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	16.2047089635264
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	0
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	10
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-30
sbp_stand3_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	30
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-8.96666666666667
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	16.8839514359629
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-8
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-20
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	1
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-40
sbp_stand3_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	30
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	83
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.53012048192771
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	16.6054188550353
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-4
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-12
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	6
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-40
sbp_stand3_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	48
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	83
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-3.49397590361446
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	16.5126510952825
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-4
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-12
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-52
sbp_stand3_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	60
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	81
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-8.25925925925926
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	15.2108331278876
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-8
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-20
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	2
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-40
sbp_stand3_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	30
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.793103448275862
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	10.8203165318192
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-0.5
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-18
dbp_lying_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	41
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.888888888888889
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	7.71279323508542
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-2
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-6
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-20
dbp_lying_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	16
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.16666666666667
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	9.20301050194177
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-1
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-8
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	2
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-20
dbp_lying_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	21
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	83
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.975903614457831
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	10.9866614290443
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	0
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-34
dbp_lying_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	41
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	84
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.01190476190476
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	8.8037424238513
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-2
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-6.5
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-30
dbp_lying_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	18
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	82
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-3.09756097560976
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	8.79479329145637
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-4
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-9
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	2
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-24
dbp_lying_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	21
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.25862068965517
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	10.0813538926942
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-4
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-23
dbp_stand1_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	24
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	1
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	7.29594197007962
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	2
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-2
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	6
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-20
dbp_stand1_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	18
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.33333333333333
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	10.8511347994936
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-7
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	8
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-18
dbp_stand1_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	22
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	83
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.83132530120482
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	10.1738776897772
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	-2
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-34
dbp_stand1_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	24
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	84
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-1.21428571428571
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	8.93493404965032
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	0
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-6
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-30
dbp_stand1_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	20
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	82
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-2.10975609756098
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	12.1004092345458
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-2
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-10
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	4
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-34
dbp_stand1_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	28
dbp_stand3_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	58

Showing the first 250 of 441 rows — the full ARD is committed beside the display.

Schema: opencsr/ard/v1
Generated: 2026-08-27T04:06:03Z
Spec hash: sha256:0d204e9c533b1d93eb583c63b8aa9eac5db5b6c58b7ea53e4609d472abbd2f6b
Display hash: sha256:590c09c0f2481bc89ee2e9f5bd6011a95861fbd02fad072b4771518acf4af54c
ARD file: outputs/t-vitals-change/v001/ard.json
ARD hash: sha256:2561647451f1514c5997684dc2d556425f683ddb34689f60dd767741d14d3777

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-change/analysis.yaml

# ------------------------------------------------------------------------------
# t-vitals-change — Summary of Vital Signs Change from Baseline at End of Treatment
# ------------------------------------------------------------------------------
# Target: Table 14-7.02 of the CDISCPILOT01 clinical study report (27 June 2006).
#
# Eighteen summaries: three measures (systolic and diastolic blood pressure,
# pulse) x three positions x two post-baseline 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.
#
# CHGBL is the subject's value minus that subject's own observed Week 0 value in
# the same position, derived in prepare_data(). A subject with no Week 0
# measurement has no change and is absent from every row here, which is why the
# n on a change row can be one below the n on the matching value row in t-vitals.
#
# 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-change
title: "Summary of Vital Signs Change from Baseline at End of Treatment"
regulatory_id: VST02
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_wk24
    method: continuous
    label: "Systolic Blood Pressure (mmHg) — After lying down for 5 minutes — Week 24"
    variables: [CHGBL]
    filter: 'PARAMCD == "SYSBP" & ATPT == "AFTER LYING DOWN FOR 5 MINUTES" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(CHGBL)'

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

library/tfl/t-vitals-change/display.yaml

id: t-vitals-change
title: "Summary of Vital Signs Change from Baseline at 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."
  - "Change from baseline is the subject's value minus that subject's own observed Week 0 value in the same position. A subject with no Week 0 measurement contributes to no row here, so n can be one below the corresponding n in the vital signs summary."
  - "n is the number of subjects contributing a change; 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: "Week 24", section: true, indent: 2 }
  - { analysis: sbp_lying_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_lying_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: sbp_lying_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_lying_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_lying_eot, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_lying_eot, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }

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

  - { label: "After standing for 3 minutes", section: true, indent: 1 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: sbp_stand3_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand3_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: sbp_stand3_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: sbp_stand3_eot, variable: CHGBL, 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: "Week 24", section: true, indent: 2 }
  - { analysis: dbp_lying_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_lying_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: dbp_lying_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_lying_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_lying_eot, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_lying_eot, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }

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

  - { label: "After standing for 3 minutes", section: true, indent: 1 }
  - { label: "Week 24", section: true, indent: 2 }
  - { analysis: dbp_stand3_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand3_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: dbp_stand3_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: dbp_stand3_eot, variable: CHGBL, 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: "Week 24", section: true, indent: 2 }
  - { analysis: pulse_lying_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_lying_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }
  - { label: "End of treatment", section: true, indent: 2 }
  - { analysis: pulse_lying_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 3 }
  - { analysis: pulse_lying_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 3 }
  - { analysis: pulse_lying_eot, variable: CHGBL, pattern: median, label: "Median", indent: 3 }
  - { analysis: pulse_lying_eot, variable: CHGBL, pattern: range, label: "Min, Max", indent: 3 }

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

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

variants:
  post_text: {}

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