Demographic and Baseline Characteristics

Age, sex, race and baseline characteristics by treatment arm over the safety analysis set.

Slug: t-demographics
Regulatory ID: DMT01
Type: Table
E3 position: §14.1
Status: evidenced
Current iteration: v002
Datasets: adsl
Evidence: 4/4 passing
Requirements: DSP-AE-001 DSP-AE-002 DSP-AE-003 DSP-AE-004 DSP-AE-005 DSP-ALL-001 DSP-ALL-002 DSP-DEMO-001 DSP-DEMO-002 DSP-DISP-001 DSP-DISP-002 DSP-EXP-001 DSP-EXP-002 DSP-SAE-001

RTFFull displaybfb8fa2 RTFIn-text variantb46fe1b

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

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Demographic and Baseline Characteristics
Study CDISCPILOT01 — Safety Analysis Set
Age (years)
n	86	96	72	254
Mean (SD)	75.2 (8.59)	76.0 (8.11)	73.8 (7.94)	75.1 (8.25)
Median	76.0	78.0	75.5	77.0
Min, Max	52, 89	51, 88	56, 88	51, 89
Age group, n (%)
18-64	14 (16.3%)	8 (8.3%)	11 (15.3%)	33 (13.0%)
>64	72 (83.7%)	88 (91.7%)	61 (84.7%)	221 (87.0%)
Sex, n (%)
F	53 (61.6%)	55 (57.3%)	35 (48.6%)	143 (56.3%)
M	33 (38.4%)	41 (42.7%)	37 (51.4%)	111 (43.7%)
Race, n (%)
WHITE	78 (90.7%)	90 (93.8%)	62 (86.1%)	230 (90.6%)
BLACK OR AFRICAN AMERICAN	8 (9.3%)	6 (6.3%)	9 (12.5%)	23 (9.1%)
AMERICAN INDIAN OR ALASKA NATIVE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
Ethnicity, n (%)
HISPANIC OR LATINO	3 (3.5%)	6 (6.3%)	3 (4.2%)	12 (4.7%)
NOT HISPANIC OR LATINO	83 (96.5%)	90 (93.8%)	69 (95.8%)	242 (95.3%)
Baseline weight (kg)
n	86	96	72	254
Mean (SD)	62.76 (12.77)	67.82 (14.49)	69.55 (14.35)	66.60 (14.12)
Median	60.56	66.68	68.95	66.46
Min, Max	34.02, 86.18	41.73, 106.14	44.45, 107.96	34.02, 107.96
Baseline height (cm)
Mean (SD)	162.6 (11.52)	163.7 (10.30)	165.9 (10.28)	163.9 (10.76)
Min, Max	137.2, 185.4	135.9, 195.6	146.1, 190.5	135.9, 195.6
Baseline BMI (kg/m2)
Mean (SD)	23.63 (3.67)	25.22 (4.39)	25.17 (3.97)	24.67 (4.09)
Min, Max	15.06, 33.25	15.31, 40.17	13.67, 34.57	13.67, 40.17
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Baseline weight, height and body mass index are the ADVS records flagged ABLFL = 'Y'.
Source: adsl (pharmaverseadam), baseline vital signs from advs. Data cut-off: 2014-07-01.
open.csr display t-demographics (post_text variant); generated from the committed ARD.

Rendered from outputs/t-demographics/v002/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
age	TRT01A	Placebo	—	—	AGE	—	continuous	N	N	—	—	86
age	TRT01A	Placebo	—	—	AGE	—	continuous	mean	Mean	—	—	75.2093023255814
age	TRT01A	Placebo	—	—	AGE	—	continuous	sd	SD	—	—	8.59016712714193
age	TRT01A	Placebo	—	—	AGE	—	continuous	median	Median	—	—	76
age	TRT01A	Placebo	—	—	AGE	—	continuous	p25	Q1	—	—	69
age	TRT01A	Placebo	—	—	AGE	—	continuous	p75	Q3	—	—	82
age	TRT01A	Placebo	—	—	AGE	—	continuous	min	Min	—	—	52
age	TRT01A	Placebo	—	—	AGE	—	continuous	max	Max	—	—	89
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	N	N	—	—	96
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	mean	Mean	—	—	75.9583333333333
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	sd	SD	—	—	8.11355807037846
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	median	Median	—	—	78
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	p25	Q1	—	—	71
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	p75	Q3	—	—	82
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	min	Min	—	—	51
age	TRT01A	Xanomeline Low Dose	—	—	AGE	—	continuous	max	Max	—	—	88
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	N	N	—	—	72
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	mean	Mean	—	—	73.7777777777778
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	sd	SD	—	—	7.94385620024705
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	median	Median	—	—	75.5
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	p25	Q1	—	—	70
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	p75	Q3	—	—	79
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	min	Min	—	—	56
age	TRT01A	Xanomeline High Dose	—	—	AGE	—	continuous	max	Max	—	—	88
age	TRT01A	Total	—	—	AGE	—	continuous	N	N	—	—	254
age	TRT01A	Total	—	—	AGE	—	continuous	mean	Mean	—	—	75.0866141732284
age	TRT01A	Total	—	—	AGE	—	continuous	sd	SD	—	—	8.24623389621606
age	TRT01A	Total	—	—	AGE	—	continuous	median	Median	—	—	77
age	TRT01A	Total	—	—	AGE	—	continuous	p25	Q1	—	—	70
age	TRT01A	Total	—	—	AGE	—	continuous	p75	Q3	—	—	81
age	TRT01A	Total	—	—	AGE	—	continuous	min	Min	—	—	51
age	TRT01A	Total	—	—	AGE	—	continuous	max	Max	—	—	89
agegr	TRT01A	Placebo	—	—	AGEGR1	18-64	categorical	n	n	—	—	14
agegr	TRT01A	Placebo	—	—	AGEGR1	18-64	categorical	N	N	—	—	86
agegr	TRT01A	Placebo	—	—	AGEGR1	18-64	categorical	p	%	—	—	0.162790697674419
agegr	TRT01A	Placebo	—	—	AGEGR1	>64	categorical	n	n	—	—	72
agegr	TRT01A	Placebo	—	—	AGEGR1	>64	categorical	N	N	—	—	86
agegr	TRT01A	Placebo	—	—	AGEGR1	>64	categorical	p	%	—	—	0.837209302325581
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	18-64	categorical	n	n	—	—	8
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	18-64	categorical	N	N	—	—	96
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	18-64	categorical	p	%	—	—	0.0833333333333333
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	>64	categorical	n	n	—	—	88
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	>64	categorical	N	N	—	—	96
agegr	TRT01A	Xanomeline Low Dose	—	—	AGEGR1	>64	categorical	p	%	—	—	0.916666666666667
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	18-64	categorical	n	n	—	—	11
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	18-64	categorical	N	N	—	—	72
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	18-64	categorical	p	%	—	—	0.152777777777778
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	>64	categorical	n	n	—	—	61
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	>64	categorical	N	N	—	—	72
agegr	TRT01A	Xanomeline High Dose	—	—	AGEGR1	>64	categorical	p	%	—	—	0.847222222222222
agegr	TRT01A	Total	—	—	AGEGR1	18-64	categorical	n	n	—	—	33
agegr	TRT01A	Total	—	—	AGEGR1	18-64	categorical	N	N	—	—	254
agegr	TRT01A	Total	—	—	AGEGR1	18-64	categorical	p	%	—	—	0.12992125984252
agegr	TRT01A	Total	—	—	AGEGR1	>64	categorical	n	n	—	—	221
agegr	TRT01A	Total	—	—	AGEGR1	>64	categorical	N	N	—	—	254
agegr	TRT01A	Total	—	—	AGEGR1	>64	categorical	p	%	—	—	0.87007874015748
sex	TRT01A	Placebo	—	—	SEX	F	categorical	n	n	—	—	53
sex	TRT01A	Placebo	—	—	SEX	F	categorical	N	N	—	—	86
sex	TRT01A	Placebo	—	—	SEX	F	categorical	p	%	—	—	0.616279069767442
sex	TRT01A	Placebo	—	—	SEX	M	categorical	n	n	—	—	33
sex	TRT01A	Placebo	—	—	SEX	M	categorical	N	N	—	—	86
sex	TRT01A	Placebo	—	—	SEX	M	categorical	p	%	—	—	0.383720930232558
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	F	categorical	n	n	—	—	55
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	F	categorical	N	N	—	—	96
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	F	categorical	p	%	—	—	0.572916666666667
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	M	categorical	n	n	—	—	41
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	M	categorical	N	N	—	—	96
sex	TRT01A	Xanomeline Low Dose	—	—	SEX	M	categorical	p	%	—	—	0.427083333333333
sex	TRT01A	Xanomeline High Dose	—	—	SEX	F	categorical	n	n	—	—	35
sex	TRT01A	Xanomeline High Dose	—	—	SEX	F	categorical	N	N	—	—	72
sex	TRT01A	Xanomeline High Dose	—	—	SEX	F	categorical	p	%	—	—	0.486111111111111
sex	TRT01A	Xanomeline High Dose	—	—	SEX	M	categorical	n	n	—	—	37
sex	TRT01A	Xanomeline High Dose	—	—	SEX	M	categorical	N	N	—	—	72
sex	TRT01A	Xanomeline High Dose	—	—	SEX	M	categorical	p	%	—	—	0.513888888888889
sex	TRT01A	Total	—	—	SEX	F	categorical	n	n	—	—	143
sex	TRT01A	Total	—	—	SEX	F	categorical	N	N	—	—	254
sex	TRT01A	Total	—	—	SEX	F	categorical	p	%	—	—	0.562992125984252
sex	TRT01A	Total	—	—	SEX	M	categorical	n	n	—	—	111
sex	TRT01A	Total	—	—	SEX	M	categorical	N	N	—	—	254
sex	TRT01A	Total	—	—	SEX	M	categorical	p	%	—	—	0.437007874015748
race	TRT01A	Placebo	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	n	n	—	—	0
race	TRT01A	Placebo	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	N	N	—	—	86
race	TRT01A	Placebo	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	p	%	—	—	0
race	TRT01A	Placebo	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	n	n	—	—	8
race	TRT01A	Placebo	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	N	N	—	—	86
race	TRT01A	Placebo	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	p	%	—	—	0.0930232558139535
race	TRT01A	Placebo	—	—	RACE	WHITE	categorical	n	n	—	—	78
race	TRT01A	Placebo	—	—	RACE	WHITE	categorical	N	N	—	—	86
race	TRT01A	Placebo	—	—	RACE	WHITE	categorical	p	%	—	—	0.906976744186046
race	TRT01A	Xanomeline Low Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	n	n	—	—	0
race	TRT01A	Xanomeline Low Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	N	N	—	—	96
race	TRT01A	Xanomeline Low Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	p	%	—	—	0
race	TRT01A	Xanomeline Low Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	n	n	—	—	6
race	TRT01A	Xanomeline Low Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	N	N	—	—	96
race	TRT01A	Xanomeline Low Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	p	%	—	—	0.0625
race	TRT01A	Xanomeline Low Dose	—	—	RACE	WHITE	categorical	n	n	—	—	90
race	TRT01A	Xanomeline Low Dose	—	—	RACE	WHITE	categorical	N	N	—	—	96
race	TRT01A	Xanomeline Low Dose	—	—	RACE	WHITE	categorical	p	%	—	—	0.9375
race	TRT01A	Xanomeline High Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	n	n	—	—	1
race	TRT01A	Xanomeline High Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	N	N	—	—	72
race	TRT01A	Xanomeline High Dose	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	p	%	—	—	0.0138888888888889
race	TRT01A	Xanomeline High Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	n	n	—	—	9
race	TRT01A	Xanomeline High Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	N	N	—	—	72
race	TRT01A	Xanomeline High Dose	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	p	%	—	—	0.125
race	TRT01A	Xanomeline High Dose	—	—	RACE	WHITE	categorical	n	n	—	—	62
race	TRT01A	Xanomeline High Dose	—	—	RACE	WHITE	categorical	N	N	—	—	72
race	TRT01A	Xanomeline High Dose	—	—	RACE	WHITE	categorical	p	%	—	—	0.861111111111111
race	TRT01A	Total	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	n	n	—	—	1
race	TRT01A	Total	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	N	N	—	—	254
race	TRT01A	Total	—	—	RACE	AMERICAN INDIAN OR ALASKA NATIVE	categorical	p	%	—	—	0.00393700787401575
race	TRT01A	Total	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	n	n	—	—	23
race	TRT01A	Total	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	N	N	—	—	254
race	TRT01A	Total	—	—	RACE	BLACK OR AFRICAN AMERICAN	categorical	p	%	—	—	0.0905511811023622
race	TRT01A	Total	—	—	RACE	WHITE	categorical	n	n	—	—	230
race	TRT01A	Total	—	—	RACE	WHITE	categorical	N	N	—	—	254
race	TRT01A	Total	—	—	RACE	WHITE	categorical	p	%	—	—	0.905511811023622
ethnic	TRT01A	Placebo	—	—	ETHNIC	HISPANIC OR LATINO	categorical	n	n	—	—	3
ethnic	TRT01A	Placebo	—	—	ETHNIC	HISPANIC OR LATINO	categorical	N	N	—	—	86
ethnic	TRT01A	Placebo	—	—	ETHNIC	HISPANIC OR LATINO	categorical	p	%	—	—	0.0348837209302326
ethnic	TRT01A	Placebo	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	n	n	—	—	83
ethnic	TRT01A	Placebo	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	N	N	—	—	86
ethnic	TRT01A	Placebo	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	p	%	—	—	0.965116279069767
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	n	n	—	—	6
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	N	N	—	—	96
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	p	%	—	—	0.0625
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	n	n	—	—	90
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	N	N	—	—	96
ethnic	TRT01A	Xanomeline Low Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	p	%	—	—	0.9375
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	n	n	—	—	3
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	N	N	—	—	72
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	HISPANIC OR LATINO	categorical	p	%	—	—	0.0416666666666667
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	n	n	—	—	69
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	N	N	—	—	72
ethnic	TRT01A	Xanomeline High Dose	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	p	%	—	—	0.958333333333333
ethnic	TRT01A	Total	—	—	ETHNIC	HISPANIC OR LATINO	categorical	n	n	—	—	12
ethnic	TRT01A	Total	—	—	ETHNIC	HISPANIC OR LATINO	categorical	N	N	—	—	254
ethnic	TRT01A	Total	—	—	ETHNIC	HISPANIC OR LATINO	categorical	p	%	—	—	0.047244094488189
ethnic	TRT01A	Total	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	n	n	—	—	242
ethnic	TRT01A	Total	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	N	N	—	—	254
ethnic	TRT01A	Total	—	—	ETHNIC	NOT HISPANIC OR LATINO	categorical	p	%	—	—	0.952755905511811
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	N	N	—	—	86
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	mean	Mean	—	—	62.7574418604651
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	sd	SD	—	—	12.7703880070075
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	median	Median	—	—	60.56
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	p25	Q1	—	—	53.52
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	p75	Q3	—	—	74.39
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	min	Min	—	—	34.02
baseline	TRT01A	Placebo	—	—	BLWT	—	continuous	max	Max	—	—	86.18
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	N	N	—	—	86
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	mean	Mean	—	—	162.571395348837
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	sd	SD	—	—	11.5231419492705
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	median	Median	—	—	162.56
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	p25	Q1	—	—	153.67
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	p75	Q3	—	—	171.45
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	min	Min	—	—	137.16
baseline	TRT01A	Placebo	—	—	BLHT	—	continuous	max	Max	—	—	185.42
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	N	N	—	—	86
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	mean	Mean	—	—	23.6340247242958
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	sd	SD	—	—	3.67068805833866
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	median	Median	—	—	23.3882693104772
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	p25	Q1	—	—	21.205798028709
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	p75	Q3	—	—	25.6523064037223
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	min	Min	—	—	15.0597934331963
baseline	TRT01A	Placebo	—	—	BLBMI	—	continuous	max	Max	—	—	33.2536273779884
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	N	N	—	—	96
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	mean	Mean	—	—	67.8197916666667
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	sd	SD	—	—	14.4871334550909
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	median	Median	—	—	66.68
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	p25	Q1	—	—	55.79
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	p75	Q3	—	—	78.245
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	min	Min	—	—	41.73
baseline	TRT01A	Xanomeline Low Dose	—	—	BLWT	—	continuous	max	Max	—	—	106.14
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	N	N	—	—	96
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	mean	Mean	—	—	163.695625
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	sd	SD	—	—	10.2975503282654
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	median	Median	—	—	162.56
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	p25	Q1	—	—	157.48
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	p75	Q3	—	—	170.18
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	min	Min	—	—	135.89
baseline	TRT01A	Xanomeline Low Dose	—	—	BLHT	—	continuous	max	Max	—	—	195.58
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	N	N	—	—	96
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	mean	Mean	—	—	25.2153109575443
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	sd	SD	—	—	4.3851065005798
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	median	Median	—	—	24.681383730798
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	p25	Q1	—	—	22.2701005253174
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	p75	Q3	—	—	28.2019070938943
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	min	Min	—	—	15.3092613877535
baseline	TRT01A	Xanomeline Low Dose	—	—	BLBMI	—	continuous	max	Max	—	—	40.1653635338521
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	N	N	—	—	72
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	mean	Mean	—	—	69.5470833333333
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	sd	SD	—	—	14.3530244579862
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	median	Median	—	—	68.95
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	p25	Q1	—	—	56.7
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	p75	Q3	—	—	80.29
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	min	Min	—	—	44.45
baseline	TRT01A	Xanomeline High Dose	—	—	BLWT	—	continuous	max	Max	—	—	107.96
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	N	N	—	—	72
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	mean	Mean	—	—	165.858055555556
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	sd	SD	—	—	10.2831084847699
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	median	Median	—	—	165.1
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	p25	Q1	—	—	157.48
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	p75	Q3	—	—	172.86
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	min	Min	—	—	146.05
baseline	TRT01A	Xanomeline High Dose	—	—	BLHT	—	continuous	max	Max	—	—	190.5
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	N	N	—	—	72
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	mean	Mean	—	—	25.1654524608938
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	sd	SD	—	—	3.96585623775037
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	median	Median	—	—	24.8014213274584
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	p25	Q1	—	—	22.6763323836062
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	p75	Q3	—	—	27.6420591232493
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	min	Min	—	—	13.6674544327069
baseline	TRT01A	Xanomeline High Dose	—	—	BLBMI	—	continuous	max	Max	—	—	34.5669827142123
baseline	TRT01A	Total	—	—	BLWT	—	continuous	N	N	—	—	254
baseline	TRT01A	Total	—	—	BLWT	—	continuous	mean	Mean	—	—	66.5953937007874
baseline	TRT01A	Total	—	—	BLWT	—	continuous	sd	SD	—	—	14.1232580737977
baseline	TRT01A	Total	—	—	BLWT	—	continuous	median	Median	—	—	66.455
baseline	TRT01A	Total	—	—	BLWT	—	continuous	p25	Q1	—	—	55.34
baseline	TRT01A	Total	—	—	BLWT	—	continuous	p75	Q3	—	—	77.11
baseline	TRT01A	Total	—	—	BLWT	—	continuous	min	Min	—	—	34.02
baseline	TRT01A	Total	—	—	BLWT	—	continuous	max	Max	—	—	107.96
baseline	TRT01A	Total	—	—	BLHT	—	continuous	N	N	—	—	254
baseline	TRT01A	Total	—	—	BLHT	—	continuous	mean	Mean	—	—	163.927952755906
baseline	TRT01A	Total	—	—	BLHT	—	continuous	sd	SD	—	—	10.7614565729218
baseline	TRT01A	Total	—	—	BLHT	—	continuous	median	Median	—	—	162.835
baseline	TRT01A	Total	—	—	BLHT	—	continuous	p25	Q1	—	—	156.21
baseline	TRT01A	Total	—	—	BLHT	—	continuous	p75	Q3	—	—	171.45
baseline	TRT01A	Total	—	—	BLHT	—	continuous	min	Min	—	—	135.89
baseline	TRT01A	Total	—	—	BLHT	—	continuous	max	Max	—	—	195.58
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	N	N	—	—	254
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	mean	Mean	—	—	24.6657817141655
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	sd	SD	—	—	4.08760808621483
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	median	Median	—	—	24.2275647938254
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	p25	Q1	—	—	21.8779275003273
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	p75	Q3	—	—	27.3460889507567
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	min	Min	—	—	13.6674544327069
baseline	TRT01A	Total	—	—	BLBMI	—	continuous	max	Max	—	—	40.1653635338521

236 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-07-27T03:23:35Z
Spec hash: sha256:0f1e9b9029b61b70bfa00f93c9f0c52050859ff26cacb67ee2fed50c39392854
Display hash: sha256:47d64c3c97e9a311b8b5bfdd7ae6d2a3cb1ff5a6442ad77664da993634c629bd
ARD file: outputs/t-demographics/v002/ard.json
ARD hash: sha256:e03ca473fd5d976fa5732f0881bea51715104a90494eb4a8ffa5104186299f6c

Source datasets

Dataset	Rows	Package	Hash
adsl	254	pharmaverseadam 1.1.0	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107

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-demographics/analysis.yaml

id: t-demographics
title: "Demographic and Baseline Characteristics"
regulatory_id: DMT01
type: table
dataset: adsl
analysis_set: safety
denominator: adsl
group:
  - TRT01A
total: true
analyses:
  - name: age
    method: continuous
    label: "Age (years)"
    variables: [AGE]
  - name: agegr
    method: categorical
    label: "Age group"
    variables: [AGEGR1]
  - name: sex
    method: categorical
    label: "Sex"
    variables: [SEX]
  - name: race
    method: categorical
    label: "Race"
    variables: [RACE]
  - name: ethnic
    method: categorical
    label: "Ethnicity"
    variables: [ETHNIC]
  - name: baseline
    method: continuous
    label: "Baseline vital signs"
    variables: [BLWT, BLHT, BLBMI]

library/tfl/t-demographics/display.yaml

id: t-demographics
title: "Demographic and Baseline Characteristics"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: adsl (pharmaverseadam), baseline vital signs from advs. Data cut-off: 2014-07-01."
footnotes:
  - "Percentages are based on the number of subjects in the safety analysis set for each treatment group."
  - "Baseline weight, height and body mass index are the ADVS records flagged ABLFL = 'Y'."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
format:
  digits:
    p: 1
    mean: 1
    sd: 2
    median: 1
    min: 0
    max: 0
rows:
  - { label: "Age (years)", section: true }
  - { analysis: age, variable: AGE, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: age, variable: AGE, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: age, variable: AGE, pattern: median, label: "Median", indent: 1 }
  - { analysis: age, variable: AGE, pattern: range, label: "Min, Max", indent: 1 }
  - { label: "Age group, n (%)", section: true }
  - { analysis: agegr, variable: AGEGR1, levels: all, pattern: n_pct, indent: 1 }
  - { label: "Sex, n (%)", section: true }
  - { analysis: sex, variable: SEX, levels: all, pattern: n_pct, indent: 1,
      level_order: [F, M] }
  - { label: "Race, n (%)", section: true }
  - { analysis: race, variable: RACE, levels: all, pattern: n_pct, indent: 1,
      level_order: ["WHITE", "BLACK OR AFRICAN AMERICAN", "ASIAN", "AMERICAN INDIAN OR ALASKA NATIVE"] }
  - { label: "Ethnicity, n (%)", section: true }
  - { analysis: ethnic, variable: ETHNIC, levels: all, pattern: n_pct, indent: 1 }
  - { label: "Baseline weight (kg)", section: true }
  - { analysis: baseline, variable: BLWT, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: baseline, variable: BLWT, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 2, sd: 2 } }
  - { analysis: baseline, variable: BLWT, pattern: median, label: "Median", indent: 1,
      digits: { median: 2 } }
  - { analysis: baseline, variable: BLWT, pattern: range, label: "Min, Max", indent: 1,
      digits: { min: 2, max: 2 } }
  - { label: "Baseline height (cm)", section: true }
  - { analysis: baseline, variable: BLHT, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 1, sd: 2 } }
  - { analysis: baseline, variable: BLHT, pattern: range, label: "Min, Max", indent: 1,
      digits: { min: 1, max: 1 } }
  - { label: "Baseline BMI (kg/m2)", section: true }
  - { analysis: baseline, variable: BLBMI, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 2, sd: 2 } }
  - { analysis: baseline, variable: BLBMI, pattern: range, label: "Min, Max", indent: 1,
      digits: { min: 2, max: 2 } }
variants:
  post_text: {}
  in_text:
    title: "Demographic Characteristics (Summary)"

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