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: v007
Datasets: adsl b022f78
Evidence: 21/21 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-DEMO-001 DSP-DEMO-002 DSP-DEMO-003 DSP-DEMO-004 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 STD-GATE-001 STD-GATE-002 STD-GATE-003 STD-GATE-004 STD-GATE-005 STD-MODEL-001 STD-MODEL-002 STD-MODEL-003 STD-MODEL-004 STD-MODEL-005 STD-SRC-001 STD-SRC-002
Used in: Clinical Study Report Table 14.1.2
Study Synopsis Table 13.2
Post-Text Display Package Table 14.1.2
Abbreviated Clinical Study Report (ICH E3) Table 14.1.2
Study model: Intent-to-Treat Population ITTFL · grouped by TRT01P
Specification: 7 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: TXT-E3-1102 TXT-E3-1300
Values: age-median-total female-n-total

Inputs

adsl254 rows · b022f78
analysis.yamlwhat to compute
display.yamlhow to show it
custom.Rthe display's own method
study modelIntent-to-Treat Population

Function

prepare_data()regenerate('t-demographics')
build_ard()one row per statistic
render_display()every variant
render_rtf()the same cells

Outputs

ard.jsonv007 · 548 rows · 87af027
table.htmlthe rendered display
table.rtfsha256 7177d78
table-in-text.rtfsha256 56ad447
manifest.jsonwho, why, every hash

RTFFull display7177d78 RTFIn-text variant56ad447

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=84)	Xanomeline High Dose (N=84)	Total (N=254)	p-value
Summary of Demographic and Baseline Characteristics
Study CDISCPILOT01 — Intent-to-Treat
Age (y)
n	86	84	84	254	0.5934
Mean	75.2	75.7	74.4	75.1
SD	8.59	8.29	7.89	8.25
Median	76.0	77.5	76.0	77.0
Min	52.0	51.0	56.0	51.0
Max	89.0	88.0	88.0	89.0
<65 yrs	14 (16%)	8 (10%)	11 (13%)	33 (13%)	0.1439
65-80 yrs	42 (49%)	47 (56%)	55 (65%)	144 (57%)
>80 yrs	30 (35%)	29 (35%)	18 (21%)	77 (30%)
Sex
n	86	84	84	254	0.1409
Male	33 (38%)	34 (40%)	44 (52%)	111 (44%)
Female	53 (62%)	50 (60%)	40 (48%)	143 (56%)
Race (Origin)
n	86	84	84	254	0.6477
Caucasian	75 (87%)	72 (86%)	71 (85%)	218 (86%)
African Descent	8 (9%)	6 (7%)	9 (11%)	23 (9%)
Hispanic	3 (3%)	6 (7%)	3 (4%)	12 (5%)
Other	0	0	1 (1%)	1 (<1%)
MMSE
n	86	84	84	254	0.5947
Mean	18.0	17.9	18.5	18.1
SD	4.27	4.22	4.16	4.21
Median	19.5	18.0	20.0	19.0
Min	10.0	10.0	10.0	10.0
Max	23.0	24.0	24.0	24.0
Duration of disease
n	86	84	84	254	0.1530
Mean	42.7	48.7	40.5	43.9
SD	30.24	29.58	24.69	28.40
Median	35.3	40.3	36.0	36.3
Min	7.2	7.8	2.2	2.2
Max	183.1	130.8	135.0	183.1
<12 months	5 (6%)	3 (4%)	4 (5%)	12 (5%)	0.7885
>=12 months	81 (94%)	81 (96%)	80 (95%)	242 (95%)
Years of education
n	86	84	84	254	0.3875
Mean	12.6	13.2	12.5	12.8
SD	2.95	4.15	2.92	3.38
Median	12.0	12.0	12.0	12.0
Min	6.0	3.0	6.0	3.0
Max	21.0	24.0	20.0	24.0
Baseline weight(kg)
n	86	83	84	253	0.0030
Mean	62.8	67.3	70.0	66.6
SD	12.77	14.12	14.65	14.13
Median	60.6	64.9	69.2	66.7
Min	34.0	45.4	41.7	34.0
Max	86.2	106.1	108.0	108.0
Baseline height(cm)
n	86	84	84	254	0.1262
Mean	162.6	163.4	165.8	163.9
SD	11.52	10.42	10.13	10.76
Median	162.6	162.6	165.1	162.9
Min	137.2	135.9	146.1	135.9
Max	185.4	195.6	190.5	195.6
Baseline BMI
n	86	83	84	253	0.0133
Mean	23.6	25.1	25.3	24.7
SD	3.67	4.27	4.16	4.09
Median	23.4	24.3	24.8	24.2
Min	15.1	17.7	13.7	13.7
Max	33.3	40.1	34.5	40.1
<25	59 (69%)	47 (56%)	44 (52%)	150 (59%)	0.2326
25-<30	21 (24%)	27 (32%)	28 (33%)	76 (30%)
>=30	6 (7%)	10 (12%)	12 (14%)	28 (11%)
[1] P-values are results of ANOVA treatment group comparison for continuous variables and Pearson's chi-square test for categorical variables, as the reference report (Table 14-2.01) states; each block carries one test across the three treatment groups.
Race (Origin) is the reference report's classification, with Hispanic as a category. The study's ADaM carries race and ethnicity separately (230 White, 23 Black or African American, 1 American Indian or Alaska Native; 12 Hispanic or Latino, all of them White by race). The recode is ethnicity first, then race: 218 Caucasian, 23 African Descent, 12 Hispanic, 1 Other. It is a coding convention, not a disagreement between the data and the report.
Duration of disease is DURDIS, months from onset of the first definite symptoms of Alzheimer's disease to enrolment, as the study's ADaM carries it. Years of education is EDUCLVL. MMSE is MMSETOT.
n is the number of subjects with a value; one subject on low dose has no baseline weight or BMI. Percentages are based on the number of subjects in the intent-to-treat population for each treatment group; the Total column pools the three groups. Treatment groups are planned treatment, TRT01P, which agrees with actual treatment for every subject in this study.
Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01.
open.csr display t-demographics (post_text variant); generated from the committed ARD.

Rendered from outputs/t-demographics/v007/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
age_n	TRT01P	Placebo	—	—	AGE	—	block_n	N	N	—	—	86
age_n	TRT01P	Xanomeline Low Dose	—	—	AGE	—	block_n	N	N	—	—	84
age_n	TRT01P	Xanomeline High Dose	—	—	AGE	—	block_n	N	N	—	—	84
age_n	statistic	p-value	—	—	AGE	—	hypothesis_test	p_value	One-way ANOVA p-value	—	—	0.593435775283096
age_n	statistic	p-value	—	—	AGE	—	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.5934
age_n	TRT01P	Total	—	—	AGE	—	block_n	N	N	—	—	254
age	TRT01P	Placebo	—	—	AGE	—	continuous	N	N	—	—	86
age	TRT01P	Placebo	—	—	AGE	—	continuous	mean	Mean	—	—	75.2093023255814
age	TRT01P	Placebo	—	—	AGE	—	continuous	sd	SD	—	—	8.59016712714193
age	TRT01P	Placebo	—	—	AGE	—	continuous	median	Median	—	—	76
age	TRT01P	Placebo	—	—	AGE	—	continuous	p25	Q1	—	—	69
age	TRT01P	Placebo	—	—	AGE	—	continuous	p75	Q3	—	—	82
age	TRT01P	Placebo	—	—	AGE	—	continuous	min	Min	—	—	52
age	TRT01P	Placebo	—	—	AGE	—	continuous	max	Max	—	—	89
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	N	N	—	—	84
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	mean	Mean	—	—	75.6666666666667
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	sd	SD	—	—	8.28605059954093
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	median	Median	—	—	77.5
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	p25	Q1	—	—	71
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	p75	Q3	—	—	82
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	min	Min	—	—	51
age	TRT01P	Xanomeline Low Dose	—	—	AGE	—	continuous	max	Max	—	—	88
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	N	N	—	—	84
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	mean	Mean	—	—	74.3809523809524
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	sd	SD	—	—	7.88609384869824
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	median	Median	—	—	76
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	p25	Q1	—	—	70.5
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	p75	Q3	—	—	80
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	min	Min	—	—	56
age	TRT01P	Xanomeline High Dose	—	—	AGE	—	continuous	max	Max	—	—	88
age	TRT01P	Total	—	—	AGE	—	continuous	N	N	—	—	254
age	TRT01P	Total	—	—	AGE	—	continuous	mean	Mean	—	—	75.0866141732284
age	TRT01P	Total	—	—	AGE	—	continuous	sd	SD	—	—	8.24623389621606
age	TRT01P	Total	—	—	AGE	—	continuous	median	Median	—	—	77
age	TRT01P	Total	—	—	AGE	—	continuous	p25	Q1	—	—	70
age	TRT01P	Total	—	—	AGE	—	continuous	p75	Q3	—	—	81
age	TRT01P	Total	—	—	AGE	—	continuous	min	Min	—	—	51
age	TRT01P	Total	—	—	AGE	—	continuous	max	Max	—	—	89
agegr_n	TRT01P	Placebo	—	—	AGEGR1	—	block_n	N	N	—	—	86
agegr_n	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	—	block_n	N	N	—	—	84
agegr_n	TRT01P	Xanomeline High Dose	—	—	AGEGR1	—	block_n	N	N	—	—	84
agegr_n	statistic	p-value	—	—	AGEGR1	<65	hypothesis_test	p_value	Pearson chi-square p-value	—	—	0.143917025502502
agegr_n	statistic	p-value	—	—	AGEGR1	<65	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.1439
agegr_n	TRT01P	Total	—	—	AGEGR1	—	block_n	N	N	—	—	254
agegr	TRT01P	Placebo	—	—	AGEGR1	<65	categorical	n	n	—	—	14
agegr	TRT01P	Placebo	—	—	AGEGR1	<65	categorical	N	N	—	—	86
agegr	TRT01P	Placebo	—	—	AGEGR1	<65	categorical	p	%	—	—	0.162790697674419
agegr	TRT01P	Placebo	—	—	AGEGR1	65-80	categorical	n	n	—	—	42
agegr	TRT01P	Placebo	—	—	AGEGR1	65-80	categorical	N	N	—	—	86
agegr	TRT01P	Placebo	—	—	AGEGR1	65-80	categorical	p	%	—	—	0.488372093023256
agegr	TRT01P	Placebo	—	—	AGEGR1	>80	categorical	n	n	—	—	30
agegr	TRT01P	Placebo	—	—	AGEGR1	>80	categorical	N	N	—	—	86
agegr	TRT01P	Placebo	—	—	AGEGR1	>80	categorical	p	%	—	—	0.348837209302326
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	<65	categorical	n	n	—	—	8
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	<65	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	<65	categorical	p	%	—	—	0.0952380952380952
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	65-80	categorical	n	n	—	—	47
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	65-80	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	65-80	categorical	p	%	—	—	0.55952380952381
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	>80	categorical	n	n	—	—	29
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	>80	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline Low Dose	—	—	AGEGR1	>80	categorical	p	%	—	—	0.345238095238095
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	<65	categorical	n	n	—	—	11
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	<65	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	<65	categorical	p	%	—	—	0.130952380952381
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	65-80	categorical	n	n	—	—	55
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	65-80	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	65-80	categorical	p	%	—	—	0.654761904761905
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	>80	categorical	n	n	—	—	18
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	>80	categorical	N	N	—	—	84
agegr	TRT01P	Xanomeline High Dose	—	—	AGEGR1	>80	categorical	p	%	—	—	0.214285714285714
agegr	TRT01P	Total	—	—	AGEGR1	<65	categorical	n	n	—	—	33
agegr	TRT01P	Total	—	—	AGEGR1	<65	categorical	N	N	—	—	254
agegr	TRT01P	Total	—	—	AGEGR1	<65	categorical	p	%	—	—	0.12992125984252
agegr	TRT01P	Total	—	—	AGEGR1	65-80	categorical	n	n	—	—	144
agegr	TRT01P	Total	—	—	AGEGR1	65-80	categorical	N	N	—	—	254
agegr	TRT01P	Total	—	—	AGEGR1	65-80	categorical	p	%	—	—	0.566929133858268
agegr	TRT01P	Total	—	—	AGEGR1	>80	categorical	n	n	—	—	77
agegr	TRT01P	Total	—	—	AGEGR1	>80	categorical	N	N	—	—	254
agegr	TRT01P	Total	—	—	AGEGR1	>80	categorical	p	%	—	—	0.303149606299213
sex_n	TRT01P	Placebo	—	—	SEX	—	block_n	N	N	—	—	86
sex_n	TRT01P	Xanomeline Low Dose	—	—	SEX	—	block_n	N	N	—	—	84
sex_n	TRT01P	Xanomeline High Dose	—	—	SEX	—	block_n	N	N	—	—	84
sex_n	statistic	p-value	—	—	SEX	—	hypothesis_test	p_value	Pearson chi-square p-value	—	—	0.140859828596478
sex_n	statistic	p-value	—	—	SEX	—	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.1409
sex_n	TRT01P	Total	—	—	SEX	—	block_n	N	N	—	—	254
sex	TRT01P	Placebo	—	—	SEX	F	categorical	n	n	—	—	53
sex	TRT01P	Placebo	—	—	SEX	F	categorical	N	N	—	—	86
sex	TRT01P	Placebo	—	—	SEX	F	categorical	p	%	—	—	0.616279069767442
sex	TRT01P	Placebo	—	—	SEX	M	categorical	n	n	—	—	33
sex	TRT01P	Placebo	—	—	SEX	M	categorical	N	N	—	—	86
sex	TRT01P	Placebo	—	—	SEX	M	categorical	p	%	—	—	0.383720930232558
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	F	categorical	n	n	—	—	50
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	F	categorical	N	N	—	—	84
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	F	categorical	p	%	—	—	0.595238095238095
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	M	categorical	n	n	—	—	34
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	M	categorical	N	N	—	—	84
sex	TRT01P	Xanomeline Low Dose	—	—	SEX	M	categorical	p	%	—	—	0.404761904761905
sex	TRT01P	Xanomeline High Dose	—	—	SEX	F	categorical	n	n	—	—	40
sex	TRT01P	Xanomeline High Dose	—	—	SEX	F	categorical	N	N	—	—	84
sex	TRT01P	Xanomeline High Dose	—	—	SEX	F	categorical	p	%	—	—	0.476190476190476
sex	TRT01P	Xanomeline High Dose	—	—	SEX	M	categorical	n	n	—	—	44
sex	TRT01P	Xanomeline High Dose	—	—	SEX	M	categorical	N	N	—	—	84
sex	TRT01P	Xanomeline High Dose	—	—	SEX	M	categorical	p	%	—	—	0.523809523809524
sex	TRT01P	Total	—	—	SEX	F	categorical	n	n	—	—	143
sex	TRT01P	Total	—	—	SEX	F	categorical	N	N	—	—	254
sex	TRT01P	Total	—	—	SEX	F	categorical	p	%	—	—	0.562992125984252
sex	TRT01P	Total	—	—	SEX	M	categorical	n	n	—	—	111
sex	TRT01P	Total	—	—	SEX	M	categorical	N	N	—	—	254
sex	TRT01P	Total	—	—	SEX	M	categorical	p	%	—	—	0.437007874015748
raceor_n	TRT01P	Placebo	—	—	RACEOR	—	block_n	N	N	—	—	86
raceor_n	TRT01P	Xanomeline Low Dose	—	—	RACEOR	—	block_n	N	N	—	—	84
raceor_n	TRT01P	Xanomeline High Dose	—	—	RACEOR	—	block_n	N	N	—	—	84
raceor_n	statistic	p-value	—	—	RACEOR	—	hypothesis_test	p_value	Pearson chi-square p-value	—	—	0.647674941661787
raceor_n	statistic	p-value	—	—	RACEOR	—	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.6477
raceor_n	TRT01P	Total	—	—	RACEOR	—	block_n	N	N	—	—	254
raceor	TRT01P	Placebo	—	—	RACEOR	Caucasian	categorical	n	n	—	—	75
raceor	TRT01P	Placebo	—	—	RACEOR	Caucasian	categorical	N	N	—	—	86
raceor	TRT01P	Placebo	—	—	RACEOR	Caucasian	categorical	p	%	—	—	0.872093023255814
raceor	TRT01P	Placebo	—	—	RACEOR	African Descent	categorical	n	n	—	—	8
raceor	TRT01P	Placebo	—	—	RACEOR	African Descent	categorical	N	N	—	—	86
raceor	TRT01P	Placebo	—	—	RACEOR	African Descent	categorical	p	%	—	—	0.0930232558139535
raceor	TRT01P	Placebo	—	—	RACEOR	Hispanic	categorical	n	n	—	—	3
raceor	TRT01P	Placebo	—	—	RACEOR	Hispanic	categorical	N	N	—	—	86
raceor	TRT01P	Placebo	—	—	RACEOR	Hispanic	categorical	p	%	—	—	0.0348837209302326
raceor	TRT01P	Placebo	—	—	RACEOR	Other	categorical	n	n	—	—	0
raceor	TRT01P	Placebo	—	—	RACEOR	Other	categorical	N	N	—	—	86
raceor	TRT01P	Placebo	—	—	RACEOR	Other	categorical	p	%	—	—	0
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Caucasian	categorical	n	n	—	—	72
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Caucasian	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Caucasian	categorical	p	%	—	—	0.857142857142857
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	African Descent	categorical	n	n	—	—	6
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	African Descent	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	African Descent	categorical	p	%	—	—	0.0714285714285714
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Hispanic	categorical	n	n	—	—	6
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Hispanic	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Hispanic	categorical	p	%	—	—	0.0714285714285714
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Other	categorical	n	n	—	—	0
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Other	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline Low Dose	—	—	RACEOR	Other	categorical	p	%	—	—	0
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Caucasian	categorical	n	n	—	—	71
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Caucasian	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Caucasian	categorical	p	%	—	—	0.845238095238095
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	African Descent	categorical	n	n	—	—	9
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	African Descent	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	African Descent	categorical	p	%	—	—	0.107142857142857
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Hispanic	categorical	n	n	—	—	3
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Hispanic	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Hispanic	categorical	p	%	—	—	0.0357142857142857
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Other	categorical	n	n	—	—	1
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Other	categorical	N	N	—	—	84
raceor	TRT01P	Xanomeline High Dose	—	—	RACEOR	Other	categorical	p	%	—	—	0.0119047619047619
raceor	TRT01P	Total	—	—	RACEOR	Caucasian	categorical	n	n	—	—	218
raceor	TRT01P	Total	—	—	RACEOR	Caucasian	categorical	N	N	—	—	254
raceor	TRT01P	Total	—	—	RACEOR	Caucasian	categorical	p	%	—	—	0.858267716535433
raceor	TRT01P	Total	—	—	RACEOR	African Descent	categorical	n	n	—	—	23
raceor	TRT01P	Total	—	—	RACEOR	African Descent	categorical	N	N	—	—	254
raceor	TRT01P	Total	—	—	RACEOR	African Descent	categorical	p	%	—	—	0.0905511811023622
raceor	TRT01P	Total	—	—	RACEOR	Hispanic	categorical	n	n	—	—	12
raceor	TRT01P	Total	—	—	RACEOR	Hispanic	categorical	N	N	—	—	254
raceor	TRT01P	Total	—	—	RACEOR	Hispanic	categorical	p	%	—	—	0.047244094488189
raceor	TRT01P	Total	—	—	RACEOR	Other	categorical	n	n	—	—	1
raceor	TRT01P	Total	—	—	RACEOR	Other	categorical	N	N	—	—	254
raceor	TRT01P	Total	—	—	RACEOR	Other	categorical	p	%	—	—	0.00393700787401575
mmse_n	TRT01P	Placebo	—	—	MMSETOT	—	block_n	N	N	—	—	86
mmse_n	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	block_n	N	N	—	—	84
mmse_n	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	block_n	N	N	—	—	84
mmse_n	statistic	p-value	—	—	MMSETOT	—	hypothesis_test	p_value	One-way ANOVA p-value	—	—	0.594659759410275
mmse_n	statistic	p-value	—	—	MMSETOT	—	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.5947
mmse_n	TRT01P	Total	—	—	MMSETOT	—	block_n	N	N	—	—	254
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	N	N	—	—	86
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	mean	Mean	—	—	18.046511627907
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	sd	SD	—	—	4.2727783404855
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	median	Median	—	—	19.5
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	p25	Q1	—	—	15
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	p75	Q3	—	—	22
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	min	Min	—	—	10
mmse	TRT01P	Placebo	—	—	MMSETOT	—	continuous	max	Max	—	—	23
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	N	N	—	—	84
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	mean	Mean	—	—	17.8690476190476
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	sd	SD	—	—	4.22208696726523
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	median	Median	—	—	18
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	p25	Q1	—	—	14
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	p75	Q3	—	—	22
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	min	Min	—	—	10
mmse	TRT01P	Xanomeline Low Dose	—	—	MMSETOT	—	continuous	max	Max	—	—	24
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	N	N	—	—	84
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	mean	Mean	—	—	18.5119047619048
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	sd	SD	—	—	4.15800591577738
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	median	Median	—	—	20
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	p25	Q1	—	—	16
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	p75	Q3	—	—	22
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	min	Min	—	—	10
mmse	TRT01P	Xanomeline High Dose	—	—	MMSETOT	—	continuous	max	Max	—	—	24
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	N	N	—	—	254
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	mean	Mean	—	—	18.1417322834646
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	sd	SD	—	—	4.21032874412179
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	median	Median	—	—	19
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	p25	Q1	—	—	15
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	p75	Q3	—	—	22
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	min	Min	—	—	10
mmse	TRT01P	Total	—	—	MMSETOT	—	continuous	max	Max	—	—	24
durdis_n	TRT01P	Placebo	—	—	DURDIS	—	block_n	N	N	—	—	86
durdis_n	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	block_n	N	N	—	—	84
durdis_n	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	block_n	N	N	—	—	84
durdis_n	statistic	p-value	—	—	DURDIS	—	hypothesis_test	p_value	One-way ANOVA p-value	—	—	0.152960564175341
durdis_n	statistic	p-value	—	—	DURDIS	—	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.1530
durdis_n	TRT01P	Total	—	—	DURDIS	—	block_n	N	N	—	—	254
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	N	N	—	—	86
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	mean	Mean	—	—	42.65
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	sd	SD	—	—	30.241571504451
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	median	Median	—	—	35.3
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	p25	Q1	—	—	24.3
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	p75	Q3	—	—	50.3
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	min	Min	—	—	7.2
durdis	TRT01P	Placebo	—	—	DURDIS	—	continuous	max	Max	—	—	183.1
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	N	N	—	—	84
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	mean	Mean	—	—	48.6916666666667
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	sd	SD	—	—	29.5841711516636
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	median	Median	—	—	40.25
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	p25	Q1	—	—	25.9
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	p75	Q3	—	—	67.2
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	min	Min	—	—	7.8
durdis	TRT01P	Xanomeline Low Dose	—	—	DURDIS	—	continuous	max	Max	—	—	130.8
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	N	N	—	—	84
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	mean	Mean	—	—	40.5071428571429
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	sd	SD	—	—	24.6935472070355
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	median	Median	—	—	35.95
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	p25	Q1	—	—	23.85
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	p75	Q3	—	—	52.55
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	min	Min	—	—	2.2
durdis	TRT01P	Xanomeline High Dose	—	—	DURDIS	—	continuous	max	Max	—	—	135
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	N	N	—	—	254
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	mean	Mean	—	—	43.9393700787402
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	sd	SD	—	—	28.3973156262964
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	median	Median	—	—	36.25
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	p25	Q1	—	—	24.3
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	p75	Q3	—	—	57.7
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	min	Min	—	—	2.2
durdis	TRT01P	Total	—	—	DURDIS	—	continuous	max	Max	—	—	183.1
durdisgr_n	TRT01P	Placebo	—	—	DURDSGR1	—	block_n	N	N	—	—	86
durdisgr_n	TRT01P	Xanomeline Low Dose	—	—	DURDSGR1	—	block_n	N	N	—	—	84
durdisgr_n	TRT01P	Xanomeline High Dose	—	—	DURDSGR1	—	block_n	N	N	—	—	84
durdisgr_n	statistic	p-value	—	—	DURDSGR1	<12	hypothesis_test	p_value	Pearson chi-square p-value	—	—	0.788536928535063
durdisgr_n	statistic	p-value	—	—	DURDSGR1	<12	hypothesis_test	p_value_fmt	p-value (formatted)	—	—	0.7885
durdisgr_n	TRT01P	Total	—	—	DURDSGR1	—	block_n	N	N	—	—	254
durdisgr	TRT01P	Placebo	—	—	DURDSGR1	<12	categorical	n	n	—	—	5
durdisgr	TRT01P	Placebo	—	—	DURDSGR1	<12	categorical	N	N	—	—	86
durdisgr	TRT01P	Placebo	—	—	DURDSGR1	<12	categorical	p	%	—	—	0.0581395348837209
durdisgr	TRT01P	Placebo	—	—	DURDSGR1	>=12	categorical	n	n	—	—	81

Showing the first 250 of 548 rows — the full ARD is committed beside the display.

Schema: opencsr/ard/v1
Generated: 2026-09-02T16:11:27Z
Spec hash: sha256:bc60600be035071da384b07199fb4b48cfc3f8b46e764e2db96d568a2bd34e20
Display hash: sha256:c2a1f1710bcf057a83819c6e6e29b95aeaa30bc0bedf5d3c7bbca9d63d356b0c
ARD file: outputs/t-demographics/v007/ard.json
ARD hash: sha256:87af02747ecd7e74df308ac7fc521b68e22f7fad3fb86607e5e93d9d28cb82a5

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:b022f78fdd0ade028f6c4e9e7cc5187284a5249f30c16646931a1856d5fff2f6

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

# ------------------------------------------------------------------------------
# t-demographics — Summary of Demographic and Baseline Characteristics
# ------------------------------------------------------------------------------
# Target: Table 14-2.01 of the CDISCPILOT01 clinical study report (27 June 2006),
# pages 46–48. Intent-to-treat population; Placebo, low dose, high dose, Total,
# and a p-value column — one-way ANOVA for a continuous block, Pearson's
# chi-square for a categorical one (the report's footnote [1]).
#
# Every block is two entries. The `<block>_n` entry is dispatched to custom.R and
# produces the block's "n" row (subjects with a value) together with the block's
# single test; its sibling produces the statistics or the levels through the
# built-in method. Three sub-blocks — age groups, duration-of-disease groups and
# BMI groups — have no "n" row in the report and print their p-value beside the
# first level, which `p_on_level` declares.
#
# Race (Origin) is the report's one classification with Hispanic as a category;
# the data carry race and ethnicity separately. `RACEOR` is derived in the data
# layer (prep_adsl: ethnicity first, then race, with the report's labels) and the
# display's footnote says so. The CDISC-coded `race` and `ethnic` analyses stay
# in the ARD, unrendered, because the report's narrative binds them by name.
#
# Until v0.4.0 this display was the FDA-standard DMT01 shape on the safety
# analysis set, without a p-value column. The regulatory identifier is kept; the
# shape is the reference's (D0032, #61).
# ------------------------------------------------------------------------------
id: t-demographics
title: "Summary of Demographic and Baseline Characteristics"
regulatory_id: DMT01
type: table
dataset: adsl
analysis_set: itt
denominator: adsl
group:
  - TRT01P
total: true
analyses:
  # ---- Age ----
  - name: age_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Age (years): n and ANOVA"
    variables: [AGE]
  - name: age
    method: continuous
    label: "Age (years)"
    variables: [AGE]
  - name: agegr_n
    method: categorical
    custom: ard_block_n_and_test
    test: chisq
    p_on_level: "<65"
    label: "Age group: chi-square"
    variables: [AGEGR1]
  - name: agegr
    method: categorical
    label: "Age group"
    variables: [AGEGR1]
  # ---- Sex ----
  - name: sex_n
    method: categorical
    custom: ard_block_n_and_test
    test: chisq
    label: "Sex: n and chi-square"
    variables: [SEX]
  - name: sex
    method: categorical
    label: "Sex"
    variables: [SEX]
  # ---- Race (Origin) ----
  - name: raceor_n
    method: categorical
    custom: ard_block_n_and_test
    test: chisq
    label: "Race (Origin): n and chi-square"
    variables: [RACEOR]
  - name: raceor
    method: categorical
    label: "Race (Origin)"
    variables: [RACEOR]
  # ---- MMSE ----
  - name: mmse_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "MMSE: n and ANOVA"
    variables: [MMSETOT]
  - name: mmse
    method: continuous
    label: "MMSE"
    variables: [MMSETOT]
  # ---- Duration of disease ----
  - name: durdis_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Duration of disease (months): n and ANOVA"
    variables: [DURDIS]
  - name: durdis
    method: continuous
    label: "Duration of disease (months)"
    variables: [DURDIS]
  - name: durdisgr_n
    method: categorical
    custom: ard_block_n_and_test
    test: chisq
    p_on_level: "<12"
    label: "Duration of disease group: chi-square"
    variables: [DURDSGR1]
  - name: durdisgr
    method: categorical
    label: "Duration of disease group"
    variables: [DURDSGR1]
  # ---- Education ----
  - name: educ_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Years of education: n and ANOVA"
    variables: [EDUCLVL]
  - name: educ
    method: continuous
    label: "Years of education"
    variables: [EDUCLVL]
  # ---- Baseline weight, height, BMI ----
  - name: weight_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Baseline weight (kg): n and ANOVA"
    variables: [BLWT]
  - name: weight
    method: continuous
    label: "Baseline weight (kg)"
    variables: [BLWT]
  - name: height_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Baseline height (cm): n and ANOVA"
    variables: [BLHT]
  - name: height
    method: continuous
    label: "Baseline height (cm)"
    variables: [BLHT]
  - name: bmi_n
    method: continuous
    custom: ard_block_n_and_test
    test: anova
    label: "Baseline BMI: n and ANOVA"
    variables: [BLBMI]
  - name: bmi
    method: continuous
    label: "Baseline BMI"
    variables: [BLBMI]
  - name: bmigr_n
    method: categorical
    custom: ard_block_n_and_test
    test: chisq
    p_on_level: "<25"
    label: "Baseline BMI group: chi-square"
    variables: [BMIBLGR1]
  - name: bmigr
    method: categorical
    label: "Baseline BMI group"
    variables: [BMIBLGR1]
  # ---- Race as the report's in-text Table 11-1 groups it ----
  - name: racew
    method: categorical
    label: "Race: White/Caucasian or other"
    variables: [RACEW]
  # ---- CDISC-coded race and ethnicity: in the ARD for the narrative's bindings, not rendered ----
  - name: race
    method: categorical
    label: "Race (CDISC coding)"
    variables: [RACE]
  - name: ethnic
    method: categorical
    label: "Ethnicity (CDISC coding)"
    variables: [ETHNIC]

library/tfl/t-demographics/display.yaml

id: t-demographics
title: "Summary of Demographic and Baseline Characteristics"
study: CDISCPILOT01
population_label: "Intent-to-Treat"
cutoff: "2014-07-01"
source: "Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01."
footnotes:
  - "[1] P-values are results of ANOVA treatment group comparison for continuous variables and Pearson's chi-square test for categorical variables, as the reference report (Table 14-2.01) states; each block carries one test across the three treatment groups."
  - "Race (Origin) is the reference report's classification, with Hispanic as a category. The study's ADaM carries race and ethnicity separately (230 White, 23 Black or African American, 1 American Indian or Alaska Native; 12 Hispanic or Latino, all of them White by race). The recode is ethnicity first, then race: 218 Caucasian, 23 African Descent, 12 Hispanic, 1 Other. It is a coding convention, not a disagreement between the data and the report."
  - "Duration of disease is DURDIS, months from onset of the first definite symptoms of Alzheimer's disease to enrolment, as the study's ADaM carries it. Years of education is EDUCLVL. MMSE is MMSETOT."
  - "n is the number of subjects with a value; one subject on low dose has no baseline weight or BMI. Percentages are based on the number of subjects in the intent-to-treat population for each treatment group; the Total column pools the three groups. Treatment groups are planned treatment, TRT01P, which agrees with actual treatment for every subject in this study."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total, "p-value"]
  patterns:
    "p-value": pvalue
format:
  pvalue: "{p_value_fmt}"
  zero_count: "0"
  sub_one_pct: true
  digits:
    p: 0
    mean: 1
    sd: 2
    median: 1
    min: 1
    max: 1
rows:
  - { label: "Age (y)", section: true }
  - { analysis: age_n, variable: AGE, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: age, variable: AGE, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: age, variable: AGE, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: age, variable: AGE, pattern: median, label: "Median", indent: 1 }
  - { analysis: age, variable: AGE, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: age, variable: AGE, pattern: "{max}", label: "Max", indent: 1 }
  - { analysis: agegr, variable: AGEGR1, levels: all, pattern: n_pct, indent: 1,
      level_order: ["<65", "65-80", ">80"],
      level_labels: { "<65": "<65 yrs", "65-80": "65-80 yrs", ">80": ">80 yrs" },
      p_from: agegr_n }
  - { label: "Sex", section: true }
  - { analysis: sex_n, variable: SEX, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: sex, variable: SEX, levels: all, pattern: n_pct, indent: 1,
      level_order: [M, F], level_labels: { M: Male, F: Female } }
  - { label: "Race (Origin)", section: true }
  - { analysis: raceor_n, variable: RACEOR, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: raceor, variable: RACEOR, levels: all, pattern: n_pct, indent: 1,
      level_order: [Caucasian, "African Descent", Hispanic, Other] }
  - { label: "MMSE", section: true }
  - { analysis: mmse_n, variable: MMSETOT, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: mmse, variable: MMSETOT, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: mmse, variable: MMSETOT, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: mmse, variable: MMSETOT, pattern: median, label: "Median", indent: 1 }
  - { analysis: mmse, variable: MMSETOT, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: mmse, variable: MMSETOT, pattern: "{max}", label: "Max", indent: 1 }
  - { label: "Duration of disease", section: true }
  - { analysis: durdis_n, variable: DURDIS, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: durdis, variable: DURDIS, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: durdis, variable: DURDIS, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: durdis, variable: DURDIS, pattern: median, label: "Median", indent: 1 }
  - { analysis: durdis, variable: DURDIS, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: durdis, variable: DURDIS, pattern: "{max}", label: "Max", indent: 1 }
  - { analysis: durdisgr, variable: DURDSGR1, levels: all, pattern: n_pct, indent: 1,
      level_order: ["<12", ">=12"],
      level_labels: { "<12": "<12 months", ">=12": ">=12 months" },
      p_from: durdisgr_n }
  - { label: "Years of education", section: true }
  - { analysis: educ_n, variable: EDUCLVL, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: educ, variable: EDUCLVL, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: educ, variable: EDUCLVL, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: educ, variable: EDUCLVL, pattern: median, label: "Median", indent: 1 }
  - { analysis: educ, variable: EDUCLVL, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: educ, variable: EDUCLVL, pattern: "{max}", label: "Max", indent: 1 }
  - { label: "Baseline weight(kg)", section: true }
  - { analysis: weight_n, variable: BLWT, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: weight, variable: BLWT, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: weight, variable: BLWT, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: weight, variable: BLWT, pattern: median, label: "Median", indent: 1 }
  - { analysis: weight, variable: BLWT, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: weight, variable: BLWT, pattern: "{max}", label: "Max", indent: 1 }
  - { label: "Baseline height(cm)", section: true }
  - { analysis: height_n, variable: BLHT, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: height, variable: BLHT, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: height, variable: BLHT, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: height, variable: BLHT, pattern: median, label: "Median", indent: 1 }
  - { analysis: height, variable: BLHT, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: height, variable: BLHT, pattern: "{max}", label: "Max", indent: 1 }
  - { label: "Baseline BMI", section: true }
  - { analysis: bmi_n, variable: BLBMI, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: bmi, variable: BLBMI, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: bmi, variable: BLBMI, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: bmi, variable: BLBMI, pattern: median, label: "Median", indent: 1 }
  - { analysis: bmi, variable: BLBMI, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: bmi, variable: BLBMI, pattern: "{max}", label: "Max", indent: 1 }
  - { analysis: bmigr, variable: BMIBLGR1, levels: all, pattern: n_pct, indent: 1,
      level_order: ["<25", "25-<30", ">=30"],
      p_from: bmigr_n }
variants:
  post_text: {}
  # The report's in-text Table 11-1: the same ARD, redrawn — mean and range,
  # percentages only, race as White/Caucasian against other, no p-value column.
  in_text:
    title: "Demographic Characteristics"
    columns:
      order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
    format:
      mean_range: "{mean} ({min}-{max})"
      pct: "{p}%"
      digits:
        mean: 1
        min: 0
        max: 0
        p: 0
    rows:
      - { analysis: age, variable: AGE, pattern: mean_range, label: "Age (years), mean (range)", indent: 0 }
      - { label: "Gender (%)", section: true }
      - { analysis: sex, variable: SEX, levels: all, pattern: pct, indent: 1,
          level_order: [M, F], level_labels: { M: Male, F: Female } }
      - { label: "Race (%)", section: true }
      - { analysis: racew, variable: RACEW, levels: all, pattern: pct, indent: 1,
          level_order: ["White/Caucasian", "Other"] }
      - { analysis: educ, variable: EDUCLVL, pattern: mean_range, label: "Education (years), mean (range)", indent: 0 }

library/tfl/t-demographics/custom.R

# Custom statistics for t-demographics — the reference report's Table 14-2.01.
#
# The 2006 report prints, for every block of the demographics table, an "n" row
# carrying the number of subjects with a value and, in a final column, one
# p-value for the block: a one-way ANOVA across the three treatment groups for a
# continuous measure, Pearson's chi-square for a categorical one (the table's
# own footnote [1]). Each block's "n" row is therefore its own analysis entry,
# dispatched here, while the block's statistics and levels come from the
# built-in `continuous` and `categorical` methods on a sibling entry — so the
# p-value lands on exactly one row of the block rather than on every row the
# analysis feeds.
#
# Three sub-blocks (age groups, duration-of-disease groups, BMI groups) have no
# "n" row of their own in the report and print their p-value beside the first
# level instead. `p_on_level: "<65"` on the analysis entry puts the test rows
# under that level so the renderer places them there.

`%||%` <- function(x, y) if (is.null(x)) y else x

#' N per group and one test across the groups
#'
#' @param data The analysis dataset after the analysis set and filter.
#' @param spec The analysis entry: `variables` (one column), `test` ("anova" or
#'   "chisq"), optional `p_on_level`, and the `group` the engine supplies.
#' @param denominator Ignored; N here is the number of subjects with a value.
#' @return Rows in the `{cards}` ARD shape: `N` per group, and — when there is
#'   more than one group to compare — `p_value` and `p_value_fmt` at group level
#'   `p-value`.
ard_block_n_and_test <- function(data, spec, denominator) {
  group <- spec$group
  var <- spec$variables[[1]]
  x <- data[[var]]
  g <- as.character(data[[group]])
  present <- !is.na(x) & !is.na(g)
  if (is.factor(x)) present <- present & !is.na(as.character(x))

  levels_present <- if (is.factor(data[[group]])) {
    intersect(levels(data[[group]]), unique(g[present]))
  } else {
    sort(unique(g[present]))
  }

  n_rows <- data.frame(
    group1 = group,
    group1_level = levels_present,
    group2 = NA_character_,
    group2_level = NA_character_,
    variable = var,
    variable_level = NA_character_,
    context = "block_n",
    stat_name = "N",
    stat_label = "N",
    warning = NA_character_,
    error = NA_character_,
    stringsAsFactors = FALSE
  )
  n_rows$stat <- lapply(levels_present, function(lv) sum(present & g == lv))

  # The Total column is produced by re-running this function against a constant
  # grouping column; there is nothing to compare there, so no test row.
  if (length(levels_present) < 2) {
    return(n_rows)
  }

  test <- spec$test %||% "anova"
  p_value <- if (identical(test, "anova")) {
    fit <- stats::aov(x[present] ~ factor(g[present], levels = levels_present))
    summary(fit)[[1]][["Pr(>F)"]][[1]]
  } else if (identical(test, "chisq")) {
    tab <- table(factor(g[present], levels = levels_present), as.character(x[present]))
    # SAS PROC FREQ's CHISQ is Pearson's statistic with no continuity correction,
    # and it prints the p-value whatever the expected counts are.
    suppressWarnings(stats::chisq.test(tab, correct = FALSE))$p.value
  } else {
    stop("analysis '", spec$name, "': unknown test '", test, "' (anova or chisq).", call. = FALSE)
  }

  test_rows <- data.frame(
    group1 = "statistic",
    group1_level = "p-value",
    group2 = NA_character_,
    group2_level = NA_character_,
    variable = var,
    variable_level = spec$p_on_level %||% NA_character_,
    context = "hypothesis_test",
    stat_name = c("p_value", "p_value_fmt"),
    stat_label = c(
      if (identical(test, "anova")) "One-way ANOVA p-value" else "Pearson chi-square p-value",
      "p-value (formatted)"
    ),
    warning = NA_character_,
    error = NA_character_,
    stringsAsFactors = FALSE
  )
  # The numeric p-value is the result; the string is its presentation. The report
  # writes p < 0.0001 as "<.0001", which no {stat_name} pattern can express, and
  # a display must never round a small p-value to "0.0000".
  test_rows$stat <- list(
    p_value,
    if (p_value < 0.0001) "<.0001" else formatC(p_value, format = "f", digits = 4)
  )
  rbind(n_rows, test_rows)
}

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.