ADAS-Cog (11) - Mean and Mean Change from Baseline over Time

ADAS-Cog scores and their change from baseline at every scheduled visit, so the shape of the trajectory is visible rather than just its endpoints. Presented with treatment across the columns.

Slug: t-eff-adas-overtime
Regulatory ID: EFT07
Type: Table
E3 position: §14.2
Status: evidenced
Current iteration: v002
Datasets: adqsadas d6ee9a3, adsl 70c7278
Evidence: 26/26 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-EFF-001 DSP-EFF-002 DSP-EFF-003 DSP-EFF-004 DSP-EFF-005 DSP-EFF-006 DSP-EFF-007 DSP-EFF-008 DSP-EFF-009 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 14.2.10
Post-Text Display Package Table 14.2.10
Abbreviated Clinical Study Report (ICH E3) Table 14.2.10
Study model: Efficacy Analysis Set EFFFL · grouped by TRTP
Specification: 2 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: No text block binds it
Values: No value is sourced from it

Inputs

adsl254 rows · 70c7278
adqsadas12463 rows · d6ee9a3
analysis.yamlwhat to compute
display.yamlhow to show it
custom.Rthe display's own method
study modelEfficacy Analysis Set

Function

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

Outputs

ard.jsonv002 · 459 rows · ae89465
table.htmlthe rendered display
table.rtfsha256 fca112c
manifest.jsonwho, why, every hash

RTFFull displayfca112c

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-eff-adas-overtime · post_text variant · study CDISCPILOT01 · data cut-off 2015-02-17

	Placebo (N=79)	Xanomeline Low Dose (N=81)	Xanomeline High Dose (N=74)
ADAS-Cog (11) - Mean and Mean Change from Baseline over Time
Study CDISCPILOT01 — Efficacy Analysis Set
Baseline
n	79	81	74
Mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)
Median (Range)	21.0 (5;61)	21.0 (5;57)	18.0 (3;57)
Week 8 (windowed)
n	79	81	74
Mean (SD)	25.0 (13.10)	26.2 (12.98)	22.3 (12.41)
Median (Range)	22.0 (5;62)	25.0 (5;62)	19.0 (2;62)
Baseline of these subjects, mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)
Change from baseline, mean (SD)	0.8 (4.81)	1.8 (4.14)	1.0 (3.62)
Change from baseline, median (Range)	1.0 (-12;16)	2.0 (-12;14)	1.0 (-8;13)
Week 16 (windowed)
n	68	42	40
Mean (SD)	25.1 (13.42)	26.2 (12.23)	21.9 (12.39)
Median (Range)	21.0 (5;63)	25.0 (8;53)	19.5 (4;49)
Baseline of these subjects, mean (SD)	23.4 (11.32)	25.0 (12.52)	21.1 (11.79)
Change from baseline, mean (SD)	1.7 (5.92)	1.2 (4.33)	0.8 (4.92)
Change from baseline, median (Range)	2.0 (-17;23)	1.0 (-8;13)	1.0 (-11;10)
Week 24 (windowed)
n	65	49	41
Mean (SD)	25.7 (13.90)	25.6 (13.81)	21.8 (12.38)
Median (Range)	23.0 (5;59)	24.0 (7;57)	19.0 (3;45)
Baseline of these subjects, mean (SD)	23.6 (12.13)	24.4 (13.76)	20.1 (11.13)
Change from baseline, mean (SD)	2.1 (5.99)	1.3 (6.05)	1.7 (4.74)
Change from baseline, median (Range)	2.0 (-11;16)	1.0 (-11;17)	1.0 (-7;13)
Week 8 (LOCF)
n	79	81	74
Mean (SD)	25.0 (13.10)	26.2 (12.98)	22.3 (12.41)
Median (Range)	22.0 (5;62)	25.0 (5;62)	19.0 (2;62)
Baseline of these subjects, mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)
Change from baseline, mean (SD)	0.8 (4.81)	1.8 (4.14)	1.0 (3.62)
Change from baseline, median (Range)	1.0 (-12;16)	2.0 (-12;14)	1.0 (-8;13)
Week 16 (LOCF)
n	79	81	74
Mean (SD)	26.1 (14.16)	26.0 (13.05)	22.5 (12.33)
Median (Range)	23.0 (5;63)	25.0 (5;62)	20.0 (4;62)
Baseline of these subjects, mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)
Change from baseline, mean (SD)	2.0 (5.89)	1.6 (4.10)	1.2 (4.33)
Change from baseline, median (Range)	2.0 (-17;23)	2.0 (-9;14)	1.0 (-11;13)
Week 24 (LOCF)
n	79	81	74
Mean (SD)	26.7 (13.79)	26.4 (13.18)	22.8 (12.48)
Median (Range)	24.0 (5;62)	25.0 (6;62)	20.0 (3;62)
Baseline of these subjects, mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)
Change from baseline, mean (SD)	2.5 (5.80)	2.0 (5.55)	1.5 (4.26)
Change from baseline, median (Range)	2.0 (-11;16)	2.0 (-11;17)	1.0 (-7;13)
Windowed rows include only assessments that fell inside the visit's assessment window, and impute nothing; a subject with no assessment in that window contributes to none of the statistics for that row, so n is below the column N. LOCF rows carry the last observation forward, so every subject contributes at every visit and n equals the column N.
The baseline row of each visit is the mean baseline score of the subjects contributing to that visit, not the baseline of the whole column. The two differ wherever a visit is missing for some subjects, which is why the windowed rows are the ones that move.
ORIENTED HERE, NOT INHERITED: the reference report lays this table out with treatment as row groups and thirteen statistic columns. It is presented here with treatment in the columns, as every other display in this library does, and the statistics as rows. No number, no record selection and no rounding differs; only the axis the reader scans. The reference orientation is recoverable from the same ARD without recomputation.
Assessments are selected by AVISITN rather than the AVISIT label throughout.
Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them.
CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package.
Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, sections 8.1, 8.2 and 10.1.1, and its display specification Template 9. Reference report display: Table 14-3.10. Data cut-off: 2015-02-17.
open.csr display t-eff-adas-overtime (post_text variant); generated from the committed ARD.

Rendered from outputs/t-eff-adas-overtime/v002/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
population	TRTP	Placebo	—	—	USUBJID	—	population	N	N	—	—	79
population	TRTP	Xanomeline High Dose	—	—	USUBJID	—	population	N	N	—	—	74
population	TRTP	Xanomeline Low Dose	—	—	USUBJID	—	population	N	N	—	—	81
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	79
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	24.121780881711
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	12.1863695136042
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	21
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	15
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	31
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
baseline	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	61
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	74
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	21.2972972972973
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	11.7365250390648
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	18
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	13
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	27
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	3
baseline	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	57
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	81
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	24.4074074074074
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.9224478515241
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	21
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	15
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	30
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	5
baseline	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	56.7241379310345
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	79
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	24.9690091663029
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.098714295561
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	22
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	16
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	31
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
wk8_win	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	61.551724137931
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	79
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	24.121780881711
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	12.1863695136042
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	21
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	15
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	31
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
wk8_win	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	61
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	79
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	0.847228284591881
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	4.80856009390139
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	1
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	-2
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	4
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	min	Min	—	—	-12
wk8_win	TRTP	Placebo	—	—	CHG	—	continuous	max	Max	—	—	16
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	74
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	22.260018639329
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.4104640332084
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	19
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	12
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	30
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	2
wk8_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	61.551724137931
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	N	N	—	—	74
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	21.2972972972973
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	11.7365250390648
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	18
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	13
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	27
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	3
wk8_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	57
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	74
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	0.962721342031687
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	3.62493062804096
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	1
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-1
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	3
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-8
wk8_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	13
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	81
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	26.1715623669647
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.9822731686826
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	25
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	18
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	33
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	5
wk8_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	62
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	81
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	24.4074074074074
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	12.9224478515241
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	21
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	15
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	30
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	5
wk8_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	56.7241379310345
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	81
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.76415495955726
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.14217977560178
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	2
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	0
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	4
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-12
wk8_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	14
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	68
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	25.0893864097363
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.419574957694
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	21
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	15.5
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	32.5
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
wk16_win	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	63
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	68
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	23.3620689655172
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	11.3229996801316
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	21
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	15
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	30
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
wk16_win	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	51
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	68
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	1.72731744421907
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	5.91854907463522
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	2
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	-2
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	6
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	min	Min	—	—	-17
wk16_win	TRTP	Placebo	—	—	CHG	—	continuous	max	Max	—	—	23
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	40
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	21.9258620689655
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.387019339507
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	19.5
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	12
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	30
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	4
wk16_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	49
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	N	N	—	—	40
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	21.125
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	11.7891464643957
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	17
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	13
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	26.5
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	3
wk16_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	49
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	40
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	0.800862068965517
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.92454413556611
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	1
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-2.5
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	3
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-11
wk16_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	10
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	42
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	26.1518883415435
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.2283576829308
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	25
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	18
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	31
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	8
wk16_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	53.1034482758621
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	42
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	24.9802955665025
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	12.5190036058678
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	21.5
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	17
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	30
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	5
wk16_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	56.7241379310345
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	42
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.17159277504105
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.3329197769411
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	1
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-1
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	3
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-7.72413793103448
wk16_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	13
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	65
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	25.7246684350133
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.9021584430363
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	23
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	16
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	31
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
wk24_win	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	59
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	65
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	23.5787798408488
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	12.1283705679416
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	21
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	15
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	29
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
wk24_win	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	51
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	65
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	2.14588859416446
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	5.99011016460797
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	2
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	-1
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	6
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	min	Min	—	—	-11
wk24_win	TRTP	Placebo	—	—	CHG	—	continuous	max	Max	—	—	16
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	41
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	21.7701149425287
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.3837842372974
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	19
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	11
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	31
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	3
wk24_win	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	45
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	N	N	—	—	41
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	20.0731707317073
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	11.1274216328457
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	17
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	12
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	26
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	3
wk24_win	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	49
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	41
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.69694421082142
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.73917800247089
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	1
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-1
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	5
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-6.75862068965517
wk24_win	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	13
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	49
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	25.6038001407459
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	13.8148340359052
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	24
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	15
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	36
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	7
wk24_win	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	56.7241379310345
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	49
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	24.350457424349
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	13.7614243732168
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	20
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	14
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	32
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	5
wk24_win	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	56.7241379310345
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	49
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.2533427163969
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	6.04795110720524
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	1
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-2
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	5
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-11
wk24_win	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	17
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	79
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	24.9690091663029
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.098714295561
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	22
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	16
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	31
wk8_locf	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5

Showing the first 250 of 459 rows — the full ARD is committed beside the display.

Schema: opencsr/ard/v1
Generated: 2026-09-02T15:23:23Z
Spec hash: sha256:37f6ffad430e7d6da5cdc7f273ced45902f6ca9850b7abb07d14d45ac224341a
Display hash: sha256:cc82b9a1359e9f859ec2909372b35bd75e31daeea2e4ce91319e942ebefbd088
ARD file: outputs/t-eff-adas-overtime/v002/ard.json
ARD hash: sha256:ae89465726a08192b7f1e4c039a58e503e53789a3e64fe322c2253183269586a

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:70c7278e83e571a7d4a94fd864c98bf8ca243c7c2cc9eec8b99a40fa7bc98e35
adqsadas	12463	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:d6ee9a321a2a9d338285cc702d750624eefd6da11b0da0ae260a4133a492215f

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-eff-adas-overtime/analysis.yaml

id: t-eff-adas-overtime
title: "ADAS-Cog (11) - Mean and Mean Change from Baseline over Time"
regulatory_id: EFT07
type: table
dataset: adqsadas
analysis_set: efficacy
denominator: adsl
sources: phuse
group:
  - TRTP
total: false
# Each visit is its own analysis entry because each one summarises a different
# record set, and the two imputation lanes summarise different record sets at
# the same visit:
#
#   windowed  ANL01FL == 'Y' and the record is not an LOCF carry-forward. Only
#             assessments that actually fell in the visit window; a subject who
#             missed it contributes nothing.
#   LOCF      ANL01FL == 'Y', carry-forward records included. Every subject
#             contributes, so n is the full column N at every visit.
#
# Visits are selected by AVISITN rather than AVISIT so the selection cannot be
# broken by whitespace in a character label.
analyses:
  - name: population
    method: continuous
    custom: population_n
    label: "Subjects in the analysis population"
    filter: "PARAMCD == 'ACTOT'"

  - name: baseline
    method: continuous
    label: "ADAS-Cog (11) total score at baseline"
    variables: [AVAL]
    filter: "PARAMCD == 'ACTOT' & AVISITN == 0"

  - name: wk8_win
    method: continuous
    label: "Week 8, windowed: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 8 & !(DTYPE %in% 'LOCF')"

  - name: wk16_win
    method: continuous
    label: "Week 16, windowed: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 16 & !(DTYPE %in% 'LOCF')"

  - name: wk24_win
    method: continuous
    label: "Week 24, windowed: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 24 & !(DTYPE %in% 'LOCF')"

  - name: wk8_locf
    method: continuous
    label: "Week 8, LOCF: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 8"

  - name: wk16_locf
    method: continuous
    label: "Week 16, LOCF: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 16"

  - name: wk24_locf
    method: continuous
    label: "Week 24, LOCF: score, the baseline it is compared with, and the change"
    variables: [AVAL, BASE, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & AVISITN == 24"

library/tfl/t-eff-adas-overtime/display.yaml

id: t-eff-adas-overtime
title: "ADAS-Cog (11) - Mean and Mean Change from Baseline over Time"
study: CDISCPILOT01
population_label: "Efficacy Analysis Set"
cutoff: "2015-02-17"
source: "Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, sections 8.1, 8.2 and 10.1.1, and its display specification Template 9. Reference report display: Table 14-3.10. Data cut-off: 2015-02-17."
footnotes:
  - "Windowed rows include only assessments that fell inside the visit's assessment window, and impute nothing; a subject with no assessment in that window contributes to none of the statistics for that row, so n is below the column N. LOCF rows carry the last observation forward, so every subject contributes at every visit and n equals the column N."
  - "The baseline row of each visit is the mean baseline score of the subjects contributing to that visit, not the baseline of the whole column. The two differ wherever a visit is missing for some subjects, which is why the windowed rows are the ones that move."
  - "ORIENTED HERE, NOT INHERITED: the reference report lays this table out with treatment as row groups and thirteen statistic columns. It is presented here with treatment in the columns, as every other display in this library does, and the statistics as rows. No number, no record selection and no rounding differs; only the axis the reader scans. The reference orientation is recoverable from the same ARD without recomputation."
  - "Assessments are selected by AVISITN rather than the AVISIT label throughout."
  - "Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them."
  - "CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package."
columns:
  order: ["Placebo", "Xanomeline Low Dose", "Xanomeline High Dose"]
format:
  mean_sd: "{mean} ({sd})"
  median_range: "{median} ({min};{max})"
  digits:
    mean: 1
    sd: 2
    median: 1
    min: 0
    max: 0
rows:
  - { label: "Baseline", section: true }
  - { analysis: baseline, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: baseline, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: baseline, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }

  - { label: "Week 8 (windowed)", section: true }
  - { analysis: wk8_win, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk8_win, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk8_win, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk8_win, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk8_win, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk8_win, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }

  - { label: "Week 16 (windowed)", section: true }
  - { analysis: wk16_win, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk16_win, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk16_win, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk16_win, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk16_win, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk16_win, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }

  - { label: "Week 24 (windowed)", section: true }
  - { analysis: wk24_win, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk24_win, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk24_win, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk24_win, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk24_win, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk24_win, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }

  - { label: "Week 8 (LOCF)", section: true }
  - { analysis: wk8_locf, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk8_locf, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk8_locf, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk8_locf, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk8_locf, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk8_locf, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }

  - { label: "Week 16 (LOCF)", section: true }
  - { analysis: wk16_locf, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk16_locf, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk16_locf, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk16_locf, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk16_locf, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk16_locf, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }

  - { label: "Week 24 (LOCF)", section: true }
  - { analysis: wk24_locf, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: wk24_locf, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: wk24_locf, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { analysis: wk24_locf, variable: BASE, pattern: mean_sd, label: "Baseline of these subjects, mean (SD)", indent: 1 }
  - { analysis: wk24_locf, variable: CHG, pattern: mean_sd, label: "Change from baseline, mean (SD)", indent: 1 }
  - { analysis: wk24_locf, variable: CHG, pattern: median_range, label: "Change from baseline, median (Range)", indent: 1 }
variants:
  post_text: {}

library/tfl/t-eff-adas-overtime/custom.R

# Display-specific statistics (contract section 2).
#
# Both functions are thin wrappers: the statistics themselves live in
# {opencsr} so that the seven ADAS-Cog displays share one tested
# implementation, and every model term is declared in this display's
# analysis.yaml rather than written in code.

ancova_change <- function(data, spec, denominator = NULL) {
  opencsr::ard_ancova(data, spec, denominator)
}

population_n <- function(data, spec, denominator = NULL) {
  opencsr::ard_population_n(data, spec, denominator)
}

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