EXT01 · Table

Extent of Exposure to Study Drug

Duration and cumulative dose of study treatment by arm.

Slug: t-exposure
Regulatory ID: EXT01
Type: Table
E3 position: §14.3.1
Status: evidenced
Current iteration: v002
Datasets: adex, 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 display0eb9294 RTFIn-text variantcbff476

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-exposure · 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)
Extent of Exposure to Study Drug
Study CDISCPILOT01 — Safety Analysis Set
Duration of exposure (days)
n	86	96	72	254
Mean (SD)	147.8 (62.13)	85.9 (70.66)	112.2 (65.52)	114.3 (71.17)
Median	182.0	62.5	96.5	130.5
Q1, Q3	130.0, 183.0	21.5, 180.5	53.5, 183.0	43.0, 183.0
Min, Max	0, 210	0, 212	15, 200	0, 212
Total dose administered (mg)
Mean (SD)	0.0 (0.0)	4638.9 (3815.6)	8341.5 (5182.9)	4117.8 (4893.8)
Median	0.0	3375.0	7114.5	2025.0
Min, Max	0, 0	0, 11448	810, 15417	0, 15417
Average daily dose (mg)
Mean (SD)	0.00 (0.00)	54.00 (0.00)	72.89 (9.68)	41.18 (30.85)
Median	0.00	54.00	75.90	54.00
Overall dose intensity (%)
n	0	95	72	167
Mean (SD)		100.0 (0.00)	135.0 (17.92)	115.1 (20.96)
Median		100.0	140.6	100.0
Cumulative exposure, n (%)
≥ 1 day	85 (98.8%)	95 (99.0%)	72 (100.0%)	252 (99.2%)
≥ 30 days	78 (90.7%)	65 (67.7%)	67 (93.1%)	210 (82.7%)
≥ 90 days	67 (77.9%)	40 (41.7%)	38 (52.8%)	145 (57.1%)
≥ 180 days	55 (64.0%)	25 (26.0%)	26 (36.1%)	106 (41.7%)
Duration, total dose, average daily dose and dose intensity are the overall-study ADEX parameters TDURD, TDOSE, AVDDSE and TDOSINT respectively.
Exposure categories are cumulative: a subject exposed for 200 days is counted in every category up to 180 days.
Q1 and Q3 are type-2 (SAS-compatible) quantiles, as computed by {cards}; they differ from R’s default type-7 quantiles.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Placebo subjects have no ADEX dose-intensity (TDOSINT) records because planned placebo dose is zero; the dose-intensity rows are therefore empty for that column.
Source: adex, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-exposure (post_text variant); generated from the committed ARD.

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

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	N	N	—	—	86
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	147.802325581395
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	62.1275386068978
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	182
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	130
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	183
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	0
duration	TRT01A	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	210
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	96
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	85.90625
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	70.6594617830739
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	62.5
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	21.5
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	180.5
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	0
duration	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	212
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	72
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	112.222222222222
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	65.5232938307347
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	96.5
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	53.5
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	183
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	15
duration	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	200
duration	TRT01A	Total	—	—	AVAL	—	continuous	N	N	—	—	254
duration	TRT01A	Total	—	—	AVAL	—	continuous	mean	Mean	—	—	114.322834645669
duration	TRT01A	Total	—	—	AVAL	—	continuous	sd	SD	—	—	71.1691057334947
duration	TRT01A	Total	—	—	AVAL	—	continuous	median	Median	—	—	130.5
duration	TRT01A	Total	—	—	AVAL	—	continuous	p25	Q1	—	—	43
duration	TRT01A	Total	—	—	AVAL	—	continuous	p75	Q3	—	—	183
duration	TRT01A	Total	—	—	AVAL	—	continuous	min	Min	—	—	0
duration	TRT01A	Total	—	—	AVAL	—	continuous	max	Max	—	—	212
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	N	N	—	—	86
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	0
total_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	0
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	96
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	4638.9375
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	3815.61093628599
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	3375
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	1161
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	9747
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	0
total_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	11448
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	72
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	8341.5
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	5182.94597559298
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	7114.5
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	3604.5
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	13972.5
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	810
total_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	15417
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	N	N	—	—	254
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	mean	Mean	—	—	4117.8188976378
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	sd	SD	—	—	4893.7841948464
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	median	Median	—	—	2025
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	p25	Q1	—	—	0
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	p75	Q3	—	—	7263
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	min	Min	—	—	0
total_dose	TRT01A	Total	—	—	AVAL	—	continuous	max	Max	—	—	15417
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	N	N	—	—	85
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	0
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	95
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	0
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	54
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	72
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	72.8923295967697
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	9.67607884778698
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	75.9041501976285
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	72.8103146853147
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	76.9144736842105
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	4.42622950819672
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	78.5748502994012
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	N	N	—	—	252
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	mean	Mean	—	—	41.1835227419342
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	sd	SD	—	—	30.845436785601
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	median	Median	—	—	54
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	p25	Q1	—	—	0
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	p75	Q3	—	—	69.206279809221
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	min	Min	—	—	0
avg_daily_dose	TRT01A	Total	—	—	AVAL	—	continuous	max	Max	—	—	78.5748502994012
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	N	N	—	—	0
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	—
dose_intensity	TRT01A	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	—
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	95
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	100
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	0
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	100
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	100
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	100
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	100
dose_intensity	TRT01A	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	100
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	72
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	134.985795549574
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	17.9186645329388
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	140.563241106719
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	134.833916083916
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	142.434210526316
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	8.19672131147541
dose_intensity	TRT01A	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	145.508982035928
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	N	N	—	—	167
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	mean	Mean	—	—	115.083696284846
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	sd	SD	—	—	20.9603055866314
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	median	Median	—	—	100
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	p25	Q1	—	—	100
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	p75	Q3	—	—	138.571428571429
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	min	Min	—	—	8.19672131147541
dose_intensity	TRT01A	Total	—	—	AVAL	—	continuous	max	Max	—	—	145.508982035928
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	85
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.988372093023256
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	95
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	96
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.989583333333333
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	72
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	72
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	1
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	252
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.992125984251969
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	78
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.906976744186046
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	65
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	96
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.677083333333333
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	67
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	72
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.930555555555556
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	210
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.826771653543307
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	67
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.779069767441861
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	40
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	96
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.416666666666667
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	38
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	72
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.527777777777778
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	145
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.570866141732283
dur_180	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	55
dur_180	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_180	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.63953488372093
dur_180	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	25
dur_180	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	96
dur_180	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.260416666666667
dur_180	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	26
dur_180	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	72
dur_180	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.361111111111111
dur_180	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	106
dur_180	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_180	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.417322834645669

176 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-07-27T03:23:36Z
Spec hash: sha256:dcb569bb84c890fe5d3322fbb111cdaeabd917ad388c89d10b2e754b8d322dd8
Display hash: sha256:5cf918ab32731b85dcf031052e201c763ba0972d98f2badb1c8d7a216b812c44
ARD file: outputs/t-exposure/v002/ard.json
ARD hash: sha256:f14f5e37bcd2a6ddbbc146d05fbbf599b1362fd28d2f1c13895e0d61dadcfb4c

Source datasets

Dataset	Rows	Package	Hash
adsl	254	pharmaverseadam 1.1.0	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
adex	6315	pharmaverseadam 1.1.0	sha256:e89d24c9364ba5a20a49a86de8428a8e4d8b35899b4d154ff83f89645c733f5f

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-exposure/analysis.yaml

id: t-exposure
title: "Extent of Exposure to Study Drug"
regulatory_id: EXT01
type: table
dataset: adex
analysis_set: safety
denominator: adsl
group:
  - TRT01A
total: true
analyses:
  - name: duration
    method: continuous
    label: "Duration of exposure (days)"
    variables: [AVAL]
    filter: "PARAMCD == 'TDURD'"
  - name: total_dose
    method: continuous
    label: "Total dose administered (mg)"
    variables: [AVAL]
    filter: "PARAMCD == 'TDOSE'"
  - name: avg_daily_dose
    method: continuous
    label: "Average daily dose (mg)"
    variables: [AVAL]
    filter: "PARAMCD == 'AVDDSE'"
  - name: dose_intensity
    method: continuous
    label: "Overall dose intensity (%)"
    variables: [AVAL]
    filter: "PARAMCD == 'TDOSINT'"
  - name: dur_any
    method: subject_count
    label: "Exposed for at least 1 day"
    variable: EXPCAT
    filter: "PARAMCD == 'TDURD' & AVAL >= 1"
  - name: dur_30
    method: subject_count
    label: "Exposed for at least 30 days"
    variable: EXPCAT
    filter: "PARAMCD == 'TDURD' & AVAL >= 30"
  - name: dur_90
    method: subject_count
    label: "Exposed for at least 90 days"
    variable: EXPCAT
    filter: "PARAMCD == 'TDURD' & AVAL >= 90"
  - name: dur_180
    method: subject_count
    label: "Exposed for at least 180 days"
    variable: EXPCAT
    filter: "PARAMCD == 'TDURD' & AVAL >= 180"

library/tfl/t-exposure/display.yaml

id: t-exposure
title: "Extent of Exposure to Study Drug"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: adex, adsl (pharmaverseadam). Data cut-off: 2014-07-01."
footnotes:
  - "Duration, total dose, average daily dose and dose intensity are the overall-study ADEX parameters TDURD, TDOSE, AVDDSE and TDOSINT respectively."
  - "Exposure categories are cumulative: a subject exposed for 200 days is counted in every category up to 180 days."
  - "Q1 and Q3 are type-2 (SAS-compatible) quantiles, as computed by {cards}; they differ from R\u2019s default type-7 quantiles."
  - "Percentages are based on the number of subjects in the safety analysis set for each treatment group."
  - "Placebo subjects have no ADEX dose-intensity (TDOSINT) records because planned placebo dose is zero; the dose-intensity rows are therefore empty for that column."
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: "Duration of exposure (days)", section: true }
  - { analysis: duration, variable: AVAL, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: duration, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: duration, variable: AVAL, pattern: median, label: "Median", indent: 1 }
  - { analysis: duration, variable: AVAL, pattern: q1_q3, label: "Q1, Q3", indent: 1 }
  - { analysis: duration, variable: AVAL, pattern: range, label: "Min, Max", indent: 1 }
  - { label: "Total dose administered (mg)", section: true }
  - { analysis: total_dose, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 1, sd: 1 } }
  - { analysis: total_dose, variable: AVAL, pattern: median, label: "Median", indent: 1 }
  - { analysis: total_dose, variable: AVAL, pattern: range, label: "Min, Max", indent: 1 }
  - { label: "Average daily dose (mg)", section: true }
  - { analysis: avg_daily_dose, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 2, sd: 2 } }
  - { analysis: avg_daily_dose, variable: AVAL, pattern: median, label: "Median", indent: 1,
      digits: { median: 2 } }
  - { label: "Overall dose intensity (%)", section: true }
  - { analysis: dose_intensity, variable: AVAL, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: dose_intensity, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1,
      digits: { mean: 1, sd: 2 } }
  - { analysis: dose_intensity, variable: AVAL, pattern: median, label: "Median", indent: 1 }
  - { label: "Cumulative exposure, n (%)", section: true }
  - { analysis: dur_any, label: "≥ 1 day", pattern: n_pct, indent: 1 }
  - { analysis: dur_30, label: "≥ 30 days", pattern: n_pct, indent: 1 }
  - { analysis: dur_90, label: "≥ 90 days", pattern: n_pct, indent: 1 }
  - { analysis: dur_180, label: "≥ 180 days", pattern: n_pct, indent: 1 }
variants:
  post_text: {}
  in_text:
    title: "Extent of Exposure (Summary)"

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