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: v004
Datasets: adex, adsl 70c7278
Evidence: 19/19 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-EXP-001 DSP-EXP-002 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 14.3.1.1
Study Synopsis Table 13.3
Post-Text Display Package Table 14.3.1.1
Abbreviated Clinical Study Report (ICH E3) Table 14.3.1.1
Study model: Safety Analysis Set SAFFL · grouped by TRT01A
Specification: 4 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: TXT-E3-1201 TXT-E3-1206 TXT-E3-1300 TXT-SYN-0700
Values: No value is sourced from it

Inputs

adsl254 rows · 70c7278
analysis.yamlwhat to compute
display.yamlhow to show it
study modelSafety Analysis Set

Function

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

Outputs

ard.jsonv004 · 208 rows · de9e7ac
table.htmlthe rendered display
table.rtfsha256 aae09a8
table-in-text.rtfsha256 1f08304
manifest.jsonwho, why, every hash

RTFFull displayaae09a8 RTFIn-text variant1f08304

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=84)	Xanomeline High Dose (N=84)	Total (N=254)
Summary of Planned Exposure to Study Drug, as of End of Study
Study CDISCPILOT01 — Safety Analysis Set
Safety population
Average daily dose (mg)
n	86	84	84	254
Mean	0.0	54.0	71.6	41.5
SD	0.00	0.00	8.11	30.98
Median	0.0	54.0	75.1	54.0
Min	0.0	54.0	54.0	0.0
Max	0.0	54.0	78.6	78.6
Cumulative dose at end of study (mg)
n	86	84	84	254
Mean	0.0	5347.3	7551.0	4265.6
SD	0.00	3680.35	5531.04	4963.57
Median	0.0	4455.0	5778.0	2322.0
Min	0.0	108.0	54.0	0.0
Max	0.0	11448.0	15417.0	15417.0
Completers at Week 24
Average daily dose (mg)
n	60	28	30	118
Mean	0.0	54.0	77.0	32.4
SD	0.00	0.00	0.58	34.05
Median	0.0	54.0	76.9	0.0
Min	0.0	54.0	76.1	0.0
Max	0.0	54.0	78.6	78.6
Cumulative dose at end of study (mg)
n	60	28	30	118
Mean	0.0	9918.6	14089.5	5935.7
SD	0.00	603.84	481.01	6249.26
Median	0.0	9936.0	14080.5	0.0
Min	0.0	7884.0	12960.0	0.0
Max	0.0	11448.0	15417.0	15417.0
Duration of treatment (days) — not in the reference table
n	86	84	84	254
Mean	149.1	99.0	99.4	116.1
SD	60.30	68.15	70.64	70.30
Median	182.0	82.5	76.5	133.5
Min	7.0	2.0	1.0	1.0
Max	210.0	212.0	200.0	212.0
Cumulative exposure, n (%) — not in the reference table
≥ 1 day	86 (100.0%)	84 (100.0%)	84 (100.0%)	254 (100.0%)
≥ 30 days	79 (91.9%)	66 (78.6%)	69 (82.1%)	214 (84.3%)
≥ 90 days	68 (79.1%)	41 (48.8%)	39 (46.4%)	148 (58.3%)
≥ 180 days	55 (64.0%)	25 (29.8%)	26 (31.0%)	106 (41.7%)
Average daily dose and cumulative dose are the subject-level AVGDD and CUMDOSE the study's own ADaM package carries; no exposure (ADEX) dataset is used. End of study is Week 26 or early termination.
The reference report (Table 14-4.01) presents completers at Week 24 and the safety population as two column groups. This display presents the same statistics with the two populations as row blocks under one set of treatment columns; no number differs.
Completers at Week 24 are the subjects flagged COMP24FL = 'Y' in the safety analysis set: 60, 28 and 30 subjects.
Duration of treatment (ADSL TRTDUR, days from first to last dose inclusive) and the cumulative exposure categories over it are not part of the reference table; they are carried here because the narrative in Section 12.1 quotes them. A subject treated for 200 days is counted in every category up to 180 days.
Placebo subjects have a planned dose of zero, so every placebo dose statistic is 0. The Total column pools the three treatment groups.
Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01.
open.csr display t-exposure (post_text variant); generated from the committed ARD.

Rendered from outputs/t-exposure/v004/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	N	N	—	—	86
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	mean	Mean	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	sd	SD	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	median	Median	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	p25	Q1	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	p75	Q3	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	min	Min	—	—	0
avg_daily_dose	TRT01A	Placebo	—	—	AVGDD	—	continuous	max	Max	—	—	0
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	N	N	—	—	84
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	mean	Mean	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	sd	SD	—	—	0
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	median	Median	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	p25	Q1	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	p75	Q3	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	min	Min	—	—	54
avg_daily_dose	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	max	Max	—	—	54
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	N	N	—	—	84
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	mean	Mean	—	—	71.602380952381
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	sd	SD	—	—	8.10806494512295
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	median	Median	—	—	75.1
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	p25	Q1	—	—	70.2
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	p75	Q3	—	—	76.9
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	min	Min	—	—	54
avg_daily_dose	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	max	Max	—	—	78.6
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	N	N	—	—	254
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	mean	Mean	—	—	41.5377952755906
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	sd	SD	—	—	30.9794970554353
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	median	Median	—	—	54
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	p25	Q1	—	—	0
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	p75	Q3	—	—	70.2
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	min	Min	—	—	0
avg_daily_dose	TRT01A	Total	—	—	AVGDD	—	continuous	max	Max	—	—	78.6
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	N	N	—	—	86
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	sd	SD	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	median	Median	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	min	Min	—	—	0
total_dose	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	max	Max	—	—	0
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	N	N	—	—	84
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	5347.28571428571
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	sd	SD	—	—	3680.35242737336
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	median	Median	—	—	4455
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	1971
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	9828
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	min	Min	—	—	108
total_dose	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	max	Max	—	—	11448
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	N	N	—	—	84
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	7551
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	sd	SD	—	—	5531.04234059856
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	median	Median	—	—	5778
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	2619
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	13959
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	min	Min	—	—	54
total_dose	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	max	Max	—	—	15417
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	N	N	—	—	254
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	4265.57480314961
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	sd	SD	—	—	4963.57205466116
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	median	Median	—	—	2322
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	0
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	7884
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	min	Min	—	—	0
total_dose	TRT01A	Total	—	—	CUMDOSE	—	continuous	max	Max	—	—	15417
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	N	N	—	—	60
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	mean	Mean	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	sd	SD	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	median	Median	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	p25	Q1	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	p75	Q3	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	min	Min	—	—	0
avg_daily_dose_comp	TRT01A	Placebo	—	—	AVGDD	—	continuous	max	Max	—	—	0
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	N	N	—	—	28
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	mean	Mean	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	sd	SD	—	—	0
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	median	Median	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	p25	Q1	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	p75	Q3	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	min	Min	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline Low Dose	—	—	AVGDD	—	continuous	max	Max	—	—	54
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	N	N	—	—	30
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	mean	Mean	—	—	76.9633333333333
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	sd	SD	—	—	0.584561924588115
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	median	Median	—	—	76.9
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	p25	Q1	—	—	76.6
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	p75	Q3	—	—	77.2
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	min	Min	—	—	76.1
avg_daily_dose_comp	TRT01A	Xanomeline High Dose	—	—	AVGDD	—	continuous	max	Max	—	—	78.6
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	N	N	—	—	118
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	mean	Mean	—	—	32.3805084745763
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	sd	SD	—	—	34.0482143273996
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	median	Median	—	—	0
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	p25	Q1	—	—	0
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	p75	Q3	—	—	76.1
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	min	Min	—	—	0
avg_daily_dose_comp	TRT01A	Total	—	—	AVGDD	—	continuous	max	Max	—	—	78.6
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	N	N	—	—	60
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	sd	SD	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	median	Median	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	min	Min	—	—	0
total_dose_comp	TRT01A	Placebo	—	—	CUMDOSE	—	continuous	max	Max	—	—	0
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	N	N	—	—	28
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	9918.64285714286
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	sd	SD	—	—	603.837371672681
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	median	Median	—	—	9936
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	9828
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	10179
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	min	Min	—	—	7884
total_dose_comp	TRT01A	Xanomeline Low Dose	—	—	CUMDOSE	—	continuous	max	Max	—	—	11448
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	N	N	—	—	30
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	14089.5
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	sd	SD	—	—	481.013208650814
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	median	Median	—	—	14080.5
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	13932
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	14283
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	min	Min	—	—	12960
total_dose_comp	TRT01A	Xanomeline High Dose	—	—	CUMDOSE	—	continuous	max	Max	—	—	15417
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	N	N	—	—	118
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	mean	Mean	—	—	5935.65254237288
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	sd	SD	—	—	6249.25815409573
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	median	Median	—	—	0
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	p25	Q1	—	—	0
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	p75	Q3	—	—	12960
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	min	Min	—	—	0
total_dose_comp	TRT01A	Total	—	—	CUMDOSE	—	continuous	max	Max	—	—	15417
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	N	N	—	—	86
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	mean	Mean	—	—	149.06976744186
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	sd	SD	—	—	60.2955057729502
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	median	Median	—	—	182
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	p25	Q1	—	—	130
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	p75	Q3	—	—	183
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	min	Min	—	—	7
duration	TRT01A	Placebo	—	—	TRTDUR	—	continuous	max	Max	—	—	210
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	N	N	—	—	84
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	mean	Mean	—	—	99.0238095238095
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	sd	SD	—	—	68.1546745809881
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	median	Median	—	—	82.5
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	p25	Q1	—	—	36.5
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	p75	Q3	—	—	182
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	min	Min	—	—	2
duration	TRT01A	Xanomeline Low Dose	—	—	TRTDUR	—	continuous	max	Max	—	—	212
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	N	N	—	—	84
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	mean	Mean	—	—	99.3928571428572
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	sd	SD	—	—	70.6428345187735
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	median	Median	—	—	76.5
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	p25	Q1	—	—	37.5
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	p75	Q3	—	—	181.5
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	min	Min	—	—	1
duration	TRT01A	Xanomeline High Dose	—	—	TRTDUR	—	continuous	max	Max	—	—	200
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	N	N	—	—	254
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	mean	Mean	—	—	116.090551181102
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	sd	SD	—	—	70.2955060529228
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	median	Median	—	—	133.5
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	p25	Q1	—	—	46
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	p75	Q3	—	—	183
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	min	Min	—	—	1
duration	TRT01A	Total	—	—	TRTDUR	—	continuous	max	Max	—	—	212
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	86
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_any	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	1
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	84
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_any	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	1
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	84
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_any	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	1
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	254
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_any	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	1
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	79
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_30	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.918604651162791
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	66
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_30	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.785714285714286
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	69
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_30	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.821428571428571
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	214
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_30	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.84251968503937
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	n	n	—	—	68
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	N	N	—	—	86
dur_90	TRT01A	Placebo	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.790697674418605
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	41
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_90	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.488095238095238
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	n	n	—	—	39
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	N	N	—	—	84
dur_90	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.464285714285714
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	n	n	—	—	148
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	N	N	—	—	254
dur_90	TRT01A	Total	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.582677165354331
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	—	—	84
dur_180	TRT01A	Xanomeline Low Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.297619047619048
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	—	—	84
dur_180	TRT01A	Xanomeline High Dose	—	—	EXPCAT	Y	subject_count	p	%	—	—	0.30952380952381
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

208 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-09-02T15:23:19Z
Spec hash: sha256:065027fd70c7f99747dbb9c73a6e94ca1205bd29ba1f88f62d8a125124cc3cc9
Display hash: sha256:d4dbe6344e5ee371b1d5cb708be04cb14039868c8469972fc116b27d1622064a
ARD file: outputs/t-exposure/v004/ard.json
ARD hash: sha256:de9e7ac7bedab71bc5e127e92efa72f80a1e39215132b55ff52f46e4402675d6

Source datasets

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

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

# ------------------------------------------------------------------------------
# t-exposure — Summary of Planned Exposure to Study Drug, as of End of Study
# ------------------------------------------------------------------------------
# Target: Table 14-4.01 of the CDISCPILOT01 clinical study report (27 June 2006).
#
# The reference summarises two ADSL columns — average daily dose (AVGDD) and
# cumulative dose at end of study (CUMDOSE) — for the safety population and, in
# a second column group, for the subjects who completed Week 24. No exposure
# dataset is involved: the pilot's ADaM package ships no ADEX, and the table
# never needed one. Until v0.4.0 this display read the pharmaverse
# re-derivation's ADEX and grouped by an actual-treatment column that moved
# twelve subjects between arms; it now reads the study's own package and agrees
# with the rest of the report on who was in it (D0032 R2, #60).
#
# The reference lays the two populations out as column groups. v0 supports one
# grouping variable, which the treatment column uses, so the completers appear
# as a second block of ROWS under the same three columns — the transposition
# t-vitals makes. Every number is the reference's number; only the axis differs.
#
# Two blocks the reference table does not carry are kept, and say so on the
# display: duration of treatment in days (ADSL TRTDUR) and the cumulative
# exposure categories over it. Section 12.1's approved narrative quotes them,
# and the analysis names `duration` and `dur_*` are the addresses that prose
# binds, unchanged from the ADEX-based display so the words still resolve.
# ------------------------------------------------------------------------------
id: t-exposure
title: "Summary of Planned Exposure to Study Drug, as of End of Study"
regulatory_id: EXT01
type: table
dataset: adsl
analysis_set: safety
denominator: adsl
group:
  - TRT01A
total: true
analyses:
  - name: avg_daily_dose
    method: continuous
    label: "Average daily dose (mg) — safety population"
    variables: [AVGDD]
  - name: total_dose
    method: continuous
    label: "Cumulative dose at end of study (mg) — safety population"
    variables: [CUMDOSE]
  - name: avg_daily_dose_comp
    method: continuous
    label: "Average daily dose (mg) — completers at Week 24"
    variables: [AVGDD]
    filter: "COMP24FL == 'Y'"
  - name: total_dose_comp
    method: continuous
    label: "Cumulative dose at end of study (mg) — completers at Week 24"
    variables: [CUMDOSE]
    filter: "COMP24FL == 'Y'"
  - name: duration
    method: continuous
    label: "Duration of treatment (days)"
    variables: [TRTDUR]
  - name: dur_any
    method: subject_count
    label: "Treated for at least 1 day"
    variable: EXPCAT
    filter: "!is.na(TRTDUR) & TRTDUR >= 1"
  - name: dur_30
    method: subject_count
    label: "Treated for at least 30 days"
    variable: EXPCAT
    filter: "!is.na(TRTDUR) & TRTDUR >= 30"
  - name: dur_90
    method: subject_count
    label: "Treated for at least 90 days"
    variable: EXPCAT
    filter: "!is.na(TRTDUR) & TRTDUR >= 90"
  - name: dur_180
    method: subject_count
    label: "Treated for at least 180 days"
    variable: EXPCAT
    filter: "!is.na(TRTDUR) & TRTDUR >= 180"

library/tfl/t-exposure/display.yaml

id: t-exposure
title: "Summary of Planned Exposure to Study Drug, as of End of Study"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01."
footnotes:
  - "Average daily dose and cumulative dose are the subject-level AVGDD and CUMDOSE the study's own ADaM package carries; no exposure (ADEX) dataset is used. End of study is Week 26 or early termination."
  - "The reference report (Table 14-4.01) presents completers at Week 24 and the safety population as two column groups. This display presents the same statistics with the two populations as row blocks under one set of treatment columns; no number differs."
  - "Completers at Week 24 are the subjects flagged COMP24FL = 'Y' in the safety analysis set: 60, 28 and 30 subjects."
  - "Duration of treatment (ADSL TRTDUR, days from first to last dose inclusive) and the cumulative exposure categories over it are not part of the reference table; they are carried here because the narrative in Section 12.1 quotes them. A subject treated for 200 days is counted in every category up to 180 days."
  - "Placebo subjects have a planned dose of zero, so every placebo dose statistic is 0. The Total column pools the three treatment groups."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
format:
  digits:
    p: 1
    mean: 1
    sd: 2
    median: 1
    min: 1
    max: 1
rows:
  - { label: "Safety population", section: true }
  - { label: "Average daily dose (mg)", section: true, indent: 1 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: "{mean}", label: "Mean", indent: 2 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: "{sd}", label: "SD", indent: 2 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: median, label: "Median", indent: 2 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: "{min}", label: "Min", indent: 2 }
  - { analysis: avg_daily_dose, variable: AVGDD, pattern: "{max}", label: "Max", indent: 2 }
  - { label: "Cumulative dose at end of study (mg)", section: true, indent: 1 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: "{mean}", label: "Mean", indent: 2 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: "{sd}", label: "SD", indent: 2 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: median, label: "Median", indent: 2 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: "{min}", label: "Min", indent: 2 }
  - { analysis: total_dose, variable: CUMDOSE, pattern: "{max}", label: "Max", indent: 2 }
  - { label: "Completers at Week 24", section: true }
  - { label: "Average daily dose (mg)", section: true, indent: 1 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: "{mean}", label: "Mean", indent: 2 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: "{sd}", label: "SD", indent: 2 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: median, label: "Median", indent: 2 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: "{min}", label: "Min", indent: 2 }
  - { analysis: avg_daily_dose_comp, variable: AVGDD, pattern: "{max}", label: "Max", indent: 2 }
  - { label: "Cumulative dose at end of study (mg)", section: true, indent: 1 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: "{mean}", label: "Mean", indent: 2 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: "{sd}", label: "SD", indent: 2 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: median, label: "Median", indent: 2 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: "{min}", label: "Min", indent: 2 }
  - { analysis: total_dose_comp, variable: CUMDOSE, pattern: "{max}", label: "Max", indent: 2 }
  - { label: "Duration of treatment (days) — not in the reference table", section: true }
  - { analysis: duration, variable: TRTDUR, pattern: "{N}", label: "n", indent: 1 }
  - { analysis: duration, variable: TRTDUR, pattern: "{mean}", label: "Mean", indent: 1 }
  - { analysis: duration, variable: TRTDUR, pattern: "{sd}", label: "SD", indent: 1 }
  - { analysis: duration, variable: TRTDUR, pattern: median, label: "Median", indent: 1 }
  - { analysis: duration, variable: TRTDUR, pattern: "{min}", label: "Min", indent: 1 }
  - { analysis: duration, variable: TRTDUR, pattern: "{max}", label: "Max", indent: 1 }
  - { label: "Cumulative exposure, n (%) — not in the reference table", section: true }
  - { analysis: dur_any, variable: EXPCAT, pattern: n_pct, label: "≥ 1 day", indent: 1 }
  - { analysis: dur_30, variable: EXPCAT, pattern: n_pct, label: "≥ 30 days", indent: 1 }
  - { analysis: dur_90, variable: EXPCAT, pattern: n_pct, label: "≥ 90 days", indent: 1 }
  - { analysis: dur_180, variable: EXPCAT, pattern: n_pct, label: "≥ 180 days", 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.