Demographic and Baseline Characteristics — evidence

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

Open the display →

23reviewed requirementsdisplays.md

4test recordsr-unit

0failing4 passing

17%requirement coverage4/23 evidenced

Requirements

ID	Requirement	Result
DSP-DEMO-001	The age summary (n, mean, SD, median, min, max) by treatment arm equals the value computed directly from ADSL, at the display's declared precision.	1 passing
DSP-DEMO-002	Sex, race and age-group counts and percentages by treatment arm and overall equal the values computed directly from ADSL.	1 passing
DSP-DISP-001	Randomised, treated, completed and discontinued counts reproduce `EOSSTT` by treatment arm, with percentages based on randomised subjects.	no test
DSP-DISP-002	The derived discontinuation reasons partition the discontinued subjects exactly, in every column including Total, and the death count matches `DTHFL`.	no test
DSP-EXP-001	Duration-of-exposure statistics equal those computed directly from the ADEX `TDURD` parameter for each treatment arm.	no test
DSP-EXP-002	Cumulative exposure categories are monotone non-increasing and each equals the number of subjects reaching that duration threshold.	no test
DSP-AE-001	Any-AE and serious-AE subject counts and percentages equal the values computed directly from ADAE over the safety analysis set.	no test
DSP-AE-002	Severity, seriousness and relatedness rows never exceed the any-AE row in any column — a subject counted in a subset must be counted in the whole.	no test
DSP-AE-003	The event-count row supplied by `custom.R` counts ADAE records, not subjects, and exceeds the number of subjects reporting them.	no test
DSP-AE-004	System organ class and preferred term subject counts equal the values computed directly from ADAE, with each subject counted once per term.	no test
DSP-AE-005	The in-text variant of AET02 applies the 5% threshold declared in its spec: terms reaching 5% in any treatment group are shown, terms below it in every group are not, and the full display is unaffected.	no test
DSP-SAE-001	The serious-AE listing has exactly one row per `AESER == "Y"` record, reports the recorded preferred terms and subjects, and is sorted as its spec declares.	no test
DSP-VS-001	Every rendered cell of the vital signs summary -- three measures, three positions, three visits, three treatment groups -- equals the value the reference clinical study report printed for the same cell.	no test
DSP-VS-002	Baseline and end of treatment each select at most one observed record per subject, parameter and position; end of treatment is that series' last planned visit after Week 0 up to and including Week 24, and never the Week 26 follow-up visit or a derived record.	no test
DSP-VSC-001	Every rendered cell of the vital signs change display equals the value the reference report printed, and a subject with no observed Week 0 measurement contributes to no change row -- so a change row's n falls below the matching value row's n by exactly the number of subjects without a baseline.	no test
DSP-WT-001	Every rendered cell of the weight display -- weight and weight change, at baseline, Week 24 and end of treatment -- equals the value the reference report printed.	no test
DSP-CM-001	Subject counts by therapeutic class and coded medication equal those computed directly from ADCM, with each subject counted once per class and once per medication however many records they have, and the rendered percentage is that count over the treatment group's safety analysis set.	no test
DSP-CM-002	No therapeutic class count exceeds the number of subjects taking any concomitant medication, and no medication count exceeds the class it is nested under -- a subject counted in a part is counted in the whole.	no test
DSP-CM-003	The in-text variant of CMT01 applies the 5% threshold declared in its spec: medications reaching 5% in any treatment group are shown, medications below it in every group are not, and the full display is unaffected.	no test
DSP-VWC-001	All four displays group by planned treatment over the safety analysis set, carry no pooled Total column, and head their columns with the safety analysis set sizes -- which differ from the actual-treatment sizes, so the choice is consequential rather than cosmetic.	no test
DSP-VWC-002	The committed three-route agreement record reports no disagreement, leaves no publishable statistic unchecked, and describes the iteration of each display that is committed now rather than an earlier one.	no test
DSP-ALL-001	Every display in the library renders a table containing real numbers — no shells, no placeholder output.	1 passing
DSP-ALL-002	Every display declares a regulatory identifier, a source line naming the data cut-off, and at least one footnote.	1 passing

Test records

Result	Suite	Test	Requirements	File
pass	r-unit	DSP-ALL-001: every display renders a table that actually contains numbers (#1)	DSP-ALL-001	test-displays.R
pass	r-unit	DSP-ALL-002: every display declares a regulatory identifier and a source line (#1)	DSP-ALL-002	test-displays.R
pass	r-unit	DSP-DEMO-001: the age summary matches ADSL computed directly (#1)	DSP-DEMO-001	test-displays.R
pass	r-unit	DSP-DEMO-002: sex, race and age-group counts match ADSL (#1)	DSP-DEMO-002	test-displays.R

Traceability

ADaM datasets: adsl
ARD: outputs/t-demographics/v002/ard.json
ARD hash: sha256:e03ca473fd5d976fa5732f0881bea51715104a90494eb4a8ffa5104186299f6c
Display spec: library/tfl/t-demographics/display.yaml
Spec hash: sha256:0f1e9b9029b61b70bfa00f93c9f0c52050859ff26cacb67ee2fed50c39392854
Iteration: v002

Provenance

Generated: 2026-08-27T04:14:45.503Z
Environment: os Darwin 23.6.0 · node v24.14.0 · r 4.3.3
CI run: Not recorded for this evidence set