Summary of Vital Signs at Baseline and End of Treatment — evidence

Blood pressure and pulse in three positions, at baseline, Week 24 and end of treatment, by planned treatment.

Open the display →

23reviewed requirementsdisplays.md

6test recordsr-unit

0failing6 passing

26%requirement coverage6/23 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.	no test
DSP-DEMO-002	Sex, race and age-group counts and percentages by treatment arm and overall equal the values computed directly from ADSL.	no test
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.	1 passing
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.	1 passing
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.	1 passing
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.	1 passing
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-VS-001: every rendered cell of the vital signs summary is what the reference report printed (#1)	DSP-VS-001	test-displays-vitals.R
pass	r-unit	DSP-VS-002: baseline and end of treatment select one record per subject, parameter and position (#1)	DSP-VS-002	test-displays-vitals.R
pass	r-unit	DSP-VWC-001: all four displays group by planned treatment over the safety analysis set (#1)	DSP-VWC-001	test-displays-vitals.R
pass	r-unit	DSP-VWC-002: the committed three-route agreement record is green and describes this iteration (#1)	DSP-VWC-002	test-displays-vitals.R

Traceability

ADaM datasets: adsl, advs
ARD: outputs/t-vitals/v001/ard.json
ARD hash: sha256:88e8ee0b9d51761c4bafa4a2b13ee72b699117f76d08849535d26674ecf8e961
Display spec: library/tfl/t-vitals/display.yaml
Spec hash: sha256:2aeb25861d2864c68dec7cb56a37435df974e048d036e1a3a1b256a5604d4290
Iteration: v001

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