Quality / l-ae-serious
Display
Listing of Serious Adverse Events — evidence
Subject-level listing of serious adverse events with onset, severity, outcome and relationship.
14reviewed requirementsdisplays.md
3test recordsr-unit
0failing3 passing
21%requirement coverage3/14 evidenced
Requirements
| ID | Area | Requirement | Evidence type | 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. | 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-SAE-001: the serious-AE listing has one row per serious event record (#1) | DSP-SAE-001 | test-displays.R |
Traceability
- ADaM datasets
- adae, adsl
- ARD
- outputs/l-ae-serious/v002/ard.json
- ARD hash
- sha256:0395149df9ea9e04395bc28a568415b8cec29d736acb92dce4613453f72728b0
- Display spec
- library/tfl/l-ae-serious/display.yaml
- Spec hash
- sha256:a046fb1cdc11ed10d586284efeb97e30ab743f4ad394869bd83ae1bfb401d140
- Iteration
- v002
Provenance
- Generated
- 2026-07-27T04:44:02.378Z
- Environment
- os Darwin 23.6.0 · node v24.14.0 · vitest 2.1.9 · r 4.3.3
- CI run
- Not recorded for this evidence set