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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give one row for each adverse event with the one medication of the
same subject given for it: its sequence number (CMSEQ) and name (CMTRT).
Input: one spec.yaml over adverse events, each with its sequence number
and reported term, and concomitant medications, each with its sequence
number, name and indication, the indication written as the term of the event
it was given for.
Variables:
CMSEQwould be the sequence number of the medication given for the event.CMTRTwould be the name of that medication.
Note: each event is to have one treating medication, yet both subjects' headaches were treated with two medications each, so their events and medications pair twice. Nothing says which medication an event keeps, so the run stops before any row is built and no artifact is accepted.
How to fix
Confirm with the data owner whether an event may have several treating medications. If it may, keep every pair and give each its own row, adding the medication's sequence number to the row identifiers and removing the one-medication expectation:
keys: [USUBJID, AESEQ, CMSEQ]
If an event keeps one of them, state which one: read the pairs of each event through an intermediate that declares a key of the subject and the event's sequence number, an order and the record to keep, such as the medication with the lowest sequence number.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- verification
- condition
- duplicate_intermediate_records
- rule
- LOOKUP-17
expected/error.yaml
phase: verification
condition: duplicate_intermediate_records
spec_paths:
- intermediates.TREATMENT.verifications[0].unique
rule: LOOKUP-17
context:
intermediate: TREATMENT
dataset: TREATMENT
columns: [USUBJID, AESEQ]
duplicate_count: 2
Inputs
Under review2 source filesUnexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| USUBJID | Unique Subject Identifier | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 1 | ||||
| AESEQ | Sequence Number of the Adverse Event | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 2 | ||||
| CMSEQ | Sequence Number of the Medication | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 3 | ||||
| CMTRT | Reported Name of Drug, Med, or Therapy | Char | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 4 |
| Template | Include when | USUBJID | AESEQ | CMSEQ | CMTRT |
|---|---|---|---|---|---|
| treatment | Copy USUBJID from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where USUBJID is derived as AE.USUBJID, and no match yields blank | Copy AESEQ from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where AESEQ is derived as AE.AESEQ, and no match yields blank | Copy CMSEQ from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where CMSEQ is derived as CM.CMSEQ, and no match yields blank | Copy CMTRT from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where CMTRT is derived as CM.CMTRT, and no match yields blank |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 1.7 | 2026-10-20 | yamaa docs build | Read a specification in the 1.0 surface as its 0.5 counterpart; state that missing values stay missing where a mapping declares no missing handler, and leave out a declared missing answer that restates a handler's default | ||
| 1.6 | 2026-10-17 | yamaa docs build | Describe collected date parts written as ISO 8601 date text and times of day counted in seconds since midnight | ||
| 1.5 | 2026-10-17 | yamaa docs build | Name collected precision in words instead of letter codes; state imputation fallbacks, minimum source precision, bounds ignored outside the collected period, and invalid text with no handler as an error; describe date and datetime shifts, imputation flag codes, and partial text giving no date part | ||
| 1.4 | 2026-10-15 | yamaa docs build | State datetime precision codes through the hour and minute, and complete only the time parts a collected datetime lacks | ||
| 1.3 | 2026-09-29 | yamaa docs build | Show study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata | ||
| 1.2 | 2026-09-29 | yamaa docs build | Classify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived | ||
| 1.1 | 2026-09-29 | yamaa docs build | Resolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML | ||
| 1.0 | yamaa docs build | Initial generation from spec.yaml |
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