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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 and each medication of the same
subject given for its term: their sequence numbers (AESEQ, CMSEQ), the
medication's name (CMTRT) and its dose as a whole number (CMDOSE); and a
run report that counts the doses left empty.
Input: one spec.yaml over adverse events, each with its sequence number
and reported term, and concomitant medications, each with its sequence
number, name, indication and dose as collected text; one dose is written in
words.
Variables:
CMTRT: the name of a medication of the same subject whose indication is the event's term.CMDOSE: the medication's dose as a whole number; empty when the collected dose is not a number.
The run report (aecm-report.csv) has one row per item the run handled,
each naming the dataset (ARTIFACT), the kind of item (KIND), where the
spec states it (SPEC_PATH) and the item's name (NAME): the run and its
outcome (OUTCOME) with the rows it built (COUNT); the two collected
datasets, each with the records read and its file facts (DETAILS); the
pairs that built the rows, out of all pairs (TOTAL); then the doses left
empty because they are not numbers, counted once for each pair that holds
one. That count gives the rule its empty dose stands in for (RULE) and no
output column (TARGET), since each pair's dose is read before any row is
built. One row per output column follows, with its missing values and
longest text. Nothing is checked, so no row has a label (ID), a
SEVERITY, a CONDITION or KEYS.
Note: a subject who reports the same term twice pairs each of its medications with both events, so a dose written in words is left empty in each of those rows, and the run report counts it once for each: twice here.
Inputs
Under review2 source filesExpected output
Under review16 expected rowsexpected/aecm-report.csv
Edit10 rows| ARTIFACT | KIND | SPEC_PATH | NAME | ID | TARGET | RULE | SEVERITY | OUTCOME | CONDITION | COUNT | TOTAL | KEYS | DETAILS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| aecm.csv | run | output | — | — | — | — | — | succeeded | — | 6 | — | — | {} |
| aecm.csv | input | input.AE | AE | — | — | — | — | — | — | 4 | — | — | {"bytes":72,"path":"input/ae.csv","profile":"csv"} |
| aecm.csv | input | input.CM | CM | — | — | — | — | — | — | 4 | — | — | {"bytes":151,"path":"input/cm.csv","profile":"csv"} |
| aecm.csv | rows | rows.pairs | GIVEN | — | — | — | — | — | — | 6 | 6 | — | {} |
| aecm.csv | handler | intermediates.GIVEN.derivations.CMDOSE.unconvertible | unconvertible | — | — | VALUE-3 | — | — | — | 2 | — | — | {} |
| aecm.csv | column | columns.USUBJID | USUBJID | — | — | — | — | — | — | 0 | 6 | — | {"max_length":2} |
| aecm.csv | column | columns.AESEQ | AESEQ | — | — | — | — | — | — | 0 | 6 | — | {} |
| aecm.csv | column | columns.CMSEQ | CMSEQ | — | — | — | — | — | — | 0 | 6 | — | {} |
| aecm.csv | column | columns.CMTRT | CMTRT | — | — | — | — | — | — | 0 | 6 | — | {"max_length":11} |
| aecm.csv | column | columns.CMDOSE | CMDOSE | — | — | — | — | — | — | 2 | 6 | — | {} |
expected/aecm.csv
Edit6 rows| USUBJID | AESEQ | CMSEQ | CMTRT | CMDOSE |
|---|---|---|---|---|
| 1 | 1 | PARACETAMOL | 500 | |
| 1 | 3 | IBUPROFEN | — | |
| 2 | 2 | ONDANSETRON | 8 | |
| 3 | 1 | PARACETAMOL | 500 | |
| 3 | 3 | IBUPROFEN | — | |
| 1 | 1 | IBUPROFEN | 200 |
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 | ||||
| CMDOSE | Dose per Administration | Num | Derived | Set per constructed row; see the Row construction sheet. | SDTM | 5 |
| Template | Include when | USUBJID | AESEQ | CMSEQ | CMTRT | CMDOSE |
|---|---|---|---|---|---|---|
| pairs | 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 | Copy CMDOSE from the AE record whose USUBJID equals AE.USUBJID and CMINDC equals AE.AETERM, where CMDOSE is derived as {'type': 'int', 'derivation': 'CM.CMDOSE', 'unconvertible': None}, 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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