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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give each adverse event the number of medications the
related-records dataset relates to it (CMCOUNT).
Input: one spec.yaml over adverse events, each with its sequence number
and reported term, and the related-records dataset (RELREC), one record for
each member of a relationship.
Variables:
AETERM: the reported term of the adverse event.CMCOUNT: how many medications share a relationship with the event, a medication counted once for each relationship it shares with the event; empty when no relationship relates the event to a medication.
Inputs
Under review2 source filesExpected output
Under review4 expected rowsexpected/aecm.csv
Edit4 rows| USUBJID | AESEQ | AETERM | CMCOUNT |
|---|---|---|---|
| 1 | HEADACHE | 3 | |
| 2 | NAUSEA | 2 | |
| 3 | RASH | — | |
| 1 | FEVER | 1 |
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 | Collected | Copy value from AE.USUBJID. | SDTM | 1 | ||||
| AESEQ | Sequence Number | Num | Collected | Copy value from AE.AESEQ. | SDTM | 2 | ||||
| AETERM | Reported Term for the Adverse Event | Char | Collected | Copy value from AE.AETERM. | SDTM | 3 | ||||
| CMCOUNT | Number of Related Medication Pairs | Num | Derived | Aggregate COUNT(PAIRS.*) over records matching on USUBJID and AESEQ. | SDTM | 4 |
| 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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