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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry three record-level supplemental qualifiers of each adverse
event onto its analysis row: the location detail (AEXSITE), the suspected
cause (AEXCAUS) and the reaction size (AEXSIZE).
Input: one spec.yaml over adverse event records and the supplemental
qualifier records of the AE domain (SDTMIG section 8.4), each naming the
parent event by its sequence number, the qualifier name and its value.
Variables:
AETERMis the reported term of the event, as collected.AEXSITEis the value of the event'sAEXSITEqualifier; empty when the event has none.AEXCAUSis the value of the event'sAEXCAUSqualifier; empty when the event has none.AEXSIZEis the value of the event'sAEXSIZEqualifier as a number; empty when the event has none.
Note: one declaration names the three qualifiers, and each becomes a field of the event's supplemental records. A subject-level qualifier, which names no sequence number, and a qualifier of a sequence number no event carries change nothing. A qualifier record whose name is none of the three would stop the run rather than be dropped.
Inputs
Under review2 source filesinput/ae.csv
Edit5 rows| STUDYID | USUBJID | AESEQ | AETERM |
|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | |
| YAMAA-01 | 2 | RASH | |
| YAMAA-01 | 1 | NAUSEA | |
| YAMAA-01 | 2 | RASH | |
| YAMAA-01 | 1 | FATIGUE |
input/suppae.csv
Edit9 rows| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | AE | AESEQ | 1 | AEXSITE | Location Detail | LEFT TEMPLE | CRF | |
| YAMAA-01 | AE | AESEQ | 1 | AEXCAUS | Suspected Cause | STRESS | CRF | |
| YAMAA-01 | AE | AESEQ | 2 | AEXSITE | Location Detail | RIGHT FOREARM | CRF | |
| YAMAA-01 | AE | AESEQ | 2 | AEXSIZE | Reaction Size (mm) | 12 | CRF | |
| YAMAA-01 | AE | — | — | AEXSUBJ | Subject Note | ATOPIC | CRF | |
| YAMAA-01 | AE | AESEQ | 2 | AEXSIZE | Reaction Size (mm) | 30 | CRF | |
| YAMAA-01 | AE | AESEQ | 2 | AEXSITE | Location Detail | UPPER BACK | CRF | |
| YAMAA-01 | AE | AESEQ | 9 | AEXSITE | Location Detail | ORPHAN | CRF | |
| YAMAA-01 | AE | AESEQ | 1 | AEXCAUS | Suspected Cause | UNKNOWN | CRF |
Expected output
Under review5 expected rowsexpected/adae.csv
Edit5 rows| STUDYID | USUBJID | AESEQ | AETERM | AEXSITE | AEXCAUS | AEXSIZE |
|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | LEFT TEMPLE | STRESS | — | |
| YAMAA-01 | 2 | RASH | RIGHT FOREARM | — | 12 | |
| YAMAA-01 | 1 | NAUSEA | — | — | — | |
| YAMAA-01 | 2 | RASH | UPPER BACK | — | 30 | |
| YAMAA-01 | 1 | FATIGUE | — | UNKNOWN | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Copy value from AE.STUDYID. | Predecessor | ||
| ADAE | USUBJID | Unique Subject Identifier | character | Copy value from AE.USUBJID. | Predecessor | ||
| ADAE | AESEQ | Sequence Number | numeric | Copy value from AE.AESEQ. | Predecessor | ||
| ADAE | AETERM | Reported Term for the Adverse Event | character | Copy value from AE.AETERM. | Predecessor | ||
| ADAE | AEXSITE | Location Detail | character | Take AEXSITE from the SUPPAE record whose STUDYID equals AE.STUDYID, USUBJID equals AE.USUBJID and IDVARVAL equals AE.AESEQ, where SUPPAE.RDOMAIN = 'AE' AND SUPPAE.IDVAR = 'AESEQ', and no match yields blank. | Derived | ||
| ADAE | AEXCAUS | Suspected Cause | character | Take AEXCAUS from the SUPPAE record whose STUDYID equals AE.STUDYID, USUBJID equals AE.USUBJID and IDVARVAL equals AE.AESEQ, where SUPPAE.RDOMAIN = 'AE' AND SUPPAE.IDVAR = 'AESEQ', and no match yields blank. | Derived | ||
| ADAE | AEXSIZE | Reaction Size (mm) | numeric | Take AEXSIZE from the SUPPAE record whose STUDYID equals AE.STUDYID, USUBJID equals AE.USUBJID and IDVARVAL equals AE.AESEQ, where SUPPAE.RDOMAIN = 'AE' AND SUPPAE.IDVAR = 'AESEQ', and no match yields blank. | Derived |
| 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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