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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: count each subject's treatment-emergent adverse events
(TEAENUM), the events that start on or after the first dose.
Input: one spec.yaml over subject-level records carrying the date of
first dose (TRTSDT), and adverse events carrying a sequence number and a
start date.
Variables:
TEAENUMis the number of the subject's adverse events that start on or after the subject's first dose date, that day included. It is blank when no event does, and when the subject has no first dose date.
Note: the first dose date comes from the subject-level record that built the row; the output carries no copy of it.
Inputs
Under review2 source filesExpected output
Under review3 expected rowsexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | TEAENUM |
|---|---|---|
| YAMAA-01 | 2 | |
| YAMAA-01 | — | |
| YAMAA-01 | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from ADSL_RAW.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from ADSL_RAW.USUBJID. | Predecessor | ||
| ADSL | TEAENUM | Number of Treatment-Emergent Adverse Events | numeric | Aggregate COUNT(AE.AESEQ) over records matching on the shared output keys, where ADSL_RAW.TRTSDT is AESTDTC or less. | 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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