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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 the subject's treatment
period (APERIOD) whose days hold the event's start date (ASTDT).
Input: one spec.yaml over adverse events, each carrying a reported term
(AETERM) and a start date, and a period table giving each subject's
treatment periods, each from a first day (APERSDT) to a last day
(APEREDT).
Variables:
APERIODis the number of the subject's period whose first and last days, both inclusive, hold the event's start date. It is blank when the event has no start date, when none of the subject's periods holds the date, or when the period that would hold it has no last day.
Note: the period is chosen among the subject's own periods by the start date of the event itself, so a subject with several periods still gives each event at most one period. An event outside every period is kept with the period blank, and each such blank is counted so the run reports how often it happened.
Inputs
Under review2 source filesinput/ae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | ASTDT |
|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-01-10 | |
| YAMAA-01 | 2 | NAUSEA | 2025-02-01 | |
| YAMAA-01 | 3 | RASH | 2025-01-31 | |
| YAMAA-01 | 4 | COUGH | 2024-12-20 | |
| YAMAA-01 | 1 | DIZZINESS | — | |
| YAMAA-01 | 2 | FATIGUE | 2025-03-15 | |
| YAMAA-01 | 1 | HEADACHE | 2025-01-05 |
input/periods.csv
Edit3 rows| STUDYID | USUBJID | APERIOD | APERSDT | APEREDT |
|---|---|---|---|---|
| YAMAA-01 | 1 | 2025-01-01 | 2025-01-31 | |
| YAMAA-01 | 2 | 2025-02-01 | 2025-02-28 | |
| YAMAA-01 | 1 | 2025-03-01 | — |
Expected output
Under review7 expected rowsexpected/adae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | ASTDT | APERIOD |
|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-01-10 | 1 | |
| YAMAA-01 | 2 | NAUSEA | 2025-02-01 | 2 | |
| YAMAA-01 | 3 | RASH | 2025-01-31 | 1 | |
| YAMAA-01 | 4 | COUGH | 2024-12-20 | — | |
| YAMAA-01 | 1 | DIZZINESS | — | — | |
| YAMAA-01 | 2 | FATIGUE | 2025-03-15 | — | |
| YAMAA-01 | 1 | HEADACHE | 2025-01-05 | — |
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 | ASTDT | Analysis Start Date | numeric | ISO 8601 | Copy value from AE.ASTDT. | Predecessor | |
| ADAE | APERIOD | Period | numeric | Copy value from PERIODS.APERIOD. | Predecessor |
| 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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