myCSG © |Area: TASKS| Concept: ONCO : Oncology: SDTM and ADaM related programming tasks | Lesson: L330 : ADaM - Analysis Flag for Last Evaluable Visit |
- Example of an analysis derived in ADaM datasets of a oncology clinical trial
- Using only post-treatment records
- Using only records upto follow-up anti-cancer therapy
- Records with a response of CR, PR or SD are considered evaluable
- This flag enables us to identify the required date, which can subsequently be used to choose selected assessments upto that date
| VARIABLE_NAME | VARIABLE_LABEL | DERIVATION |
|---|---|---|
| ANL01FL | Analysis Flag 01 | Flag to capture 'last evaluable assessment documenting absence of progressive disease': Populate as "Y" on the latest 'allowable' overall response record where response is any of ("CR" "PR" "SD"). 'Allowable': 1) Consider only the records where the assessement date(RSDTC) is on or after treatment start date (TRTSDT) 2) If a subject took follow-up anticancer therapy then assessment date should be on or before this therapy start date (FUACTDT). |
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