myCSG © |Area: TASKS| Concept: ONCO : Oncology: SDTM and ADaM related programming tasks | Lesson: L331 : ADaM - Analysis Flag for First Response |
- 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
- A value of either CR or PR is considered as having a response
- This flag enables us to identify the required date, which can be subsequently be used to choose date of response
| VARIABLE_NAME | VARIABLE_LABEL | DERIVATION |
|---|---|---|
| ANL03FL | Analysis Flag 03 | Flag to capture 'first response': Populate as "Y" on the earliest record where result (RSSTRESC) is any of ("CR", "PR"). Note: Consider only the records which are on or after treatment and on or before follow-up anticancer therapy start date |
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