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The Oncology Codetable on the CDISC website at https://www.cdisc.org/standards/terminology/controlled-terminology contains the valid value list for the tests in the TU, TR, and RS domains.
RSORRES is populated with the original result and RSSTRESC is populated with the standardized character result according to the associated controlled terminology. For example RSORRES = "CR" and RSSTRESC = "CR" where "CR" is a valid value in the associated controlled terminology.
- TUORRES is populated with the original result and TUSTRESC is populated with the standardized character result according to the associated controlled terminology. For example TUORRES = "TARGET" and TUSTRESC = "TARGET" where "TARGET" is a valid value in the associated controlled terminology.
For the TR domain, TRORRES and TRSTRESC can contain numeric or character results and TRSTRESN is only populated for numeric results. There are situations when a character result in TRORRES is standardized to a numeric representation of the result in TRSTRESC and TRSTRESN.
3.2 General Points on Representation of Data within the Oncology Disease Response Domains for RECIST 1.1
In RECIST 1.1 a subject's tumors are identified as target tumors, non-target tumors and new tumors. At a specific disease assessment timepoint, the overall response in RECIST 1.1 is based on measurements of target tumors (target response), qualitative assessments of non-target tumors (non-target response) and the appearance of new tumors. Subjects with at least one target tumor can have overall response of Complete Response (CR), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease) and NE (Not Evaluable). Subjects with only non-measurable disease (i.e., no target tumors) can have overall response of CR (Complete Response), Non-CR/Non-PD, PD (Progressive Disease) and NE (Not Evaluable).
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