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"NE" (Not Evaluable) is a standard result in the Oncology Response Assessment Result codelist (ONCRSR) which is applicable to RECIST 1.1. Therefore, in RS, "NE" (Not Evaluable) is a valid RSORRES/RSSTRESC for RSTEST = "Overall Response". For RS, a suppqual for "Reason Response Not Evaluable" (REASNE) has been used in some examples. However, in TR, the current modeling for NE (not evaluable) results follows the approach where TRSTAT is populated with "NOT DONE". TRSTAT = "NOT DONE" means that the result was missing and the reason that the result was missing is mapped to TRREASND. The TRREASND values cover reasons such as scan was not performed or the various reason that the tumor was not evaluable. This modelling does not always explicitly or consistently identify the tumors which are not evaluable but some of the examples include "NOT EVALUABLE" in the TRREASND.
In the case where there is an independent review and the investigator identified tumors at baseline but the independent assessor found no evidence of disease (NED) was found at baseline, this can be represented by a RS record with RSTEST = "Overall Response" and RSORRES = "NED" and RSSTRESC = "NED".
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In TR, the TRDTC is populated with the date of tumor/lesion assessment/measurement, i.e., the date of the scan, image, or physical exam. In the examples, the summary results (e.g., Sum of Diameter) do not have TRMETHOD and TRDTC associated with them. However, if an appropriate TRDTC is available, it can be populated. AlsoIn TR, scans which are not performed do not have a TRDTC populated.
Symptomatic c deterioration may be collected in studies using RECIST 1.1 but it is not part of an objective RECIST 1.1 response. See example 4.3 for a detailed example for representing these data.
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