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The representation of data collected for the disease the disease response criteria is based on the Study Data Tabulation Model Implementation Guide: Human Clinical Trials (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

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The CDISC Intellectual Property Policy can be found on the CDISC web site website at: https://www.cdisc.org/about/bylaws.

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This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

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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 1 target tumor can have overall response of CR (Complete Response), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease) and NE (Not Evaluable). Subjects with only nonmeasurable 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).

Target tumors are measured in the longest diameter except when the location is a lymph node, when they are measured in the longest perpendicular. The examples in this supplement use TRTESTCD = "LDIAM" (Longest Diameter) for measurements of non-lymph node target tumors and TRTESTCD = "LPERP" (Longest Perpendicular) for measurements of lymph node target tumors. SDTMIG examples have previously used TRTESTCD = "DIAMETER" (Diameter) for measurements of both lymph nodes and non-lymph nodes. Either representation is acceptable for RECIST 1.1. The latter approach requires looking at the anatomical location in conjunction with the TRTESTCD to know whether the diameter was measured in the longest diameter or the longest perpendicular. The LDIAM and LPERP tests provide more specificity in the TRTESTCD itself and do not require looking to at the anatomical location. In addition, the LDIAM and LPERP tests are used in other disease response criteria; the use of these 2 tests provides standardization across criteria for the same measurement. Some sponsors prefer the approach used within this disease response supplement due to these reasons. 

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In RECIST1.1, the following calculations are used in determination of the target response: sum of the diameters of target tumors (target sum), percentage change from baseline in the target sum, and percentage change from nadir in the target sum (smallest target sum at any assessment). These are referred to as summary values in the examples belowthat follow. These summary values are not typically collected/calculated in investigator CRFs, but rather are usually provided by independent assessors. When not derived in EDC, summary values not in the collected data may be derived in the analysis datasets (i.e., ADaM).

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The examples in this supplement use RSTESTCD = "NEWLPROG" (New Lesion Progression) to indicate whether a new lesion is equivocal or unequivocal. There are different methods of collecting data when there is an equivocal new lesion. Some sponsors update the overall response when unequivocal evidence of a new lesion has been later confirmed (i.e., documented as unequivocal). Other sponsors programmatically derive the new lesion progression date as the date when the new lesion was first identified during the analysis. RSTESTCD = "NEWLSIND" can have RSORRES = "Y" or RSORRES = "N" values only. This test can be used if the sponsor collects yes and no responses to indicate that new lesion(s) were identified at the disease assessment timepoint.

"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 supplemental qualifier for "Reason Response Not Evaluable" (RSREASNE) 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 that the scan was not performed or the other reason that the tumor was not evaluable. This modeling does not always explicitly or consistently identify the tumors which are not evaluable but some of the examples include "NOT EVALUABLE" in TRREASND.

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Per the SDTMIG, "When a clinical classification result is based on multiple procedures/scans/images/physical exams performed on different dates, RSDTC may be derived." Some sponsors assign or derive the date of overall response (RSDTC) associated with the disease assessment timepoint, and some sponsors collect the date of overall response (RSDTC) associated with the disease assessment timepoint and provide instructions to the site/vendor on how to populate it when there is more than 1 evaluation date. In the RS examples, when there are multiple dates of evaluation performed as part of the disease assessment timepoint, RSDTC is populated using the following commonly used common convention (either entered by the investigator, assigned by the sponsor, or assigned by an independent assessor): For responses of CR (Complete Response) and PR (Partial Response), the latest date associated with the evaluation is used; for responses of PD (Progressive Disease), the earliest date associated with an evaluation is used. This convention is based on the following concepts: When evaluating measures of disease burden over time (e.g., duration of response, progression-free survival), it is generally considered conservative to assign a negative outcome (e.g., disease progression) to the date the assessment is initiated but not to assign a date to a positive response until the assessment is completed. For SD (Stable Disease), different conventions have been used in industry and the rationale varies. For the examples in this supplement, the convention used for SD is to assign the earliest date to RSDTC. However, picking the latest date is acceptable and a common approach. For NE (Not Evaluable), a date associated with the assessment is required but it generally does not impact the analysis, so either the earliest or latest date can be used.

In TR, TRDTC is populated with the date of tumor/lesion assessment/measurement (ie.eg., 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. In TR, scans which are not performed do not have TRDTC populated.

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1. Examples in this supplement are based on assumptions about the data collection forms. For example, the collection of split and merged tumors may be collected in different ways depending on the form design and system limitations. The preferred SDTM data representation is shown in the examples.
2. Examples in this supplement assume that no protocol modifications were made to RECIST 1.1.

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The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at the week 6, week 12, and subsequent 8-week follow-up visits. Note: Sponsors may include the New Lesion Indicator new lesion indicator test (RSTESTCD = "NEWLIND") at every timepoint if the new lesion yes or /no question is part of the data collection.

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The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. This example shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements of other non-lymph node target tumors (i.e., longest diameter). In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node tumor is less than 10mm10 mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm10 mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL". The image identifier is in TRREFID and matches a PRREFID in the PR domain.

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4.2.3 TR Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows the data for 1 subject collected at screening, week 6, and subsequent 8-week follow-up visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This preferred approach provides transparent traceability with to parent lesions. This example shows how to represent data on a single row when a target tumor becomes too small to measure. In terms of Per RECIST 1.1, the original results would be "TOO SMALL TO MEASURE" and the standard results (TRSTRESN and TRSTRESC) would be "5". In addition, the this example represents a situation where a result was not provided because the image was obscured and the tumor was not assessable.

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The acceptance flag (RSACPTFL) is used to identify records when multiple assessments are performed by independent assessors (ie.eg., radiologist 1, radiologist 2) for the same timepoint. RSACPTFL indicates the "selected" response when more than 1 reading is performed. In some instances, a vendor may only supply a single response record for the " selected " response, either because there was adjudication or because the vendor selected the appropriate response. This alternative approach would result in only the selected response records in the RS domain. It is not expected that the RSACPTFL flag would be populated by the sponsor. That ; this type of record selection or censoring would be part of the analysis dataset.

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This example uses RSNAM (name of the vendor), RSEVAL (role of the person providing the assessment; ie.eg., "INDEPENDENT ASSESSOR"), and RSEVALID (specific type of medical reviewer who performed the independent assessment). In this case, 2 radiologists independently reviewed the scans (RSEVALID = "RADIOLOGIST 1", "RADIOLOGIST 2"). The acceptance flag (RSACPTFL) indicates that the "RADIOLOGIST 2" records are the accepted records (rows 9-16). The best overall response (RSTESTCD = "BESTRESP") is provided by the vendor in the data transfer in rows 4, 8, 12 and 16.

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4.4.2 TU Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. This 1 in the TU domain. This example shows the use of the acceptance flag (TUACPTFL) to identify records when multiple assessments are performed by independent assessors (ie.eg., radiologist 1, radiologist 2) for the same timepoint. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported (i.e., only accepted records are transferred). It is not expected that TUACPTFL would be populated by the sponsor; this type of record selection or censoring would be part of the analysis dataset. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain. 

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4.4.3 TR Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain. This 1 in the TR domain. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (ie.eg., radiologist 1, radiologist 2) for the same timepoint. It is not expected that TUACPTFL would be populated by the sponsor; this type of record selection or censoring would be part of the analysis dataset.

This example shows that situation where In this example, the independent assessor provided the summary values for target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD", and "PCNSD". Note that sponsors should not derive these values if they were not part of the data capture or not provided in the transfer from the vendor.

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This example shows investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject who has with 1 target tumor and no non-targets at screening (i.e., a subject with target tumors only). This example also includes an unscheduled assessment.

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The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data for a subject who has only target tumors at screening. This includes an unscheduled assessment.   

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4.5.2 TU Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The 1 in the TU domain. The example shows a subject who has with only target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.  

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4.5.3 TR Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows investigator tumor results for a subject who has with only target tumors at screening. This example includes an unscheduled assessment and an unreadable image.

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This example shows investigator and independent assessor response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the investigator's tumor identification, tumor results, and response data using RECIST 1.1 measurements along with as well as the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements. 

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The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator and independent radiologist 's response data. 

4.6.2 TU Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. This 1 in the TU domain. This example shows investigator and independent radiologist 's tumor identification, and includes the identification of a new tumor; the investigator only identified the new tumor, and the independent assessor identified and measured it. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain. 

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4.7.2 TU Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The 1 in the TU domain. The example shows a subject who has with only non-target tumors at screening.

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4.8.4 PR Domain Model

The following table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the PR domainPR domain. This example shows the data for 1 subject collected at screening, week 12, and week 24. Per protocol, non-target lesions in the bone were assessed using scintigraphy as the primary method of assessment. Correlative imaging was used in addition to the primary method for the RECIST 1.1 evaluation in order to more closely assess bone lesion(s). The primary method of assessment (i.e., scintigraphy) is represented in TU and TR domains along with assessment results. Correlative imaging (e.g., MRI of the femur) is represented only in the PR domain. Scintigraphy and correlative imaging were not required at every disease assessment per protocol. However, often correlative imaging is performed at every disease assessment timepoint because the same scans cover lesions that are assessed at every disease assessment timepoint. The image identifier is in PRREFID.

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The following supppr.xpt table shows the data to represent the multiple locations covered by the CT SCAN. The anatomical location supplemental qualifiers (QNAM = "PRLOC1" and QNAM = "PRLOC2")   are used and controlled terminology is available (LOC).

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This example shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements  (i.e., longest diameter) of other non-lymph node target tumors. In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node tumor is less than 10mm10 mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm10 mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL".

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