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Target tumors are measured in the longest diameter except when the location is a lymph node, then they are measured in the short axis (i.e., longest perpendicular measurement). The examples in this disease response supplement use TRTESTCD = "LDIAM" (Longest Diameter) for measurements of non-lymph node target tumors and TRTESTCD = "LPERP" (Longest Perpendicular) for measurements in the short axis longest perpendicular of lymph node target tumors. The 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 short axislongest perpendicular. The "LDIAM" and "LPERP" tests provide more specificity in the TRTESTCD itself and does not required looking to the anatomical location. In addition, "LDIAM" and "LPERP" are tests used in other disease response criteria so the use of these two tests provides standardization that work 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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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the short axis longest perpendicular (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular") in the TR domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at screening, week 6, week 12 and subsequent 8-week follow-up visits. It The example below shows measurements of lymph nodes, (i.e., longest perpendicular (measured in the short axis), ) 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 lesion was not pathological, i.e. the diameter has reduced below 10mm. The assessment of a lymph node tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL" when that all target lymph node lesions have short axis less than 10mm or TRORRES = "PATHOLOGICAL" when at least one target lymph node tumor has short axis greater than or equal to 10mm. The image identifier is in TRREFID and matches a PRREFID in the PR Domain.

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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one 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 with traceability with 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 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 example represents a situations situation where a result was not provided because the image was obscured and the tumor was not assessable.

This examples example shows that a situation where the Investigator provided the summary values for Target for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCD = "SUMDIAM" is used for the assessments.  Note Note that the sponsor should not derived these values if they were not part of the data capture.

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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator. In addition, the example represents a situations situation where a result was not provided because the scan was not performed.

4.4 Example 4: RECIST 1.1 example to show independent assessor response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint.

4.4.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 8 and week 16. 

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

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

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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would by part be part of the analysis dataset.

This examples example shows that situation where the Independent Assessor provided the summary values for Target for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD" and "PCNSD".  Note Note that the sponsor should not derived derive these values if they were not part of the data capture or not provided in the transfer from the vendorthe vendor.

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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the short axis longest perpendicular (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular"). The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

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The example below shows measurements (i.e., short axislongest 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 lesion was not pathological, i.e. the diameter has reduced below 10mm. The assessment of a lymph node tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL" when that all target lymph node lesions have short axis less than 10mm or TRORRES = "PATHOLOGICAL" when at least one target lymph node tumor has short axis greater than or equal to 10mm.

This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". 

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