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4.3.3 TR Domain Model

The following tr.xpt 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 represents a situation where a result was not provided because the scan was not performed.

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4.8.3 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 the screening, week 12, and week 24 visits.  This This example also shows that the tumor state for the non-target in the pleural cavity is an assessment of the pleural effusion. Scintigraphy of the bone was not required at every disease assessment per protocol.  The The image identifier is in TRREFID. 

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4.8.4 PR Domain Model

The  pr.xpt table below shows following 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 one 1 subject collected at the screening, week 12, and week 24 visits.  Per Per protocol, non-target lesions in the "BONE" are assessed using "SCINTIGRAPHY" bone were assessed using scintigraphy as the primary method of assessment for RECIST 1.1. Correlative imaging is was used in addition to the primary method for the RECIST 1.1 evaluation in order to more closely assess the 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 FEMURfemur) is represented only in the PR domain. Scintigraphy and the correlative imaging are were not required at every disease assessment per protocol. However, often times the 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.

The following supppr.xpt table below shows the data to represent the multiple locations covered by the CT SCAN. The Anatomical Location 1 and Anatomical Location 2 anatomical location supplemental qualifiers (QNAM = "PRLOC1" and QNAM = "PRLOC2") supplemental qualifiers   are used and controlled terminology is available (LOC).

4.9 Example 9 Example 9: No Evidence of Disease at Baseline

RECIST 1.1 example to show This example shows an assessment where the independent radiologist found no evidence of disease at baseline. 

4.9.1 RS Domain Model

The rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the RS domainRS domain. This example shows the data collected for one 1 subject at screening for which ; the independent radiologist found no evidence of disease at baseline (RSSTRESC = "NED"). This a rare case where a response assessment would be recorded based on the screening assessment. RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" was used to indicate that this result is not based on RECIST 1.1. In this example, there are no data in TU or TR, because no tumors were identified.

4.10 Example 10: Enlargement from Nadir of a Single Non-

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target 

This example shows

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RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent independent assessment. This example shows the situation where  In this situation, enlargement from nadir of a single Nonnon-target lesion/tumor does not necessarily mean necessarily mean that the Nonnon-Target Response is PDtarget response is progressive disease.

4.10.1 RS Domain Model

The rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the RS domainRS domain. This example shows the data for one 1 subject collected at the week 12 and a subsequent 12-week follow-up visit. 

4.10.2 TU Domain Model

The  tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain1 in the TU domain. This example shows the data for one 1 subject with target with target and non-target tumors identified at screening. The subject has 1 target lesion with (TULNKID = "R-T01") and 2 non-target lesions/sites with TULNKID "(R-NT01" and ", R-NT02" ) identified at screening. " T01 " and " R-NT01 " are located in the "LIVER" liver, and " R-NT02 " is located in the "CHEST WALL"chest wall.

4.10.3 TR Domain Model

The  tr.xpt table below shows following 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 one 1 subject collected at the screening, week 12, and subsequent 12-week follow-up visits.

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