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4 Examples for the Oncology Disease Response Domains Model for RECIST 1.1
4.1 Example 1: Investigator Assessment of Subject with Lymph Nodes as Target Lesions
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data. The example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
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| Rows 1-3: | Show the scans performed at screening. The results of the scans are in TU and TR. | | Rows 4-6: | Show that the MRI and CT scan were performed (PROCCUR = "Y") and that the medical photography was not performed (PROCCUR = "N") at week 6. | | Rows 7-22: | Show the scans performed at weeks 12, 20, 28, 36 and 44. The results of the scans are in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR, i.e., "ULTRASOUND". |
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| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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| 1 | EX11111 | PR | 90001 | 1 | IMG-00001 | A1 | MRI | Y | Y | HEAD AND NECK | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 2 | EX11111 | PR | 90001 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | CHEST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX11111 | PR | 90001 | 3 | IMG-00003 | A1 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | | 4 | EX11111 | PR | 90001 | 4 | IMG-00004 | A2 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | | 5 | EX11111 | PR | 90001 | 5 | IMG-00005 | A2 | CT SCAN | Y | Y | CHEST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | | 6 | EX11111 | PR | 90001 | 6 |
| A2 | PHOTOGRAPHY | Y | N | SKIN OF THE TRUNK | TREATMENT | 40 | WEEK 6 |
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| | 7 | EX11111 | PR | 90001 | 7 | IMG-00007 | A3 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | | 8 | EX11111 | PR | 90001 | 8 | IMG-00008 | A3 | CT SCAN | Y | Y | CHEST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | | 9 | EX11111 | PR | 90001 | 9 | IMG-00009 | A3 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | | 10 | EX11111 | PR | 90001 | 10 | IMG-00010 | A4 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 11 | EX11111 | PR | 90001 | 11 | IMG-00011 | A4 | CT SCAN | Y | Y | CHEST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | | 12 | EX11111 | PR | 90001 | 12 | IMG-00012 | A4 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | | 13 | EX11111 | PR | 90001 | 13 | IMG-00013 | A5 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | | 14 | EX11111 | PR | 90001 | 14 | IMG-00014 | A5 | CT SCAN | Y | Y | CHEST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | | 15 | EX11111 | PR | 90001 | 15 | IMG-00015 | A5 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | | 16 | EX11111 | PR | 90001 | 16 | IMG-00016 | A6 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 17 | EX11111 | PR | 90001 | 17 | IMG-00017 | A6 | CT SCAN | Y | Y | CHEST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 18 | EX11111 | PR | 90001 | 18 | IMG-00018 | A6 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 19 | EX11111 | PR | 90001 | 19 | IMG-00019 | A7 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | | 20 | EX11111 | PR | 90001 | 20 | IMG-00020 | A7 | CT SCAN | Y | Y | CHEST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | | 21 | EX11111 | PR | 90001 | 21 | IMG-00021 | A7 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | | 22 | EX11111 | PR | 90001 | 22 | IMG-00022 | A7 | ULTRASOUND |
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| PELVIS | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
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4.2 Example 2: Split and Merged Tumors
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX22222 | TR | 90002 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
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4.3 Example 3: Cases with --STAT Not Done
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data.
4.3.1 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 subsequent 8-week follow-up visits. The Overall Response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done.
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX33333 | TR | 90003 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
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4.4 Example 4: Accepted Flag for Multiple Independent Assessors
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.
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| Rows 1-32: | Show that two radiologists independently reviewed the scans. TRLNKGRP has values "R1-A2" and "R1-A3" to indicate the assessments by "RADIOLOGIST 1" which are linked to the results determine by "RADIOLOGIST 1" in RS. Likewise, the values "R2-A2" and "R2-A3" to indicate the assessments by "RADIOLOGIST 2" which are linked to the results determine by "RADIOLOGIST 2" in RS. | | Rows 17-32: | Show that the results provided by "RADIOLOGIST 2" are the accepted records (TRACPTFL). The accepted record flags are per the data transfer from the independent reviewer. |
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| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | TRACPTFL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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| 1 | EX44444 | TR | 90004 | 1 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 2 | EX44444 | TR | 90004 | 2 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 3 | EX44444 | TR | 90004 | 3 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 40 | mm | 40 | 40 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 4 | EX44444 | TR | 90004 | 4 | NON-TARGET | R1-A1 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 5 | EX44444 | TR | 90004 | 5 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 6 | EX44444 | TR | 90004 | 6 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 7 | EX44444 | TR | 90004 | 7 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 35 | mm | 35 | 35 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
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| | 8 | EX44444 | TR | 90004 | 8 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
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| | 9 | EX44444 | TR | 90004 | 9 | TARGET | R1-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
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| | 10 | EX44444 | TR | 90004 | 10 | NON-TARGET | R1-A2 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 11 | EX44444 | TR | 90004 | 11 | TARGET | R1-A3 | R1-T01 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 12 | EX44444 | TR | 90004 | 12 | TARGET | R1-A3 | R1-T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 13 | EX44444 | TR | 90004 | 13 | TARGET | R1-A3 |
| SUMDIAM | Sum of Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
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| | 14 | EX44444 | TR | 90004 | 14 | TARGET | R1-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -63 | % | -63 | -63 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
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| | 15 | EX44444 | TR | 90004 | 15 | TARGET | R1-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -57 | % | -57 | -57 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
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| | 16 | EX44444 | TR | 90004 | 16 | NON-TARGET | R1-A3 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 17 | EX44444 | TR | 90004 | 17 | TARGET | R2-A1 | R2-T01 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 18 | EX44444 | TR | 90004 | 18 | TARGET | R2-A1 | R2-T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 19 | EX44444 | TR | 90004 | 19 | TARGET | R2-A1 |
| SUMDIAM | Sum of Diameter | 45 | mm | 45 | 45 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING |
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| | 20 | EX44444 | TR | 90004 | 20 | NON-TARGET | R2-A1 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 21 | EX44444 | TR | 90004 | 21 | TARGET | R2-A2 | R2-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 22 | EX44444 | TR | 90004 | 22 | TARGET | R2-A2 | R2-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 23 | EX44444 | TR | 90004 | 23 | TARGET | R2-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
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| | 24 | EX44444 | TR | 90004 | 24 | TARGET | R2-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
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| | 25 | EX44444 | TR | 90004 | 25 | TARGET | R2-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
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| | 26 | EX44444 | TR | 90004 | 26 | NON-TARGET | R2-A2 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 27 | EX44444 | TR | 90004 | 27 | TARGET | R2-A3 | R2-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 28 | EX44444 | TR | 90004 | 28 | TARGET | R2-A3 | R2-T02 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 29 | EX44444 | TR | 90004 | 29 | TARGET | R2-A3 |
| SUMDIAM | Sum of Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
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| | 30 | EX44444 | TR | 90004 | 30 | TARGET | R2-A3 |
| PCBSD | Percent Change From Baseline in Sum of Longest Diameter | -56 | % | -56 | -56 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
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| | 31 | EX44444 | TR | 90004 | 31 | TARGET | R2-A3 |
| PCNSLD | Percent Change From Nadir in Sum of Longest Diameter | 11 | % | 11 | 11 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
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| | 32 | EX44444 | TR | 90004 | 32 | NON-TARGET | R2-A3 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 |
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4.5 Example 5: Subject with Only Target Tumors at Screening and an Unscheduled Assessment
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject that has only Target tumors at screening. This example includes an unscheduled assessment.
4.5.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data for a subject that has only target tumors at screening. This includes an unscheduled assessment.
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX55555 | TR | 90005 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | | 2 | EX55555 | TR | 90005 | TRSEQ | 10 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
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4.6 Example 6: RECIST 1.1 Uni-Dimensional Measurements Along with Volumetric Measurements
RECIST 1.1 example to show investigator and independent assessor response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the investigator tumor identification, tumor results, and response data using RECIST 1.1 along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
4.6.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator and independent radiologist's response data.
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| Rows 1-6, 18-23, 38-39: | Show Longest Diameter, Sum of Longest Diameter, and Tumor State for assessments at screening, cycle 2 and cycle 3 from the investigator. | | Rows 7-17, 24-37, 40-44: | Show the volumetric measurements at screening, cycle 2 and cycle 3 from the independent radiologist. |
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| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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| 1 | EX66666 | TR | 90006 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 2 | EX66666 | TR | 90006 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 3 | EX66666 | TR | 90006 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 4 | EX66666 | TR | 90006 | 4 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
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| INVESTIGATOR |
| SCREEN | 1 | SCREENING |
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| | 5 | EX66666 | TR | 90006 | 5 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 6 | EX66666 | TR | 90006 | 6 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 7 | EX66666 | TR | 90006 | 7 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 8 | EX66666 | TR | 90006 | 8 | TARGET | R1-A1 | R1-T01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 9 | EX66666 | TR | 90006 | 9 | TARGET | R1-A1 | R1-T01 | PPD | Product of Perpendicular Diameters | 50 | mm2 | 50 | 50 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
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| | 10 | EX66666 | TR | 90006 | 10 | TARGET | R1-A1 | R1-T01 | VOLUME | Volume | 250 | uL | 250 | 250 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 11 | EX66666 | TR | 90006 | 11 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 12 | EX66666 | TR | 90006 | 12 | TARGET | R1-A1 | R1-T02 | LPERP | Longest Perpendicular | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 13 | EX66666 | TR | 90006 | 13 | TARGET | R1-A1 | R1-T02 | PPD | Product of Perpendicular Diameters | 70 | mm2 | 70 | 70 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
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| | 14 | EX66666 | TR | 90006 | 14 | TARGET | R1-A1 | R1-T02 | VOLUME | Volume | 350 | uL | 350 | 350 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 15 | EX66666 | TR | 90006 | 15 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
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| | 16 | EX66666 | TR | 90006 | 16 | TARGET | R1-A1 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 120 | mm2 | 120 | 120 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
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| | 17 | EX66666 | TR | 90006 | 17 | TARGET | R1-A1 |
| SUMVOL | Sum of Volume | 600 | uL | 600 | 600 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
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| | 18 | EX66666 | TR | 90006 | 18 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 19 | EX66666 | TR | 90006 | 19 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 20 | EX66666 | TR | 90006 | 20 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 21 | EX66666 | TR | 90006 | 21 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
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| INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 |
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| | 22 | EX66666 | TR | 90006 | 22 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 23 | EX66666 | TR | 90006 | 23 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 24 | EX66666 | TR | 90006 | 24 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 25 | EX66666 | TR | 90006 | 25 | TARGET | R1-A2 | R1-T01 | LPERP | Longest Perpendicular | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 26 | EX66666 | TR | 90006 | 26 | TARGET | R1-A2 | R1-T01 | PPD | Product of Perpendicular Diameters | 84 | mm2 | 84 | 84 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 27 | EX66666 | TR | 90006 | 27 | TARGET | R1-A2 | R1-T01 | VOLUME | Volume | 420 | uL | 420 | 420 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 28 | EX66666 | TR | 90006 | 28 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 29 | EX66666 | TR | 90006 | 29 | TARGET | R1-A2 | R1-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 30 | EX66666 | TR | 90006 | 30 | TARGET | R1-A2 | R1-T02 | PPD | Product of Perpendicular Diameters | 54 | mm2 | 54 | 54 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 31 | EX66666 | TR | 90006 | 31 | TARGET | R1-A2 | R1-T02 | VOLUME | Volume | 315 | uL | 315 | 315 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 32 | EX66666 | TR | 90006 | 32 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 33 | EX66666 | TR | 90006 | 33 | TARGET | R1-A2 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 138 | mm2 | 138 | 138 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 34 | EX66666 | TR | 90006 | 34 | TARGET | R1-A2 |
| SUMVOL | Sum of Volume | 735 | uL | 735 | 735 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 35 | EX66666 | TR | 90006 | 35 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | 6 | % | 6 | 6 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 36 | EX66666 | TR | 90006 | 36 | TARGET | R1-A2 |
| PCBSPPD | Percent Change Baseline in Sum of PPD | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 37 | EX66666 | TR | 90006 | 37 | TARGET | R1-A2 |
| PCBSV | Percent Change From Baseline in Sum of Volume | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 38 | EX66666 | TR | 90006 | 38 | NEW | A3 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 39 | EX66666 | TR | 90006 | 39 | NEW | A3 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 40 | EX66666 | TR | 90006 | 40 | NEW | R1-A3 | R1-NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 41 | EX66666 | TR | 90006 | 41 | NEW | R1-A3 | R1-NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 42 | EX66666 | TR | 90006 | 42 | NEW | R1-A3 | R1-NEW01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 43 | EX66666 | TR | 90006 | 43 | NEW | R1-A3 | R1-NEW01 | PPD | Product of Perpendicular Diameters | 45 | mm2 | 45 | 45 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 |
|
| | 44 | EX66666 | TR | 90006 | 44 | NEW | R1-A3 | R1-NEW01 | VOLUME | Volume | 270 | uL | 270 | 270 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 |
|
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4.7 Example 7: Subject with Non-target Disease Only
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data.
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The procedure (PR) data shows the scans performed for the disease assessment. This example shows data for a subject with non-target disease only.
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The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
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| Rowcaps |
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Rows 1-2: Show the 2 locations of the MRI at screening for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 3: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at screening for PRSEQ = "1". Rows 4-5: Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 6: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 6 for PRSEQ = "3". Rows 7-8: Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 9: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 12 for PRSEQ = "5". Row 10: Shows the overall image quality issue (QNAM = "PROIQ") of the MRI at week 12 for PRSEQ = "5". |
| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 10 | EX77777 | PR | 90007 | PRSEQ | 5 | PROIQ | Overall Image Quality | Motion issues and lesions where obscured | CRF | | 11 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | PRSLTHK | Slice Thickness | 5 mm | CRF |
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4.8 Example 8: Bone Scans (SCINTIGRAPHY) Not Required at Each Disease Assessment
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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 assessment. This example shows data from a breast cancer study in a metastatic setting.
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The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
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| Dataset wrap |
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| Rowcaps |
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Rows 1-2: Show the 2 locations of the CT SCAN for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "CHEST" and QNAM = "PRLOC2" with QVAL = "ABDOMEN". Rows 3-6: Show the 2 locations of the CT SCAN for PRSEQ 4 and 7. |
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 2 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC | | 3 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 4 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC | | 5 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 6 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC |
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4.9 Example 9: No Evidence of Disease at Baseline
RECIST 1.1 example to show an assessment where independent radiologist found no evidence of disease at baseline.
4.9.1 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 screening. In this example, there are no data in TU or TR because no tumors were identified.
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| Rowcaps |
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Row 1: Shows a case where the independent radiologist found no evidence of disease (RSSTRESC = "NED") at baseline. This a rare case where a response assessment would be recorded based on the screening assessment. |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
|---|
| 1 | EX99999 | RS | 90009 | 1 | A1 | OVRLRESP | Overall Response | RECIST 1.1 | NED | NED | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-03-29 | 1 | |
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4.10 Example 10:
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Enlargement from Nadir of a Single Non-Target
RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows the situation where enlargement from nadir of a single Non-target does not necessarily mean that the Non-Target Response is PD.
4.10.1 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 the week 12 and a subsequent 12-week follow-up visit.
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| Rowcaps |
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Rows 1-4: Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-Target lesions/sites "R-NT01" and "R-NT02" in the "LIVER" and "CHEST WALL" at screening. Rows 5-11: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 12. "R-T01" shows a decrease from 17mm at baseline to 7mm which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. "R-NT01" has a TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "ENLARGEMENT FROM NADIR". Rows 12-18: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 24. "R-T01" is absent (LDIAM = "0") which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. "R-NT01" remains TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "PRESENT". |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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| 1 | EX01010 | TR | 90010 | 1 | TARGET | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 2 | EX01010 | TR | 90010 | 2 | TARGET | R-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| | 3 | EX01010 | TR | 90010 | 3 | NON-TARGET | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 4 | EX01010 | TR | 90010 | 4 | NON-TARGET | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 5 | EX01010 | TR | 90010 | 5 | TARGET | R-R-A2 | R-T01 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 6 | EX01010 | TR | 90010 | 6 | TARGET | R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 7 | EX01010 | TR | 90010 | 7 | TARGET | R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 8 | EX01010 | TR | 90010 | 8 | TARGET | R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 9 | EX01010 | TR | 90010 | 9 | TARGET | R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 10 | EX01010 | TR | 90010 | 10 | NON-TARGET | R-A2 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 11 | EX01010 | TR | 90010 | 11 | NON-TARGET | R-A2 | R-NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 12 | EX01010 | TR | 90010 | 12 | TARGET | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 13 | EX01010 | TR | 90010 | 13 | TARGET | R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 14 | EX01010 | TR | 90010 | 14 | TARGET | R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 15 | EX01010 | TR | 90010 | 15 | TARGET | R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 16 | EX01010 | TR | 90010 | 16 | TARGET | R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 17 | EX01010 | TR | 90010 | 17 | NON-TARGET | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 18 | EX01010 | TR | 90010 | 18 | NON-TARGET | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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4.11 Example 11: Independent Assessment of Subject with Lymph Nodes as Target Lesions
RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU), tumor results (TR), and
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procedure (PR)
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data based on an independent assessment.
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The example shows the case where lymph nodes are selected as target lesions. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
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