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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX11111 | TR | 90011 | TRSEQ | 22 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | | 2 | EX11111 | TR | 90011 | TRSEQ | 23 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
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4.11.4 PR Domain Model
The following table shows The 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 1 subject collected at the week 6, week 12, and subsequent 8-week follow-up visits. The The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
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| Rows 1-3: | Show the scans preformed at screening. The results of the scans are recorded in TU and TR. | | Rows 4-21: | Show the scans preformed at weeks 6, 12, 20, 28, 36, and 44. The results of the scans are recorded in TU and TR. |
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| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRLOC | PRNAM | PREVAL | PREVALID | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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| 1 | EX11111 | PR | 90011 | 1 | IMG-00001 | R-A1 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 2 | EX11111 | PR | 90011 | 2 | IMG-00002 | R-A1 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX11111 | PR | 90011 | 3 | IMG-00003 | R-A1 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | | 4 | EX11111 | PR | 90011 | 4 | IMG-00004 | R-A2 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | | 5 | EX11111 | PR | 90011 | 5 | IMG-00005 | R-A2 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | | 6 | EX11111 | PR | 90011 | 6 | IMG-00007 | R-A3 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | | 7 | EX11111 | PR | 90011 | 7 | IMG-00008 | R-A3 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | | 8 | EX11111 | PR | 90011 | 8 | IMG-00009 | R-A3 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | | 9 | EX11111 | PR | 90011 | 9 | IMG-00010 | R-A4 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 10 | EX11111 | PR | 90011 | 10 | IMG-00011 | R-A4 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | | 11 | EX11111 | PR | 90011 | 11 | IMG-00012 | R-A4 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | | 12 | EX11111 | PR | 90011 | 12 | IMG-00013 | R-A5 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | | 13 | EX11111 | PR | 90011 | 13 | IMG-00014 | R-A5 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | | 14 | EX11111 | PR | 90011 | 14 | IMG-00015 | R-A5 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | | 15 | EX11111 | PR | 90011 | 15 | IMG-00016 | R-A6 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 16 | EX11111 | PR | 90011 | 16 | IMG-00017 | R-A6 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 17 | EX11111 | PR | 90011 | 17 | IMG-00018 | R-A6 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 18 | EX11111 | PR | 90011 | 18 | IMG-00019 | R-A7 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | | 19 | EX11111 | PR | 90011 | 19 | IMG-00020 | R-A7 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | | 20 | EX11111 | PR | 90011 | 20 | IMG-00021 | R-A7 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | | 21 | EX11111 | PR | 90011 | 21 | IMG-00022 | R-A7 | ULTRASOUND | PELVIS | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
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