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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 the screening, week 12, and subsequent 12-week follow-up visits.
This example shows the 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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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 target tumor and the tumor states of the non-targets at week 12. R-T01 shows a decrease from 17mm at baseline to 7mm, which is a 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 the non-targets at week 24. R-T01 is absent (LDIAM = "0"), which is a PCBSD of -100%. R-NT01 remains TUMSTATE = "ABSENT" and R-NT02 has a TUMSTATE = "PRESENT". |
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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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 10 | EX01010 | TR | 90010 | 10 | NON-TARGET | R-A2 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 17 | EX01010 | TR | 90010 | 17 | NON-TARGET | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
| 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 This example shows response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data based on an independent independent assessment. The example shows the case where In this example, 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 Domaindomain.
4.11.1 RS Domain Model
The rs.xpt table below shows the following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain1 in the RS domain. This example shows the data for one 1 subject collected at the at the week 6, week 12 and 12, and subsequent 8-week follow-up visits.
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Rows 1-3: | Show the Target Response target response (RSTESTCD = "TRGRESP") and Nonnon-Target Response target resposne (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response overall response (RSTESTCD = "OVRLRESP") at the week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP , and is used to associate underlying data in other domains to the Overall Responseoverall response. | Rows 4-12: | Show the week 12, week 20, and week 28 responses. | Rows 13-20: | At week 36, the New Lesion Progression new lesion progression test (RSTESTCD = "NEWLPROG") test is used to represent an equivocal new lesion (RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSORRES = "UNEQUIVOCAL"). |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX11111 | RS | 90011 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 2 | EX11111 | RS | 90011 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 3 | EX11111 | RS | 90011 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 4 | EX11111 | RS | 90011 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 5 | EX11111 | RS | 90011 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 6 | EX11111 | RS | 90011 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 7 | EX11111 | RS | 90011 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 8 | EX11111 | RS | 90011 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 9 | EX11111 | RS | 90011 | 9 | R-A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 10 | EX11111 | RS | 90011 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 11 | EX11111 | RS | 90011 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 12 | EX11111 | RS | 90011 | 12 | R-A5 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 13 | EX11111 | RS | 90011 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 14 | EX11111 | RS | 90011 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 15 | EX11111 | RS | 90011 | 15 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | EQUIVOCAL | EQUIVOCAL | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 16 | EX11111 | RS | 90011 | 16 | R-A6 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | RS | 90011 | 17 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 18 | EX11111 | RS | 90011 | 18 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 19 | EX11111 | RS | 90011 | 19 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | UNEQUIVOCAL | UNEQUIVOCAL | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 20 | EX11111 | RS | 90011 | 20 | R-A7 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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4.11.2 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 domain. This 1 in the TU domain. This example shows the data for one 1 subject at screening and and at weeks 36 and 44, where new lesions are identified. In this example, lymph lymph nodes are selected as target tumors. In In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP"). The image identifier is in TUREFID and matches a PRREFID in the PR Domaindomain.
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Rows 1-6: | Show a subject with 4 target lesions with (TULNKID = "R-T01"-"R-T04") and 2 non-target lesions with (TULNKID = "R-NT01" and "R-NT02") identified at screening. "Target lesions R-T01 " and " R-T02 " target lesions are located in the lymph nodes. "; R-T01 " is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality Laterality and directionality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality. | Row 7: | Shows that, at week 36, an equivocal new lesion (TULNKID = "R-NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location. | Rows 8-9: | Show that, at week 44, new unequivocal new lesions (TULNKID = "R-NEW02" and "R-NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE"). |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUDIR | TUMETHOD | TUNUM | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX11111 | TU | 90011 | 1 | IMG-00001 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | SUPRACLAVICULAR LYMPH NODE | RIGHT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TU | 90011 | 2 | IMG-00002 | R-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | THORACIC LYMPH NODE |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | TU | 90011 | 3 | IMG-00001 | R-T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | THYROID GLAND | LEFT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX11111 | TU | 90011 | 4 | IMG-00003 | R-T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | SKIN OF THE TRUNK |
| UPPER | PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 5 | EX11111 | TU | 90011 | 5 | IMG-00002 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | MEDIASTINAL LYMPH NODE | RIGHT |
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 6 | EX11111 | TU | 90011 | 6 | IMG-00001 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | CEREBELLUM | RIGHT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | 1 | 7 | EX11111 | TU | 90011 | 7 | IMG-00020 | R-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LUNG, LEFT LOWER LOBE |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 8 | EX11111 | TU | 90011 | 8 | IMG-00019 | R-NEW02 | TUMIDENT | Tumor Identification | NEW | NEW | CEREBELLUM | LEFT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-18 | 317 | 9 | EX11111 | TU | 90011 | 9 | IMG-00022 | R-NEW03 | TUMIDENT | Tumor Identification | NEW | NEW | FEMORAL LYMPH NODE | LEFT |
| ULTRASOUND | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-18 | 317 |
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4.11.3 TR Domain Model
The tr.xpt table below The following table shows the terminology used to implement implement RECIST 1.1 in the TR domain. The example shows the TR domain. The example shows the data for one 1 subject collected at the screening, week 6, week 12, and subsequent 8-week follow-up visits.
The This example below shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements of other non-lymph node Target tumors 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 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 = "PATHOLOGICAL".
This examples shows that situation where the Independent Assessor In this example, 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", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD".
The image identifier is in TRREFID and matches a PRREFID in the PR Domaindomain.
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Rows 1-6: | Show the screening identification of the target and non-target lesions. For lymph node target lesions " R-T01 " and " RT02 " the TRTESTCD used for the assessments are "LPREP" and "LNSTATE". For non-lymph node target lesions " R-T03 " and " R-T04" the TRTESTCD used for the assessments is , TRTESTCD = "LDIAM". | Rows 7-8: | Show the results for the Target target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs are Sum sum of Diameter diameter (TRTESTCD = "SUMDIAM") and Sum Diameters of Non Lymph Node Tumors sum diameters of non-lymph node tumors (TRTESTCD = "SUMNLNLD"). | Rows 9-10: | Show the results for the non-targets. ": R-NT01 " is a lymph node where the TRTEST used for the assessments is "Lymph Node State" lymph node state (TRTESTCD = "LNSTATE"). "; R-NT02 " is a non-lymph node where the TRTESTCD used for the assessments is Tumor State (TRTESTCD = "TUMSTATE")tumor state. | Row 16: | Shows a case where TRSTAT is = "NOT DONE" with . TRREASND contains the reason for the result being not done as TRTEST of Longest Diameter with TRREASND as "SCAN NOT PERFORMED". this result; for TRTEST = "Longest Diameter", the scan was not performed. | Rows 17-21: | Show the week 6 results for the Target target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". Within Row row 20, the PCBSD could not be calculated because " R-T04 " was not measured. TRSTAT is assigned = "NOT DONE" and TRREASND contains the reason , (in this case, at least one 1 target lesion was not measured). | Rows 22-23: | Show the that, at week 6 that ", R-NT02 " was not not evaluable and the results the ", while providing results for R-NT01 " non-target lesion using TRTESTCD as TUMSTATE. | Rows 30-34: | Show the week 12 results for the Target target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". | Row 70: | Shows the Sum Diameters of Non Lymph node Tumors sum diameters of non-lymph node tumors (TRTESTCD = "SUMNLNLD") is "0". This means that the non-lymph node target tumors are all absent. |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TRNAM | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX11111 | TR | 90011 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90011 | 2 | TARGET | IMG-00001 | R-A1 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90011 | 3 | TARGET | IMG-00002 | R-A1 | R-T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90011 | 4 | TARGET | IMG-00002 | R-A1 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90011 | 5 | TARGET | IMG-00001 | R-A1 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90011 | 6 | TARGET | IMG-00003 | R-A1 | R-T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
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| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90011 | 7 | TARGET |
| R-A1 |
| SUMDIAM | Sum of Diameter | 62 | mm | 62 | 62 | mm |
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| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
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| 8 | EX11111 | TR | 90011 | 8 | TARGET |
| R-A1 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 29 | mm | 29 | 29 | mm |
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| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
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| 9 | EX11111 | TR | 90011 | 9 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 10 | EX11111 | TR | 90011 | 10 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 11 | EX11111 | TR | 90011 | 11 | TARGET | IMG-00004 | R-A2 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 12 | EX11111 | TR | 90011 | 12 | TARGET | IMG-00004 | R-A2 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 13 | EX11111 | TR | 90011 | 13 | TARGET | IMG-00005 | R-A2 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 14 | EX11111 | TR | 90011 | 14 | TARGET | IMG-00005 | R-A2 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 15 | EX11111 | TR | 90011 | 15 | TARGET | IMG-00004 | R-A2 | R-T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 16 | EX11111 | TR | 90011 | 16 | TARGET |
| R-A2 | R-T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 17 | EX11111 | TR | 90011 | 17 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 52 | mm | 52 | 52 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 18 | EX11111 | TR | 90011 | 18 | TARGET |
| R-A2 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 28 | mm | 28 | 28 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 19 | EX11111 | TR | 90011 | 19 | TARGET |
| R-R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 20 | EX11111 | TR | 90011 | 20 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter |
|
|
|
|
| NOT DONE | At least one target lesions was not measured |
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 21 | EX11111 | TR | 90011 | 21 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -16 | % | -16 | -16 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 22 | EX11111 | TR | 90011 | 22 | NON-TARGET | IMG-00005 | R-A2 | R-NT01 | LNSTATE | Lymph Node State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 23 | EX11111 | TR | 90011 | 23 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 24 | EX11111 | TR | 90011 | 24 | TARGET | IMG-00007 | R-A3 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90011 | 25 | TARGET | IMG-00007 | R-A3 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 26 | EX11111 | TR | 90011 | 26 | TARGET | IMG-00008 | R-A3 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 27 | EX11111 | TR | 90011 | 27 | TARGET | IMG-00008 | R-A3 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 28 | EX11111 | TR | 90011 | 28 | TARGET | IMG-00007 | R-A3 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 29 | EX11111 | TR | 90011 | 29 | TARGET | IMG-00009 | R-A3 | R-T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 30 | EX11111 | TR | 90011 | 30 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 47 | mm | 47 | 47 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 31 | EX11111 | TR | 90011 | 31 | TARGET |
| R-A3 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 32 | EX11111 | TR | 90011 | 32 | TARGET |
| R-R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -5 | mm | -5 | -5 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 33 | EX11111 | TR | 90011 | 33 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -24 | % | -24 | -24 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 34 | EX11111 | TR | 90011 | 34 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -9 | % | -9 | -9 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 35 | EX11111 | TR | 90011 | 35 | NON-TARGET | IMG-00008 | R-A3 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 36 | EX11111 | TR | 90011 | 36 | NON-TARGET | IMG-00007 | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 37 | EX11111 | TR | 90011 | 37 | TARGET | IMG-00010 | R-A4 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 38 | EX11111 | TR | 90011 | 38 | TARGET | IMG-00010 | R-A4 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 39 | EX11111 | TR | 90011 | 39 | TARGET | IMG-00011 | R-A4 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 40 | EX11111 | TR | 90011 | 40 | TARGET | IMG-00011 | R-A4 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 41 | EX11111 | TR | 90011 | 41 | TARGET | IMG-00010 | R-A4 | R-T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 42 | EX11111 | TR | 90011 | 42 | TARGET | IMG-00012 | R-A4 | R-T04 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 43 | EX11111 | TR | 90011 | 43 | TARGET |
| R-A4 |
| SUMDIAM | Sum of Diameter | 37 | mm | 37 | 37 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 44 | EX11111 | TR | 90011 | 44 | TARGET |
| R-A4 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 16 | mm | 16 | 16 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 45 | EX11111 | TR | 90011 | 45 | TARGET |
| R-A4 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 46 | EX11111 | TR | 90011 | 46 | TARGET |
| R-A4 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -40 | % | -40 | -40 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 47 | EX11111 | TR | 90011 | 47 | TARGET |
| R-A4 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -21 | % | -21 | -21 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 48 | EX11111 | TR | 90011 | 48 | NON-TARGET | IMG-00011 | R-A4 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 49 | EX11111 | TR | 90011 | 49 | NON-TARGET | IMG-00010 | R-A4 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 50 | EX11111 | TR | 90011 | 50 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 51 | EX11111 | TR | 90011 | 51 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 52 | EX11111 | TR | 90011 | 52 | TARGET | IMG-00014 | R-A5 | R-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 53 | EX11111 | TR | 90011 | 53 | TARGET | IMG-00014 | R-A5 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 54 | EX11111 | TR | 90011 | 54 | TARGET | IMG-00013 | R-A5 | R-T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 55 | EX11111 | TR | 90011 | 55 | TARGET | IMG-00015 | R-A5 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 56 | EX11111 | TR | 90011 | 56 | TARGET |
| R-A5 |
| SUMDIAM | Sum of Diameter | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 57 | EX11111 | TR | 90011 | 57 | TARGET |
| R-A5 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 6 | mm | 6 | 6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 58 | EX11111 | TR | 90011 | 58 | TARGET |
| R-A5 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -14 | mm | -14 | -14 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 59 | EX11111 | TR | 90011 | 59 | TARGET |
| R-A5 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -62 | % | -62 | -62 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 60 | EX11111 | TR | 90011 | 60 | TARGET |
| R-A5 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -37 | % | -37 | -37 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 61 | EX11111 | TR | 90011 | 61 | NON-TARGET | IMG-00014 | R-A5 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 62 | EX11111 | TR | 90011 | 62 | NON-TARGET | IMG-00013 | R-A5 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 63 | EX11111 | TR | 90011 | 63 | TARGET | IMG-00016 | R-A6 | R-T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 64 | EX11111 | TR | 90011 | 64 | TARGET | IMG-00016 | R-A6 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 65 | EX11111 | TR | 90011 | 65 | TARGET | IMG-00017 | R-A6 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 66 | EX11111 | TR | 90011 | 66 | TARGET | IMG-00017 | R-A6 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 67 | EX11111 | TR | 90011 | 67 | TARGET | IMG-00016 | R-A6 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 68 | EX11111 | TR | 90011 | 68 | TARGET | IMG-00018 | R-A6 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 69 | EX11111 | TR | 90011 | 69 | TARGET |
| R-A6 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 70 | EX11111 | TR | 90011 | 70 | TARGET |
| R-A6 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 71 | EX11111 | TR | 90011 | 71 | TARGET |
| R-A6 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -6 | mm | -6 | -6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 72 | EX11111 | TR | 90011 | 72 | TARGET |
| R-A6 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -72 | % | -72 | -72 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 73 | EX11111 | TR | 90011 | 73 | TARGET |
| R-A6 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -26 | % | -26 | -26 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 74 | EX11111 | TR | 90011 | 74 | NON-TARGET | IMG-00017 | R-A6 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 75 | EX11111 | TR | 90011 | 75 | NON-TARGET | IMG-00016 | R-A6 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 76 | EX11111 | TR | 90011 | 76 | NEW | IMG-00017 | R-A6 | R-NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 77 | EX11111 | TR | 90011 | 77 | TARGET | IMG-00019 | R-A7 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 78 | EX11111 | TR | 90011 | 78 | TARGET | IMG-00019 | R-A7 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 79 | EX11111 | TR | 90011 | 79 | TARGET | IMG-00020 | R-A7 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 80 | EX11111 | TR | 90011 | 80 | TARGET | IMG-00020 | R-A7 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 81 | EX11111 | TR | 90011 | 81 | TARGET | IMG-00019 | R-A7 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 82 | EX11111 | TR | 90011 | 82 | TARGET | IMG-00021 | R-A7 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 83 | EX11111 | TR | 90011 | 83 | TARGET |
| R-A7 |
| SUMDIAM | Sum of Diameter | 21 | mm | 21 | 21 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 84 | EX11111 | TR | 90011 | 84 | TARGET |
| R-A7 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 85 | EX11111 | TR | 90011 | 85 | TARGET |
| R-A7 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | 4 | mm | 4 | 4 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 86 | EX11111 | TR | 90011 | 86 | TARGET |
| R-A7 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -66 | % | -66 | -66 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 87 | EX11111 | TR | 90011 | 87 | TARGET |
| R-A7 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | 23 | % | 23 | 23 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 88 | EX11111 | TR | 90011 | 88 | NON-TARGET | IMG-00020 | R-A7 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 89 | EX11111 | TR | 90011 | 89 | NON-TARGET | IMG-00019 | R-A7 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 90 | EX11111 | TR | 90011 | 90 | NEW | IMG-00020 | R-A7 | R-NEW01 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 91 | EX11111 | TR | 90011 | 91 | NEW | IMG-00020 | R-A7 | R-NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 92 | EX11111 | TR | 90011 | 92 | NEW | IMG-00019 | R-A7 | R-NEW02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 93 | EX11111 | TR | 90011 | 93 | NEW | IMG-00019 | R-A7 | R-NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 94 | EX11111 | TR | 90011 | 94 | NEW | IMG-00022 | R-A7 | R-NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| ULTRASOUND | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
|
The following supptr.xpt table below shows the data on for the reason that the a tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
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Dataset2 |
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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 pr.xpt table below shows following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one 1 subject collected at the week 6, week 12, and subsequent 8-week follow-up visits. 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 record 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 record recorded in TU and TR. |
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Dataset2 |
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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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5 RELREC
This example shows how the RELREC dataset is used for RECIST 1.1 to represent related information between two 2 domains which have a one-to-many relationship. This example represents dataset-to-dataset relationships where records in one domain are being related to records in another domain using the IDVAR as the join key. Both USUBJID and IDVARVAL are null when representing dataset-to-dataset relationships.
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Rows 1-2: | Show the one-to-many relationship between TU and TR using --LNKID. --LNKID is the tumor identifier. The matching RELID value indicates that the two 2 rows form the relationship. | Rows 3-4: | Show the many-to-one relationship between TR and RS using --LNKGRP. --LNKGRP is the identifier used to group and link all of the measurement/assessment records used in the assessment of the overall response record in the RS domain. The matching RELID value indicates that the two 2 rows form the relationship. | Rows 5-6: | Show the one-to-many relationship between TU and PR using --REFID. --REFID contains the image identifier. The matching RELID value indicates that the two 2 rows form the relationship. |
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | ABC12345 | TU |
| TULNKID |
| One | TUTR1 | 2 | ABC12345 | TR |
| TRLNKID |
| Many | TUTR1 | 3 | ABC12345 | TR |
| TRLNKGRP |
| Many | TRRS1 | 4 | ABC12345 | RS |
| RSLNKGRP |
| One | TRRS1 | 5 | ABC12345 | PR |
| PRREFID |
| One | PRTU1 | 6 | ABC12345 | TU |
| TUREFID |
| Many | PRTU1 |
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The following table contains additional standard name codes for use in the Supplemental Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets SUPPRS, SUPPTU and SUPPPR datasets.
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Variable | Label | Type | Codelist | Role |
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RSREASNE | Reason Response Not Evaluable | Char |
| Non-Standard Qualifier | TUPRVIR | Previously Irradiated Indicator | Char | (NY) | Non-Standard Qualifier | TUPRVIRP | Previously Irradiated Progression | Char | (NY) | Non-Standard Qualifier | TUPRTYP | Tumor or Lesion Presentation Type | Char | (DSPRTYP) | Non-Standard Qualifier | TULOCDTL | Location Detail | Char |
| Non-Standard Qualifier | TUSLNUM | Slice Number | Char |
| Non-Standard Qualifier | TUANTPLN | Anatomical Plane | Char |
| Non-Standard Qualifier | TRREASNE | Reason Tumor/Lesion Not Evaluable | Char |
| Non-Standard Qualifier | PRLOC1 | Anatomical Location 1 | Char | (LOC) | Non-Standard Qualifier | PRLOC2 | Anatomical Location 2 | Char | (LOC) | Non-Standard Qualifier | PRSLTHK | Slice Thickness | Char |
| Non-Standard Qualifier | PROIQ | Overall Image Quality | Char |
| Non-Standard Qualifier |
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End of Document
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title | Information for Reviewers |
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