Example 1: Observed abnormality that's also a lesion "target" for study intervention
The subject had a chest CT scan and an abdominal CT scan.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRLOC | VISIT |
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| 1 | ABC | PR | ABC-123 | 1 | CT SCAN | CHEST | BASELINE |
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| 2 | ABC | PR | ABC-123 | 2 | CT SCAN | ABDOMEN | BASELINE |
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An evaluator examines the images of the thoracic and abdominal regions produced by the CT scan and decides whether TAA and AAA are present as well as their locations. Note for viewing simplicity, some variables are omitted from the table belowThe chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention. Note the use of the NSV TUFLAG to show that this abnormality is also considered as a lesion for study intervention, tracking and/or disease response to treatment assessment.
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| | Rowcaps |
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| Rows 1-3: | Examination of the thoracic region indicates the presence of an aneurysm in the Thoracic Aorta spanning from the aortic arch to the descending aorta. It also shows that the descending aorta had dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area. |
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Rows 4-6: | Examination of the abdominal region indicates the presence of an aneurysm in the infrarenal aorta, proximal to the iliac bifurcation. it also shows that infrarenal aorta had dissected. |
| Dataset2 |
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| hi3 | TURESLOC |
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| hi2style | yellow |
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| hi3style | BOLD |
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RowTUSEQTUGRPIDTULNKIDTUTESTCDTUTESTTULOCTUORRESTUSTRESCTURESLOCTURLODTLTUMETHODCVMETHOD | VISITNUM | VISIT | CVDTC |
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TUDTCTU1LESIONINDLesion | Abnormality Indicator | Thoracic region | Y | Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 2 | ABC |
TU1 | 1 | ABNEXAM | Examination for Abnormality | Thoracic region | Aneurysm | Aneurysm | Aneurysm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 3 | ABC |
TU1 | 1 | ABNEXAM | Examination for Abnormality | Thoracic region | Arterial Dissection | Arterial Dissection | Arterial Dissection | Descending aorta |
| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 4 | ABC |
TU2LESIONIND | Lesion Indicator | Abdominal region | Y | Y| TARGSINT | Target for Study Intervention |
| Target | Target | Target |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
| Y | | 5 | ABC |
TU2 | Aneurysm 2 | ABNEXAM | Examination for Abnormality | Abdominal region | Aneurysm | Aneurysm | Infrarenal aorta | proximal to the iliac bifurcation| TR-Dissection | TARGSINT | Target for Study Intervention |
| Target | Target | Target |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
6ABC | TU | ABC-123 | 6 | 2 | Dissection 2 | ABNEXAM | Examination for Abnormality | Abdominal region | Arterial Dissection | Arterial Dissection | Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
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Diameters of the identified aneurysms are measured and are mapped to TR. LNKID is used to link TU and TR.Shows the TU representation of the target lesions:
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| Dataset2 |
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| Rowcaps |
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| Rows 1-2: | Length and maximal luminal diameter of the thoracic aortic aneurysm where LNKID = Aneurysm 1. |
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| Rows 3-4: | Length and maximal luminal diameter of the thoracic aortic aneurysm where LNKID = Aneurysm 2. |
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| Dataset2 |
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| hi1style | #e3fcef |
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| hi1 | TRLOC,TRLOCDTL |
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tableid | TR1 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID |
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TRSEQTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRMETHODCVDTCTRAneurysm 1 | Length | 4 | cm| TR-Aneurysm |
| Lesion (Role) Identification | Thoracic Aorta | Aortic Arch to Descending aorta | Target | Target | CT SCAN | 1 | BASELINE | 2020-04-27 | | 2 | ABC |
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TRAneurysm 1 | Maximal Luminal Diameter | 3 | cm| TR-Dissection |
| Lesion (Role) Identification | Descending aorta |
| Target | Target | CT SCAN | 1 | BASELINE | 2020-04-27 |
3
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Shows the diameter measurements of the target lesion in TR:
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | VISITNUM | VISIT | TUDTC |
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| 1 | ABC |
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TR3 25CT SCAN | 14TR4 2 | MAXLDIA | Maximal Luminal Diameter |
4CT SCAN | 1 |
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Example 2: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is managed by a non-study drug (e.g. beta blockers, hypertension drug).
| Dataset wrap |
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| Dataset2 |
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| hi3 | TURESLOC |
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| hi2style | yellow |
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| hi3style | BOLD |
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ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
| TUFLAG |
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| 1 | 1 | ABC | CV | ABC-123 | 1 | TR | ABNIND | Abnormality Indicator | Thoracic region | Y | Y | Y | CT SCAN | 1 | BASELINE | 2020-04-27 | 2 | ABC | CV | ABC-123 | 2 | TR-Aneurysm | ABNEXAM | Examination for Abnormality | Thoracic region | Aneurysm | Aneurysm | Aneurysm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 | 3 | ABC | CV | ABC-123 | 3 | 1 | TR-Dissection | ABNEXAM | Examination for Abnormality | Thoracic region | Arterial Dissection | Arterial Dissection | Arterial Dissection | Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 | 4 | ABC | CV | ABC-123 | 4 |
| AR | ABNIND | Abnormality Indicator | Abdominal region | Y |
| Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 52 | ABC | CV | ABC-123 | 52 |
| AR-Aneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | Aneurysm |
| Aneurysm | Aneurysm |
| Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 6| 3 | ABC | CV | ABC-123 | 65 |
| AR-DissectionAneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | Arterial Dissection | Arterial Dissection | Arterial Dissection | Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Target for Study Intervention |
| non-target for study intervention |
| non-target for study intervention | non-target for study intervention |
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| 7 | ABC | CV | ABC-123 | 7 | TR-Aneurysm | LENGTH | Length | 4 | cm | 4 | 4 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 84 | ABC | CV | ABC-123 | 8 | TR-Aneurysm | MAXLDIA | Maximal Luminal Diameter | 3 | cm | 3 | 3 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 | 9 | ABC | CV | ABC-123 | 9 |
| AR-Aneurysm | LENGTH | Length |
| 52 | cm | 52 | 52 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 105 | ABC | CV | ABC-123 | 104 |
| AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| 42.5 | cm | 4 | 2.5 | 2.54 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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