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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 | TU | ABC-123 | 1 | TR-Aneurysm | LENGTH | Length | 4 | cm | 4 | 4 | cm | cm | BASELINE | 2020-04-27 |
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2 | ABC | TU | ABC-123 | 2 | TR-Aneurysm | MAXLDIA | Maximal Luminal Diameter | 5 | cm | 5 | 5 | cm | cm | BASELINE | 2020-04-27 |
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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), continue monitoring is required.
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRLOC | VISIT |
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1 | ABC | PR | ABC-123 | 1 | CT SCAN | ABDOMEN | BASELINE |
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A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention even though it can be considered as a lesion, it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysm.
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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 | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
| TUFLAG |
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1 | ABC | CV | ABC-123 | 1 | AR | ABNIND | Abnormality Indicator | Abdominal region | Y |
| Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | CV | ABC-123 | 2 | 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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| 3 | ABC | CV | ABC-123 | 5 | AR-Aneurysm |
| Target for Study Intervention |
| non-target for study intervention |
| non-target for study intervention | non-target for study intervention |
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| 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | CV | ABC-123 | 3 | AR-Aneurysm | LENGTH | Length |
| 2 | cm | 2 | 2 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | CV | ABC-123 | 4 | AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| 2.5 | cm | 2.5 | 2.5 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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Nsvmeta |
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Variable | Label | Type | Role | Origin |
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CVTUFLAG | Flag for TU, TR or RS Data | text | Non-Standard Record Qualifier | CRF |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | VISITNUM | VISIT | CVDTC |
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1 | ABC | RS(CC) | ABC-123 | 11 | TR-Dissection | STAN0101 | STAN01-Stanford Aortic Dissection Classification Type | STANFORD AOD CLASSIFICATION | STANFORD B | STANFORD B | 1 | BASELINE | 2020-04-27 |
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