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Dataset wrap
titlecv.xpt
NameTR


Dataset2


Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKIDTRTESTCD

TRTEST

TRORRES

TRORRESU

TRSTRESC

TRSTRESN

TRSTRESU

VISITNUM

VISIT

TUDTC

1ABCTUABC-1231TR-AneurysmLENGTHLength4cm44cmcmBASELINE2020-04-27
2ABCTUABC-1232TR-AneurysmMAXLDIAMaximal Luminal Diameter5cm55cmcmBASELINE2020-04-27




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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titlecv.xpt
NamePR


Dataset2


Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

1  ABCPR  ABC-1231CT SCANABDOMENBASELINE



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.

Dataset wrap
titlecv.xpt
Namecv


Dataset2
hi3TURESLOC
hi2styleyellow
hi3styleBOLD


ROW

STUDYID

DOMAIN

USUBJID

CVSEQCVGRPIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVORRESUCVSTRESCCVSTRESNCVSTRESUCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


TUFLAG
1ABCCVABC-1231ARABNINDAbnormality IndicatorAbdominal regionY
YY


CT SCAN

1BASELINE2020-04-27

2ABCCVABC-1232AR-AneurysmABNEXAMExamination for AbnormalityAbdominal regionAneurysm
AneurysmAneurysm
Infrarenal aortaproximal to the iliac bifurcation

CT SCAN

1BASELINE2020-04-27

3ABCCVABC-1235AR-Aneurysm
Target for Study Intervention
non-target for study intervention
non-target for study interventionnon-target for study intervention



1BASELINE2020-04-27

4ABCCVABC-1233AR-AneurysmLENGTHLength
2cm22cm

CT SCAN

1BASELINE2020-04-27

5ABCCVABC-1234AR-AneurysmMAXLDIAMaximal Luminal Diameter
2.5cm2.52.5cm

CT SCAN

1BASELINE2020-04-27



Nsvmeta
DomainCV


VariableLabelTypeRoleOrigin
CVTUFLAGFlag for TU, TR or RS DatatextNon-Standard Record QualifierCRF



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Dataset wrap
titlecv.xpt
NameRS


Dataset2


Row

STUDYID

DOMAIN

USUBJID

RSSEQ

RSLNKID

RSTESTCD

RSTESTRSCAT

RSORRES

RSSTRESC

VISITNUM

VISIT

CVDTC

1ABCRS(CC)ABC-12311TR-DissectionSTAN0101STAN01-Stanford Aortic Dissection Classification TypeSTANFORD AOD CLASSIFICATIONSTANFORD BSTANFORD B1BASELINE2020-04-27



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