The Tumor/Lesion domains (TU, TR) represent data collected in clinical trials where sites of disease (e.g., tumors/lesions/locations of interest, lymph nodes, organs of interest in the assessment of the disease) are identified and then repeatedly measured/assessed at subsequent time points and often used in an evaluation of disease response(s).
The below examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation (CV).
Rows 1-3:
Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis.
Rows 4-5:
Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium.
Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis, as well as regurgitation.
Rows 5-8:
Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.
Rows 9-11:
Examination of the heart indicates flail aortic cusp and aortic valve stenosis, as well as regurgitation.
Rows 5-8:
Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS.
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
CVSEQ
CVLNKID
CVGRPID
CVTESTCD
CVTEST
CVLOC
CVORRES
CVSTRESC
CVSTRESN
CVRESLOC
CVRESLOC Detail
CVMETHOD
VISITNUM
VISIT
CVDTC
1
ABC
CV
ABC-456
1
ABNIND
Abnormality Indicator
HEART
Y
Y
Y
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
2
ABC
CV
ABC-456
2
mv
ABNEXAM
Examination for Abnormality
HEART
Valvular Calcification
Valvular Calcification
Valvular Calcification
Mitral Valve Annulus
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
3
ABC
CV
ABC-456
3
1
mv
ABNEXAM
Examination for Abnormality
HEART
Valvular Stenosis
Valvular Stenosis
Valvular Stenosis
Mitral Valve
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
4
ABC
CV
ABC-456
4
2
mv
ABNEXAM
Examination for Abnormality
HEART
Blood Regurgitation
Blood Regurgitation
Blood Regurgitation
Mitral Valve
From left ventricle into the left atrium
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
5
ABC
CV
ABC-456
5
av
ABNEXAM
Examination for Abnormality
HEART
Flail Cusp
Flail Cusp
Flail Cusp
Aortic Valve, Right Coronary Cusp
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
6
ABC
CV
ABC-456
6
3
av
ABNEXAM
Examination for Abnormality
HEART
Valvular Stenosis
Valvular Stenosis
Valvular Stenosis
Aortic Valve
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
7
ABC
CV
ABC-456
7
4
av
ABNEXAM
Examination for Abnormality
HEART
Blood Regurgitation
Blood Regurgitation
Blood Regurgitation
Aortic Valve
From aorta to left ventricle
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
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The following example shows how to model severity assessments of the identified lesions and abnormalities based on peer-reviewed, validated and published instruments (either copyrighted or public domain). Note these tests were originally created as a CVTESTs, if users are using SDTMIG versions prior to 3.4. Per SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.