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.
The below example shows how to represent calcification diameter and severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
TRLNKID
TRTEST
TRCAT
TRORRES
TRORRESU
VISITNUM
VISIT
RSDTC
1
ABC
TR
ABC-456
1
mv calcification
Calcification Diameter
1.2
mm
1
BASELINE
2020-04-27
2
ABC
TR
ABC-456
2
mv calcification
Calcification Severity
Sponsor-defined Criteria
Severe
1
BASELINE
2020-04-27
$warningHtml
Alternatively modeling all of the above in 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.
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
CVSEQ
CVGRPID
CVTESTCD
CVTEST
CVLOC
CVORRES
CVORRESU
CVSTRESC
CVRESLOC
CVRESLOC Detail
CVMETHOD
VISITNUM
VISIT
CVDTC
1
ABC
CV
ABC-456
1
LESIONIND
Lesion Indicator
HEART
Y
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
2
ABC
CV
ABC-456
2
mv calcification
ABNEXAM
Examination for Abnormality
HEART
Valvular Calcification
Valvular Calcification
Mitral Valve Annulus
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
3
ABC
CV
ABC-456
3
mv stenosis
ABNEXAM
Examination for Abnormality
HEART
Valvular Stenosis
Valvular Stenosis
Mitral Valve
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
4
ABC
CV
ABC-456
4
Abnormality Indicator
HEART
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
5
ABC
CV
ABC-456
5
mv regurgitation
ABNEXAM
Examination for Abnormality
HEART
Blood Regurgitation
Blood Regurgitation
Mitral Valve
From left ventricle into the left atrium
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
6
ABC
CV
ABC-456
6
mv calcification
Calcification Diameter
Mitral Valve Annulus
1.2
mm
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
Dataset Debug Messages
There is a leading, trailing, or non-breaking space in the dataset.
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.
Row 1:
Mitral valve stenosis is moderate.
Row 2:
Mitral valve regurgitation is severe.
$titleHtml
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKID
RSTEST
RSCAT
RSORRES
VISITNUM
VISIT
RSDTC
1
ABC
RS(CC)
ABC-456
1
mv stenosis
VSC-Cardiac Valvular Stenosis Severity
VALVE STENOSIS CLASSIFICATION 2009 VERSION
Moderate
1
BASELINE
2020-04-27
2
ABC
RS(CC)
ABC-456
2
mv regurgitation
SNVRC-Cardiac Valvular Regurgitation Severity
SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003
Severe
1
BASELINE
2020-04-27
Dataset Debug Messages
There seem to be multiple domains (RS(CC)) present in the dataset.