The transthoracic electrocardiography (TTE) produced images of the heart.
Valvular regurgitation technically is not considered as a lesion, can this be mapped to TU? – This is considered as a site of disease so it is in scope?
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).
Agreed modeling approach allows us to represent the variety of lesions and abnormal findings associated with said lesion into TUORRES.
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.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTESTCD
TUTEST
TULOC
TUORRES
TUSTRESC
TURESLOC
TURESLOC Detail
TUMETHOD
VISITNUM
VISIT
TUDTC
1
ABC
TU
ABC-456
1
LESIONIND
Lesion Indicator
Pathological Finding Indicator
Abnormality Indicator
HEART
Y
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
2
ABC
TU
ABC-456
2
calcification 1
ABNEXAM
Examination for Abnormality
HEART
Calcification
Calcification
Mitral Valve Annulus
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
3
ABC
TU
ABC-456
3
stenosis 1
ABNEXAM
Examination for Abnormality
HEART
Stenosis
Stenosis
Mitral Valve
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
4
ABC
TU
ABC-456
4
This is not a lesion so we can't use lesion indicator
Cardiac Valvular Regurgitation Indicator
Pathological Finding Indicator
Abnormality Indicator
HEART
Y
TRANSTHORACIC ECHOCARDIOGRAPHY
1
BASELINE
2020-04-27
5
ABC
TU
ABC-456
5
regurgitation 1
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
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
REGUR 1
VSC-Cardiac Valvular Stenosis Severity
VALVE STENOSIS CLASSIFICATION 2009 VERSION
Moderate
1
BASELINE
2020-04-27
2
ABC
RS(CC)
ABC-456
2
STEN 1
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.
The below example shows how to represent calcification severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.