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).
Rows 1-2:
I examined the TTE image of the heart (test location) and found calcified mitral valve annulus (result location).
Rows 3-4:
I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenotic.
Rows 5-6:
I examined the TTE image of the heart (test location) and regurgitation of blood in the mitral valve back into the left atrium.
Note these tests were originally created as a CVTEST, based on SDTMIG 3.4, this is considered as a grading scale and therefore should now be represented as CC/RS. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.
Row 1:
Mitral valve stenosis is moderate.
Row 2:
Mitral valve regurgitation is severe.
rs.xpt
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKID
RSTEST
RSCAT
RSORRES
RSMETHOD
VISITNUM
VISIT
RSDTC
1
ABC
RS
ABC-456
1
REGUR 1
Cardiac Valvular Stenosis Severity
Baumgartner Valve Stenosis 2009
Moderate
TTE
1
BASELINE
2020-04-27
2
ABC
RS
ABC-456
2
STEN 1
Cardiac Valvular Regurgitation Severity
Zoghbi Severity of Native Valvular Regurgitation 2003
Severe
TTE
1
BASELINE
2020-04-27
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Please add a row column to your dataset.
The below example shows how to represent calcification severity from a sponsor defined criteria using the CV domain. The Mitral Valve Annulus identified in TU is severely calcified.