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titleTU Domain Definition and Scope

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titlecv.xpt
NamePR

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STUDYID

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DOMAIN

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USUBJID

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PRTRT

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VISIT

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The transthoracic electrocardiography (TTE) produced images of the heart.

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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).


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STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

VISIT

 1  ABCPR  ABC-4561TRANSTHORACIC ECHOCARDIOGRAPHYBASELINE




The below example shows the identification of calcification in the mitral valve annulus as well as mitral valve stenosis. It also shows mitral valve regurgitation. Technically,  regurgitation is not considered as a lesion, however it is the direct result of the lesion (mitral valve stenosis/narrowing and structural change, caused by the annular calcification). Should this be mapped to TU as well?  I suppose you could consider this as a site of disease, specifically locations of interest where you identify then repeatedly assess?

Agreed modeling approach allows us to represent the variety of lesions and abnormal findings associated with said

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lesions into TUORRES. It also allows us to represent other abnormal findings associated with that lesion.

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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.



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STUDYID

DOMAIN

USUBJID

TUSEQTULNKIDTUTESTCD

TUTEST

TULOC

TUORRES

TUSTRESCTURESLOCTURESLOC Detail

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-4561
LESIONIND

Lesion Indicator

Pathological Finding Indicator

Abnormality Indicator

HEARTY


TRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
2ABCTUABC-4562calcification 1ABNEXAMExamination for AbnormalityHEARTCalcificationCalcificationMitral Valve Annulus
TRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
3ABCTUABC-4563stenosis 1ABNEXAMExamination for AbnormalityHEARTStenosisStenosisMitral Valve
TRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
4ABCTUABC-4564
This is not a lesion so we can't use lesion indicator

Cardiac Valvular Regurgitation Indicator

Pathological Finding Indicator

Abnormality Indicator


HEARTY


TRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
5ABCTUABC-4565regurgitation  1ABNEXAMExamination for AbnormalityHEARTBlood RegurgitationBlood RegurgitationMitral ValveFrom left ventricle into the left atriumTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27



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