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title | TU Domain Definition and Scope |
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Row
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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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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | VISIT |
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1 | ABC | PR | ABC-456 | 1 | TRANSTHORACIC ECHOCARDIOGRAPHY | BASELINE |
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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. |
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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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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TULOC | TUORRES | TUSTRESC | TURESLOC | TURESLOC Detail | TUMETHOD | VISITNUM | VISIT | TUDTC |
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1 | ABC | TU | ABC-456 | 1 |
| LESIONIND | Lesion Indicator Pathological Finding Indicator Abnormality Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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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 |
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3 | ABC | TU | ABC-456 | 3 | stenosis 1 | ABNEXAM | Examination for Abnormality | HEART | Stenosis | Stenosis | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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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 |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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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 |
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