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| title | TU Domain Definition and Scope |
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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). Tumor/Lesion Identification (TU) |
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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 lesions into TUORRES.
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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 | mv calcification | 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 | mv stenosis | 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 | 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 |
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Previous modeling approach requires the creation of "lesion-type" specific TUTESTs, shown here just as a comparison.
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| Rows 1-2: | I examined the TTE image of the heart (test location) and found calcified mitral valve annulus (result location). |
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| Rows 3-4: | I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenotic. |
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| 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. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TULOC | TUORRES | TURESLOC | TURESLOC Detail | TUMETHOD | VISITNUM | VISIT | TUDTC |
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| 1 | ABC | TU | ABC-456 | 1 | 1 | mv calcification | Calcification Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-456 | 2 | 1 | mv calcification | Calcification Location Identification | HEART | identified | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 3 | ABC | TU | ABC-456 | 3 | 2 | mv stenosis | Cardiac Valvular Stenosis Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | TU | ABC-456 | 4 | 2 | mv stenosis | Cardiac Valvular Stenosis Location Identification | HEART | identified | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | TU | ABC-456 | 5 | 3 | mv regurgitation | Cardiac Valvular Regurgitation Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 6 | ABC | TU | ABC-456 | 6 | 3 | mv regurgitation | Cardiac Valvular Regurgitation Location Identification | HEART | identified | Mitral Valve | Into the left atrium | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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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.
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| Row 1: | Mitral valve stenosis is moderate. |
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| Row 2: | Mitral valve regurgitation is severe. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | VISITNUM | VISIT | RSDTC |
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| 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 |
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| 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 |
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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.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | TRLNKID | TRTEST | TRCAT | TRORRES | VISITNUM | VISIT | RSDTC |
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| 1 | ABC | TR | ABC-456 | 1 | mv calcification | Calcification Severity | Sponsor-defined Criteria | Severe | 1 | BASELINE | 2020-04-27 |
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