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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).
Agreed modeling approach allows us to represent the variety of lesions and abnormal findings associated with said lesion 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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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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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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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 | CAL 1 | 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 | CAL 1 | 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 | STEN 1 | 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 | STEN 1 | 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 | REGUR 1 | 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 | REGUR 1 | 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 version 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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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.Jordan: i originally mapped this to CV but this is an assessment of lesion severity, thusly can be considered as lesion properties? So I changed this dataset to TR instead. I seriously wonder whose idea it was to create a separate non-tumor lesion domain when everything on this page could have been mapped to the single CV domain (except the peer-reviewed, published clinical classifications). How do you expect users to know these details by just reading the SDTMIG?
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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 | CAL 1 | Calcification Severity | Sponsor-defined Criteria | Severe | 1 | BASELINE | 2020-04-27 |
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