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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 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).
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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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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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| Row 1: | Mitral valve stenosis is moderate. |
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| Row 2: | Mitral valve regurgitation is severe. |
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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 | REGUR 1 | 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 | STEN 1 | 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.
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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