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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 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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| hi1style | aqua |
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| hi1 | 2,4,6 |
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| tableid | TU1 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
| TURESLOC | TURESLOC Detail |
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| 1 | ABC | TU | ABC-456 | 1 | 1 | CAL 1 | Calcification Indicator | Y | HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-456 | 2 | 1 | CAL 1 | Calcification Location Identification | Located | HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
| Mitral Valve Annulus |
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| 3 | ABC | TU | ABC-456 | 3 | 2 | STEN 1 | Cardiac Valvular Stenosis Indicator | Y | HEART | 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 | Located | HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
| Mitral Valve |
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| 5 | ABC | TU | ABC-456 | 5 | 3 | REGUR 1 | Cardiac Valvular Regurgitation Indicator | Y | HEART | 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 | Located | HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
| Mitral Valve | Into the left atrium |
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Note these tests were originally created as a CVTEST, based on SDTMIG 3.4, this is considered as a grading scale and therefore should now be represented as CC/RS. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.
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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 | ABC-456 | 1 | REGUR 1 | Cardiac Valvular Stenosis Severity | Baumgartner Valve Stenosis 2009 | Moderate | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | RS | ABC-456 | 2 | STEN 1 | Cardiac Valvular Regurgitation Severity | Zoghbi Severity of Native Valvular Regurgitation 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 CV 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 | CVLNKID | CVTEST | CVCAT | CVORRES | CVMETHOD | VISITNUM | VISIT | RSDTC |
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| 1 | ABC | CV | ABC-456 | 1 | CAL 1 | Calcification Severity | Sponsor-defined Criteria | Severe | TTE | 1 | BASELINE | 2020-04-27 |
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