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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 | Target?Located Identified | 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 | Target?Located Identified | 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 | Target?Located Identified | 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: | The annulus of the mitral valve is severely calcified. | Row 2: | Mitral valve stenosis is moderate. |
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Row 32: | Mitral valve regurgitation is severe. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | RSMETHOD | VISITNUM | VISIT | RSDTC |
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1 | ABC | RS | ABC-456 | 1CAL | REGUR 1 | Calcification Severity | Cardiac Valvular Stenosis Severity | Baumgartner Valve Stenosis 2009 | ModerateSevere | TTE | 1 | BASELINE | 2020-04-27 |
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32 | ABC | RS | ABC-456 | 2 | REGUR STEN 1 | Cardiac Valvular | Stenosis Regurgitation Severity | Baumgartner Valve Stenosis 2009 | ModerateZoghbi Severity of Native Valvular Regurgitation 2003 | Severe | TTE | 1 | BASELINE | 2020-04-27 | 2 |
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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 | RS | ABC-456 | 31 | STEN CAL 1 | Cardiac Valvular Regurgitation Severity | Calcification Severity | Sponsor-defined CriteriaZoghbi Severity of Native Valvular Regurgitation 2003 | Severe | TTE | 1 | BASELINE | 2020-04-27 |
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