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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | TUDTC |
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1 | ABC | CV | ABC-456 | 1 |
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| Abnormality Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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2 | ABC | CV | ABC-456 | 2 | 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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The below example shows how to represent calcification diameter and severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.
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Row
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STUDYID
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DOMAIN
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USUBJID
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TRTEST
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TRORRES
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VISITNUM
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VISIT
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RSDTC
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Alternatively modeling all of the above in CV:
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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 | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | CVDTC |
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1 | ABC | CV | ABC-456 | 1 |
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| LESIONIND | Lesion Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 2 | ABC | CV | ABC-456 | 2 | mv calcification | mv calcification | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification |
| Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 3 | ABC | CV | ABC-456 | 3 | mv stenosis | mv stenosis | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis |
| Valvular Stenosis | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 4 | ABC | CV | ABC-456 | 4 |
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| ABNIND | Abnormality IndicatorAbnormality Indicator | HEART |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 5 | ABC | CV | 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 | 6 | ABC | CV | ABC-456 | 6 |
| mv calcification | Diameter | 1.2 | regurgitation | EFFRGOA | Effective Regurgitant Orifice Area | Mitral Valve | 26 | mm2 |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 7 | ABC | CV | ABC-456 | 7 |
| mv regurgitation | MVRGF | Mitral Valve Regurgitant Fraction |
| 35 | % |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 8 | ABC | CV | ABC-456 | 8 |
| mv regurgitation | MVRGF | Mitral Valve Regurgitant Volume |
| 36 | mL/beat |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 9 | ABC | CV | ABC-456 | 9 |
| mv regurgitation | MVVCA | Mitral Valve Vena Contracta Area |
| 26 | mm2 |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 10 | ABC | CV | ABC-456 | 10 |
| mv regurgitation | MVVCW | Mitral Valve Vena Contracta Width |
| 58 | mm |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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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 | SevereModerate | 1 | BASELINE | 2020-04-27 |
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