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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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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 | 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 | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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2 | ABC | TU | ABC-456 | 2 | mv calcification | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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3 | ABC | TU | ABC-456 | 3 | mv stenosis | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
| 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 versions 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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