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| title | TU Domain Definition and Scope |
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STUDYID
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DOMAIN
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USUBJID
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PRTRT
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VISIT
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The transthoracic electrocardiography (TTE) produced images of the heart.
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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). Tumor/Lesion Identification (TU) |
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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 below examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation (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 |
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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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| Dataset2 |
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hi1style |
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| aqua | | hi1 | 2,4,6 |
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| tableid | TU1 |
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| Row | STUDYID | DOMAIN | USUBJID | TUSEQ |
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TUGRPIDTULNKID| TUTESTCD | TUTEST | TULOC | TUORRES |
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TULOCTURESLOC | TURESLOC Detail | 1 | | 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 | | 2 |
| ABC | TU | ABC-456 | 2 | mv calcification | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 |
1 | CAL 1 | | BASELINE | 2020-04-27 | | 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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| Dataset2 |
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| Calcification Indicator | Y | HEART | 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 | | 2 | ABC |
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TU| 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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Alternatively modeling all of the above in CV:
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| -4: | Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis, as well as regurgitation. |
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| Rows 5-8: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS. |
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| Rows 9-11: | Examination of the heart indicates flail aortic cusp and aortic valve stenosis, as well as regurgitation. |
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| Rows 5-8: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS. |
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| Dataset2 |
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| CAL 1 | Calcification Location Identification | Located | HEART | | Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVSTRESN | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | CVDTC |
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| 1 | ABC | CV | ABC-456 | 1 |
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| ABNIND | Abnormality Indicator | HEART | Y | Y | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC | CV | ABC-456 | 2 |
| mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 3 | ABC |
TU2 | STEN 1 | Cardiac Valvular Stenosis Indicator | Y | | 1 | mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
HEART |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 4 | ABC |
TUSTEN 1 | Cardiac Valvular Stenosis Location Identification | Located | | mv | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium |
HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
Mitral Valve | TU3 | REGUR 1 | Cardiac Valvular Regurgitation Indicator | Y | |
| av | ABNEXAM | Examination for Abnormality | HEART | Flail Cusp | Flail Cusp | Flail Cusp | Aortic Valve, Right Coronary Cusp |
HEART |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 6 | ABC |
TUREGUR 1 | Cardiac Valvular Regurgitation Location Identification | Located | | av | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Aortic Valve |
HEART |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
Mitral Valve | Into the left atrium | | | 7 | ABC | CV | ABC-456 | 7 | 4 | av | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Aortic Valve | From aorta to left ventricle | 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 CVTEST, based on 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. 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 severemoderate. |
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| Rows 3-4: | Aortic valve regurgitation and stenosis are mild. |
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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 |
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REGUR | 1 | VSC-Cardiac Valvular Stenosis Severity |
Baumgartner Valve Stenosis 2009| : Mitral Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Moderate | 1 | BASELINE | 2020-04-27 | | 2 | ABC | RS(CC) | ABC-456 | 2 |
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STEN 1| 2 | SNVRC-Cardiac Valvular Regurgitation Severity |
Zoghbi Severity of Native Valvular Regurgitation 2003 | Severe| : Mitral Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Moderate | 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.
| 3 | ABC | RS(CC) | ABC-456 | 3 | 3 | VSC-Cardiac Valvular Stenosis Severity: Aortic Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Mild | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | RS(CC) |
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| Dataset wrap |
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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 | CV1CAL 1 | Calcification Severity | Sponsor-defined Criteria | Severe | TTE | | 4 | SNVRC-Cardiac Valvular Regurgitation Severity: Aortic Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Mild | 1 | BASELINE | 2020-04-27 |
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