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| title | TU Domain Definition and Scope |
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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 transthoracic electrocardiography (TTE) produced images of the heartbelow 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 1-23: | I examined the TTE image Examination of the heart (test location) and found indicates calcified mitral valve annulus (result location). | Rows 3-4: | I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenoticstenosis. |
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| Rows 4-5-6: | I examined the TTE image Examination of the heart (test location) and regurgitation of blood in indicates regurgitation at the mitral valve back , blood is regurgitating from the left ventricle 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 |
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TUGRPIDTULNKID| TUTESTCD | TUTEST | TULOC | TUORRES |
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| TUSTRESC | TURESLOC | TURESLOC Detail |
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TULOCTURESLOC | TURESLOC Detail | 1 | | 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 | 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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| CAL 1 | 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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| Rows 1-4: | 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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| 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 |
CAL Calcification Location IdentificationLocatedAbnormality 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 | HEART | | mv | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium | 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 |
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RSMETHOD | 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 |
TTE | | 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 | TTE| : 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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| 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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