...
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | TUDTC |
|---|
| 1 | ABC | CV | ABC-456 | 1 |
|
| Abnormality Indicator | HEART | Y |
|
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
|---|
| 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 |
|---|
|
|
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.
...
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
TRTEST
...
TRORRES
...
VISITNUM
...
VISIT
...
RSDTC
...
Alternatively modeling all of the above in CV:
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-34: | Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis, as well as regurgitation. |
|---|
| Rows 5-8: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS. |
|---|
| Rows 49-511: | Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atriumflail aortic cusp and aortic valve stenosis, as well as regurgitation. |
|---|
| Rows 5-8: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS. |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES |
|---|
CVORRESUCVSTRESC| CVSTRESN | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|
| 1 | ABC | CV | ABC-456 | 1 |
LESIONINDLesion IndicatorAbnormality Indicator | HEART | Y | Y | Y |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC | CV | ABC-456 | 2 |
| mv |
calcification | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 3 | ABC | CV | ABC-456 | 3 | 1 | mv |
stenosis | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 4 | ABC | CV | ABC-456 | 4 | 2 | mv | ABNEXAM | Examination for Abnormality |
Indicator | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 5 | ABC | CV | ABC-456 | 5 |
mv regurgitation
| av | ABNEXAM | Examination for Abnormality | HEART |
| Flail Cusp | Flail Cusp | Flail Cusp | Aortic Valve, Right Coronary Cusp |
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 | Calcification Diameter | Mitral Valve Annulus | 1.2 | mm | 3 | av | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Aortic Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 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 |
|
|
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.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Mitral valve stenosis is moderate. |
|---|
| Row 2: | Mitral valve regurgitation is severemoderate. |
|---|
| Rows 3-4: | Aortic valve regurgitation and stenosis are mild. |
|---|
|
| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | VISITNUM | VISIT | RSDTC |
|---|
| 1 | ABC | RS(CC) | ABC-456 | 1 | mv stenosis1 | VSC-Cardiac Valvular Stenosis Severity: Mitral Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Moderate | 1 | BASELINE | 2020-04-27 |
|---|
| 2 | ABC | RS(CC) | ABC-456 | 2 | 2mv regurgitation | SNVRC-Cardiac Valvular Regurgitation Severity: Mitral Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Moderate | 1 | BASELINE | 2020-04-27 |
|---|
| 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 |
|---|
| 4 | ABC | RS(CC) | ABC-456 | 4 | 4 | SNVRC-Cardiac Valvular Regurgitation Severity: Aortic Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | SevereMild | 1 | BASELINE | 2020-04-27 |
|---|
|
|