...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-3: | Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis. |
|---|
| Rows 4-5: | Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium. |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | SCSTRESU | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|
| 1 | ABC | CV | ABC-456 | 1 |
|
| ABNIND | Abnormality 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| stennosis | 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 regurgitation | 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 | | 5 | ABC | CV | ABC-456 | 5 |
| mv regurgitation | EFFRGOA | Effective Regurgitant Orifice Area |
| 26 | mm2 | 26 | 26 | mm2 |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 6 | ABC | CV | ABC-456 | 6 |
| mv regurgitation | MVRGF | Regurgitant Fraction |
| 35 | % | 35 | 35 | % |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 7 | ABC | CV | ABC-456 | 7 |
| mv regurgitation | MVRGF | Regurgitant Volume |
| 36 | mL/beat | 36 | 36 | mL/beat |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 8 | ABC | CV | ABC-456 | 8 |
| mv regurgitation | MVVCA | Vena Contracta Area |
| 26 | mm2 | 26 | 26 | mm2 |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 9 | ABC | CV | ABC-456 | 2 |
| av cusp | ABNEXAM | Examination for Abnormality | HEART | Flail Cusp |
| Flail Cusp | Flail Cusp |
| Aortic Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 10 | ABC | CV | ABC-456 | 3 |
| av stenosis | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis |
| Valvular Stenosis | Valvular Stenosis |
| Aortic Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 11 | ABC | CV | ABC-456 | 4 | 3 | av regurgitation | 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 | | 12 | ABC | CV | ABC-456 | 5 |
| av regurgitation | EFFRGOA | Effective Regurgitant Orifice Area |
| 15 | mm2 | 15 | 15 | mm2 |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 13 | ABC | CV | ABC-456 | 6 |
| av regurgitation | MVRGF | Regurgitant Fraction |
| 20 | % | 20 | 20 | % |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 14 | ABC | CV | ABC-456 |
9 | mv regurgitation | MVVCW | Vena Contracta Width | 58 | mm | 58 | 58 | | 7 |
| av regurgitation | MVRGF | Regurgitant Volume |
| 277 | mL/beat | 27 | 27 | mL/beat |
|
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 15 | ABC | CV | ABC-456 | 8 |
| av regurgitation | MVVCA | Vena Contracta Area |
| 22 | mm2 | 22 | 22 | mm2 |
mm |
|
| 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 severe. |
|---|
|
| 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 | 3 | VSC-Cardiac Valvular Stenosis Severity: Aortic Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Mild | 1 | BASELINE | 2020-04-27 |
|---|
| 3 | ABC | RS(CC) | ABC-456 | 3 | 2mv regurgitation | SNVRC-Cardiac Valvular Regurgitation Severity | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Moderate | 1 | BASELINE | 2020-04-27 |
|---|
|
|
...