The Demographics (DM) domain is used to represent information about the participants in a clinical study. Note there are 4 participants in this DM dataset; test results are shown for 1 participant.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | DTHDTC | DTHFL | SITEID | BRTHDTC | AGE | AGEU | SEX | RACE | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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| 1 | DMD-EF | DM | DMD-EF-01-101 | 101 | 2022-05-16T09:00 |
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| 2022-05-16 |
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| 01 | 2010-02-07 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | A | Drug A | A | Drug A |
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| USA | | 2 | DMD-EF | DM | DMD-EF-01-102 | 102 | 2022-06-13T08:00 |
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| 2022-06-13 |
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| 01 | 2008-05-01 | 14 | YEARS | M | ASIAN | A | Drug A | A | Drug A |
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| MYS | | 3 | DMD-EF | DM | DMD-EF-01-103 | 103 | 2022-07-15T10:15 |
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| 2022-07-15 |
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| 01 | 2003-07-10 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | B | Drug B | B | Drug B |
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| BRA | | 4 | DMD-EF | DM | DMD-EF-01-104 | 104 | 2022-09-06T09:30 |
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| 2022-09-06 |
| 2023-11-23 | Y | 01 | 1999-01-15 | 23 | YEARS | M | WHITE | B | Drug B | B | Drug B |
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| IRL |
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It is important to record the height and weight for patients with DMD since cardiac index and spirometry results are affected by body surface area.[2] The Vital Signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height, and weight. The height in the population may be estimated from the ulna length measuring between the point of the elbow and the midpoint of the prominent bone of the wrist.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSPOS | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOBFXL | VISITNUM | VISIT | VSDTC |
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| 1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | STANDING | 47 | in | 119 | 119 | cm |
| 1 | VISIT 1 | 2022-05-16 | | 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | STANDING | 20 | kg | 20 | 20 | kg |
| 1 | VISIT 1 | 2022-05-16 | | 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | HEIGHT | Height | STANDING | 52 | in | 132 | 132 | cm |
| 6 | VISIT 6 | 2023-04-06 | | 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | WEIGHT | Weight | STANDING | 32 | kg | 32 | 32 | kg |
| 6 | VISIT 6 | 2023-04-06 |
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The Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular system.
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- CVORRES: Result of the measurement or finding as originally received or collected.
- CVORRESU: Original units in which the data were collected. Unit for CVORRES.
- CVSTRESC: Result value for all findings from CVORRES in a standard format or in standard units. If results are numeric, they should also be stored in numeric format in CVSTRESN.
- CVSTRESN: Used for continuous or numeric results or findings in standard format; copied in numeric format from CVSTRESC.
- CVSTRESU: Standardized units used for CVSTRESC and CVSTRESN.
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Questions for the team:
- Are there RV Cardiac Output and RV Cardiac Index measurements obtained?
- Would there be a baseline at diagnosis of DMD and then a regular follow-up? How often would this occur?
- What would the anticipated abnormalities be on follow-up CMR?
- We discussed if the ECG GATED MRI was the same as the Cardiac Magnetic Resonance Imaging Procedure. I think the conclusion was that it was so this is the CVMETHOD that was used.
- AS - this new new method term will be requested: CARDIAC MAGNETIC RESONANCE IMAGING
The following example shows the findings associated with a Cardiac Magnetic Resonance Imaging Procedure related to the ejection fraction.
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| Rows 1-8: | Show the baseline CMR ejection fraction measurements for the participant at visit 1. | | Rows 9-16: | Show the CMR ejection fraction measurements for the participant at visit 6. |
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| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBXFL | VISITNUM | VISIT | CVDTC | CVDY |
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| 1 | DMD- |
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CI100RVSYSVOLRight Ventricle 38/m2 | 38 | 38 | ECG GATED | 32 | 32 | mL | HEART, LEFT VENTRICLE |
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SCREENING | 6/1/2023CI100RVDIAVOLRight Ventricle 8/m28 | 8 | ECG GATED MRI | 1 | SCREENING | | 95 | 95 | mL | HEART, LEFT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 |
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6/1/2023CI100RVEFRight | Left Ventricular Ejection Fraction, |
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Calculated38ECG GATED 38 | 38 | | 70 | 70 | % | HEART, LEFT VENTRICLE |
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SCREENING | 6/1/2023 | | VISIT 1 | 2022-05-16 | 1 | | 4 | DMD-EF | CV | DMD-EF-01-101 | 4 | 2-1 | CARDOUT | Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min | HEART, LEFT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 5 | DMD-EF | CV | DMD-EF-01-101 | 5 |
| ESV | End Systolic Volume | 24 | mL | 24 | 24 | mL | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 6 | DMD-EF | CV | DMD-EF-01-101 | 6 |
| EDV | End Diastolic Volume | 90 | mL | 90 | 90 | mL | HEART, RIGHT VENTRICLE | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2-1 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 75 | % | 75 | 75 | % | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 8 | DMD-EF | CV | DMD-EF-01-101 | 8 | 2-1 | CARDOUT | Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 9 | DMD-EF | CV | DMD-EF-01-101 | 9 |
| ESV | End Systolic Volume | 37 | mL | 37 | 37 | mL | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 |
| EDV | End Diastolic Volume | 94 | mL | 94 | 94 | mL | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | | 11 | DMD-EF | CV | DMD-EF-01-101 | 11 | 2-2 |
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4 | DMD-CI | CV | 100 | 4 | LVSYSVOL | Left Ventricle Systolic Volume | 100 | mL/m2 | 100 | 100 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | 5 | DMD-CI | CV | 100 | 5 | LVDIAVOL | Left Ventricle Diastolic Volume | 60 | mL/m2 | 60 | 60 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | 6 | DMD-CI | CV | 100 | 6 | LVEF_C | Left Ventricular Ejection Fraction, |
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Calculated507 | DMD-CI | CV | 100 | 7 | LVCO | LV 50 | 50 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | | 65 | 65 | % | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | | 12 | DMD-EF | CV | DMD-EF-01-101 | 12 | 2-2 | CARDOUT |
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554.5 | ECG GATED MRI | 1 | SCREENING | 6/1/2023 | 8 | DMD-CI | CV | 100 | 8 | LVCI | LV Cardiac Index | 3.6 | L/min/m2 | 3.6 | 3.6 | ECG GATED MRI | 1 | SCREENING | 6/1/2023| 0 | 4.0 | L/min | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 |
| ESV | End Systolic Volume | 36 | mL | 36 | 36 | mL | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 |
| EDV | End Diastolic Volume | 93 | mL | 93 | 93 | mL | HEART, RIGHT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2-2 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 70 | % | 70 | 70 | % | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | | 16 | DMD-EF | CV | DMD-EF-01-101 | 16 | 2-2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 |
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The lab test, N-terminal pro-B-type natriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment.[3,4] These test results are represented in the Laboratory Test Results (LB) domain.
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| Row 1: | Shows the results for the NT-proBNP test at visit 1. | | Row 2: | Shows the results for the NT-proBNP test at visit 6. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBLNKID | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTRNHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | VISITNUM | VISIT | LBDTC | LBDY |
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| 1 | DMD-EF | LB | DMD-EF-01-101 | 1 | 2-1 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 40 | pg/mL | 0 | 100 | 40 | 40 | ng/L | 0 | 100 | NORMAL | 71425-3 | BLOOD |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 2 | DMD-EF | LB | DMD-EF-01-101 | 2 | 2-2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 900 | pg/mL | 0 | 100 | 900 | 900 | ng/L | 0 | 100 | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06 | 326 |
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A Related Records (RELREC) dataset is used to show the relationship between the CV and LB domains.
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| key | TAUGDMDCIS-18 |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-19 |
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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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| 1 | DMD-EF | CV |
| CVLNKID |
| MANY | 2 | | 2 | DMD-EF | LB |
| LBLNKID |
| ONE | 2 |
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