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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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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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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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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...
Dataset2 |
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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-EF | CV | DMD-EF-01-101 | 1 |
| RVESVRight Ventricle 393939CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 1 |
| SCREENINGVISIT 1 | 2022-05-16 | 1 | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 |
| RVEDVRight Ventricle 115115115CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2-1 |
| RVEFRight Left Ventricular Ejection Fraction, |
| Calculated666666CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 1 |
| SCREENINGVISIT 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 |
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| LVESV | Left Ventricle Systolic Volume | 20 | mL | 20 | 20 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | 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 |
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SCREENING55LVEDVLeft Ventricle 100100100CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | MRI |
| 1 |
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SCREENING66LVEFLeft Right Ventricular Ejection Fraction, |
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Calculated505050CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING77LVCOLV 45445CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 9 | DMD-EF | CV | DMD-EF-01-101 |
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8RVESVRight Ventricle 393939CARDIAC MAGNETIC RESONANCE IMAGING-0137629RVEDVRight Ventricle 115115115CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 |
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-01376310RVEFRight Left Ventricular Ejection Fraction, |
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Calculated666666CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 12 | DMD-EF | CV | DMD-EF-01 |
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376 | 4 | -101 | 12 | 2-2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 13 |
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11LVESVLeft Ventricle 202020CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 |
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-01376512LVEDVLeft Ventricle 100100100 | HEART, RIGHT VENTRICLE | MRI |
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CARDIAC MAGNETIC RESONANCE IMAGING-01376613LVEFLeft Right Ventricular Ejection Fraction, |
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Calculated505050CARDIAC MAGNETIC RESONANCE IMAGING-01376714LVCOLV 555CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 |
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-01376
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 N-Terminal ProB-type Natriuretic Peptide test for subject 101 at ScreeningNT-proBNP test at visit 1. | Row 2: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at Visit visit 6. |
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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 | IUng/L | 0 | 10040 | NORMAL | 7142571425-3 | BLOOD |
| 1SCREENING | 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 | IUng/L | 0 | 100900 | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06-01 | 376 | 326 |
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A Related Records (RELREC) dataset is used to show the The relationship between CV and LB is represented in the Related Records dataset (RELREC) . For more information on relating records, see the SDTMIG v3.4, Section 8.2.1.the CV and LB domains.
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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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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