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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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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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 1: | Shows the representation of results from ... Right Ventricle Systolic Volume | Row 2: | Shows the representation of results from ... Right Ventricle Diastolic Volume | Row 3: | Shows the representation of results from ... Right Ventricular Ejection Fraction, Calculated | Row 4: | Shows the representation of results from ... Left Ventricle Systolic Volume | Row 5: | Shows the representation of results from ... Left Ventricle Diastolic Volume | Row 6: | Shows the representation of results from ... Left Ventricular Ejection Fraction, Calculated | Row 7: | Shows the representation of results from ... LV Cardiac Output | Row 8: | Shows the representation of results from ... LV Cardiac Index | 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 |
| RVSYSVOL 1Right Ventricle 38/m23838/m2CARDIAC MAGNETIC RESONANCE IMAGING | HEART, LEFT VENTRICLE | MRI |
| 1 |
| SCREENING2023060116 | 1 | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 |
| RVDIAVOLRight Ventricle 8/m288/m2CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING2023060116 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2-1 |
| RVEFRight Left Ventricular Ejection Fraction, |
| Calculated383838 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | 4 | | HEART, LEFT VENTRICLE | MRI |
| 1 | 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 |
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4LVSYSVOLLeft Ventricle 100/m2100100/m2CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING2023060155LVDIAVOLLeft Ventricle 60 | mL/m2 | 60 | 60 | mL/m2 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | | 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 |
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662-2 | LVEF_C | Left Ventricular Ejection Fraction, |
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Calculated505050CARDIAC MAGNETIC RESONANCE IMAGING | 1 | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 |
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SCREENING-01712 | DMD-EF | CV | DMD-EF-01-101 | 12 |
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7LVCOLV 555CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | | 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 |
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88LVCILV Index36/m23.6 | 3.6 | L/min/m2 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | 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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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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showSummary | false |
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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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showSummary | false |
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server | Issue Tracker (JIRA) |
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columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
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columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
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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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