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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Does this need to be LVEDV? It is currently LVDV.
The CVTESTCD have "E", should the CVTEST have "End" in the term?
Ejection Fraction - Liters/minutes or percentage?
This example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.
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Rows 1-8: | Show the baseline CMR ejection fraction measurements for the participant 101 at Screeningvisit 1. | Rows 9-16: | Show the CMR ejection fraction measurements for the participant 101 at VISIT 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-EF | CV | DMD-EF-01-101 | 1 | RVESVRight Ventricle 23.523.5 | 23.5CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 1 | SCREENINGVISIT 1 | 2022-05-16 | 1 | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 | RVEDVRight Ventricle 89.789.7 | 89.7CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2-1 | RVEFRight Left Ventricular Ejection Fraction, | Calculated73.873.8 | 73.8CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 1 | SCREENINGVISIT 1 | 2022-05-16 | 1 | 4 | DMD-EF | CV | DMD-EF-01-101 | 4 | 2-1 | RVCORV 666CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 5 | DMD-EF | CV | DMD-EF-01-101 | 5 | LVESVLeft Ventricle 31.731.7 | 31.7CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 6 | DMD-EF | CV | DMD-EF-01-101 | 6 | LVEDVLeft Ventricle 94.894.8 | 94.8CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | MRI |
| 1 | SCREENINGVISIT 1 | 2022-05-16 | 1 | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2-1 | LVEFLeft Right Ventricular Ejection Fraction, | Calculated66.566.5 | 66.5CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 8 | DMD-EF | CV | DMD-EF-01-101 | 8 | 2-1 | LVCOLV 444CARDIAC MAGNETIC RESONANCE IMAGINGSCREENINGVISIT 1 | 2022-05-16 | 1 | 9 | DMD-EF | CV | DMD-EF-01-101 | 9 | RVESVRight Ventricle 35.935.9 | 35.9CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | -01376326 | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 | RVEDVRight Ventricle 92.892.8 | 92.8CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | -01376326 | 11 | DMD-EF | CV | DMD-EF-01-101 | 11 | 2-2 | RVEFRight Left Ventricular Ejection Fraction, | Calculated61.361.3 | 61.3CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | -01376326 | 12 | DMD-EF | CV | DMD-EF-01-101 | 12 | 2-2 | RVCORV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | -01376326 | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 | LVESVLeft Ventricle 37.437.4 | 37.4CARDIAC MAGNETIC RESONANCE IMAGING-01376326 | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 | LVEDVLeft Ventricle .8.8.8CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | -01376326 | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2-2 | LVEFLeft Right Ventricular Ejection Fraction, | Calculated606060CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | -01376326 | 16 | DMD-EF | CV | DMD-EF-01-101 | 16 | 2-2 | LVCOLV Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | CARDIAC MAGNETIC RESONANCE IMAGINGHEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | -01376 | |
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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 N-Terminal ProB-type Natriuretic Peptide test for participant 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 | 100 | 900 | 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.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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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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