Shows the demographics for one subject. RFSTDTC represents the beginning of the trial, or subject registration date.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 | 20142010-02-07 | 812 | YEARS | M | | Row | STUDYID | DOMAIN | USUBJID | RFSTDTC | AGE | AGEU | SEX | ARM | | 1 | RD005 | DM | RD005-001-001 | 2021-02-15T09:00 | 8 | YEARS | M | Drug A | | 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 | 2 | RD005 | DM | RD005-001-002 | 2021-01-13T08:00 | 14 | YEARS | M | ASIAN | A | Drug A | A | Drug A |
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| MYS | | 3RD005 | DMD-EF | DM | RD005DMD-EF-00101-003103 | 103 | 20212022-0407-15T10:15 |
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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 | | 4RD005 | DMD-EF | DM | RD005DMD-EF-00101-004104 | 104 | 20212022-0509-06T09:30 | 22 | YEARS | M | Drug B |
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VS Dataset
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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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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 | RFSTDTC | 1 | DMD-EF | VS | DMD-EF-01-101 | 2022-05-16 |
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| Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSPOS | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSDRVFLVSLOBFXL | VISITNUM | VISIT | VSDTC |
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| 1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 32 | | STANDING | 47 | in | 119 | 119cm | 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 | BSAHeight | Body Surface Area | 1.1 | m2 | 0.98 | m2 | Y | 1 | VISIT 1 | 4 | DMD-EF | VS | STANDING | 52 | in | 132 | 132 | cm |
| 6 | VISIT 6 | 2023-04-06 | | 4 | DMD-EF-01-101 | 4 | HEIGHT | Height | cm | cm | 6 | VISIT 6 | 5 | DMD-EF | VS | DMD-EF-01-101 | 54 | WEIGHT | Weight | STANDING | 32 | kg | 32 | 32 | kg |
| 6 | VISIT 6 | | 6 | DMD-EF | VS | DMD-EF-01-101 | 6 | BSA | Body Surface Area | 1.2 | m2 | 1.1 | m2 | Y | 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 systemThe cardiovascular system findings (CV) dataset shows the results of several systolic function tests measured using cardiac magnetic resonance (CMR) imaging. CVDTC is the date the measurements were taken, and CVDY is the study day.
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| Rows 1-8: | Show the baseline CMR ejection fraction measurements for the participant at VISIT visit 1. | | Rows 9-16: | Show the CMR ejection fraction measurements for the participant 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 |
| ESV | End Systolic Volume | 32 | mL | 32 | 32 | mL | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 |
| EDV | End Diastolic Volume | 95 | mL | 95 | 95 | mL | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 1 | VISIT 1 | 2022-05-16 | 1 | | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2-1 | LVEF_C | Left Ventricular Ejection Fraction, CalculatedCal | 6770 | % | 677067 | 70 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2-1 | RVEF_C | Right Ventricular Ejection Fraction, CalculatedCal | 7475 | % | 747574 | 75 | % | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 6 | VISIT 6 | 2023-04-06 | 325326 | | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 |
| EDV | End Diastolic Volume | 94 | mL | 94 | 94 | mL | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 6 | VISIT 6 | 2023-04-06 | 325326 | | 11 | DMD-EF | CV | DMD-EF-01-101 | 11 | 2-2 | LVEF_C | Left Ventricular Ejection Fraction, CalculatedCal | 6065 | % | 606560 | 65 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 6 | VISIT 6 | 2023-04-06 | 325326 | | 12 | DMD-EF | CV | DMD-EF-01-101 | 12 | 2-2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 6 | VISIT 6 | 2023-04-06 | 325326 | | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 |
| ESV | End Systolic Volume | 36 | mL | 36 | 36 | mL | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 6 | VISIT 6 | 2023-04-06 | 325326 | | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 |
| EDV | End Diastolic Volume | 93 | mL | 93 | 93 | mL | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 6 | VISIT 6 | 2023-04-06 | 325326 | | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2-2 | RVEF_C | Right Ventricular Ejection Fraction, CalculatedCal | 6170 | % | 617061 | 70 | % | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 6 | VISIT 6 | 2023-04-06 | 325326 | | 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 | CARDIAC MAGNETIC RESONANCE IMAGINGMRI | | 6 | VISIT 6 | 2023-04-06 | 325326 |
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The laboratory lab test, N-terminal pro-Terminal ProBB-type Natriuretic Peptidenatriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment (https://pubmed.ncbi.nlm.nih.gov/34918487/; https://pubmed.ncbi.nlm.nih.gov/33039447/). .[3,4] These test results are represented in the laboratory test results Laboratory Test Results (LB) domain.
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| Row 1: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at VISIT 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 | 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 | IUng/L | 0 | 100900 | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06 | 325326 |
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A related records Related Records (RELREC) dataset is used to show the relationship between the CV and LB domains. For more information on relating records, see the SDTMIG v3.4, Section 8.2.
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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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| 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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