Shows the demographics for one subject. RFSTDTC represents the beginning of the trial, or subject registration date.
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Row | STUDYID | DOMAIN | USUBJID | RFSTDTC | BRTHDTC | AGE | AGEU | SEX |
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1 | DMD-EF | DM | DMD-EF-01-101 | 2022-05-16 | 2014-02-07 | 8 | YEARS | M |
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| Row | STUDYID | DOMAIN | USUBJID | RFSTDTC | AGE | AGEU | SEX | ARM | 1 | RD005 | DM | RD005-001-001 | 2021-02-15T09:00 | 8 | YEARS | M | Drug A | 2 | RD005 | DM | RD005-001-002 | 2021-01-13T08:00 | 14 | YEARS | M | Drug A | 3 | RD005 | DM | RD005-001-003 | 2021-04-15T10:15 | 19 | YEARS | M | Drug B | 4 | RD005 | DM | RD005-001-004 | 2021-05-06T09:30 | 22 | YEARS | M | Drug B |
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VS Dataset
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Row | STUDYID | DOMAIN | USUBJID | RFSTDTC |
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1 | DMD-EF | VS | DMD-EF-01-101 | 2022-05-16 |
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| Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESN | VSSTRESU | VSDRVFL | VISITNUM | VISIT | 1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 32 | cm |
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| 1 | VISIT 1 | 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | 20 | kg |
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| 1 | VISIT 1 | 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | BSA | Body Surface Area | 1.1 | m2 | 0.98 | m2 | Y | 1 | VISIT 1 | 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | HEIGHT | Height |
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| 6 | VISIT 6 | 5 | DMD-EF | VS | DMD-EF-01-101 | 5 | WEIGHT | Weight |
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| 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 |
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The 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 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 | 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 IMAGING | 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 IMAGING | 1 | VISIT 1 | 2022-05-16 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 67 | % | 67 | 67 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | VISIT 1 | 2022-05-16 | 1 | 4 | DMD-EF | CV | DMD-EF-01-101 | 4 | 2 | CARDOUT | Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 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 IMAGING | 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 IMAGING | 1 | VISIT 1 | 2022-05-16 | 1 | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 74 | % | 74 | 74 | % | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | VISIT 1 | 2022-05-16 | 1 | 8 | DMD-EF | CV | DMD-EF-01-101 | 8 | 2 | CARDOUT | Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 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 IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 |
| EDV | End Diastolic Volume | 94 | mL | 94 | 94 | mL | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 11 | DMD-EF | CV | DMD-EF-01-101 | 11 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Calculated | 60 | % | 60 | 60 | % | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 12 | DMD-EF | CV | DMD-EF-01-101 | 12 | 2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, LEFT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 |
| ESV | End Systolic Volume | 36 | mL | 36 | 36 | mL | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 |
| EDV | End Diastolic Volume | 93 | mL | 93 | 93 | mL | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Calculated | 61 | % | 61 | 61 | % | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 | 16 | DMD-EF | CV | DMD-EF-01-101 | 16 | 2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, RIGHT VENTRICLE | CARDIAC MAGNETIC RESONANCE IMAGING | 6 | VISIT 6 | 2023-04-06 | 325 |
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The laboratory test, N-Terminal ProB-type Natriuretic Peptide, 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/). 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 at VISIT 1. | Row 2: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide 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 | VISITNUM | VISIT | LBDTC | LBDY |
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1 | DMD-EF | LB | DMD-EF-01-101 | 1 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 40 | pg/mL | 0 | 100 | 40 | 40 | IU/L | 100 | 40 | NORMAL | 71425-3 | BLOOD | 1 | VISIT 1 | 2022-05-16 | 1 | 2 | DMD-EF | LB | DMD-EF-01-101 | 2 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 900 | pg/mL | 0 | 100 | 900 | 900 | IU/L | 100 | 900 | HIGH | 71425-3 | BLOOD | 6 | VISIT 6 | 2023-04-06 | 325 |
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A 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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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-EF | CV |
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| MANY | 2 | 2 | DMD-EF | LB |
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| ONE | 2 |
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