The demographics (DM) domain is used to represent information about the participants in a clinical study. For more information on this domain, see Section 5.2, Demographics (DM), of the SDTMIG v3.4. Note there are 4 participants noted in this dataset while the other datasets only have one participant. This purpose is to show an example of the demographics dataset.
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For patients with DMD, it is important to record the height and weight since cardiac index and spirometry results are affected by body surface area (ref: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.115.003810). The vitals signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight.For more information on domain see Section 6.3.13, Vital Signs (VS) in the SDTMIG v3.4.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOBFXL | VISITNUM | VISIT | VSDTC |
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1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 47 | in | 119 | 119 | cm |
| 1 | VISIT 1 | 2022-05-16 | 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | 20 | kg | 20 | 20 | kg |
| 1 | VISIT 1 | 2022-05-16 | 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | HEIGHT | Height | 52 | in | 132 | 132 | cm |
| 6 | VISIT 6 | 2023-04-06 | 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | WEIGHT | Weight | 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. For more information on this domain see Section 6.3.7.2, Cardiovascular System Findings (CV), of the SDTMIG v3.4.
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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 |
| 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 lab test, N-Terminal ProB-type Natriuretic Peptide, is a biomarker used in heart failure and ejection fraction for diagnosis and treatment (ref: https://pubmed.ncbi.nlm.nih.gov/34918487/; ref: https://pubmed.ncbi.nlm.nih.gov/33039447/). These test results are represented in the laboratory test results (LB) domain. For more information on this domain, see Section 6.3.5.6, Laboratory Test Results (LB), in the SDTMIG 3.4.
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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 | LBLOBXFL | 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 Section 8.2.1, Related Records (RELREC) in the SDTMIG v3.4.
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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 |
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| MANY | 2 | 2 | DMD-EF | LB |
| LBLNKID |
| ONE | 2 |
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