Shows the demographics for one subjectThe demographics (DM) dataset shows the information about the four participants in a clinical study with a Study Identifier of DMD-EF. The USUBJID represents the identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique value, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. RFSTDTC represents the beginning of the trial, or subject registration date. The ARMCD, ARM, ACTARMCD, and ACTARM represent the planned arm code, the description of the planned arm, the actual arm code, and the description of the actual arm. For more information on the Demographics (DM) Special Purpose Domain see Section 5.2 of the SDTMIG v3.4.
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| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | SITEID | BRTHDTC | AGE | AGEU | SEX | ARMCD | ARM | ACTARMCD | ACTARM |
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| 1 | DMD-EF | DM | DMD-EF-01-101 | 101 | 20222021-05-1602-15T09:00 | 01 | 2014-02-07 | 8 | YEARS | MRow | A | STUDYIDDrug ADOMAIN | A | USUBJIDDrug A | RFSTDTC | AGE | | 2 | DMD-EF | AGEU | SEX | ARM | 1 | RD005 | DM | RD005DMD-EF-00101-001102 | 102 | 2021-0201-15T0913T08:00 | 8 | YEARS | M | Drug A | 01 | 2006-05-01 | 2 | RD005 | DM | RD005-001-002 | 2021-01-13T08:00 | 14 | YEARS | M | A | Drug A | A | Drug A | | 3RD005 | DMD-EF | DM | RD005DMD-EF-00101-003103 | 103 | 2021-04-15T10:15 | 01 | 2001-07-10 | 19 | YEARS | M | B | Drug B | B | Drug B | | 4RD005 | DMD-EF | DM | RD005DMD-EF-00101-004104 | 104 | 2021-05-06T09:30 | 01 | 1999-01-15 | 22 | YEARS | M | B | Drug B | B | Drug B |
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The vitals signs (VS) dataset contains measurements that directly measure an individual's current state of vital sign attributes. The dataset shows height and weight only. For more information on the Vital Signs (VS) Findings Domain see Section 6.3.13 in the SDTMIG v3.4.VS Dataset
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| Row | STUDYID | DOMAIN | USUBJID | RFSTDTC | 1 | DMD-EF | VS | DMD-EF-01-101 | 2022-05-16 | Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSTRESC | VSSTRESN | VSSTRESU | VSDRVFL | VISITNUM | VISIT |
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| 1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 47 | in | 32119 | cm119 | cm | 1 | VISIT 1 | | 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | 20 | kg | 20 | 20 | kg | 1 | VISIT 1 | | 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | BSAHEIGHT | Body Surface Area | 1.1 | m2 | 0.98 | m2 | Y | 1 | VISIT 1 | Height | 52 | in | 132 | 132 | 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | HEIGHT | Height | cm | cm | 6 | VISIT 6 | | 54 | DMD-EF | VS | DMD-EF-01-101 | 54 | WEIGHT | Weight | kg32 | kg | 632VISIT 6 | 32 | 6 | DMD-EF | VS | DMD-EF-01-101 | 6 | BSA | Body Surface Area | 1.2 | m2 | 1.1 | m2 | Y | kg | 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. For more information on the Cardiovascular System Findings (CV) domain see Section 6.3.7.2 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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| | 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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