The demographics Demographics (DM) dataset shows the domain is used to represent 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. 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 | 20212022-0205-15T0916T09:00 |
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| 2022-05-16 |
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| 01 | 20142010-02-07 | 812 | 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 | 20212022-0106-13T08:00 |
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| 2022-06-13 |
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| 01 | 20062008-05-01 | 14 | YEARS | M | ASIAN | A | Drug A | A | Drug A |
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| MYS | 3 | DMD-EF | DM | DMD-EF-01-103 | 103 | 20212022-0407-15T10:15 |
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| 2022-07-15 |
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| 01 | 20012003-07-10 | 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 | 20212022-0509-06T09:30 |
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| 2022-09-06 |
| 2023-11-23 | Y | 01 | 1999-01-15 | 2223 | 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 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 v3.4including 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 | VSTRESCVSSTRESC | 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 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 v3.4contains physiological and morphological findings related to the cardiovascular system.
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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 Blood 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 Blood 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 Blood 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 Blood 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 Blood 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 Blood 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 Blood 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 Blood 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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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TAUGDMDCIS-18 |
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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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