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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| Dataset2 |
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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 | 2010-02-07 | 12 | 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 | 2022-06-13T08:00 |
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| 2022-06-13 |
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| 01 | 2008-05-01 | 14 | YEARS | M | ASIAN | A | Drug A | A | Drug A |
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| MYS | | 3 | DMD-EF | DM | DMD-EF-01-103 | 103 | 2022-07-15T10:15 |
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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 | | 4 | DMD-EF | DM | DMD-EF-01-104 | 104 | 2022-09-06T09:30 |
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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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| IRL |
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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 | VSSEQ | VSTESTCD | VSTEST | VSPOS | VSORRES | VSORRESU | VSSTRESC | 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 Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular systemThis example dataset shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every two months. The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.
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| Rows 1-8: | Show the baseline CMR ejection fraction measurements for the participant 101 at VISIT visit 1. | | Rows 9-16: | Show the CMR ejection fraction measurements for the participant 101 at VISIT 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- |
EFLGELVESVLeft Ventricle | End Systolic Volume | 32 | mL | 32 | 32 | mL |
CARDIAC MAGNETIC RESONANCE IMAGING | HEART, LEFT VENTRICLE | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 2 | DMD- |
EFLGELVEDVLeft Ventricle | End Diastolic Volume | 95 | mL | 95 | 95 | mL |
CARDIAC MAGNETIC RESONANCE IMAGINGEFLGE| EF | CV | DMD-EF-01-101 | 3 | 2-1 | LVEF_C | Left Ventricular Ejection Fraction, |
Calculated676767CARDIAC MAGNETIC RESONANCE IMAGINGEFLGELVCOLV | Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min |
CARDIAC MAGNETIC RESONANCE IMAGINGEFLGERVESVRight Ventricle | End Systolic Volume | 24 | mL | 24 | 24 | mL |
CARDIAC MAGNETIC RESONANCE IMAGINGEFLGERVEDVRight Ventricle | End Diastolic Volume | 90 | mL | 90 | 90 | mL |
| HEART, RIGHT VENTRICLE | MRI |
CARDIAC MAGNETIC RESONANCE IMAGINGEFLGE| EF | CV | DMD-EF-01-101 | 7 | 2-1 | RVEF_C | Right Ventricular Ejection Fraction, |
Calculated747474CARDIAC MAGNETIC RESONANCE IMAGING| HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 8 | DMD- |
EFLGERVCORV | Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min |
CARDIAC MAGNETIC RESONANCE IMAGING| HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | | 9 | DMD- |
EFLGELVESVLeft Ventricle | End Systolic Volume | 37 | mL | 37 | 37 | mL |
CARDIAC MAGNETIC RESONANCE IMAGING| HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 |
-01355EFLGELVEDVLeft Ventricle | End Diastolic Volume | 94 | mL | 94 | 94 | mL |
CARDIAC MAGNETIC RESONANCE IMAGING| HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 |
-01355EFLGE| EF | CV | DMD-EF-01-101 | 11 | 2-2 | LVEF_C | Left Ventricular Ejection Fraction, |
Calculated606060CARDIAC MAGNETIC RESONANCE IMAGING-01355EFLGELVCOLV | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min |
CARDIAC MAGNETIC RESONANCE IMAGING| HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 |
-01355EFLGERVESVRight Ventricle | End Systolic Volume | 36 | mL | 36 | 36 | mL |
CARDIAC MAGNETIC RESONANCE IMAGING-01355EFLGERVEDVRight Ventricle | End Diastolic Volume | 93 | mL | 93 | 93 | mL |
| HEART, RIGHT VENTRICLE | MRI |
CARDIAC MAGNETIC RESONANCE IMAGING-01355EFLGE| EF | CV | DMD-EF-01-101 | 15 | 2-2 | RVEF_C | Right Ventricular Ejection Fraction, |
Calculated616161CARDIAC MAGNETIC RESONANCE IMAGING-01355EFLGERVCORV | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min |
CARDIAC MAGNETIC RESONANCE IMAGING-01355 |
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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 is used with 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 (LB) domain.
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| Row 1: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide test for participant 101 at VISIT NT-proBNP test at 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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| Dataset2 |
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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- |
EFLGE| EF | LB | DMD-EF-01-101 | 1 | 2-1 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 40 | pg/mL | 0 | 100 | 40 | 40 |
IU40 | NORMAL | 71425-3 | BLOOD |
| 1 | VISIT 1 | 2022-05-16 | 1 | | 2 | DMD- |
EFLGE| EF | LB | DMD-EF-01-101 | 2 | 2-2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 900 | pg/mL | 0 | 100 | 900 | 900 |
IU900 | | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06 |
-01355 | |
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A Related Records (RELREC) dataset is used to show the The relationship between CV and LB is represented in the Related Records dataset (RELREC). For more information on relating records, see the SDTMIG v3.4, Section 8.2.the CV and LB domains.
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-18 |
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| server | Issue Tracker (JIRA) |
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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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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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| 1 | DMD-EFLGEEF | CV |
| CVLNKID |
| MANY | 2 | | 2 | DMD-EFLGEEF | LB |
| LBLNKID |
| ONE | 2 |
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