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.
Dataset wrap |
---|
|
Dataset2 |
---|
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 |
---|
1 | DMD-EF | DM | DMD-EF-01-101 | 101 | 2022-05-16T09:00 |
|
|
| 2022-05-16 |
|
|
| 01 | 2010-02-07 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | A | Drug A | A | Drug A |
|
| USA | 2 | DMD-EF | DM | DMD-EF-01-102 | 102 | 2022-06-13T08:00 |
|
|
| 2022-06-13 |
|
|
| 01 | 2008-05-01 | 14 | YEARS | M | ASIAN | A | Drug A | A | Drug A |
|
| MYS | 3 | DMD-EF | DM | DMD-EF-01-103 | 103 | 2022-07-15T10:15 |
|
|
| 2022-07-15 |
|
|
| 01 | 2003-07-10 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | B | Drug B | B | Drug B |
|
| BRA | 4 | DMD-EF | DM | DMD-EF-01-104 | 104 | 2022-09-06T09:30 |
|
|
| 2022-09-06 |
| 2023-11-23 | Y | 01 | 1999-01-15 | 23 | YEARS | M | WHITE | B | Drug B | B | Drug B |
|
| IRL |
|
|
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.
Dataset wrap |
---|
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSPOS | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOBFXL | VISITNUM | VISIT | VSDTC |
---|
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 |
|
|
The Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular system.
Dataset wrap |
---|
|
Rowcaps |
---|
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. |
|
Dataset2 |
---|
| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBXFL | VISITNUM | VISIT | CVDTC | CVDY |
---|
1 | DMD-EF | CV | DMD-EF-01-101 | 1 |
|
| RVSYSVOL
RVESV | Right Ventricle 383838CARDIAC MAGNETIC RESONANCE IMAGINGHEART, LEFT VENTRICLE | MRI |
| 1 |
|
SCREENING2023060116 | 1 | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 |
|
RVDIAVOL
RVEDV | Right Ventricle 888CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING2023060116 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2-1 |
|
RVEFRight Left Ventricular Ejection Fraction, |
|
Calculated383838CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING2023060116 | 1 | 4 | DMD-EF | CV | DMD-EF-01-101 | 4 | 2-1 | CARDOUT | Cardiac Output |
|
4 | LVSYSVOL
LVESV | Left Ventricle Systolic Volume | 100 | mL | 100 | 100 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | 5.4 | L/min | 5.4 | 5.4 | L/min | HEART, LEFT VENTRICLE | | | 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 | | | 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 | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2-1 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 75 | % | 75 | 75 | % | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 8 |
|
5 | DMD-EF | CV | DMD-EF-01-101 | 8 | 2-1 | CARDOUT | Cardiac Output | 5.6 | L/min | 5.6 | 5 |
|
LVDIAVOL
LVEDV | Left Ventricle Diastolic Volume | 60 | mL | 60 | 60 | mL | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | .6 | L/min | HEART, RIGHT VENTRICLE | | | 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 | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 |
| EDV | End Diastolic Volume | 94 | mL | 94 | 94 | mL | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 11 |
|
662-2 | LVEF_C | Left Ventricular Ejection Fraction, |
|
Calculated505050CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 12 |
|
77LVCOLV 555CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 |
| ESV | End Systolic Volume | 36 | mL | 36 | 36 | mL | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 |
| EDV | End Diastolic Volume | 93 | mL | 93 | 93 | mL | HEART, RIGHT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2-2 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 70 | % | 70 | 70 | % | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 16 |
|
88LVCILV Index36/m23.6 | 3.6 | L/min/m2 | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 2023-06-01 | 4.0 | 4.0 | L/min | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 |
|
The lab test, N-terminal pro-B-type natriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment.[3,4] These test results are represented in the Laboratory Test Results (LB) domain.
Dataset wrap |
---|
|
Rowcaps |
---|
Row 1: | Shows the results for the NT-proBNP test at visit 1. | Row 2: | Shows the results for the NT-proBNP test at visit 6. |
|
Dataset2 |
---|
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 |
---|
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 | ng/L | 0 | 100 | 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 | ng/L | 0 | 100 | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06 | 326 |
|
|
A Related Records (RELREC) dataset is used to show the relationship between the CV and LB domains.
Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | TAUGDMDCIS-18 |
---|
|
Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
---|
columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | TAUGDMDCIS-19 |
---|
|
Dataset wrap |
---|
|
Dataset2 |
---|
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
---|
1 | DMD-EF | CV |
| CVLNKID |
| MANY | 2 | 2 | DMD-EF | LB |
| LBLNKID |
| ONE | 2 |
|
|