The 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.
dm.xpt
dm.xpt
Row
STUDYID
DOMAIN
USUBJID
SUBJID
RFSTDTC
SITEID
BRTHDTC
AGE
AGEU
SEX
ARMCD
ARM
ACTARMCD
ACTARM
1
DMD-EF
DM
DMD-EF-01-101
101
2021-02-15T09:00
01
2014-02-07
8
YEARS
M
A
Drug A
A
Drug A
2
DMD-EF
DM
DMD-EF-01-102
102
2021-01-13T08:00
01
2006-05-01
14
YEARS
M
A
Drug A
A
Drug A
3
DMD-EF
DM
DMD-EF-01-103
103
2021-04-15T10:15
01
2001-07-10
19
YEARS
M
B
Drug B
B
Drug B
4
DMD-EF
DM
DMD-EF-01-104
104
2021-05-06T09:30
01
1999-01-15
22
YEARS
M
B
Drug B
B
Drug B
$warningHtml
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.xpt
vs.xpt
Row
STUDYID
DOMAIN
USUBJID
VSSEQ
VSTESTCD
VSTEST
VSORRES
VSORRESU
VSTRESC
VSSTRESN
VSSTRESU
VISITNUM
VISIT
1
DMD-EF
VS
DMD-EF-01-101
1
HEIGHT
Height
47
in
119
119
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
HEIGHT
Height
52
in
132
132
cm
6
VISIT 6
4
DMD-EF
VS
DMD-EF-01-101
4
WEIGHT
Weight
32
kg
32
32
kg
6
VISIT 6
$warningHtml
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.
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.
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.
lb.xpt
lb.xpt
Row
STUDYID
DOMAIN
USUBJID
LBSEQ
LBLNKID
LBTESTCD
LBTEST
LBCAT
LBORRES
LBORRESU
LBORNRLO
LBORNRHI
LBSTRESC
LBSTRESN
LBSTRESU
LBSTNRLO
LBSTRNHI
LBNRIND
LBLOINC
LBSPEC
VISITNUM
VISIT
LBDTC
LBDY
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
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
A 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.