Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit.
WEIGHT
Weight (kg)
Num
Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit.
BSA
Body Surface Area (m2)
Num
Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425× H0.725
There are multiple methods and the study protocol should describe which one to use (e.g., Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich).
ACEINHFL
ACE Inhibitor Medications Flag
Char
Y; N
ADSL.ACEINHFL
PARAM
Parameter
Char
Left Ventricular Ejection Fraction, Calculated (%);
Right Ventricular Ejection Fraction, Calculated (%);
N-Terminal ProB-type Natriuretic Peptide (pg/mL)
CV.CVTEST
LB.LBTEST
PARAMCD
Parameter Code
Char
LVEF_C;
RVEF_C;
BNPPRONT
CV.CVTESTCD
LB.LBTESTCD
PARAMN
Parameter (N)
Num
Number PARAMCD as follows:
LVEF_C = "1"
RVEF_C = "2"
BNPPRONT = "3"
AVAL
Analysis Value
Num
See Parameter Value Metadata
AVISIT
Analysis Visit
Char
Visit 1 (Baseline);
Visit 6 (1 Year)
If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)".
If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)".
AVISITN
Analysis Visit (N)
Num
1; 6
CV.VISITNUM
LB.VISITNUM
VISIT
Visit
Num
VISIT 1; VISIT 6
CV.VISIT
LB.VISIT
ADT
Analysis Date
Num
date9.
Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9.
ABLFL
Baseline Record Flag
Char
Y
If CV.VISIT = "VISIT 1" then ABLFL = "Y".
BASE
Baseline Value
Num
Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y".
Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD.
CHG
Change from Baseline
Num
Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records.
PCHG
Percent Change from Baseline
Num
Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.
CHGCAT1
Change from Baseline Category 1
Char
Decline >=5%; Decline <5%; Increase GT 100 pg/mL
See Parameter Value Metadata
SRCDOM
Source Data
Char
CV; LB
Set to the SDTM domain name that relates to the analysis value.
SRCVAR
Source Variable
Char
Set to the SDTM variable that relates to the analysis value.
SRCSEQ
Source Sequence Number
Num
CV.CVSEQ
LB.LBSEQ
Set to the SDTM domain sequence number that relates to the analysis value.
...
Dataset wrap
Show
true
Name
adcvntp
Rowcaps
Rows 1-2:
Show the baseline ejection fraction measurements at VISIT 1.
Row 3:
Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1.
Rows 4-5:
Show the baseline ejection fraction measurements at VISIT 6.
Row 6:
Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6.
Dataset2
tableid
adcvntp
Row
STUDYID
USUBJID
AAGE
AGEU
SEX
RACE
TRT01P
TRT01A
ITTFLBSASC
HEIGHT
WEIGHT
BSA
ACEINHFL
PARAM
PARAMCD
PARAMN
AVAL
AVISIT
AVISITN
VISIT
ADT
ABLFL
BASE
CHG
PCHG
CHGCAT1
SRCDOM
SRCVAR
SRCSEQ
1
DMD-EFLGE
DMD-EF-01-101
12.3
YEARS
M
BLACK OR AFRICAN AMERICAN
Drug A
Drug A
Y0.82
119
20
0.82
Y
Left Ventricular Ejection Fraction, Calculated (%)
LVEF_C
1
67
Visit 1 (Baseline)
1
VISIT 1
16MAY2022
Y
67
CV
CVTESTCD
3
2
DMD-EFLGE
DMD-EF-01-101
12.3
YEARS
M
BLACK OR AFRICAN AMERICAN
Drug A
Drug A
Y
0.82
119
20
0.82
Y
Right Ventricular Ejection Fraction, Calculated (%)
RVEF_C
2
74
Visit 1 (Baseline))
1
VISIT 1
16MAY2022
Y
74
CV
CVTESTCD
7
3
DMD-EFLGE
DMD-EF-01-101
12.3
YEARS
M
BLACK OR AFRICAN AMERICAN
Drug A
Drug A
Y0.82
119
20
0.82
Y
N-Terminal ProB-type Natriuretic Peptide (IU/L)
BNPPRONT
3
40
Visit 1 (Baseline)
1
VISIT 1
16MAY2022
Y
40
LB
LBTESTCD
1
4
DMD-EFLGE
DMD-EF-01-101
12.3
YEARS
M
BLACK OR AFRICAN AMERICAN
Drug A
Drug A
Y0.82
132
32
1.08
Y
Left Ventricular Ejection Fraction, Calculated (%)
LVEF_C
1
60
Visit 6 (1 Year)
6
VISIT 6
06APR2023
67
-7
-10.447761
Decline >=5.0%
CV
CVTESTCD
11
5
DMD-EFLGE
DMD-EF-01-101
12.3
YEARS
M
BLACK OR AFRICAN AMERICAN
Drug A
Drug A
Y0.82
132
32
1.08
Y
Right Ventricular Ejection Fraction, Calculated (%)