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.
...
Definexmltable
Dataset
ADCVCMR
Level
Variable
Purpose
Analysis
Name
Variable
Variable Name
Variable Label
Type
Codelist/Controlled Terms/Format
Source
Derivation/Comment
STUDYID
Study Identifier
Char
ADCVNTP.STUDYID
USUBJID
Unique Subject Identifier
Char
ADCVNTP.USUBJID
BRTHDT
Date of Birth
Num
date9.
ADCVNTP.BRTHDT
AGE
Age
Num
ADCVNTP.AGE
AGEU
Age Unit
Char
YEARS
ADCVNTPL.AGEU
TRTSDT
Date of First Exposure to Treatment
Num
date9.
ADCVNTP.TRTSDT
TRT01P
Planned Treatment for Period 01
Char
Drug A; Drug B
ADCVNTP.TRT01P
ITTFL
Intent-To-Treat Population Flag
Char
Y; N
ADCVNTP.ITTFL
BSASC
Body Surface Area at Screening
Num
ADCVNTP.BSASC
BSA
Body Surface Area (m2)
Num
ADCVNTP.BSA
ACEINHFL
ACE Inhibitor Medications Flag
Char
Y; N
ADCVNTP.ACEINHFL
BNPPRONT
Num
BNPPRONT = AVAL where PARAMCD = ADCVNTP.BNPPRONT, and merge by USUBJID and AVISITN.
Note: there are many ways to add this including transposing the data.
PARAM
Parameter
Char
Left Ventricular Ejection Fraction, Calculated (%);
Right Ventricular Ejection Fraction, Calculated (%);