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Definexmltable
DatasetADCVNTP
LevelValue
PurposeAnalysis
OIDAVAL
DatasetVariableWhereTypeOriginDerivation/Comment
ADCVNTPAVALPARAMCD in ("LVEF_C", "RVEF_C")NumPredecessorSet to CV.CVSTRESN 
ADCVNTPAVALPARAMCD = "BNPPRONT"NumPredecessorSet to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT"
ADCVNTPCHGCAT1PARAMCD in ("LVEF_C", "RVEF_C")Char

Categorize the value of CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-9
".

Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-10
"

ADCVNTPCHGCAT1PARAMCD = "BNPPRONT"Char

Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-11
"

Definexmltable
DatasetADCVNTP
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled Terms/FormatSourceDerivation/Comment
STUDYIDStudy IdentifierChar

CV.STUDYID


USUBJIDUnique Subject IdentifierChar

CV.USUBJID


BRTHDTDate of BirthNumDate9.

ADSL.BRTHDT


AAGEAnalysis AgeNum

ADSL.AAGE


AGEUAge UnitCharYEARS

ADSL.AGEU


SEX

SexChar(SEX)

DM.SEX


RACE

RaceNum(RACE)

DM.RACE


TRTSDT

Date of First Exposure to Treatment

Numdate9ADSL.TRTSDT
TRT01P

Planned Treatment for Period 01

CharDrug A; Drug BADSL.TRT01P
TRT01A

Actual Treatment for Period 01

CharDrug A; Drug BADSL.TRT01A

ITTFL

Intent-To-Treat Population Flag

Char

Y; N

ADSL.ITTFL


HEIGHT

Height (cm)

Num



Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit.

WEIGHT

Weight (kg)

Num



Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit.

BSABody 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 for calculating BSA; the study protocol should describe which to use.

ACEINHFL

ACE Inhibitor Medications Flag

Char

Y; N

ADSL.ACEINHFL


PARAMParameterChar

Left Ventricular Ejection Fraction, Cal (%);

Right Ventricular Ejection Fraction, Cal (%);

N-Terminal ProB-type Natriuretic Peptide (ng/L)

CV.CVTEST

LB.LBTEST


PARAMCDParameter CodeChar

LVEF_C;

RVEF_C;

BNPPRONT

CV.CVTESTCD

LB.LBTESTCD


PARAMNParameter (N)Num



Number PARAMCD as follows:

LVEF_C = "1"

RVEF_C = "2"

BNPPRONT = "3"

AVALAnalysis ValueNum


See Parameter Value Metadata

AVISITAnalysis VisitChar

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)".

AVISITNAnalysis Visit (N)Num1; 6

CV.VISITNUM

LB.VISITNUM


VISITVisitNum

VISIT 1; VISIT 6

CV.VISIT

LB.VISIT


ADTAnalysis DateNumdate9.
Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. 
ABLFLBaseline Record FlagCharY

If CV.VISIT = "VISIT 1" then ABLFL = "Y".

BASEBaseline ValueNum

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.

CHGChange from BaselineNum

Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records.
PCHGPercent Change from BaselineNum

Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.
CHGCAT1Change from Baseline Category 1Char

Decline >=5%; Decline <5%; Increase GT 100 ng/L


See Parameter Value Metadata
SRCDOMSource DataChar

CV; LB


Set to the SDTM domain name that relates to the analysis value.
SRCVARSource VariableChar



Set to the SDTM variable that relates to the analysis value.
SRCSEQSource Sequence NumberNum


CV.CVSEQ

LB.LBSEQ

Set to the SDTM domain sequence number that relates to the analysis value.

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