Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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

ADCVNTP.STUDYID


USUBJIDUnique Subject IdentifierChar

ADCVNTP.USUBJID


BRTHDTDate of BirthNumdate9.

ADCVNTP.BRTHDT


AAGEAnalysis AgeNum

ADCVNTP.AAGE


AGEUAge UnitCharYEARS

ADCVNTPL.AGEU


SEX

SexChar(SEX)

ADCVNTPL.SEX


RACE

RaceNum(RACE)

ADCVNTPL.RACE


TRTSDT

Date of First Exposure to Treatment

Numdate9.ADCVNTP.TRTSDT
TRT01P

Planned Treatment for Period 01

CharDrug A; Drug BADCVNTP.TRT01P

ITTFL

Intent-To-Treat Population Flag

Char

Y; N

ADCVNTP.ITTFL


BSASCBody Surface Area at ScreeningNum

ADCVNTP.BSASC

BSABody 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.

PARAMParameterChar

Left Ventricular Ejection Fraction, Calculated (%);

Right Ventricular Ejection Fraction, Calculated (%);

N-Terminal ProB-type Natriuretic Peptide (pg/mL)

ADCVNTP.PARAM


PARAMCDParameter CodeChar

LVEF_C;

RVEF_C;

BNPPRONT

ADCVNTP.PARAMCD


PARAMNParameter (N)Num


ADCVNTP.PARAMN


AVALAnalysis ValueNum

ADCVNTP.AVAL


AVISITAnalysis VisitChar

Visit 1 (Baseline);

Visit 6 (1 Year)

ADCVNTP.AVISIT


AVISITNAnalysis Visit (N)Num1; 6

ADCVNTP.AVISITN


ADTAnalysis DateNumdate9.ADCVNTP.ADT
ABLFLBaseline Record FlagCharYADCVNTP.ABLFL


BASEBaseline ValueNum
ADCVNTP.BASE


CHGChange from BaselineNum
ADCVNTP.CHG
PCHGPercent Change from BaselineNum
ADCVNTP.PCHG
CHGCAT1Change from Baseline Category 1Char

Decline >=5%; Decline <5%; Increase GT 100 pg/mL

ADCVNTP.CHGCAT1


...