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The ADCVNTP dataset includes tests pertinent to these analyses. The records from LB CV where CVTESTCD is equal to = "LVEF_C" or and "RVEF_C" and the records from LB where LBTESTCD = "BNPPRONT" were selected. The relationship dataset RELREC illustrates the relationship between datasets. In this case, many Many lab draws may occur throughout the year, but only those linked to a specific visit are were included. By subsetting the LB dataset with by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT. In the example, only two LB records are shown which are linked to CV where CVTESTCD = "LVEF_C" or CVTESTCD = "R.VEF_C".

ADCVMR is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the ProB-type test results. It is an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVNTP.

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This is a simplified example ADSL dataset; it is expected that additional variables for stratification, or of interest for analysis, would be included.

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

DM.STUDYID


USUBJIDUnique Subject IdentifierChar

DM.USUBJID


BRTHDTDate of BirthNumdate9.

ADSL.BRTHDTC

Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.)
TRTSDTDate of First Exposure to TreatmentNumdate9.
Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as DATE9.
TRT01P

Planned Treatment for Period 01

CharTreatment AADSL.TRT01PFor this example we are using "Treatment A". In a Real World Evidence study this could be non-treatment related, e.g. "Group A".

ITTFL

Intent-To-Treat Population Flag

Char

Y; N

ADSL.ITTFL

Derive the intent-to-treat population as per the protocol and SAP.

ACEINHFL

ACE Inhibitor Medications Flag

Char

Y


Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors.

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