<?xml version="1.0" encoding="utf-8"?>
<?xml-stylesheet type="text/xsl" href="define2-0-0.xsl"?>
<ODM
xmlns:xlink="http://www.w3.org/1999/xlink"
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ODMVersion="1.3.2"
FileType="Snapshot"
FileOID=".SDTM-IG.3.1.2"
CreationDateTime="2020-02-12T17:15:51+05:30"
SourceSystem="Pinnacle 21 Community"
SourceSystemVersion="3.0.2">
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<!-- MetaDataVersion = MDV. -->
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<!-- def:WhereClauseDef = WC. -->
<!-- ItemGroupDef = IG. -->
<!-- ItemDef = IT. -->
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<Study OID="EXACTV70_SDTM_UBXX">
<GlobalVariables>
<StudyName>EXACTV70_SDTM_UBXX</StudyName>
<StudyDescription>Test for auto mapping - multiple</StudyDescription>
<ProtocolName>EXACTV70_SDTM_UBXX</ProtocolName>
</GlobalVariables>
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<!-- ******************** -->
<!-- Supporting Documents -->
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<!-- ********************************** -->
<!-- Value List Definitions Section -->
<!-- ********************************** -->
<!--**************************************************************************
WhereClause Definitions Section (Used/Referenced in Value List Definitions)
**************************************************************************-->
<!-- ************************************************************************************ -->
<!-- ItemGroupDef Definitions Section (Datasets and and first set of variable properties) -->
<!-- ************************************************************************************ -->
<!-- Dataset Definition (AE) -->
<ItemGroupDef OID="IG.AE" Name="AE" Domain="AE" SASDatasetName="AE" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Structure="One record per adverse event per subject" def:Class="Events Observation Class" def:ArchiveLocationID="LF.AE">
<Description>
<TranslatedText xml:lang="en">Adverse Events</TranslatedText>
</Description>
<ItemRef ItemOID="IT.AE.STUDYID" OrderNumber="1" Mandatory="Yes" KeySequence="1" />
<ItemRef ItemOID="IT.AE.DOMAIN" OrderNumber="2" Mandatory="Yes" />
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<ItemRef ItemOID="IT.AE.AEBDSYCD" OrderNumber="22" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AESOCCD" OrderNumber="24" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AESER" OrderNumber="26" Mandatory="No" />
<ItemRef ItemOID="IT.AE.AEACN" OrderNumber="27" Mandatory="No" />
<ItemRef ItemOID="IT.AE.AEACNOTH" OrderNumber="28" Mandatory="No" />
<ItemRef ItemOID="IT.AE.AEREL" OrderNumber="29" Mandatory="No" />
<ItemRef ItemOID="IT.AE.AERELNST" OrderNumber="30" Mandatory="No" />
<ItemRef ItemOID="IT.AE.AEPATT" OrderNumber="31" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AESCONG" OrderNumber="34" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AECONTRT" OrderNumber="41" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AEENRF" OrderNumber="48" Mandatory="No" />
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<ItemRef ItemOID="IT.AE.AEENTPT" OrderNumber="50" Mandatory="No" />
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<def:leaf ID="LF.AE" xlink:href="ae.xpt">
<def:title>ae.xpt</def:title>
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<!-- **************************************************************************** -->
<!-- ItemDef Definitions Section (Variables and Value List, remaining properties) -->
<!-- **************************************************************************** -->
<ItemDef OID="IT.AE.AEACN" Name="AEACN" DataType="text" Length="16" SASFieldName="AEACN">
<Description>
<TranslatedText xml:lang="en">Action Taken with Study Treatment</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEACNOTH" Name="AEACNOTH" DataType="text" Length="200" SASFieldName="AEACNOTH">
<Description>
<TranslatedText xml:lang="en">Other Action Taken</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEBDSYCD" Name="AEBDSYCD" DataType="text" Length="8" SASFieldName="AEBDSYCD">
<Description>
<TranslatedText xml:lang="en">Body System or Organ Class Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEBODSYS" Name="AEBODSYS" DataType="text" Length="200" SASFieldName="AEBODSYS">
<Description>
<TranslatedText xml:lang="en">Body System or Organ Class</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AECAT" Name="AECAT" DataType="text" Length="50" SASFieldName="AECAT">
<Description>
<TranslatedText xml:lang="en">Category for Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AECONTRT" Name="AECONTRT" DataType="text" Length="1" SASFieldName="AECONTRT">
<Description>
<TranslatedText xml:lang="en">Concomitant or Additional Trtmnt Given</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEDECOD" Name="AEDECOD" DataType="text" Length="200" SASFieldName="AEDECOD">
<Description>
<TranslatedText xml:lang="en">Dictionary-Derived Term</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEDUR" Name="AEDUR" DataType="text" Length="19" SASFieldName="AEDUR">
<Description>
<TranslatedText xml:lang="en">Duration of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEENDTC" Name="AEENDTC" DataType="text" Length="19" SASFieldName="AEENDTC">
<Description>
<TranslatedText xml:lang="en">End Date/Time of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEENDY" Name="AEENDY" DataType="text" Length="8" SASFieldName="AEENDY">
<Description>
<TranslatedText xml:lang="en">Study Day of End of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEENRF" Name="AEENRF" DataType="text" Length="25" SASFieldName="AEENRF">
<Description>
<TranslatedText xml:lang="en">End Relative to Reference Period</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEENRTPT" Name="AEENRTPT" DataType="text" Length="25" SASFieldName="AEENRTPT">
<Description>
<TranslatedText xml:lang="en">End Relative to Reference Time Point</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEENTPT" Name="AEENTPT" DataType="text" Length="25" SASFieldName="AEENTPT">
<Description>
<TranslatedText xml:lang="en">End Reference Time Point</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEGRPID" Name="AEGRPID" DataType="text" Length="50" SASFieldName="AEGRPID">
<Description>
<TranslatedText xml:lang="en">Group ID</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEHLGT" Name="AEHLGT" DataType="text" Length="200" SASFieldName="AEHLGT">
<Description>
<TranslatedText xml:lang="en">High Level Group Term</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEHLGTCD" Name="AEHLGTCD" DataType="text" Length="8" SASFieldName="AEHLGTCD">
<Description>
<TranslatedText xml:lang="en">High Level Group Term Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEHLT" Name="AEHLT" DataType="text" Length="200" SASFieldName="AEHLT">
<Description>
<TranslatedText xml:lang="en">High Level Term</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEHLTCD" Name="AEHLTCD" DataType="text" Length="8" SASFieldName="AEHLTCD">
<Description>
<TranslatedText xml:lang="en">High Level Term Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AELLT" Name="AELLT" DataType="text" Length="200" SASFieldName="AELLT">
<Description>
<TranslatedText xml:lang="en">Lowest Level Term</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AELLTCD" Name="AELLTCD" DataType="text" Length="8" SASFieldName="AELLTCD">
<Description>
<TranslatedText xml:lang="en">Lowest Level Term Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AELOC" Name="AELOC" DataType="text" Length="50" SASFieldName="AELOC">
<Description>
<TranslatedText xml:lang="en">Location of Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEMODIFY" Name="AEMODIFY" DataType="text" Length="200" SASFieldName="AEMODIFY">
<Description>
<TranslatedText xml:lang="en">Modified Reported Term</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AENO" Name="AENO" DataType="text" Length="200" SASFieldName="AENO">
<Description>
<TranslatedText xml:lang="en">AE Number</TranslatedText>
</Description>
<def:Origin Type="CRF" />
</ItemDef>
<ItemDef OID="IT.AE.AEOUT" Name="AEOUT" DataType="text" Length="200" SASFieldName="AEOUT">
<Description>
<TranslatedText xml:lang="en">Outcome of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEPATT" Name="AEPATT" DataType="text" Length="200" SASFieldName="AEPATT">
<Description>
<TranslatedText xml:lang="en">Pattern of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEPRESP" Name="AEPRESP" DataType="text" Length="1" SASFieldName="AEPRESP">
<Description>
<TranslatedText xml:lang="en">Pre-Specified Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEPTCD" Name="AEPTCD" DataType="text" Length="8" SASFieldName="AEPTCD">
<Description>
<TranslatedText xml:lang="en">Preferred Term Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEREFID" Name="AEREFID" DataType="text" Length="25" SASFieldName="AEREFID">
<Description>
<TranslatedText xml:lang="en">Reference ID</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AEREL" Name="AEREL" DataType="text" Length="20" SASFieldName="AEREL">
<Description>
<TranslatedText xml:lang="en">Causality</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AERELNST" Name="AERELNST" DataType="text" Length="50" SASFieldName="AERELNST">
<Description>
<TranslatedText xml:lang="en">Relationship to Non-Study Treatment</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESCAN" Name="AESCAN" DataType="text" Length="1" SASFieldName="AESCAN">
<Description>
<TranslatedText xml:lang="en">Involves Cancer</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESCAT" Name="AESCAT" DataType="text" Length="50" SASFieldName="AESCAT">
<Description>
<TranslatedText xml:lang="en">Subcategory for Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESCONG" Name="AESCONG" DataType="text" Length="1" SASFieldName="AESCONG">
<Description>
<TranslatedText xml:lang="en">Congenital Anomaly or Birth Defect</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESDISAB" Name="AESDISAB" DataType="text" Length="1" SASFieldName="AESDISAB">
<Description>
<TranslatedText xml:lang="en">Persist or Signif Disability/Incapacity</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESDTH" Name="AESDTH" DataType="text" Length="1" SASFieldName="AESDTH">
<Description>
<TranslatedText xml:lang="en">Results in Death</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESEQ" Name="AESEQ" DataType="text" Length="8" SASFieldName="AESEQ">
<Description>
<TranslatedText xml:lang="en">Sequence Number</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESER" Name="AESER" DataType="text" Length="1" SASFieldName="AESER">
<Description>
<TranslatedText xml:lang="en">Serious Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESEV" Name="AESEV" DataType="text" Length="200" SASFieldName="AESEV">
<Description>
<TranslatedText xml:lang="en">Severity/Intensity</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESHOSP" Name="AESHOSP" DataType="text" Length="1" SASFieldName="AESHOSP">
<Description>
<TranslatedText xml:lang="en">Requires or Prolongs Hospitalization</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESLIFE" Name="AESLIFE" DataType="text" Length="1" SASFieldName="AESLIFE">
<Description>
<TranslatedText xml:lang="en">Is Life Threatening</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESMIE" Name="AESMIE" DataType="text" Length="1" SASFieldName="AESMIE">
<Description>
<TranslatedText xml:lang="en">Other Medically Important Serious Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESOC" Name="AESOC" DataType="text" Length="200" SASFieldName="AESOC">
<Description>
<TranslatedText xml:lang="en">Primary System Organ Class</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESOCCD" Name="AESOCCD" DataType="text" Length="8" SASFieldName="AESOCCD">
<Description>
<TranslatedText xml:lang="en">Primary System Organ Class Code</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESOD" Name="AESOD" DataType="text" Length="1" SASFieldName="AESOD">
<Description>
<TranslatedText xml:lang="en">Occurred with Overdose</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESPID" Name="AESPID" DataType="text" Length="8" SASFieldName="AESPID">
<Description>
<TranslatedText xml:lang="en">Sponsor-Defined Identifier</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESTDTC" Name="AESTDTC" DataType="text" Length="19" SASFieldName="AESTDTC">
<Description>
<TranslatedText xml:lang="en">Start Date/Time of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AESTDY" Name="AESTDY" DataType="text" Length="8" SASFieldName="AESTDY">
<Description>
<TranslatedText xml:lang="en">Study Day of Start of Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AETERM" Name="AETERM" DataType="text" Length="200" SASFieldName="AETERM">
<Description>
<TranslatedText xml:lang="en">Reported Term for the Adverse Event</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.AETOXGR" Name="AETOXGR" DataType="text" Length="50" SASFieldName="AETOXGR">
<Description>
<TranslatedText xml:lang="en">Standard Toxicity Grade</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" SASFieldName="DOMAIN">
<Description>
<TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.EPOCH" Name="EPOCH" DataType="text" Length="50" SASFieldName="EPOCH">
<Description>
<TranslatedText xml:lang="en">Epoch</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<ItemDef OID="IT.AE.STUDYID" Name="STUDYID" DataType="text" Length="6" SASFieldName="STUDYID">
<Description>
<TranslatedText xml:lang="en">Study Identifier(ID)</TranslatedText>
</Description>
<def:Origin Type="Protocol" />
</ItemDef>
<ItemDef OID="IT.AE.USUBJID" Name="USUBJID" DataType="text" Length="20" SASFieldName="USUBJID">
<Description>
<TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
</Description>
<def:Origin Type="Derived" />
</ItemDef>
<!-- ******************************** -->
<!-- Code List Definitions Section -->
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<!-- ******************************** -->
<!-- Methods Definitions Section -->
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<!-- ******************************** -->
<!-- Comments Definitions Section -->
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<!-- ****************************************** -->
<!-- End of Metadata Definitions Section -->
<!-- ****************************************** -->
</MetaDataVersion>
</Study>
</ODM>