<?xml version="1.0" encoding="windows-1252" ?>
<!--
Clinical Data Interchange Standards Consortium (CDISC)
Operational Data Model (ODM) for clinical data interchange
You can learn more about CDISC standards efforts at
http://www.cdisc.org/standards/index.html
-->
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"
xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd"
ODMVersion="1.2"
FileOID="000-00-0000"
FileType="Snapshot"
Description="Adverse events from the CTChicago file"
AsOfDateTime="2005-05-18T14:01:41"
CreationDateTime="2005-05-18T14:01:41"
SourceSystem="SAS 9.1"
SourceSystemVersion="9.01.01M3D05172005">
<Study OID="STUDY.StudyOID">
<!--
GlobalVariables is a REQUIRED section in ODM markup
-->
<GlobalVariables>
<StudyName>CDISC Connect-A-Thon Test Study III</StudyName>
<StudyDescription>This file contains test data from a previous CDISC Connect-A-Thon.
</StudyDescription>
<ProtocolName>CDISC-Protocol-00-000</ProtocolName>
</GlobalVariables>
<BasicDefinitions />
<!--
Internal ODM markup required metadata
-->
<MetaDataVersion OID="v1.1.0" Name="Version 1.1.0">
<Protocol>
<StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" />
</Protocol>
<StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common">
<FormRef FormOID="FORM.AE" OrderNumber="1" Mandatory="No" />
</StudyEventDef>
<FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes">
<ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" />
</FormDef>
<!--
Columns defined in the table
-->
<ItemGroupDef OID="IG.AE" Repeating="Yes"
SASDatasetName="AE"
Name="Adverse Events"
Domain="AE"
Comment="Some adverse events from this trial">
<ItemRef ItemOID="ID.TAREA" OrderNumber="1" Mandatory="No" />
<ItemRef ItemOID="ID.PNO" OrderNumber="2" Mandatory="No" />
<ItemRef ItemOID="ID.SCTRY" OrderNumber="3" Mandatory="No" />
<ItemRef ItemOID="ID.F_STATUS" OrderNumber="4" Mandatory="No" />
<ItemRef ItemOID="ID.LINE_NO" OrderNumber="5" Mandatory="No" />
<ItemRef ItemOID="ID.AETERM" OrderNumber="6" Mandatory="No" />
<ItemRef ItemOID="ID.AESTMON" OrderNumber="7" Mandatory="No" />
<ItemRef ItemOID="ID.AESTDAY" OrderNumber="8" Mandatory="No" />
<ItemRef ItemOID="ID.AESTYR" OrderNumber="9" Mandatory="No" />
<ItemRef ItemOID="ID.AESTDT" OrderNumber="10" Mandatory="No" />
<ItemRef ItemOID="ID.AEENMON" OrderNumber="11" Mandatory="No" />
<ItemRef ItemOID="ID.AEENDAY" OrderNumber="12" Mandatory="No" />
<ItemRef ItemOID="ID.AEENYR" OrderNumber="13" Mandatory="No" />
<ItemRef ItemOID="ID.AEENDT" OrderNumber="14" Mandatory="No" />
<ItemRef ItemOID="ID.AESEV" OrderNumber="15" Mandatory="No" />
<ItemRef ItemOID="ID.AEREL" OrderNumber="16" Mandatory="No" />
<ItemRef ItemOID="ID.AEOUT" OrderNumber="17" Mandatory="No" />
<ItemRef ItemOID="ID.AEACTTRT" OrderNumber="18" Mandatory="No" />
<ItemRef ItemOID="ID.AECONTRT" OrderNumber="19" Mandatory="No" />
</ItemGroupDef>
<!--
Column attributes as defined in the table
-->
<ItemDef OID="ID.TAREA" SASFieldName="TAREA" Name="Therapeutic Area"
DataType="text" Length="4">
<CodeListRef CodeListOID="CL.$TAREAF" />
</ItemDef>
<ItemDef OID="ID.PNO" SASFieldName="PNO" Name="Protocol Number"
DataType="text" Length="15" />
<ItemDef OID="ID.SCTRY" SASFieldName="SCTRY" Name="Country"
DataType="text" Length="4">
<CodeListRef CodeListOID="CL.$SCTRYF" />
</ItemDef>
<ItemDef OID="ID.F_STATUS" SASFieldName="F_STATUS" Name="Record status,
5 levels, internal use" DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$F_STATU" />
</ItemDef>
<ItemDef OID="ID.LINE_NO" SASFieldName="LINE_NO" Name="Line Number"
DataType="integer" Length="2" />
<ItemDef OID="ID.AETERM" SASFieldName="AETERM" Name="Conmed Indication"
DataType="text" Length="100" />
<ItemDef OID="ID.AESTMON" SASFieldName="AESTMON" Name="Start Month - Enter
Two Digits 01-12" DataType="integer" Length="2" />
<ItemDef OID="ID.AESTDAY" SASFieldName="AESTDAY" Name="Start Day - Enter Two Digits 01-31"
DataType="integer" Length="2" />
<ItemDef OID="ID.AESTYR" SASFieldName="AESTYR" Name="Start Year - Enter Four Digit Year"
DataType="integer" Length="4" />
<ItemDef OID="ID.AESTDT" SASFieldName="AESTDT" Name="Derived Start Date" DataType="date" />
<ItemDef OID="ID.AEENMON" SASFieldName="AEENMON" Name="Stop Month - Enter Two Digits 01-12"
DataType="integer" Length="2" />
<ItemDef OID="ID.AEENDAY" SASFieldName="AEENDAY" Name="Stop Day - Enter Two Digits 01-31"
DataType="integer" Length="2" />
<ItemDef OID="ID.AEENYR" SASFieldName="AEENYR" Name="Stop Year - Enter Four Digit Year"
DataType="integer" Length="4" />
<ItemDef OID="ID.AEENDT" SASFieldName="AEENDT" Name="Derived Stop Date" DataType="date" />
<ItemDef OID="ID.AESEV" SASFieldName="AESEV" Name="Severity" DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$AESEV" />
</ItemDef>
<ItemDef OID="ID.AEREL" SASFieldName="AEREL" Name="Relationship to study drug"
DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$AEREL" />
</ItemDef>
<ItemDef OID="ID.AEOUT" SASFieldName="AEOUT" Name="Outcome" DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$AEOUT" />
</ItemDef>
<ItemDef OID="ID.AEACTTRT" SASFieldName="AEACTTRT" Name="Actions taken re study drug"
DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$AEACTTR" />
</ItemDef>
<ItemDef OID="ID.AECONTRT" SASFieldName="AECONTRT" Name="Actions taken, other"
DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$AECONTR" />
</ItemDef>
<!--
Translation to ODM markup for any PROC FORMAT style
user defined or SAS internal formatting specifications
applied to columns in the table
-->
<CodeList OID="CL.$TAREAF" SASFormatName="$TAREAF" Name="$TAREAF" DataType="text">
<CodeListItem CodedValue='ONC'>
<Decode>
<TranslatedText xml:lang="en">Oncology</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$SCTRYF" SASFormatName="$SCTRYF" Name="$SCTRYF" DataType="text">
<CodeListItem CodedValue='USA'>
<Decode>
<TranslatedText xml:lang="en">United States</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$F_STATU" SASFormatName="$F_STATU" Name="$F_STATU" DataType="text">
<CodeListItem CodedValue='S'>
<Decode>
<TranslatedText xml:lang="en">Source verified, not queried</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='V'>
<Decode>
<TranslatedText xml:lang="en">Source verified, queried</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$AESEV" SASFormatName="$AESEV" Name="$AESEV" DataType="text">
<CodeListItem CodedValue='1'>
<Decode>
<TranslatedText xml:lang="en">Mild</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='2'>
<Decode>
<TranslatedText xml:lang="en">Moderate</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='3'>
<Decode>
<TranslatedText xml:lang="en">Severe</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='4'>
<Decode>
<TranslatedText xml:lang="en">Life Threatening</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$AEREL" SASFormatName="$AEREL" Name="$AEREL" DataType="text">
<CodeListItem CodedValue='0'>
<Decode>
<TranslatedText xml:lang="en">None</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='1'>
<Decode>
<TranslatedText xml:lang="en">Unlikely</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='2'>
<Decode>
<TranslatedText xml:lang="en">Possible</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='3'>
<Decode>
<TranslatedText xml:lang="en">Probable</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$AEOUT" SASFormatName="$AEOUT" Name="$AEOUT" DataType="text">
<CodeListItem CodedValue='1'>
<Decode>
<TranslatedText xml:lang="en">Resolved, no residual effects</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='2'>
<Decode>
<TranslatedText xml:lang="en">Continuing</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='3'>
<Decode>
<TranslatedText xml:lang="en">Resolved, residual effects</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='4'>
<Decode>
<TranslatedText xml:lang="en">Death</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$AEACTTR" SASFormatName="$AEACTTR" Name="$AEACTTR" DataType="text">
<CodeListItem CodedValue='0'>
<Decode>
<TranslatedText xml:lang="en">None</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='1'>
<Decode>
<TranslatedText xml:lang="en">Discontinued permanently</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='2'>
<Decode>
<TranslatedText xml:lang="en">Reduced</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='3'>
<Decode>
<TranslatedText xml:lang="en">Interrupted</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.$AECONTR" SASFormatName="$AECONTR" Name="$AECONTR" DataType="text">
<CodeListItem CodedValue='0'>
<Decode>
<TranslatedText xml:lang="en">None</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='1'>
<Decode>
<TranslatedText xml:lang="en">Medication required</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='2'>
<Decode>
<TranslatedText xml:lang="en">Hospitalization required or prolonged</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue='3'>
<Decode>
<TranslatedText xml:lang="en">Other</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
</MetaDataVersion>
</Study>
<!--
Administrative metadata
-->
<AdminData />
<!--
Clinical Data : AE
Adverse Events
Some adverse events from this trial
-->
<ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0">
<SubjectData SubjectKey="001">
<StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">
<FormData FormOID="FORM.AE" FormRepeatKey="1">
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="1" />
<ItemData ItemOID="ID.AETERM" Value="HEADACHE" />
<ItemData ItemOID="ID.AESTMON" Value="06" />
<ItemData ItemOID="ID.AESTDAY" Value="10" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-10" />
<ItemData ItemOID="ID.AEENMON" Value="06" />
<ItemData ItemOID="ID.AEENDAY" Value="14" />
<ItemData ItemOID="ID.AEENYR" Value="1999" />
<ItemData ItemOID="ID.AEENDT" Value="1999-06-14" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="1" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="2" />
<ItemData ItemOID="ID.AETERM" Value="CONGESTION" />
<ItemData ItemOID="ID.AESTMON" Value="06" />
<ItemData ItemOID="ID.AESTDAY" Value="11" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-11" />
<ItemData ItemOID="ID.AEENMON" Value="" />
<ItemData ItemOID="ID.AEENDAY" Value="" />
<ItemData ItemOID="ID.AEENYR" Value="" />
<ItemData ItemOID="ID.AEENDT" Value="" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="2" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>