<?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="2009-03-31T14:01:41" CreationDateTime="2009-03-31T14:01:41"> - <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>