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CDISC_ODM_1.3.2_example.xml
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<?xml version="1.0" encoding="UTF-8"?>
<ODM FileOID="Test-Trial"
FileType="Snapshot"
Description="Test trial contaning selected CRF forms from CDISC"
CreationDateTime="2022-07-07T10:54:53+02:00"
ODMVersion="1.3.2"
Originator="JMI"
SourceSystem="Geany"
SourceSystemVersion="1.36"
xmlns:xml="http://www.w3.org/XML/1998/namespace"
xmlns="http://www.cdisc.org/ns/odm/v1.3">
<Study OID="S.0000">
<GlobalVariables>
<StudyName>Test Trial</StudyName>
<StudyDescription>Selection of CRF forms available at CDISC</StudyDescription>
<ProtocolName>Test CRF</ProtocolName>
</GlobalVariables>
<BasicDefinitions/>
<MetaDataVersion OID="MDV.0000" Name="Generic ODM" Description="Generic ODM version of CRF">
<Protocol>
<StudyEventRef StudyEventOID="SE.0000" Mandatory="Yes" OrderNumber="1"/>
<StudyEventRef StudyEventOID="SE.0001" Mandatory="Yes" OrderNumber="2"/>
<StudyEventRef StudyEventOID="SE.0002" Mandatory="Yes" OrderNumber="3"/>
</Protocol>
<StudyEventDef OID="SE.0000" Name="Screening" Repeating="No" Type="Scheduled">
<FormRef FormOID="F.0005" Mandatory="Yes" OrderNumber="1"/>
<FormRef FormOID="F.0001" Mandatory="Yes" OrderNumber="2"/>
<FormRef FormOID="F.0002" Mandatory="Yes" OrderNumber="3"/>
<FormRef FormOID="F.0004" Mandatory="Yes" OrderNumber="4"/>
<FormRef FormOID="F.0003" Mandatory="Yes" OrderNumber="5"/>
<FormRef FormOID="f.ie" Mandatory="Yes" OrderNumber="0"/>
</StudyEventDef>
<StudyEventDef OID="SE.0001" Name="Visit 1" Repeating="Yes" Type="Scheduled">
<Description>
<TranslatedText>Recurng visit</TranslatedText>
</Description>
<FormRef FormOID="F.0007" Mandatory="Yes" OrderNumber="1"/>
<FormRef FormOID="F.0006" Mandatory="Yes" OrderNumber="2"/>
</StudyEventDef>
<StudyEventDef OID="SE.0002" Name="Death" Repeating="No" Type="Unscheduled">
<FormRef FormOID="F.0000" Mandatory="Yes" OrderNumber="1"/>
<FormRef FormOID="F.0007" Mandatory="Yes" OrderNumber="2"/>
</StudyEventDef>
<FormDef OID="F.0000" Name="Death" Repeating="No">
<ItemGroupRef ItemGroupOID="IG.0000.not" Mandatory="Yes" OrderNumber="1"/>
<ItemGroupRef ItemGroupOID="IG.0000" Mandatory="Yes" OrderNumber="2"/>
<ItemGroupRef ItemGroupOID="IG.0001" Mandatory="Yes" OrderNumber="3"/>
<ItemGroupRef ItemGroupOID="IG.0002" Mandatory="Yes" OrderNumber="4"/>
</FormDef>
<FormDef OID="F.0001" Name="Background Heart Failure Maintenance Medications Part 1" Repeating="No">
<Description>
<TranslatedText>Indicate whether the listed class/type of background heart failure medication was prescribed to the subject (see the study protocol for details)</TranslatedText>
</Description>
<ItemGroupRef ItemGroupOID="IG.0003" Mandatory="Yes" OrderNumber="1"/>
</FormDef>
<FormDef OID="F.0002" Name="Background Heart Failure Maintenance Medications Part 2" Repeating="No">
<Description>
<TranslatedText>List the specific background heart failure medications used. Include all heart failure medications that are to be continued. When a subject has frequent changes in the dose and schedule for oral diuretics, the dosing information can be recorded as PRN</TranslatedText>
</Description>
<ItemGroupRef ItemGroupOID="IG.0004" Mandatory="Yes" OrderNumber="1"/>
<ItemGroupRef ItemGroupOID="IG.0005" Mandatory="Yes" OrderNumber="2"/>
</FormDef>
<FormDef OID="F.0003" Name="Body Sites of Psoriasis Involvement at Baseline" Repeating="No">
<Description>
<TranslatedText>CRF Instructions: Use one page per affected area</TranslatedText>
</Description>
<ItemGroupRef ItemGroupOID="IG.0006" Mandatory="Yes" OrderNumber="1"/>
</FormDef>
<FormDef OID="F.0004" Name="Prior Psoriasis Treatments" Repeating="No">
<ItemGroupRef ItemGroupOID="IG.0007" Mandatory="Yes" OrderNumber="1"/>
<ItemGroupRef ItemGroupOID="IG.0008" Mandatory="Yes" OrderNumber="2"/>
<ItemGroupRef ItemGroupOID="IG.0009" Mandatory="Yes" OrderNumber="3"/>
<ItemGroupRef ItemGroupOID="IG.0010" Mandatory="Yes" OrderNumber="4"/>
</FormDef>
<FormDef OID="F.0005" Name="Demographics" Repeating="No">
<ItemGroupRef ItemGroupOID="IG.0011" Mandatory="Yes" OrderNumber="1"/>
</FormDef>
<FormDef OID="F.0006" Name="ECG Test Results" Repeating="Yes">
<ItemGroupRef ItemGroupOID="IG.0012.not" Mandatory="Yes" OrderNumber="1"/>
<ItemGroupRef ItemGroupOID="IG.0012" Mandatory="Yes" OrderNumber="2"/>
<ItemGroupRef ItemGroupOID="IG.0013" Mandatory="Yes" OrderNumber="3"/>
</FormDef>
<FormDef OID="F.0007" Name="Adverse Events" Repeating="Yes">
<ItemGroupRef ItemGroupOID="IG.0014" Mandatory="Yes" OrderNumber="1"/>
<ItemGroupRef ItemGroupOID="IG.0016" Mandatory="Yes" OrderNumber="2"/>
<ItemGroupRef ItemGroupOID="IG.0017" Mandatory="Yes" OrderNumber="3"/>
</FormDef>
<ItemGroupDef OID="IG.0000" Name="Death" Repeating="No">
<ItemRef ItemOID="I.0001" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0001" Name="Death date" Repeating="No">
<ItemRef ItemOID="I.0002" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0002" Name="Death details" Repeating="No">
<ItemRef ItemOID="I.0003" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0004" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0005" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0006" Mandatory="Yes" OrderNumber="4"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0003" Name="Background Heart Failure Maintenance Medications Part 1" Repeating="No">
<ItemRef ItemOID="I.0007" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0008" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0009" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0010" Mandatory="Yes" OrderNumber="4"/>
<ItemRef ItemOID="I.0011" Mandatory="Yes" OrderNumber="5"/>
<ItemRef ItemOID="I.0012" Mandatory="Yes" OrderNumber="6"/>
<ItemRef ItemOID="I.0013" Mandatory="Yes" OrderNumber="7"/>
<ItemRef ItemOID="I.0014" Mandatory="Yes" OrderNumber="8"/>
<ItemRef ItemOID="I.0015" Mandatory="Yes" OrderNumber="9"/>
<ItemRef ItemOID="I.0016" Mandatory="Yes" OrderNumber="10"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0004" Name="Background Heart Failure Maintenance Medications Part 2" Repeating="No">
<ItemRef ItemOID="I.0017" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0018" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0019" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0020" Mandatory="Yes" OrderNumber="4"/>
<ItemRef ItemOID="I.0021" Mandatory="Yes" OrderNumber="5"/>
<ItemRef ItemOID="I.0022" Mandatory="Yes" OrderNumber="6"/>
<ItemRef ItemOID="I.0023" Mandatory="Yes" OrderNumber="7"/>
<ItemRef ItemOID="I.0024" Mandatory="Yes" OrderNumber="8"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0005" Name="Background Heart Failure Maintenance Medications Part 2 supplement" Repeating="No">
<ItemRef ItemOID="I.0025" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0026" Mandatory="Yes" OrderNumber="2"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0006" Name="Body Sites of Psoriasis Involvement at Baseline" Repeating="No">
<ItemRef ItemOID="I.0027" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0028" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0029" Mandatory="Yes" OrderNumber="3"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0007" Name="Prior Psoriasis Treatments 1" Repeating="No">
<ItemRef ItemOID="I.0030" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0031" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0032" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0021" Mandatory="Yes" OrderNumber="4"/>
<ItemRef ItemOID="I.0033" Mandatory="Yes" OrderNumber="5"/>
<ItemRef ItemOID="I.0019" Mandatory="Yes" OrderNumber="6"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0008" Name="Prior Psoriasis Treatments device" Repeating="No">
<ItemRef ItemOID="I.0034" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0009" Name="Prior Psoriasis Treatments 2" Repeating="No">
<ItemRef ItemOID="I.0035" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0036" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0024" Mandatory="Yes" OrderNumber="3"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0010" Name="Prior Psoriasis Treatments termination" Repeating="No">
<ItemRef ItemOID="I.0037" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0011" Name="Demographics" Repeating="No">
<ItemRef ItemOID="I.0038" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0039" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0040" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0041" Mandatory="Yes" OrderNumber="4"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0012" Name="ECG Test Results" Repeating="Yes">
<ItemRef ItemOID="I.0043" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0044" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0045" Mandatory="Yes" OrderNumber="3"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0013" Name="ECG Test Results supplentary" Repeating="Yes">
<ItemRef ItemOID="I.0046" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0014" Name="Event Experienced" Repeating="No">
<ItemRef ItemOID="I.0047" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0048" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0049" Mandatory="Yes" OrderNumber="3"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0016" Name="Event Details Entry" Repeating="Yes">
<ItemRef ItemOID="I.0050" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I.0051" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I.0052" Mandatory="Yes" OrderNumber="3"/>
<ItemRef ItemOID="I.0068" Mandatory="Yes" OrderNumber="4"/>
<ItemRef ItemOID="I.0053" Mandatory="Yes" OrderNumber="5"/>
<ItemRef ItemOID="I.0054" Mandatory="Yes" OrderNumber="6"/>
<ItemRef ItemOID="I.0055" Mandatory="Yes" OrderNumber="7"/>
<ItemRef ItemOID="I.0056" Mandatory="Yes" OrderNumber="8"/>
<ItemRef ItemOID="I.0057" Mandatory="Yes" OrderNumber="9"/>
<ItemRef ItemOID="I.0058" Mandatory="Yes" OrderNumber="10"/>
<ItemRef ItemOID="I.0059" Mandatory="Yes" OrderNumber="11"/>
<ItemRef ItemOID="I.0060" Mandatory="Yes" OrderNumber="12"/>
<ItemRef ItemOID="I.0061" Mandatory="Yes" OrderNumber="13"/>
<ItemRef ItemOID="I.0062" Mandatory="Yes" OrderNumber="14"/>
<ItemRef ItemOID="I.0063" Mandatory="Yes" OrderNumber="15"/>
<ItemRef ItemOID="I.0064" Mandatory="Yes" OrderNumber="16"/>
<ItemRef ItemOID="I.0065" Mandatory="Yes" OrderNumber="17"/>
<ItemRef ItemOID="I.0066" Mandatory="Yes" OrderNumber="18"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0017" Name="Event Details Entry Supplement" Repeating="Yes">
<ItemRef ItemOID="I.0067" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0012.not" Name="ECG Test Results not submitted" Repeating="Yes">
<ItemRef ItemOID="I.0042" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemGroupDef OID="IG.0000.not" Name="Death not submitted" Repeating="No">
<ItemRef ItemOID="I.0000" Mandatory="Yes" OrderNumber="1"/>
</ItemGroupDef>
<ItemDef OID="I.0000" Name="Death collected" DataType="text" Length="1" SASFieldName="DD.DDYN">
<Description>
<TranslatedText>Indicate if the death details are known. If Yes, include the appropriate details where indicated on the CRF</TranslatedText>
</Description>
<Question>
<TranslatedText>Were any death detail assessments collected?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="NOT SUBMITTED" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0001" Name="Deat collection date" DataType="date" SDSVarName="DD.DDDTC" SASFieldName="DD.DDDAT">
<Description>
<TranslatedText>Record the date of collection using this format (DD-MON-YYYY)</TranslatedText>
</Description>
<Question>
<TranslatedText>Collection Date</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0002" Name="Death date" DataType="date" SDSVarName="DD.DTHDTC" SASFieldName="DD.DTHDAT">
<Description>
<TranslatedText>Record the date of death</TranslatedText>
</Description>
<Question>
<TranslatedText>Death Date</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0003" Name="Death primary reason" DataType="text" Length="20" SDSVarName="DD.DDORRES" SASFieldName="DD.DDORRES">
<Description>
<TranslatedText>Record the primary cause of death</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the primary cause of death?</TranslatedText>
</Question>
<Alias Name="DD.DDTESTCD='DIAGPRIM', DD.DDTEST='Primary Diagnosis'" Context="SDTM"/>
<Alias Name="DD.DDTEST='Primary Diagnosis'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0004" Name="Death secondary reason" DataType="text" Length="20" SDSVarName="DD.DDORRES" SASFieldName="DD.DDORRES">
<Description>
<TranslatedText>Record the secondary cause of death, if applicable</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the secondary cause of death?</TranslatedText>
</Question>
<Alias Name="DD.DDTESTCD='DIAGSEC', DD.DDTEST='Secondary Diagnosis'" Context="SDTM"/>
<Alias Name="DD.DDTEST='Secondary Diagnosis'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0005" Name="Death location" DataType="text" Length="20" SDSVarName="DD.DDORRES" SASFieldName="DD.DDORRES">
<Description>
<TranslatedText>Record the physical location where the subject died</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the location of death?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0001"/>
<Alias Name="DD.DDTESTCD='LOCDTH', DD.DDTEST='What is the location of death'" Context="SDTM"/>
<Alias Name="DD.DDTEST='What is the location of death'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0006" Name="Death witnessed" DataType="text" Length="1" SDSVarName="DD.DDORRES" SASFieldName="DD.DDORRES">
<Description>
<TranslatedText>Indicate if the death was witnessed, using NY codelist format</TranslatedText>
</Description>
<Question>
<TranslatedText>Was the death witnessed?</TranslatedText>
</Question>
<Alias Name="DD.DDTESTCD='DTHWIT', DD.DDTEST='Was Death Witnessed'" Context="SDTM"/>
<Alias Name="DD.DDTEST='Was Death Witnessed'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0007" Name="Angiotensin-converting enzyme (ACE) inhibitors" DataType="text" Length="20" SDSVarName="CM.CMOCCUR" SASFieldName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if any ARBs were taken. If Yes, include the appropriate information in Part 2</TranslatedText>
</Description>
<Question>
<TranslatedText>Were any angiotensin-converting enzyme (ACE) inhibitors taken?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CM.CMCAT='Heart Failure Maintenance Medication', CM.CMPRESP='Y', CM.CMTRT='ARBs'" Context="SDTM"/>
<Alias Name="CM.CMCAT='Heart Failure Maintenance Medication', CM.CMPRESP='Y', CM.CMTRT='ARBs'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0008" Name="Reason not prescribing ACE inhibitors" DataType="text" Length="20" SDSVarName="CM.CMREASND">
<Description>
<TranslatedText>Indicate the reason ACE inhibitors were not prescribed. If the reason is unknown, select "Unknown."</TranslatedText>
</Description>
<Question>
<TranslatedText>If No, provide reason for not prescribing ARBs</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0002"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARBs'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0009" Name="Angiotensin receptor/neprilysin inhibitors (ARNIs)" DataType="text" Length="1" SDSVarName="CM.CMOCCUR" SASFieldName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if any ARNIs were taken. If Yes, include the appropriate information in Part 2</TranslatedText>
</Description>
<Question>
<TranslatedText>Were any angiotensin receptor/neprilysin inhibitors (ARNIs) taken?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="SDTM"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0010" Name="Reason not prescribing ARNIs" DataType="text" Length="20" SDSVarName="CM.CMREASND">
<Description>
<TranslatedText>Indicate the reason ARNIs were not prescribed. If the reason is unknown, select "Unknown."</TranslatedText>
</Description>
<Question>
<TranslatedText>If No, provide reason for not prescribing ARNIs</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0003"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0011" Name="Aldosterone antagonists" DataType="text" Length="1" SDSVarName="CM.CMOCCUR" SASFieldName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if any aldosterone antagonists were taken. If Yes, include the appropriate information in Part 2</TranslatedText>
</Description>
<Question>
<TranslatedText>Were any aldosterone antagonists taken?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Aldosterone Antagonists'" Context="SDTM"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0012" Name="Reason not prescribing aldosterone antagonists" DataType="text" Length="20" SDSVarName="CM.CMREASND">
<Description>
<TranslatedText>Indicate the reason aldosterone antagonists were not prescribed. If the reason is unknown, select "Unknown."</TranslatedText>
</Description>
<Question>
<TranslatedText>If No, provide reason for not prescribing aldosterone antagonists</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0002"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Aldosterone Antagonists'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0013" Name="Hydralazine" DataType="text" Length="1" SDSVarName="CM.CMOCCUR" SASFieldName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if any hydralazine was taken. If Yes, include the appropriate information in Part 2</TranslatedText>
</Description>
<Question>
<TranslatedText>Was any hydralazine taken?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Hydralazine'" Context="SDTM"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0014" Name="Reason not prescribing hydralazine" DataType="text" Length="20" SDSVarName="CM.CMREASND">
<Description>
<TranslatedText>Indicate the reason hydralazine was not prescribed. If the reason is unknown, select "Unknown."</TranslatedText>
</Description>
<Question>
<TranslatedText>If No, provide reason for not prescribing hydralazine</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0002"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Hydralazine'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0015" Name="Angiotensin-converting enzyme diuretics" DataType="text" Length="1" SDSVarName="CM.CMOCCUR" SASFieldName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if any diuretics were taken. If Yes, include the appropriate information in Part 2</TranslatedText>
</Description>
<Question>
<TranslatedText>Were any diuretics taken?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Diuretics'" Context="SDTM"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='ARNIs'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0016" Name="Reason not prescribing diuretics" DataType="text" Length="20" SDSVarName="CM.CMREASND">
<Description>
<TranslatedText>Indicate the reason diuretics were not prescribed. If the reason is unknown, select "Unknown."</TranslatedText>
</Description>
<Question>
<TranslatedText>If No, provide reason for not prescribing diuretics</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0002"/>
<Alias Name="CMCAT='Heart Failure Maintenance Medication', CMPRESP='Y', CMTRT='Diuretics'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0017" Name="Medication name" DataType="text" Length="20" SDSVarName="CM.CMTRT" SASFieldName="CM.CMTRT">
<Description>
<TranslatedText>Record only 1 medication per line. Provide the full trade or proprietary name of the medication; otherwise, the generic name may be recorded</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the medication name?</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0018" Name="Dose" DataType="integer" SDSVarName="CM.CMDOSE" Length="4" SASFieldName="CM.CMDOSE">
<Description>
<TranslatedText>Record the dose of concomitant medication taken per administration (e.g., 200)</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the individual dose of the medication per administration?</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0019" Name="Dose Unit" DataType="text" SDSVarName="CM.CMDOSU" Length="20" SASFieldName="CM.CMDOSU">
<Description>
<TranslatedText>Record the dose unit of the dose of concomitant medication taken (e.g., mg)</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the unit of the medication per administration?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C71620.UNIT.1"/>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0020" Name="Dose Frequency" DataType="text" Length="20" SDSVarName="CM.CMDOSFRQ" SASFieldName="CM.CMDOSFRQ">
<Description>
<TranslatedText>Record how often the concomitant medication was taken (e.g., BID, PRN)</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the frequency of the medication?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C71113.FREQ.1"/>
</ItemDef>
<ItemDef OID="I.0021" Name="Route" DataType="text" Length="20" SDSVarName="CM.CMROUTE" SASFieldName="CM.CMROUTE">
<Description>
<TranslatedText>Provide the route of administration for the concomitant medication</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the route of administration of the medication?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66729.ROUTE.1"/>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0022" Name="CM Start Date" DataType="date" SDSVarName="CM.CMSTDTC" SASFieldName="CM.CMSTDAT">
<Description>
<TranslatedText>Record the date the concomitant medication was first taken, using this format (DD-MON-YYYY)</TranslatedText>
</Description>
<Question>
<TranslatedText>Start Date</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0023" Name="Medication ongoing" DataType="text" Length="20" SDSVarName="CM.CMENRTPT" SASFieldName="CM.CMONGO">
<Description>
<TranslatedText>Record the concomitant medication as ongoing or not, to indicate whether the subject has stopped taking the concomitant medication at the time of data collection. If the concomitant medication is ongoing, leave the end date blank</TranslatedText>
</Description>
<Question>
<TranslatedText>Is the medication ongoing?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66728.STENRF"/>
</ItemDef>
<ItemDef OID="I.0024" Name="CM End Date" DataType="date" SDSVarName="CM.CMENDTC" SASFieldName="CM.CMENDAT">
<Description>
<TranslatedText>Record the date the concomitant medication was stopped, using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication, leave this field blank</TranslatedText>
</Description>
<Question>
<TranslatedText>End Date</TranslatedText>
</Question>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
<Alias Name="CM.CMCAT='ANTIPSORIATIC'" Context="CDASH"/>
</ItemDef>
<ItemDef OID="I.0025" Name="Medication given at the recommended regimen" DataType="text" Length="1" SDSVarName="SUPPCM.QVAL">
<Description>
<TranslatedText>Indicate if, in the investigator's opinion, the dose regimen was given at the recommended regimen, according to the heart failure standard-of-care guidelines referenced in the protocol</TranslatedText>
</Description>
<Question>
<TranslatedText>If applicable, was the medication given at the recommended regimen?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="SUPPCM.QNAM='CMRRGYN', SUPPCM.QLABEL='Was medication given at recom. regimen'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0026" Name="Medication not given at the recommended regimen" DataType="text" Length="20" SDSVarName="SUPPCM.QVAL">
<Description>
<TranslatedText>Provide the reason why the recommended dose regimen was not administered at the recommended regimen</TranslatedText>
</Description>
<Question>
<TranslatedText>If applicable, why was the medication not given at the recommended regimen?</TranslatedText>
</Question>
<Alias Name="SUPPCM.QVAL='CMRRGREA', SUPPCM.QLABEL='Why the medication not given at regimen'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0027" Name="Location of psoriasis lesion involvement" DataType="text" Length="20" SDSVarName="QS.QSLOC">
<Description>
<TranslatedText>Record the body location which has plaque psoriasis involvement</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the location of psoriasis lesion involvement?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C74456.LOC.1"/>
<Alias Name="QSTESTCD='LESIDENT',QSTEST='Lesion Identification'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0028" Name="Laterality of the anatomical location" DataType="text" Length="20" SDSVarName="QS.QSLAT">
<Description>
<TranslatedText>Specify the laterality of the lesion</TranslatedText>
</Description>
<Question>
<TranslatedText>If applicable, what was the laterality of the anatomical location?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C99073.LAT.1"/>
<Alias Name="QSTESTCD='LESIDENT', QSTEST='Lesion Identification'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0029" Name="Directionality of the anatomical location" DataType="text" Length="20" SDSVarName="QS.QSDIR">
<Description>
<TranslatedText>Specify the directionality of the lesion</TranslatedText>
</Description>
<Question>
<TranslatedText>If applicable, what was the directionality of the anatomical location?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C99074.DIR.1"/>
<Alias Name="QSTESTCD='LESIDENT', QSTEST='Lesion Identification'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0030" Name="Psoriasis treatments before study start" DataType="text" Length="1" SDSVarName="CM.CMOCCUR">
<Description>
<TranslatedText>Indicate if the subject had any prior psoriasis treatments. If Yes, include the appropriate details where indicated on the CRF</TranslatedText>
</Description>
<Question>
<TranslatedText>Has the subject had any psoriasis treatments before the study start?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='ANTIPSORIATIC', CMTRT='ANTIPSORIATIC', CMPRESP='Y', CMSTRF='BEFORE'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0031" Name="Treatment subcategory" DataType="text" Length="20" SDSVarName="CM.CMSCAT">
<Description>
<TranslatedText>Record the treatment subcategory</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the subcategory for the treatment?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0004"/>
<Alias Name="CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0032" Name="Treatment name" DataType="text" Length="20" SDSVarName="CM.CMTRT">
<Description>
<TranslatedText>Record only 1 treatment per line. Provide the full trade or proprietary name of the; otherwise, the generic name may be recorded</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the name of the treatment?</TranslatedText>
</Question>
<Alias Name="CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0033" Name="Dose text" DataType="text" Length="20" SDSVarName="CM.CMDOSTXT">
<Description>
<TranslatedText>Record the dose of medication per administration (e.g., 200)</TranslatedText>
</Description>
<Question>
<TranslatedText>If the treatment was systemic, what was the individual dose?</TranslatedText>
</Question>
<Alias Name="CMCAT='ANTIPSORIATIC', CMDOSE if all values of CMDOSTXT are numeric" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0034" Name="Biologic device" DataType="text" Length="20" SDSVarName="SUPPCM.QVAL">
<Description>
<TranslatedText>Record the device that was used for drug administration</TranslatedText>
</Description>
<Question>
<TranslatedText>If the medication was a biologic, what device was used for drug administration?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0005"/>
<Alias Name="SUPPCM.QNAM='SPDEVID', SUPPCM.QLABEL='Device Identifier'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0035" Name="CM Start Date long" DataType="date" SDSVarName="CM.CMSTDTC">
<Description>
<TranslatedText>Record the date the treatment was first started using this format (DD-MON-YYYY). If the subject has been taking the medication for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior treatments that are exclusionary should have both a start date and an end date</TranslatedText>
</Description>
<Question>
<TranslatedText>Start Date</TranslatedText>
</Question>
<Alias Name="CMCAT='ANTIPSORIATIC'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0036" Name="Medication ongoing YN" DataType="text" Length="20" SDSVarName="CM.CMENRTPT">
<Description>
<TranslatedText>Record the treatment as ongoing if the subject has not stopped the treatment or medication at the time of data collection; the end date should be left blank</TranslatedText>
</Description>
<Question>
<TranslatedText>Is the medication ongoing?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="CMCAT='ANTIPSORIATIC', If Yes, CMENRTPT='ONGOING'. If No, CMENRF=blank" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0037" Name="Reason for treatment discontinuation" DataType="text" Length="20" SDSVarName="SUPPCM.QVAL">
<Description>
<TranslatedText>Record the primary reason the treatment was discontinued</TranslatedText>
</Description>
<Question>
<TranslatedText>What was the reason for treatment discontinuation?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0006"/>
<Alias Name="SUPPCM.QNAM='CMRSDISC', SUPPCM.QLABEL='Reason for treatment discontinuation'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0038" Name="Date of birth" DataType="date" SDSVarName="" SASFieldName="DM.BRTHDAT">
<Description>
<TranslatedText>Partial dates are allowed</TranslatedText>
</Description>
<Question>
<TranslatedText>Birth Date</TranslatedText>
</Question>
<Alias Name="DM.BRTHDTC, Partial dates are to be recorded according to ISO 8601" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0039" Name="Sex" DataType="text" Length="1" SDSVarName="DM.SEX" SASFieldName="DM.SEX">
<Description>
<TranslatedText>Sex</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.C66731.SEX"/>
</ItemDef>
<ItemDef OID="I.0040" Name="Ethniicity" DataType="text" Length="20" SDSVarName="DM.ETHNIC" SASFieldName="DM.ETHNIC">
<Description>
<TranslatedText>Ethnic</TranslatedText>
</Description>
<Question>
<TranslatedText>Ethnicity</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66790.ETHNIC"/>
</ItemDef>
<ItemDef OID="I.0041" Name="Race" DataType="text" Length="20" SDSVarName="DM.RACE" SASFieldName="DM.RACE">
<Description>
<TranslatedText>Race</TranslatedText>
</Description>
<Question>
<TranslatedText>Race</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C74457.RACE"/>
</ItemDef>
<ItemDef OID="I.0042" Name="ECG performed" DataType="text" Length="1" SASFieldName="EG.EGPERF">
<Question>
<TranslatedText>Was the ECG performed?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="NOT SUBMITTED" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0043" Name="ECG date" DataType="date" SDSVarName="EG.EGSTDTC" SASFieldName="EG.EGDAT">
<Question>
<TranslatedText>What was the ECG date?</TranslatedText>
</Question>
<Alias Name="Date and time are to be combined into one variable according to ISO 8601" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0044" Name="ECG time" DataType="time" SDSVarName="EG.EGSTDTC" SASFieldName="EG.EGTIM">
<Question>
<TranslatedText>What was the ECG time?</TranslatedText>
</Question>
<Alias Name="Date and time are to be combined into one variable according to ISO 8601" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0045" Name="ECG result" DataType="text" Length="20" SDSVarName="EG.EGORRES" SASFieldName="EG.EGORRES">
<Question>
<TranslatedText>What was the result of the ECG?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0007"/>
</ItemDef>
<ItemDef OID="I.0046" Name="ECG clinical significant" DataType="text" Length="1" SDSVarName="SUPPEG.QVAL" SASFieldName="EG.EGCLSIG">
<Question>
<TranslatedText>Was the ECG clinically significant?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="SUPPEG.QNAM='EGCLSIG', SUPPEG.QLABEL='ECG clinically significant'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0047" Name="Any AEs" DataType="text" Length="1" SASFieldName="AE.AEYN">
<Question>
<TranslatedText>Were any adverse events experienced?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="NOT SUBMITTED" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0048" Name="AE Group ID" DataType="text" Length="20" SDSVarName="AE.AEGRPID">
<Description>
<TranslatedText>System generated</TranslatedText>
</Description>
<Question>
<TranslatedText>AE Group ID</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0049" Name="Adverse Event Term" DataType="text" Length="20" SDSVarName="AE.AETERM" SASFieldName="AE.AETERM">
<Description>
<TranslatedText>Adverse event term</TranslatedText>
</Description>
<Question>
<TranslatedText>What is the adverse event term?</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0050" Name="AE Number" DataType="integer" SDSVarName="AE.AESPID" Length="8" SASFieldName="AE.AESPID">
<Description>
<TranslatedText>System generated</TranslatedText>
</Description>
<Question>
<TranslatedText>AE Identifier</TranslatedText>
</Question>
</ItemDef>
<ItemDef OID="I.0051" Name="AE Start Date" DataType="date" SDSVarName="AE.AESTDTC" SASFieldName="AE.AESTDAT">
<Question>
<TranslatedText>What is the date the adverse event started?</TranslatedText>
</Question>
<Alias Name="Partial dates are stored according to ISO8601" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0052" Name="AE Ongoing" DataType="text" Length="20" SDSVarName="AE.AEENTPT" SASFieldName="AE.AEONGO">
<Description>
<TranslatedText>If the adverse event is NOT ongoing, collect the end date</TranslatedText>
</Description>
<Question>
<TranslatedText>Is the adverse event still ongoing?</TranslatedText>
</Question>
<Alias Name="If Yes, AE.AEENTPT=ONGOING. If No, AE.AEENTPT=BEFORE" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0053" Name="Toxicity Grade" DataType="integer" SDSVarName="AE.AETOXGR" SASFieldName="AE.AETOXGR">
<Question>
<TranslatedText>What is the toxicity grade of the adverse event?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0021"/>
</ItemDef>
<ItemDef OID="I.0054" Name="Serious" DataType="text" Length="20" SDSVarName="AE.AESER" SASFieldName="AE.AESER">
<Description>
<TranslatedText>If Yes, Answer all Seriousness Categories</TranslatedText>
</Description>
<Question>
<TranslatedText>Is the adverse event serious?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0055" Name="Congenital Anomaly or Birth Defect" DataType="text" Length="1" SDSVarName="AE.AESCONG" SASFieldName="AE.AESCONG">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Congenital Anomaly or Birth Defect</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0056" Name="Significant Disability" DataType="text" Length="1" SDSVarName="AE.AESDISAB" SASFieldName="AE.AESDISAB">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Significant Disability</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0057" Name="Death" DataType="text" Length="1" SDSVarName="AE.AESDTH" SASFieldName="AE.AESDTH">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Death</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0058" Name="Hospitalization" DataType="text" Length="1" SDSVarName="AE.AESHOSP" SASFieldName="AE.AESHOSP">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Hospitalization</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0059" Name="Life Threatening" DataType="text" Length="1" SDSVarName="AE.AESLIFE" SASFieldName="AE.AESLIFE">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Life Threatening</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0060" Name="Occurs with Overdose" DataType="text" Length="1" SDSVarName="AE.AESOD" SASFieldName="AE.AESOD">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Occurs with Overdose</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0061" Name="Other Medically Important Event" DataType="text" Length="1" SDSVarName="AE.AESMIE" SASFieldName="AE.AESMIE">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Other Medically Important Event</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0062" Name="Concomitant or Additional Treatment Given" DataType="text" Length="1" SDSVarName="AE.AECONTRT" SASFieldName="AE.AECONTRT">
<Description>
<TranslatedText>Tick all that apply</TranslatedText>
</Description>
<Question>
<TranslatedText>Concomitant or Additional Treament Given</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0063" Name="Relationship to Study Treatment" DataType="text" Length="1" SDSVarName="AE.AEREL" SASFieldName="AE.AEREL">
<Question>
<TranslatedText>Is this event related to study treatment?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
</ItemDef>
<ItemDef OID="I.0064" Name="Relationship to Non-Study Treatment" DataType="text" Length="20" SDSVarName="AE.AERELNST" SASFieldName="AE.AERELNST">
<Description>
<TranslatedText>Sponsor-defined example using a codelist for AERELNST. If more than one AERELNST value is selected, AERELNST is derived to equal ‘MULTIPLE' and individual responses may be mapped to SUPPAE</TranslatedText>
</Description>
<Question>
<TranslatedText>Relationship to Non-Study Treatment</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.0020"/>
</ItemDef>
<ItemDef OID="I.0065" Name="Outcome" DataType="text" Length="20" SDSVarName="AE.AEOUT" SASFieldName="AE.AEOUT">
<Question>
<TranslatedText>What was the outcome of this adverse event?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66768.OUT"/>
</ItemDef>
<ItemDef OID="I.0066" Name="Action Taken with Study Treatment" DataType="text" Length="20" SDSVarName="AE.AEACN" SASFieldName="AE.AEACN">
<Question>
<TranslatedText>What action was taken with study treatment?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66767.ACN"/>
</ItemDef>
<ItemDef OID="I.0067" Name="Dose Limiting Toxicity" DataType="text" Length="1" SDSVarName="SUPPAE.QVAL">
<Description>
<TranslatedText>This question should be repeated together with the previous section</TranslatedText>
</Description>
<Question>
<TranslatedText>Is this event a dose limiting toxicity?</TranslatedText>
</Question>
<CodeListRef CodeListOID="CL.C66742.NY"/>
<Alias Name="SUPPAE.QNAM=AEDLTOXF, SUPPAE.QLABEL='Dose Limiting Toxicity'" Context="SDTM"/>
</ItemDef>
<ItemDef OID="I.0068" Name="AE End Date" DataType="date" SDSVarName="AE.AEENDTC" SASFieldName="AE.AESTTIM">
<Question>
<TranslatedText>End date</TranslatedText>
</Question>
<Alias Name="Partial dates are stored according to ISO8601" Context="SDTM"/>
</ItemDef>
<CodeList OID="CL.0001" Name="Death location" DataType="text">
<CodeListItem CodedValue="HOME" OrderNumber="1">
<Decode>
<TranslatedText>Home</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="HOSPITAL" OrderNumber="2">
<Decode>
<TranslatedText>Hospital</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NURSING/REHABILITATION HOME" OrderNumber="3">
<Decode>
<TranslatedText>Nursing/Rehabilitation Home</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.0002" Name="Reason medication not prescribed" DataType="text">
<CodeListItem CodedValue="CONTRAINDICATION" OrderNumber="1">
<Decode>
<TranslatedText>Contraindication</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="TREATMENT NOT INDICATED" OrderNumber="2">
<Decode>
<TranslatedText>Treatment not indicated</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="COST" OrderNumber="3">
<Decode>
<TranslatedText>Cost</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="UNKNOWN" OrderNumber="4">
<Decode>
<TranslatedText>Unknown</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.0003" Name="Reason medication not prescribed long" DataType="text">
<CodeListItem CodedValue="CONTRAINDICATION" OrderNumber="1">
<Decode>
<TranslatedText>Contraindication</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="TREATMENT NOT INDICATED" OrderNumber="2">
<Decode>
<TranslatedText>Treatment not indicated</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="COST" OrderNumber="3">
<Decode>
<TranslatedText>Cost</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="UNKNOWN" OrderNumber="4">
<Decode>
<TranslatedText>Unknown</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="COST2" OrderNumber="5">
<Decode>
<TranslatedText>Cost 2</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="UNKNOWN2" OrderNumber="6">
<Decode>
<TranslatedText>Unknown 2</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.C66728.STENRF" Name="Relation to Reference Period" DataType="text">
<Description>
<TranslatedText>The relative relationship of a timepoint to a reference timepoint</TranslatedText>
</Description>
<EnumeratedItem CodedValue="AFTER" OrderNumber="1">
<Alias Name="C38008" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="BEFORE" OrderNumber="2">
<Alias Name="C25629" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="COINCIDENT" OrderNumber="3">
<Alias Name="C25456" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="DURING" OrderNumber="4">
<Alias Name="C25490" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="DURING/AFTER" OrderNumber="5">
<Alias Name="C49640" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="ONGOING" OrderNumber="6">
<Alias Name="C53279" Context="nci:ExtCodeID"/>
</EnumeratedItem>
<EnumeratedItem CodedValue="UNKNOWN" OrderNumber="7">
<Alias Name="C17998" Context="nci:ExtCodeID"/>
</EnumeratedItem>
</CodeList>
<CodeList OID="CL.C66742.NY" Name="No Yes Response" DataType="text">
<Description>
<TranslatedText>A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable</TranslatedText>
</Description>
<CodeListItem CodedValue="N" OrderNumber="1">
<Decode>
<TranslatedText>No</TranslatedText>
</Decode>
<Alias Name="C49487" Context="nci:ExtCodeID"/>
</CodeListItem>
<CodeListItem CodedValue="Y" OrderNumber="2">
<Decode>
<TranslatedText>Yes</TranslatedText>
</Decode>
<Alias Name="C49488" Context="nci:ExtCodeID"/>
</CodeListItem>
</CodeList>
<CodeList OID="CL.0004" Name="Treatment subcategory" DataType="text">
<CodeListItem CodedValue="BIOLOGIC" OrderNumber="1">
<Decode>
<TranslatedText>Biologic</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NON-BIOLOGIC" OrderNumber="2">
<Decode>
<TranslatedText>Non-Biologic</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="PHOTOTHERAPY" OrderNumber="3">
<Decode>
<TranslatedText>Phototherapy</TranslatedText>
</Decode>
<Alias Name="C15301" Context="nci:ExtCodeID"/>
</CodeListItem>
</CodeList>
<CodeList OID="CL.0005" Name="Biologic device" DataType="text">
<CodeListItem CodedValue="SINGLE-DOSE PEN" OrderNumber="1">
<Decode>
<TranslatedText>Single-dose pen</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="MULTIPLE-DOSE PEN" OrderNumber="2">
<Decode>
<TranslatedText>Multiple-dose pen</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="PRE-FILLED SYRINGE" OrderNumber="3">
<Decode>
<TranslatedText>Pre-filled syringe</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="SYRINGE" OrderNumber="4">
<Decode>
<TranslatedText>Syringe</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NOT APPLICABLE" OrderNumber="5">
<Decode>
<TranslatedText>Not Applicable</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.0006" Name="Treatment discontinuation" DataType="text">
<CodeListItem CodedValue="INADEQUATE EFFICACY" OrderNumber="1">
<Decode>
<TranslatedText>Inadequate efficiacy</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="ADVERSE EVENT" OrderNumber="2">
<Decode>
<TranslatedText>Adverse event</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="OTHER-NOT RELATED TO EFFICACY/ADVERSE EVENTS" OrderNumber="3">
<Decode>
<TranslatedText>Other-not related to efficacy/adverse event</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>
<CodeList OID="CL.C66731.SEX" Name="Sex" DataType="text">
<Description>
<TranslatedText>The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI)</TranslatedText>
</Description>
<CodeListItem CodedValue="F" OrderNumber="1">
<Decode>
<TranslatedText>Female</TranslatedText>
</Decode>
<Alias Name="C16576" Context="nci:ExtCodeID"/>
</CodeListItem>
<CodeListItem CodedValue="M" OrderNumber="2">
<Decode>
<TranslatedText>Male</TranslatedText>
</Decode>