<?xml version="1.0" encoding="UTF-8"?>
<ODM FileType="Snapshot" CreationDateTime="2021-05-31T15:50:37" AsOfDateTime="2021-05-31T15:44:34" FileOID="ACT-2-odm-metadata.xml" ODMVersion="1.3.1" xmlns="http://www.cdisc.org/ns/odm/v1.3" Granularity="Metadata">
	<Study OID="ACT-2">
		<GlobalVariables>
			<StudyName>ACT-2</StudyName>
			<StudyDescription>Randomised study comparing 6 cycles of chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day intervals (CHOP-14), both with or without the monoclonal anti-CD52 antibody alemtuzumab
in patients aged 61 to 80 years with 
T-cell-Lymphoma</StudyDescription>
			<ProtocolName>DSHNHL 2006-1B (ACT-2)</ProtocolName>
		</GlobalVariables>
		<BasicDefinitions>
			<MeasurementUnit OID="MU_YEARS" Name="years">
				<Symbol>
					<TranslatedText>years</TranslatedText>
				</Symbol>
			</MeasurementUnit>
			<MeasurementUnit OID="MU_MONTHS" Name="months">
				<Symbol>
					<TranslatedText>months</TranslatedText>
				</Symbol>
			</MeasurementUnit>
		</BasicDefinitions>
		<MetaDataVersion OID="1.0.0" Name="MetaDataVersion_v1.0.0">
			<Protocol>
				<StudyEventRef StudyEventOID="SE_EVENT" Mandatory="Yes"/>
			</Protocol>
			<StudyEventDef OID="SE_EVENT" Name="Event" Repeating="No" Type="Scheduled">
				<FormRef FormOID="F_FORM" Mandatory="Yes"/>
			</StudyEventDef>
			<FormDef OID="F_FORM" Name="Form" Repeating="No">
				<ItemGroupRef ItemGroupOID="G_THERAPY_ARM" Mandatory="No"/>
				<ItemGroupRef ItemGroupOID="G_DEMOGRAPHICS" Mandatory="No"/>
				<ItemGroupRef ItemGroupOID="G_OUTCOME" Mandatory="No"/>
			</FormDef>
			<ItemGroupDef OID="G_THERAPY_ARM" Name="Therapy arm" Repeating="No">
				<ItemRef ItemOID="ARMID" Mandatory="No"/>
			</ItemGroupDef>
			<ItemGroupDef OID="G_DEMOGRAPHICS" Name="Demographics" Repeating="No">
				<ItemRef ItemOID="GENDER" Mandatory="No"/>
				<ItemRef ItemOID="AGE" Mandatory="No"/>
				<ItemRef ItemOID="IPI_AGE" Mandatory="No"/>
				<ItemRef ItemOID="IPI_LDH" Mandatory="No"/>
				<ItemRef ItemOID="IPI_ECOG" Mandatory="No"/>
				<ItemRef ItemOID="IPI_STAGE" Mandatory="No"/>
				<ItemRef ItemOID="IPI_EXBM" Mandatory="No"/>
				<ItemRef ItemOID="IPI" Mandatory="No"/>
				<ItemRef ItemOID="EXBM" Mandatory="No"/>
				<ItemRef ItemOID="BULK" Mandatory="No"/>
				<ItemRef ItemOID="BSYMP" Mandatory="No"/>
				<ItemRef ItemOID="BM" Mandatory="No"/>
				<ItemRef ItemOID="REFPATHO_T_CELL" Mandatory="No"/>
			</ItemGroupDef>
			<ItemGroupDef OID="G_OUTCOME" Name="Outcome" Repeating="No">
				<ItemRef ItemOID="EFS" Mandatory="No"/>
				<ItemRef ItemOID="EFS_STAT" Mandatory="No"/>
				<ItemRef ItemOID="PFS" Mandatory="No"/>
				<ItemRef ItemOID="PFS_STAT" Mandatory="No"/>
				<ItemRef ItemOID="OS" Mandatory="No"/>
				<ItemRef ItemOID="OS_STAT" Mandatory="No"/>
			</ItemGroupDef>
			<ItemDef OID="ARMID" Name="Therapy arm" DataType="integer" Length="1" SASFieldName="ARMID" SDSVarName="ARMID">
				<Description>
					<TranslatedText>Therapy arm</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_ARMID"/>
			</ItemDef>
			<ItemDef OID="GENDER" Name="Gender" DataType="integer" Length="1" SASFieldName="GENDER" SDSVarName="SEX" Comment="MF">
				<Description>
					<TranslatedText>Gender</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_GENDER"/>
			</ItemDef>
			<ItemDef OID="AGE" Name="Age" DataType="integer" Length="2" SASFieldName="AGE" SDSVarName="AGE">
				<Description>
					<TranslatedText>Age (years)</TranslatedText>
				</Description>
				<MeasurementUnitRef MeasurementUnitOID="MU_YEARS"/>
			</ItemDef>
			<ItemDef OID="IPI_AGE" Name="IPI factor age" DataType="integer" Length="1" SASFieldName="IPI_AGE">
				<Description>
					<TranslatedText>IPI factor age&gt;60 years</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_IPI_AGE"/>
			</ItemDef>
			<ItemDef OID="IPI_LDH" Name="IPI factor LDH" DataType="integer" Length="1" SASFieldName="IPI_LDH">
				<Description>
					<TranslatedText>IPI factor LDH&gt;N</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_IPI_LDH"/>
			</ItemDef>
			<ItemDef OID="IPI_ECOG" Name="IPI factor ECOG" DataType="integer" Length="1" SASFieldName="IPI_ECOG">
				<Description>
					<TranslatedText>IPI factor ECOG&gt;1</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_IPI_ECOG"/>
			</ItemDef>
			<ItemDef OID="IPI_STAGE" Name="IPI factor stage" DataType="integer" Length="1">
				<Description>
					<TranslatedText>IPI factor stage III/IV</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_IPI_STAGE"/>
			</ItemDef>
			<ItemDef OID="IPI_EXBM" Name="IPI factor E" DataType="integer" Length="1" SASFieldName="IPI_EXBM">
				<Description>
					<TranslatedText>IPI factor extralymphatic involvement &gt; 1</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_IPI_EXBM"/>
			</ItemDef>
			<ItemDef OID="IPI" Name="IPI score" DataType="integer" Length="1" SASFieldName="IPI">
				<Description>
					<TranslatedText>IPI score</TranslatedText>
				</Description>
			</ItemDef>
			<ItemDef OID="EXBM" Name="E involvement" DataType="integer" Length="1" SASFieldName="EXBM">
				<Description>
					<TranslatedText>Extralymphatic involvement</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_EXBM"/>
			</ItemDef>
			<ItemDef OID="BULK" Name="Bulky disease" DataType="integer" Length="1" SASFieldName="BULK">
				<Description>
					<TranslatedText>Bulky disease</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_BULK"/>
			</ItemDef>
			<ItemDef OID="BSYMP" Name="B-symptoms" DataType="integer" Length="1" SASFieldName="BSYMP">
				<Description>
					<TranslatedText>B-symptoms</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_BSYMP"/>
			</ItemDef>
			<ItemDef OID="BM" Name="Bone marrow" DataType="integer" Length="1" SASFieldName="BM">
				<Description>
					<TranslatedText>Bone marrow involvement</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_BM"/>
			</ItemDef>
			<ItemDef OID="REFPATHO_T_CELL" Name="Reference pathology (T-cell trials)" DataType="integer" Length="2">
				<Description>
					<TranslatedText>Reference pathology diagnosis</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_REFPATHO_T_CELL"/>
			</ItemDef>
			<ItemDef OID="EFS" Name="EFS time" DataType="float" Length="7" SignificantDigits="4" SASFieldName="EFS">
				<Description>
					<TranslatedText>Event-free survival (months)</TranslatedText>
				</Description>
				<MeasurementUnitRef MeasurementUnitOID="MU_MONTHS"/>
			</ItemDef>
			<ItemDef OID="EFS_STAT" Name="EFS status" DataType="integer" Length="1" SASFieldName="EFS_STAT">
				<Description>
					<TranslatedText>Event-free survival status</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_EFS_STAT"/>
			</ItemDef>
			<ItemDef OID="PFS" Name="PFS time" DataType="float" Length="7" SignificantDigits="4" SASFieldName="PFS">
				<Description>
					<TranslatedText>Progression-free survival (months)</TranslatedText>
				</Description>
				<MeasurementUnitRef MeasurementUnitOID="MU_MONTHS"/>
			</ItemDef>
			<ItemDef OID="PFS_STAT" Name="PFS status" DataType="integer" Length="1" SASFieldName="PFS_STAT">
				<Description>
					<TranslatedText>Progression-free survival status</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_PFS_STAT"/>
			</ItemDef>
			<ItemDef OID="OS" Name="OS time" DataType="float" Length="7" SignificantDigits="4" SASFieldName="OS">
				<Description>
					<TranslatedText>Overall survival (months)</TranslatedText>
				</Description>
				<MeasurementUnitRef MeasurementUnitOID="MU_MONTHS"/>
			</ItemDef>
			<ItemDef OID="OS_STAT" Name="OS status" DataType="integer" Length="1" SASFieldName="OS_STAT">
				<Description>
					<TranslatedText>Overall survival status</TranslatedText>
				</Description>
				<CodeListRef CodeListOID="CL_OS_STAT"/>
			</ItemDef>
			<CodeList OID="CL_ARMID" Name="Therapy arm" DataType="integer">
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>6 x CHOP-14</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="2">
					<Decode>
						<TranslatedText>6 x A-CHOP-14</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_GENDER" Name="Gender" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>male</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>female</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_IPI_AGE" Name="IPI factor age" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>age &lt;= 60 years</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>age &gt; 60 years</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_IPI_LDH" Name="IPI factor LDH" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>LDH &lt;= N</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>LDH &gt; N</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_IPI_ECOG" Name="IPI factor ECOG" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>ECOG &lt;= 1</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>ECOG &gt; 1</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_IPI_STAGE" Name="IPI factor stage" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>stage I/ II</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>stage III/ IV</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_IPI_EXBM" Name="IPI factor E" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>E &lt;= 1</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>E &gt; 1</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_EXBM" Name="E involvement" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>no</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>yes</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_BULK" Name="Bulky disease" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>no</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>yes</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_BSYMP" Name="B-symptoms" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>no</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>yes</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_BM" Name="Bone marrow" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>no</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>yes</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_REFPATHO_T_CELL" Name="Reference pathology (T-cell trials)" DataType="integer">
				<CodeListItem CodedValue="-2">
					<Decode>
						<TranslatedText>no T-cell</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>T-cell lymphoma, specification of subtype not possible</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="2">
					<Decode>
						<TranslatedText>Peripheral T-cell lymphoma, unspecified (PTCL-NOS)</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="3">
					<Decode>
						<TranslatedText>Angioimmunoblastic T-cell lymphoma (AILT)</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="4">
					<Decode>
						<TranslatedText>Anaplastic large cell lymphoma, ALK-negative</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="5">
					<Decode>
						<TranslatedText>Extranodal NK/T-cell lymphoma,nasal type</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="6">
					<Decode>
						<TranslatedText>Enteropathy-type T-cell lymphoma</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="9">
					<Decode>
						<TranslatedText>Other T-cell</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="22">
					<Decode>
						<TranslatedText>T-zone variant</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="24">
					<Decode>
						<TranslatedText>Perifollicular variant</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="25">
					<Decode>
						<TranslatedText>Follicular variant</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_EFS_STAT" Name="EFS status" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>censored</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>event</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_PFS_STAT" Name="PFS status" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>censored</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>event</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CL_OS_STAT" Name="OS status" DataType="integer">
				<CodeListItem CodedValue="0">
					<Decode>
						<TranslatedText>censored</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue="1">
					<Decode>
						<TranslatedText>event</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
		</MetaDataVersion>
	</Study>
</ODM>