Date of document generation: 2020-09-22T08:17:51

Stylesheet version: 2013-04-24

Tabulation Data Definition Tables

Tabulation Datasets for Study 38166.0 (SEND-IG 3.1)
Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
TA	Trial Arms	TRIAL DESIGN	One record per planned Element per Arm	Tabulation	STUDYID, ARMCD, TAETORD	ta.xpt
TE	Trial Elements	TRIAL DESIGN	One record per planned Element	Tabulation	STUDYID, ETCD	te.xpt
TS	Trial Summary	TRIAL DESIGN	One record per trial summary parameter value	Tabulation	STUDYID, TSSEQ, TSPARMCD	ts.xpt
TX	Trial Sets	TRIAL DESIGN	One record per trial set parameter per trial set	Tabulation	STUDYID, SETCD, TXPARMCD	tx.xpt
CO	Comments	SPECIAL PURPOSE	One record per comment	Tabulation	STUDYID, COSEQ	co.xpt
DM	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	dm.xpt	See Reviewer's Guide, Demographic section
SE	Subject Elements	SPECIAL PURPOSE	One record per element experienced per subject	Tabulation	STUDYID, USUBJID, ETCD, SESTDTC	se.xpt
EX	Exposure	INTERVENTIONS	One record per constant dosing interval treatment per subject or pool	Tabulation	STUDYID, USUBJID, EXTRT, EXROUTE, EXTRTV, EXSTDTC	ex.xpt
DS	Disposition	EVENTS	One record per subject	Tabulation	STUDYID, USUBJID	ds.xpt
BG	Body Weight Gain	FINDINGS	One record per test per interval per subject	Tabulation	STUDYID, USUBJID, BGTESTCD, BGDTC, BGENDTC	bg.xpt
BW	Body Weight	FINDINGS	One record per test per observation timeper subject	Tabulation	STUDYID, USUBJID, BWTESTCD, BWDTC	bw.xpt
CL	Clinical Observations	FINDINGS	One record per finding per observation time per subject or pool	Tabulation	STUDYID, USUBJID, CLTESTCD, CLCAT, CLORRES, CLLOC, CLDTC	cl.xpt
FW	Food and Water Consumption	FINDINGS	One record per test per interval per subject or pool	Tabulation	STUDYID, USUBJID, FWTESTCD, FWDTC, FWENDTC	fw.xpt
LB	Laboratory Test Results	FINDINGS	One record per test per specimen per observation time per subject or pool	Tabulation	STUDYID, USUBJID, LBTESTCD, LBSPEC, LBDTC, LBTPTNUM	lb.xpt
MA	Macroscopic Findings	FINDINGS	One record per finding per specimen per subject	Tabulation	STUDYID, USUBJID, MATESTCD, MASTRESC, MASPEC, MAANTREG, MALAT	ma.xpt
MI	Microscopic Findings	FINDINGS	One record per finding per specimen per subject	Tabulation	STUDYID, USUBJID, MITESTCD, MISTRESC, MISPEC, MIANTREG	mi.xpt
OM	Organ Measurements	FINDINGS	One record per test per specimen per subject	Tabulation	STUDYID, USUBJID, OMTESTCD, OMSPEC, OMLAT	om.xpt
VS	Vital Signs	FINDINGS	One record per measurement per observation time per subject	Tabulation	STUDYID, USUBJID, VSTESTCD, VSDTC, VSTPTNUM	vs.xpt
RELREC	Related Records	RELATIONSHIP	One record per related record, related group of records, or related dataset	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID	relrec.xpt
SUPPMA	Supplemental Qualifiers for MA	RELATIONSHIP	One record per supplemental qualifier value per original domain record	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppma.xpt
SUPPMI	Supplemental Qualifiers for MI	RELATIONSHIP	One record per supplemental qualifier value per original domain record	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmi.xpt

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Trial Arms (TA) [Location: ta.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
ARMCD	Planned Arm Code	2	text	2		OTHER
ARM	Description of Planned Arm		text	8		OTHER
TAETORD	Order of Element within Arm	3	integer	8		OTHER
ETCD	Element Code		text	6		OTHER
ELEMENT	Description of Element		text	29		OTHER
EPOCH	Trial Epoch		text	9		OTHER

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Trial Elements (TE) [Location: te.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
ETCD	Element Code	2	text	6		OTHER
ELEMENT	Description of Element		text	29		OTHER
TESTRL	Rule for Start of Element		text	50		OTHER
TEENRL	Rule for End of Element		text	30		OTHER

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Trial Summary (TS) [Location: ts.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
TSSEQ	Sequence Number	2	integer	8		DERIVED	Sequential number identifying records within each TSPARM in the domain. Sequential number identifying records within a dataset
TSGRPID	Group Identifier		text	1		OTHER
TSPARMCD	Trial Summary Parameter Short Name	3	text	8	SEND Trial Summary Parameter Test Code	OTHER
TSPARM	Trial Summary Parameter		text	39	SEND Trial Summary Parameter Test Name	OTHER
TSVAL	Parameter Value		text	152		OTHER
TSVALNF	Parameter Null Flavor		text	14		OTHER

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Trial Sets (TX) [Location: tx.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
SETCD	Set Code	2	text	2		OTHER
SET	Set Description		text	8		OTHER
TXSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
TXPARMCD	Trial Set Parameter Short Name	3	text	8	SEND Trial Summary Parameter Test Code	OTHER
TXPARM	Trial Set Parameter		text	33	SEND Trial Summary Parameter Test Name	OTHER
TXVAL	Trial Set Parameter Value		text	29		OTHER

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Comments (CO) [Location: co.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
RDOMAIN	Related Domain Abbreviation		text	2	SEND Domain Abbreviation	DERIVED	Domain abbreviation from where data originated
USUBJID	Unique Subject Identifier		text	9		DERIVED	Concatenation of STUDYID-SUBJID
COSEQ	Sequence Number	2	integer	8		DERIVED	Sequential number identifying records within a dataset
IDVAR	Identifying Variable		text	6		DERIVED	Variable identifying the related record in RDOMAIN.
IDVARVAL	Identifying Variable Value		text	23		DERIVED	Value of IDVAR in related domain.
COREF	Comment Reference		text	7		OTHER
COVAL	Comment		text	38		OTHER
CODTC	Date/Time of Comment		datetime		ISO8601	OTHER

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Demographics (DM) [Location: dm.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
SUBJID	Subject Identifier for the Study		text	3		OTHER
RFSTDTC	Subject Reference Start Date/Time		date		ISO8601	OTHER	Animal's start date of the dosing phase
RFENDTC	Subject Reference End Date/Time		date		ISO8601	OTHER	Animal's date of death on the study. If animal did not die during the study, this is the study end date
BRTHDTC	Date/Time of Birth		date		ISO8601	OTHER
AGE	Age		integer	8		OTHER	If birth date recorded, animal's start date on the dosing phase (RFSTDTC) - Birth date +1, otherwise this is the age of the animal at the start of the study defined in the study protocol. If an age
AGEU	Age Unit		text	4		OTHER
SEX	Sex		text	1		OTHER
ARMCD	Planned Arm Code		text	2		OTHER
ARM	Description of Planned Arm		text	8		OTHER
SETCD	Set Code		text	2		OTHER

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Subject Elements (SE) [Location: se.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
SESEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
ETCD	Element Code	3	text	6		OTHER
ELEMENT	Description of Element		text	29		OTHER
SESTDTC	Start Date/Time of Element	4	date		ISO8601	OTHER
SEENDTC	End Date/Time of Element		date		ISO8601	OTHER

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Exposure (EX) [Location: ex.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
EXSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
EXTRT	Name of Actual Treatment	3	text	27		OTHER
EXDOSE	Dose per Administration		integer	8		OTHER
EXDOSU	Dose Units		text	9	Unit	OTHER
EXDOSFRM	Dose Form		text	32	["INJECTION, SUSPENSION, LIPOSOMAL"] <Pharmaceutical Dosage Form>	OTHER
EXDOSFRQ	Dosing Frequency Per Interval		text	15	["1 TIME PER WEEK"] <Frequency>	OTHER
EXROUTE	Route of Administration	4	text	13	["INTRAMUSCULAR"] <Route of Administration Response>	OTHER
EXLOT	Lot Number		text	13		OTHER
EXTRTV	Treatment Vehicle	5	text	14		OTHER
EXVAMT	Amount Administered		integer	8		OTHER
EXVAMTU	Amount Administered Units		text	2	Unit	OTHER
EXSTDTC	Start Date/Time of Treatment	6	datetime		ISO8601	OTHER
EXSTDY	Study Day of Start of Treatment		integer	8		DERIVED	Calculation: = --STDTC-RFSTDTC+1 if --STDTC is on or after RFSTDTC. Calculation = --STDTC - RFSTDTC if --STDTC precedes RFSTDTC.

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Disposition (DS) [Location: ds.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
DSSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
DSTERM	Reported Term for the Disposition Event		text	28		OTHER
DSDECOD	Standardized Disposition Term		text	18	["TERMINAL SACRIFICE"] <Standardized Disposition Term>	OTHER
DSUSCHFL	Unscheduled Flag		text	1	["Y" = "Yes"] <No Yes Response>	COLLECTED
DSSTDTC	Date/Time of Disposition		datetime		ISO8601	OTHER
DSSTDY	Study Day of Disposition		integer	8		DERIVED	Calculation: = --STDTC-RFSTDTC+1 if --STDTC is on or after RFSTDTC. Calculation = --STDTC - RFSTDTC if --STDTC precedes RFSTDTC.
DSNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
DSNOMLBL	Label for Nominal Study Day		text	6		OTHER

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Body Weight Gain (BG) [Location: bg.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
BGSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
BGTESTCD	Test Short Name	3	text	6	["BWGAIN" = "Body Weight Gain"] <Body Weight Gain Test Code>	OTHER
BGTEST	Test Name		text	16	["Body Weight Gain"] <Body Weight Gain Test Name>	OTHER
BGORRES	Result or Findings as Collected		text	5		COLLECTED
BGORRESU	Unit of the Original Result		text	1	Unit	OTHER
BGSTRESC	Standardized Result in Character Format		text	5		OTHER
BGSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
BGSTRESU	Unit of the Standardized Result		text	1	Unit	OTHER
BGDTC	Date/Time Animal Weighed	4	date		ISO8601	OTHER
BGENDTC	End Date/Time Animal Weighed	5	date		ISO8601	OTHER
BGDY	Study Day of Start of Interval		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
BGENDY	Study Day of End of Weight Interval		integer	8		DERIVED	Calculation: = --ENDTC-RFSTDTC+1 if --ENDTC is on or after RFSTDTC. Calculation = --ENDTC - RFSTDTC if --ENDTC precedes RFSTDTC.

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Body Weight (BW) [Location: bw.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
BWSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
BWTESTCD	Test Short Name	3	text	6	["BW" = "Body Weight", "TERMBW" = "Terminal Body Weight"] <Body Weight Test Code>	OTHER
BWTEST	Test Name		text	20	["Body Weight", "Terminal Body Weight"] <Body Weight Test Name>	OTHER
BWORRES	Result or Findings as Collected		text	5		COLLECTED
BWORRESU	Unit of the Original Result		text	1	Unit	OTHER
BWSTRESC	Standardized Result in Character Format		text	5		OTHER
BWSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
BWSTRESU	Unit of the Standardized Result		text	1	Unit	OTHER
BWBLFL	Baseline Flag		text	1	["Y" = "Yes"] <No Yes Response>	DERIVED	Y for last non missing record on or before the first dose date (RFSTDTC); otherwise Null
BWDTC	Date/Time Animal Weighed	4	datetime		ISO8601	OTHER
BWDY	Study Day Animal Weighed		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
BWNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
BWNOMLBL	Label for Nominal Study Day		text	6		OTHER

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Clinical Observations (CL) [Location: cl.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
CLSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
CLTESTCD	Test Short Name	3	text	8		OTHER
CLTEST	Test Name		text	28		OTHER
CLCAT	Category for Clinical Observations	4	text	14	["CLINICAL SIGNS"] <Category for Clinical Observation>	OTHER
CLSCAT	Subcategory for Clinical Observations		text	5		OTHER
CLORRES	Result or Findings as Collected	5	text	36		COLLECTED
CLSTRESC	Standardized Result in Character Format		text	31		OTHER
CLLOC	Location of a Finding	6	text	15		OTHER
CLDTC	Date/Time of Observation	7	date		ISO8601	OTHER
CLDY	Study Day of Observation		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
CLNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
CLNOMLBL	Label for Nominal Study Day		text	6		OTHER

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Food and Water Consumption (FW) [Location: fw.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
FWSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
FWTESTCD	Food/Water Consumption Short Name	3	text	2	["FC" = "Food Consumption"] <Food and Water Consumption Test Code>	OTHER
FWTEST	Food/Water Consumption Name		text	16	["Food Consumption"] <Food and Water Consumption Test Name>	OTHER
FWORRES	Result or Findings as Collected		text	5		COLLECTED
FWORRESU	Unit of the Original Result		text	1	Unit	OTHER
FWSTRESC	Standardized Result in Character Format		text	5		OTHER
FWSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
FWSTRESU	Unit of the Standardized Result		text	12	Unit	OTHER
FWDTC	Start Date/Time of Observation	4	datetime		ISO8601	OTHER
FWENDTC	End Date/Time of Observation	5	datetime		ISO8601	OTHER
FWDY	Study Day of Start of Observation		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
FWENDY	Study Day of End of Observation		integer	8		DERIVED	Calculation: = --ENDTC-RFSTDTC+1 if --ENDTC is on or after RFSTDTC. Calculation = --ENDTC - RFSTDTC if --ENDTC precedes RFSTDTC.

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Laboratory Test Results (LB) [Location: lb.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
LBSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
LBTESTCD	Lab Test or Examination Short Name	3	text	8	Laboratory Test Code	OTHER
LBTEST	Lab Test or Examination Name		text	39	Laboratory Test Name	OTHER
LBCAT	Category for Lab Test		text	31		OTHER
LBSCAT	Subcategory for Lab Test		text	17		OTHER
LBORRES	Result or Findings as Collected		text	7		COLLECTED
LBORRESU	Unit of the Original Result		text	14	Unit	OTHER
LBSTRESC	Standardized Result in Character Format		text	7		OTHER
LBSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
LBSTRESU	Unit of the Standardized Result		text	14	Unit	OTHER
LBSTAT	Completion Status		text	8	["NOT DONE"] <Not Done>	OTHER
LBREASND	Reason Not Done		text	16		OTHER
LBNAM	Laboratory Name		text	59		OTHER
LBSPEC	Specimen Material Type	4	text	11	Specimen	OTHER
LBLOC	Specimen Collection Location		text	24		OTHER
LBMETHOD	Method of Test or Examination		text	16		OTHER
LBBLFL	Baseline Flag		text	1	["Y" = "Yes"] <No Yes Response>	DERIVED	Y for last non missing record on or before the first dose date (RFSTDTC); otherwise Null
LBFAST	Fasting Status		text	1	["Y" = "Yes"] <No Yes Response>	OTHER
LBDRVFL	Derived Flag		text	1	["Y" = "Yes"] <No Yes Response>	OTHER
LBEXCLFL	Exclusion Flag		text	1	["Y" = "Yes"] <No Yes Response>	OTHER
LBREASEX	Reason for Exclusion		text	89		OTHER
LBUSCHFL	Unscheduled Flag		text	1	["Y" = "Yes"] <No Yes Response>	COLLECTED
LBDTC	Date/Time of Specimen Collection	5	datetime		ISO8601	OTHER
LBDY	Study Day of Specimen Collection		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
LBNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
LBNOMLBL	Label for Nominal Study Day		text	21		OTHER
LBTPT	Planned Time Point Name		text	9		OTHER
LBTPTNUM	Planned Time Point Number	6	integer	8		OTHER
LBELTM	Planned Elapsed Time from Time Point Ref		text	4	ISO8601	OTHER
LBTPTREF	Time Point Reference		text	23		OTHER
LBRFTDTC	Date/Time of Reference Time Point		date		ISO8601	OTHER

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Macroscopic Findings (MA) [Location: ma.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
MASEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
MATESTCD	Macroscopic Examination Short Name	3	text	8	["GROSPATH" = "Gross Pathological Examination"] <Macroscopic Findings Test Code>	OTHER
MATEST	Macroscopic Examination Name		text	30	["Gross Pathological Examination"] <Macroscopic Findings Test Name>	OTHER
MAORRES	Result or Findings as Collected		text	71		COLLECTED
MASTRESC	Standardized Result in Character Format	4	text	18		OTHER
MANAM	Laboratory Name		text	45		OTHER
MASPEC	Specimen Material Type	5	text	30	Specimen	OTHER
MAANTREG	Anatomical Region of Specimen	6	text	34		OTHER
MALAT	Specimen Laterality within Subject	7	text	10	["BILATERAL", "LEFT", "RIGHT", "UNILATERAL"] <Laterality>	OTHER
MADTC	Date/Time		date		ISO8601	OTHER
MADY	Study Day		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for MA (SUPPMA)

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Microscopic Findings (MI) [Location: mi.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
MISEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
MITESTCD	Microscopic Examination Short Name	3	text	8	["GHISTXQL" = "General Histopathologic Exam, Qual"] <SEND Microscopic Findings Test Code>	OTHER
MITEST	Microscopic Examination Name		text	34	["General Histopathologic Exam, Qual"] <SEND Microscopic Findings Test Name>	OTHER
MIORRES	Result or Findings as Collected		text	102		COLLECTED
MISTRESC	Standardized Result in Character Format	4	text	31		OTHER
MIRESCAT	Result Category		text	14	["NON-NEOPLASTIC"] <Microscopic Histopathology Result Category>	COLLECTED
MICHRON	Chronicity of Finding		text	7	["ACUTE", "CHRONIC"] <Chronicity>	COLLECTED
MIDISTR	Distribution Pattern of Finding		text	10	Distribution	COLLECTED
MISTAT	Completion Status		text	8	["NOT DONE"] <Not Done>	COLLECTED
MIREASND	Reason Not Done		text	31		COLLECTED
MISPEC	Specimen Material Type	5	text	31	Specimen	OTHER
MIANTREG	Anatomical Region of Specimen	6	text	34		OTHER
MISPCCND	Specimen Condition		text	1		COLLECTED
MISPCUFL	Specimen Usability for the Test		text	1	["N" = "No"] <No Yes Response>	COLLECTED
MILAT	Specimen Laterality within Subject		text	10	["BILATERAL", "LEFT", "RIGHT", "UNILATERAL"] <Laterality>	OTHER
MISEV	Severity		text	6	SEND Severity	COLLECTED
MIDTC	Date/Time		date		ISO8601	OTHER
MIDY	Study Day		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for MI (SUPPMI)

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Organ Measurements (OM) [Location: om.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
OMSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
OMTESTCD	Test Short Name	3	text	6	["OWBW" = "Organ to Body Weight Ratio", "WEIGHT" = "Weight"] <Organ Measurement Test Code>	OTHER
OMTEST	Test Name		text	26	["Organ to Body Weight Ratio", "Weight"] <Organ Measurement Test Name>	OTHER
OMORRES	Result or Findings as Collected		text	5		COLLECTED
OMORRESU	Unit of the Original Result		text	4	Unit	OTHER
OMSTRESC	Standardized Result in Character Format		text	5		OTHER
OMSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
OMSTRESU	Unit of the Standardized Result		text	4	Unit	OTHER
OMSTAT	Completion Status		text	8	["NOT DONE"] <Not Done>	OTHER
OMREASND	Reason Not Done		text	7		OTHER
OMSPEC	Specimen Material Type	4	text	33	Specimen	OTHER
OMLAT	Specimen Laterality within Subject	5	text	5	["BILATERAL", "LEFT", "RIGHT", "UNILATERAL"] <Laterality>	OTHER
OMDTC	Date/Time Organ Measured		datetime		ISO8601	OTHER
OMDY	Study Day of Measurement		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
OMNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
OMNOMLBL	Label for Nominal Study Day		text	6		OTHER

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Vital Signs (VS) [Location: vs.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
DOMAIN	Domain Abbreviation		text	2	SEND Domain Abbreviation	OTHER
USUBJID	Unique Subject Identifier	2	text	9		DERIVED	Concatenation of STUDYID-SUBJID
VSSEQ	Sequence Number		integer	8		DERIVED	Sequential number identifying records within a dataset
VSTESTCD	Vital Signs Test Short Name	3	text	4	["TEMP" = "Temperature"] <Vital Signs Test Code>	OTHER
VSTEST	Vital Signs Test Name		text	11	["Temperature"] <Vital Signs Test Name>	OTHER
VSORRES	Result or Findings as Collected		text	4		COLLECTED
VSORRESU	Unit of the Original Result		text	1	["C"] <Unit>	OTHER
VSSTRESC	Standardized Result in Character Format		text	4		OTHER
VSSTRESN	Standardized Result in Numeric Format		float	8		DERIVED	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
VSSTRESU	Unit of the Standardized Result		text	1	["C"] <Unit>	OTHER
VSBLFL	Baseline Flag		text	1	["Y" = "Yes"] <No Yes Response>	DERIVED	Y for last non missing record on or before the first dose date (RFSTDTC); otherwise Null
VSDTC	Date/Time of Measurement	4	datetime		ISO8601	OTHER
VSDY	Study Day of Vital Signs Measurement		integer	8		DERIVED	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
VSNOMDY	Nominal Study Day for Tabulations		integer	8		OTHER
VSNOMLBL	Label for Nominal Study Day		text	16		OTHER
VSTPT	Planned Time Point Name		text	9		OTHER
VSTPTNUM	Planned Time Point Number	5	integer	8		OTHER

Go to the top of the define.xml

Related Records (RELREC) [Location: relrec.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
RDOMAIN	Related Domain Abbreviation	2	text	2	SEND Domain Abbreviation	DERIVED	Domain abbreviation from where data originated
USUBJID	Unique Subject Identifier	3	text	9		DERIVED	Concatenation of STUDYID-SUBJID
IDVAR	Identifying Variable	4	text	5		DERIVED	Variable identifying the related record in RDOMAIN.
IDVARVAL	Identifying Variable Value	5	text	2		DERIVED	Value of IDVAR in related domain.
RELID	Relationship Identifier	6	text	3		OTHER

Go to the top of the define.xml

Supplemental Qualifiers for MA (SUPPMA) [Location: suppma.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
RDOMAIN	Related Domain Abbreviation	2	text	2	SEND Domain Abbreviation	DERIVED	Domain abbreviation from where data originated
USUBJID	Unique Subject Identifier	3	text	9		DERIVED	Concatenation of STUDYID-SUBJID
IDVAR	Identifying Variable	4	text	5		DERIVED	Variable identifying the related record in RDOMAIN.
IDVARVAL	Identifying Variable Value	5	text	2		DERIVED	Value of IDVAR in related domain.
QNAM	Qualifier Variable Name	6	text	8		OTHER
QLABEL	Qualifier Variable Label		text	16		OTHER
QVAL	Data Value		text	41		COLLECTED
QORIG	Origin		text	9		COLLECTED
QEVAL	Evaluator		text	11		OTHER
Related dataset: Macroscopic Findings (MA)

Go to the top of the define.xml

Supplemental Qualifiers for MI (SUPPMI) [Location: suppmi.xpt]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	5		OTHER
RDOMAIN	Related Domain Abbreviation	2	text	2	SEND Domain Abbreviation	DERIVED	Domain abbreviation from where data originated
USUBJID	Unique Subject Identifier	3	text	9		DERIVED	Concatenation of STUDYID-SUBJID
IDVAR	Identifying Variable	4	text	5		DERIVED	Variable identifying the related record in RDOMAIN.
IDVARVAL	Identifying Variable Value	5	text	2		DERIVED	Value of IDVAR in related domain.
QNAM	Qualifier Variable Name	6	text	8		OTHER
QLABEL	Qualifier Variable Label		text	16		OTHER
QVAL	Data Value		text	47		COLLECTED
QORIG	Origin		text	9		COLLECTED
QEVAL	Evaluator		text	11		OTHER
Related dataset: Microscopic Findings (MI)

Go to the top of the define.xml

Value Level Metadata

Value Level Metadata - BG[BGORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
BGORRES	BGTESTCD EQ BWGAIN (Body Weight Gain)	float	5.1

Value Level Metadata - BW[BWORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
BWORRES	BWTESTCD EQ BW (Body Weight)	float	5.1
BWORRES	BWTESTCD EQ TERMBW (Terminal Body Weight)	float	5.1

Value Level Metadata - FW[FWORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
FWORRES	FWTESTCD EQ FC (Food Consumption)	float	5.1

Value Level Metadata - FW[FWSTRESC]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
FWSTRESC	FWTESTCD EQ FC (Food Consumption)	float	5.2

Value Level Metadata - LB[LBORRES]
Variable	Where	Type	Length / Display Format
LBORRES	LBTESTCD EQ A1AGLP (Alpha-1 Acid Glycoprotein) AND LBSPEC EQ SERUM AND LBCAT EQ acute phase proteins AND LBMETHOD EQ ELISA	integer	7
LBORRES	LBTESTCD EQ A2MACG (Alpha-2 Macroglobulin) AND LBSPEC EQ SERUM AND LBCAT EQ acute phase proteins AND LBMETHOD EQ ELISA	integer	7
LBORRES	LBTESTCD EQ ALB (Albumin) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY	float	4.1
LBORRES	LBTESTCD EQ ALP (Alkaline Phosphatase) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	3
LBORRES	LBTESTCD EQ ALT (Alanine Aminotransferase) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	3
LBORRES	LBTESTCD EQ APTT (Activated Partial Thromboplastin Time) AND LBSPEC EQ PLASMA AND LBCAT EQ COAGULATION AND LBMETHOD EQ CHRONOMETRY	float	4.1
LBORRES	LBTESTCD EQ AST (Aspartate Aminotransferase) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	3
LBORRES	LBTESTCD EQ BACT (Bacteria) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	integer	1
LBORRES	LBTESTCD EQ BASO (Basophils) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	4.2
LBORRES	LBTESTCD EQ BASOLE (Basophils/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	3.1
LBORRES	LBTESTCD EQ BILI (Bilirubin) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	3.1
LBORRES	LBTESTCD EQ BILI (Bilirubin) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	3
LBORRES	LBTESTCD EQ CA (Calcium) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	4.2
LBORRES	LBTESTCD EQ CASTS (Casts) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	integer	1
LBORRES	LBTESTCD EQ CHOL (Cholesterol) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	4.2
LBORRES	LBTESTCD EQ CK (Creatine Kinase) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	4
LBORRES	LBTESTCD EQ CL (Chloride) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ POTENTIOMETRY	integer	3
LBORRES	LBTESTCD EQ COLOR (Color) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ VISUAL APPRAISAL	text	2
LBORRES	LBTESTCD EQ CREAT (Creatinine) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	2
LBORRES	LBTESTCD EQ CRYSTALS (Crystals) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	text	3
LBORRES	LBTESTCD EQ EOS (Eosinophils) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	4.2
LBORRES	LBTESTCD EQ EOSLE (Eosinophils/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	3.1
LBORRES	LBTESTCD EQ EPIC (Epithelial Cells) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	text	1
LBORRES	LBTESTCD EQ FIBRINO (Fibrinogen) AND LBSPEC EQ PLASMA AND LBCAT EQ COAGULATION	float	5.1
LBORRES	LBTESTCD EQ GGT (Gamma Glutamyl Transferase) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	3.1
LBORRES	LBTESTCD EQ GLOBUL (Globulin) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ by subtraction	text	1
LBORRES	LBTESTCD EQ GLUC (Glucose) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	5.2
LBORRES	LBTESTCD EQ GLUC (Glucose) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	6
LBORRES	LBTESTCD EQ HCT (Hematocrit) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ HGB (Hemoglobin) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ PHOTOMETRY	float	3.1
LBORRES	LBTESTCD EQ IFNG (Interferon Gamma) AND LBSPEC EQ SERUM AND LBCAT EQ Cytokine analysis	float	5.1
LBORRES	LBTESTCD EQ INFECTIV (Infectivity) AND LBSPEC EQ SERUM AND LBCAT EQ Pseudovirus neutralization test AND LBMETHOD EQ pVNT ASSAY	float	5.1
LBORRES	LBTESTCD EQ INTLK10 (Interleukin 10) AND LBSPEC EQ SERUM AND LBCAT EQ Cytokine analysis	float	5.1
LBORRES	LBTESTCD EQ INTLK1B (Interleukin 1 Beta) AND LBSPEC EQ SERUM AND LBCAT EQ Cytokine analysis	float	5.1
LBORRES	LBTESTCD EQ INTLK6 (Interleukin 6) AND LBSPEC EQ SERUM AND LBCAT EQ Cytokine analysis	float	4.1
LBORRES	LBTESTCD EQ K (Potassium) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ POTENTIOMETRY	float	5.2
LBORRES	LBTESTCD EQ KETONES (Ketones) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	3
LBORRES	LBTESTCD EQ LGLUCLE (Large Unstained Cells/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ LGUNSCE (Large Unstained Cells) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	4.2
LBORRES	LBTESTCD EQ LYM (Lymphocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	5.2
LBORRES	LBTESTCD EQ LYMLE (Lymphocytes/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ MCH (Ery. Mean Corpuscular Hemoglobin) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.2
LBORRES	LBTESTCD EQ MCHC (Ery. Mean Corpuscular HGB Concentration) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	5.2
LBORRES	LBTESTCD EQ MCV (Ery. Mean Corpuscular Volume) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ MONO (Monocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	4.2
LBORRES	LBTESTCD EQ MONOLE (Monocytes/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	3.1
LBORRES	LBTESTCD EQ MPV (Mean Platelet Volume) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ NEUT (Neutrophils) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	5.2
LBORRES	LBTESTCD EQ NEUTLE (Neutrophils/Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ NITRITE (Nitrite) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	3
LBORRES	LBTESTCD EQ OCCBLD (Occult Blood) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	3
LBORRES	LBTESTCD EQ PDW (Platelet Distribution Width) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	5.1
LBORRES	LBTESTCD EQ PH (pH) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ POTENTIOMETRY	float	3.1
LBORRES	LBTESTCD EQ PHOS (Phosphate) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	4.2
LBORRES	LBTESTCD EQ PLAT (Platelets) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	integer	4
LBORRES	LBTESTCD EQ PLATHCT (Platelet Hematocrit) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.2
LBORRES	LBTESTCD EQ PROT (Protein) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	integer	2
LBORRES	LBTESTCD EQ PROT (Protein) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	3
LBORRES	LBTESTCD EQ PT (Prothrombin Time) AND LBSPEC EQ PLASMA AND LBCAT EQ COAGULATION AND LBMETHOD EQ CHRONOMETRY	float	4.1
LBORRES	LBTESTCD EQ RBC (Erythrocytes) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	text	1
LBORRES	LBTESTCD EQ RBC (Erythrocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	4.2
LBORRES	LBTESTCD EQ RDW (Erythrocytes Distribution Width) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	4.1
LBORRES	LBTESTCD EQ RETI (Reticulocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	5.1
LBORRES	LBTESTCD EQ RETIRBC (Reticulocytes/Erythrocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ CALCULATION	float	3.1
LBORRES	LBTESTCD EQ SODIUM (Sodium) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ POTENTIOMETRY	integer	3
LBORRES	LBTESTCD EQ SPGRAV (Specific Gravity) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ REFRACTOMETER	float	5.3
LBORRES	LBTESTCD EQ STDUVOL (Standard Volume) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS	text	1
LBORRES	LBTESTCD EQ TNF (Tumor Necrosis Factor) AND LBSPEC EQ SERUM AND LBCAT EQ Cytokine analysis	float	5.1
LBORRES	LBTESTCD EQ TRIG (Triglycerides) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	4.2
LBORRES	LBTESTCD EQ UREA (Urea) AND LBSPEC EQ PLASMA AND LBCAT EQ CLINICAL CHEMISTRY AND LBMETHOD EQ PHOTOMETRY	float	5.2
LBORRES	LBTESTCD EQ UROBIL (Urobilinogen) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ DIPSTICK	text	6
LBORRES	LBTESTCD EQ VOLUME (Volume) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS	float	4.1
LBORRES	LBTESTCD EQ WBC (Leukocytes) AND LBSPEC EQ URINE AND LBCAT EQ URINALYSIS AND LBMETHOD EQ MICROSCOPY	text	3
LBORRES	LBTESTCD EQ WBC (Leukocytes) AND LBSPEC EQ WHOLE BLOOD AND LBCAT EQ HEMATOLOGY AND LBMETHOD EQ FLOW CYTOMETRY	float	5.2

Value Level Metadata - MI[MISTRESC]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
MISTRESC	MIRESCAT EQ NON-NEOPLASTIC	text	31

Value Level Metadata - OM[OMORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
OMORRES	OMTESTCD EQ OWBW (Organ to Body Weight Ratio)	float	6.3
OMORRES	OMTESTCD EQ WEIGHT (Weight)	float	6.3

Value Level Metadata - SUPPMA[QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ MARESMOD (Result Modifiers)	text	41

Value Level Metadata - SUPPMI[QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ MIRESMOD (Result Modifiers)	text	47

Value Level Metadata - TS[TSVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format
TSVAL	TSPARMCD EQ AGETXT (Age Text)	text	5
TSVAL	TSPARMCD EQ AGEU (Age Unit)	text	4	["DAYS"] <Age Unit>
TSVAL	TSPARMCD EQ BEDDING (Bedding)	text	82
TSVAL	TSPARMCD EQ CNTRBSC (Contributing Scientist)	text	8
TSVAL	TSPARMCD EQ DIET (Basal Diet)	text	19
TSVAL	TSPARMCD EQ DOSDUR (Dosing Duration)	text	4
TSVAL	TSPARMCD EQ DOSENDTC (End Date/Time of Dose Interval)	text	10
TSVAL	TSPARMCD EQ DOSSTDTC (Start Date/Time of Dose Interval)	text	10
TSVAL	TSPARMCD EQ ENVTEMP (Environmental Temperature)	text	5
TSVAL	TSPARMCD EQ ENVTEMPU (Environmental Temperature Units)	text	1	Unit
TSVAL	TSPARMCD EQ EXPENDTC (Experimental End Date)	text	10
TSVAL	TSPARMCD EQ EXPSTDTC (Experimental Start Date)	text	10
TSVAL	TSPARMCD EQ FEEDREG (Feeding Regimen)	text	10
TSVAL	TSPARMCD EQ GLPFL (GLP Flag)	text	1	["Y" = "Yes"] <No Yes Response>
TSVAL	TSPARMCD EQ GLPTYP (Good Laboratory Practice Type)	text	4
TSVAL	TSPARMCD EQ HOUSEGRP (Housing Group)	text	13
TSVAL	TSPARMCD EQ HOUSETYP (Housing Type)	text	30
TSVAL	TSPARMCD EQ HUMIDT (Housing Humidity)	text	5
TSVAL	TSPARMCD EQ HUMIDTU (Housing Humidity Units)	text	1	Unit
TSVAL	TSPARMCD EQ IDMETH (Method of Identification)	text	23
TSVAL	TSPARMCD EQ LIGHT (Light Cycle)	text	7
TSVAL	TSPARMCD EQ MTHTRM (Method of Termination)	text	29	["CARBON DIOXIDE EXSANGUINATION"] <Method of Termination>
TSVAL	TSPARMCD EQ PCLASS (Pharmacologic Class)	text	96
TSVAL	TSPARMCD EQ PDOSFRQ (Planned Dose Frequency)	text	15
TSVAL	TSPARMCD EQ ROUTE (Route of Administration)	text	13	["INTRAMUSCULAR"] <Route of Administration Response>
TSVAL	TSPARMCD EQ SDESIGN (Study Design)	text	8	["PARALLEL"] <Study Design>
TSVAL	TSPARMCD EQ SEXPOP (Sex of Participants)	text	4	["BOTH"] <Sex of Participants Response>
TSVAL	TSPARMCD EQ SLENGTH (Study Length)	text	4
TSVAL	TSPARMCD EQ SNDCTVER (SEND Controlled Terminology Version)	text	27
TSVAL	TSPARMCD EQ SNDIGVER (SEND Implementation Guide Version)	text	37	["SEND IMPLEMENTATION GUIDE VERSION 3.1"] <SEND Implementation Guide Version>
TSVAL	TSPARMCD EQ SPECIES (Species)	text	3	["RAT"] <Species>
TSVAL	TSPARMCD EQ SPLANSUB (Planned Number of Subjects)	integer	3
TSVAL	TSPARMCD EQ SPLRLOC (Test Subject Supplier Site)	text	40
TSVAL	TSPARMCD EQ SPLRNAM (Test Subject Supplier)	text	39
TSVAL	TSPARMCD EQ SPREFID (Sponsor's Study Reference ID)	integer	5
TSVAL	TSPARMCD EQ SRANDOM (Study Is Randomized)	text	1	["Y" = "Yes"] <No Yes Response>
TSVAL	TSPARMCD EQ SSPONSOR (Sponsoring Organization)	text	28
TSVAL	TSPARMCD EQ SSTYP (Study Type)	text	20	["REPEAT DOSE TOXICITY"] <SEND Study Type>
TSVAL	TSPARMCD EQ STCAT (Study Category)	text	3	["TOX"] <Study Category>
TSVAL	TSPARMCD EQ STDIR (Study Director)	text	18
TSVAL	TSPARMCD EQ STENDTC (Study End Date)	text	10
TSVAL	TSPARMCD EQ STITLE (Study Title)	text	152
TSVAL	TSPARMCD EQ STRAIN (Strain/Substrain)	text	10	["WISTAR HAN"] <Strain/Substrain>
TSVAL	TSPARMCD EQ STSTDTC (Study Start Date)	text	10
TSVAL	TSPARMCD EQ TFCNTRY (Test Facility Country)	text	3	["DEU"] <Country>
TSVAL	TSPARMCD EQ TOTANPCH (Total Number of Study Animals Purchased)	integer	3
TSVAL	TSPARMCD EQ TRMSAC (Time to Terminal Sacrifice)	text	4
TSVAL	TSPARMCD EQ TRT (Investigational Therapy or Treatment)	text	22
TSVAL	TSPARMCD EQ TRTCAS (Primary Treatment CAS Registry Number)	text	1
TSVAL	TSPARMCD EQ TRTUNII (Primary Treatment Unique Ingredient ID)	text	1
TSVAL	TSPARMCD EQ TRTV (Treatment Vehicle)	text	1
TSVAL	TSPARMCD EQ TSTFLOC (Test Facility Location)	text	26
TSVAL	TSPARMCD EQ TSTFNAM (Test Facility Name)	text	45
TSVAL	TSPARMCD EQ WATER (Drinking Water)	text	9
TSVAL	TSPARMCD EQ WTRDLVRY (Water Delivery)	text	10

Value Level Metadata - TX[TXVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format
TXVAL	TXPARMCD EQ ARMCD (Arm Code)	text	2
TXVAL	TXPARMCD EQ GRPLBL (Group Label)	text	29
TXVAL	TXPARMCD EQ PLANFSUB (Planned Number of Female Subjects)	integer	2
TXVAL	TXPARMCD EQ PLANMSUB (Planned Number of Male Subjects)	integer	2
TXVAL	TXPARMCD EQ SETLBL (Set Label)	text	7
TXVAL	TXPARMCD EQ SEXPOP (Sex of Participants)	text	4	["BOTH"] <Sex of Participants Response>
TXVAL	TXPARMCD EQ SPGRPCD (Sponsor-Defined Group Code)	integer	1
TXVAL	TXPARMCD EQ SPLANSUB (Planned Number of Subjects)	integer	2
TXVAL	TXPARMCD EQ TCNTRL (Control Type)	text	16
TXVAL	TXPARMCD EQ TRTDOS (Dose Level)	float	5.1
TXVAL	TXPARMCD EQ TRTDOSU (Dose Units)	text	9	Unit

Value Level Metadata - VS[VSORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
VSORRES	VSTESTCD EQ TEMP (Temperature)	float	4.1

Go to the top of the define.xml

Controlled Terms

Age Unit [CL.AGEU, C66781]
Permitted Value (Code)
DAYS [C25301]

Body Weight Gain Test Name [CL.BGTEST, C89959]
Permitted Value (Code)
Body Weight Gain [C62754]

Body Weight Gain Test Code [CL.BGTESTCD, C89960]
Permitted Value (Code)	Display Value (Decode)
BWGAIN [C62754]	Body Weight Gain

Body Weight Test Name [CL.BWTEST, C89961]
Permitted Value (Code)
Body Weight [C81328]
Terminal Body Weight [C90464]

Body Weight Test Code [CL.BWTESTCD, C89962]
Permitted Value (Code)	Display Value (Decode)
BW [C81328]	Body Weight
TERMBW [C90464]	Terminal Body Weight

Chronicity [CL.CHRNCTY, C120529]
Permitted Value (Code)
ACUTE [C14140]
CHRONIC [C14141]

Category for Clinical Observation [CL.CLCAT, C89963]
Permitted Value (Code)
CLINICAL SIGNS [C100104]

Country [CL.COUNTRY, C66786]
Permitted Value (Code)
DEU [C16636]

Study Design [CL.DESIGN, C89967]
Permitted Value (Code)
PARALLEL [C82639]

Standardized Disposition Term [CL.DSDECOD, C89968]
Permitted Value (Code)
TERMINAL SACRIFICE [C90465]

Distribution [CL.DSTRBN, C120530]
Permitted Value (Code)
DIFFUSE [C14175]
FOCAL [C28224]
MULTIFOCAL [C25253]
MULTIPLE [C17648]
SINGLE [C48440]

Frequency [CL.FREQ, C71113]
Permitted Value (Code)
1 TIME PER WEEK [C64526]

Pharmaceutical Dosage Form [CL.FRM, C66726]
Permitted Value (Code)
INJECTION, SUSPENSION, LIPOSOMAL [C42951]

Food and Water Consumption Test Name [CL.FWTEST, C89969]
Permitted Value (Code)
Food Consumption [C90384]

Food and Water Consumption Test Code [CL.FWTESTCD, C89970]
Permitted Value (Code)	Display Value (Decode)
FC [C90384]	Food Consumption

Laterality [CL.LAT, C99073]
Permitted Value (Code)
BILATERAL [C13332]
LEFT [C25229]
RIGHT [C25228]
UNILATERAL [C28012]

Laboratory Test Name [CL.LBTEST, C67154]
Permitted Value (Code)
Activated Partial Thromboplastin Time [C38462]
Alanine Aminotransferase [C64433]
Albumin [C64431]
Alkaline Phosphatase [C64432]
Alpha-1 Acid Glycoprotein [C100429]
Alpha-2 Macroglobulin [C80168]
Aspartate Aminotransferase [C64467]
Bacteria [C64469]
Basophils [C64470]
Basophils/Leukocytes [C64471]
Bilirubin [C38037]
Calcium [C64488]
Casts [C74763]
Chloride [C64495]
Cholesterol [C105586]
Color [C64546]
Creatine Kinase [C64489]
Creatinine [C64547]
Crystals [C74673]
Eosinophils [C64550]
Eosinophils/Leukocytes [C64604]
Epithelial Cells [C64605]
Ery. Mean Corpuscular HGB Concentration [C64798]
Ery. Mean Corpuscular Hemoglobin [C64797]
Ery. Mean Corpuscular Volume [C64799]
Erythrocytes [C51946]
Erythrocytes Distribution Width [C64800]
Fibrinogen [C64606]
Gamma Glutamyl Transferase [C64847]
Globulin [C74738]
Glucose [C105585]
Hematocrit [C64796]
Hemoglobin [C64848]
Infectivity [*]
Interferon Gamma [C81996]
Interleukin 1 Beta [C112323]
Interleukin 10 [C74806]
Interleukin 6 [C74834]
Ketones [C64854]
Large Unstained Cells [C74659]
Large Unstained Cells/Leukocytes [C79467]
Leukocytes [C51948]
Lymphocytes [C51949]
Lymphocytes/Leukocytes [C64820]
Mean Platelet Volume [C74730]
Monocytes [C64823]
Monocytes/Leukocytes [C64824]
Neutrophils [C63321]
Neutrophils/Leukocytes [C64827]
Nitrite [C64810]
Occult Blood [C74686]
Phosphate [C64857]
Platelet Distribution Width [C81962]
Platelet Hematocrit [C100424]
Platelets [C51951]
Potassium [C64853]
Protein [C64858]
Prothrombin Time [C62656]
Reticulocytes [C51947]
Reticulocytes/Erythrocytes [C64828]
Sodium [C64809]
Specific Gravity [C64832]
Standard Volume [*]
Triglycerides [C64812]
Tumor Necrosis Factor [C74751]
Urea [C64815]
Urobilinogen [C64816]
Volume [C74720]
pH [C45997]

* Extended Value

Laboratory Test Code [CL.LBTESTCD, C65047]
Permitted Value (Code)	Display Value (Decode)
A1AGLP [C100429]	Alpha-1 Acid Glycoprotein
A2MACG [C80168]	Alpha-2 Macroglobulin
ALB [C64431]	Albumin
ALP [C64432]	Alkaline Phosphatase
ALT [C64433]	Alanine Aminotransferase
APTT [C38462]	Activated Partial Thromboplastin Time
AST [C64467]	Aspartate Aminotransferase
BACT [C64469]	Bacteria
BASO [C64470]	Basophils
BASOLE [C64471]	Basophils/Leukocytes
BILI [C38037]	Bilirubin
CA [C64488]	Calcium
CASTS [C74763]	Casts
CHOL [C105586]	Cholesterol
CK [C64489]	Creatine Kinase
CL [C64495]	Chloride
COLOR [C64546]	Color
CREAT [C64547]	Creatinine
CRYSTALS [C74673]	Crystals
EOS [C64550]	Eosinophils
EOSLE [C64604]	Eosinophils/Leukocytes
EPIC [C64605]	Epithelial Cells
FIBRINO [C64606]	Fibrinogen
GGT [C64847]	Gamma Glutamyl Transferase
GLOBUL [C74738]	Globulin
GLUC [C105585]	Glucose
HCT [C64796]	Hematocrit
HGB [C64848]	Hemoglobin
IFNG [C81996]	Interferon Gamma
INFECTIV [*]	Infectivity
INTLK10 [C74806]	Interleukin 10
INTLK1B [C112323]	Interleukin 1 Beta
INTLK6 [C74834]	Interleukin 6
K [C64853]	Potassium
KETONES [C64854]	Ketones
LGLUCLE [C79467]	Large Unstained Cells/Leukocytes
LGUNSCE [C74659]	Large Unstained Cells
LYM [C51949]	Lymphocytes
LYMLE [C64820]	Lymphocytes/Leukocytes
MCH [C64797]	Ery. Mean Corpuscular Hemoglobin
MCHC [C64798]	Ery. Mean Corpuscular HGB Concentration
MCV [C64799]	Ery. Mean Corpuscular Volume
MONO [C64823]	Monocytes
MONOLE [C64824]	Monocytes/Leukocytes
MPV [C74730]	Mean Platelet Volume
NEUT [C63321]	Neutrophils
NEUTLE [C64827]	Neutrophils/Leukocytes
NITRITE [C64810]	Nitrite
OCCBLD [C74686]	Occult Blood
PDW [C81962]	Platelet Distribution Width
PH [C45997]	pH
PHOS [C64857]	Phosphate
PLAT [C51951]	Platelets
PLATHCT [C100424]	Platelet Hematocrit
PROT [C64858]	Protein
PT [C62656]	Prothrombin Time
RBC [C51946]	Erythrocytes
RDW [C64800]	Erythrocytes Distribution Width
RETI [C51947]	Reticulocytes
RETIRBC [C64828]	Reticulocytes/Erythrocytes
SODIUM [C64809]	Sodium
SPGRAV [C64832]	Specific Gravity
STDUVOL [*]	Standard Volume
TNF [C74751]	Tumor Necrosis Factor
TRIG [C64812]	Triglycerides
UREA [C64815]	Urea
UROBIL [C64816]	Urobilinogen
VOLUME [C74720]	Volume
WBC [C51948]	Leukocytes

* Extended Value

Macroscopic Findings Test Name [CL.MATEST, C89971]
Permitted Value (Code)
Gross Pathological Examination [C90390]

Macroscopic Findings Test Code [CL.MATESTCD, C89972]
Permitted Value (Code)	Display Value (Decode)
GROSPATH [C90390]	Gross Pathological Examination

Microscopic Histopathology Result Category [CL.MIRESCAT, C90017]
Permitted Value (Code)
NON-NEOPLASTIC [C53529]

SEND Microscopic Findings Test Name [CL.MITEST, C89973]
Permitted Value (Code)
General Histopathologic Exam, Qual [C147493]

SEND Microscopic Findings Test Code [CL.MITESTCD, C89974]
Permitted Value (Code)	Display Value (Decode)
GHISTXQL [C147493]	General Histopathologic Exam, Qual

Method of Termination [CL.MTHTRM, C89975]
Permitted Value (Code)
CARBON DIOXIDE EXSANGUINATION [C106507]

Not Done [CL.ND, C66789]
Permitted Value (Code)
NOT DONE [C49484]

No Yes Response [CL.NYN, C66742]
Permitted Value (Code)	Display Value (Decode)
N [C49487]	No

No Yes Response [CL.NY, C66742]
Permitted Value (Code)	Display Value (Decode)
Y [C49488]	Yes

Organ Measurement Test Name [CL.OMTEST, C89976]
Permitted Value (Code)
Organ to Body Weight Ratio [C90426]
Weight [C25208]

Organ Measurement Test Code [CL.OMTESTCD, C89977]
Permitted Value (Code)	Display Value (Decode)
OWBW [C90426]	Organ to Body Weight Ratio
WEIGHT [C25208]	Weight

Route of Administration Response [CL.ROUTE, C66729]
Permitted Value (Code)
INTRAMUSCULAR [C28161]

SEND Domain Abbreviation [CL.SDOMAIN, C111113]
Permitted Value (Code)	Display Value (Decode)
BG [C95083]	Body Weight Gain
BW [C95085]	Body Weight
CL [C95086]	Clinical Observations
CO [C49569]	Comments
DM [C49572]	Demographics
DS [C49576]	Disposition
EX [C49587]	Exposure
FW [C95090]	Food and Water Consumption
LB [C49592]	Laboratory Test Results
MA [C95094]	Macroscopic Findings
MI [C95095]	Microscopic Findings
OM [C49605]	Organ Measurements
RELREC [*]	Related Records
SE [C49616]	Subject Elements
SUPPMA [*]	Supplemental Qualifiers for MA
SUPPMI [*]	Supplemental Qualifiers for MI
TA [C49618]	Trial Arms
TE [C49619]	Trial Elements
TS [C53483]	Trial Summary
TX [C95103]	Trial Sets
VS [C49622]	Vital Signs

* Extended Value

SEND Severity [CL.SEV, C90000]
Permitted Value (Code)
1 OF 3 [C147499]
1 OF 4 [C147500]
1 OF 5 [C147501]
2 OF 3 [C147502]
2 OF 4 [C147503]
2 OF 5 [C147504]
3 OF 3 [C147505]
3 OF 4 [C147506]
3 OF 5 [C147507]
4 OF 4 [C147508]
4 OF 5 [C147509]
5 OF 5 [C147510]

Sex of Participants Response [CL.SEXPOP, C66732]
Permitted Value (Code)
BOTH [C49636]

SEND Implementation Guide Version [CL.SNDIGVER, C89982]
Permitted Value (Code)
SEND IMPLEMENTATION GUIDE VERSION 3.1 [C120925]

Specimen [CL.SPEC, C77529]
Permitted Value (Code)
ARTERY, AORTA [C12669]
BONE MARROW, FEMUR [C77686]
BONE, FEMUR [C12717]
BONE, FEMUR/JOINT, FEMOROTIBIAL [C135523]
BONE, STERNUM [C12793]
BRAIN [C12439]
BRAIN, BRAIN STEM [C12441]
BRAIN, CEREBELLUM [C12445]
BRAIN, CEREBRUM [C12351]
CERVIX [C12311]
EPIDIDYMIS [C12328]
ESOPHAGUS [C12389]
EYE [C12401]
GLAND, ADRENAL [C12666]
GLAND, HARDERIAN [C77619]
GLAND, LACRIMAL [C12346]
GLAND, MAMMARY [C12367]
GLAND, PARATHYROID [C12765]
GLAND, PITUITARY [C12399]
GLAND, PROSTATE [C12410]
GLAND, SALIVARY [C12426]
GLAND, SALIVARY, PAROTID [C12427]
GLAND, SALIVARY, SUBLINGUAL [C12234]
GLAND, SALIVARY, SUBMANDIBULAR [C12233]
GLAND, SEMINAL VESICLE [C12787]
GLAND, THYROID [C12400]
GLAND, THYROID/GLAND, PARATHYROID [C77667]
GUT-ASSOCIATED LYMPHOID TISSUE [C12936]
HEART [C12727]
KIDNEY [C12415]
LARGE INTESTINE, CECUM [C12381]
LARGE INTESTINE, COLON [C12382]
LARGE INTESTINE, RECTUM [C12390]
LIVER [C12392]
LUNG [C12468]
LUNG/BRONCHUS [C92218]
LYMPH NODE, CERVICAL [C32298]
LYMPH NODE, ILIAC [C32761]
LYMPH NODE, MESENTERIC [C77641]
LYMPH NODE, RENAL [C77646]
MUSCLE, SKELETAL [C13050]
NERVE, OPTIC [C12761]
NERVE, SCIATIC [C52810]
OVARY [C12404]
OVIDUCT [C12403]
PANCREAS [C12393]
PEYER'S PATCH [C12771]
PLASMA [C13356]
SERUM [C13325]
SITE, INJECTION [C77680]
SKIN [C12470]
SMALL INTESTINE, DUODENUM [C12263]
SMALL INTESTINE, ILEUM [C12387]
SMALL INTESTINE, JEJUNUM [C12388]
SPINAL CORD [C12464]
SPLEEN [C12432]
STOMACH [C12391]
STOMACH, GLANDULAR [C77661]
STOMACH, NONGLANDULAR [C77662]
TESTIS [C12412]
THYMUS [C12433]
TONGUE [C12422]
TRACHEA [C12428]
URETER [C12416]
URINARY BLADDER [C12414]
URINE [C13283]
UTERUS [C12405]
VAGINA [C12407]
WHOLE BLOOD [C41067]

Species [CL.SPECIES, C77808]
Permitted Value (Code)
RAT [C14266]

SEND Study Type [CL.SSTYP, C90003]
Permitted Value (Code)
REPEAT DOSE TOXICITY [C79376]

Study Category [CL.STCAT, C90002]
Permitted Value (Code)
TOX [C17206]

Strain/Substrain [CL.STRAIN, C77530]
Permitted Value (Code)
WISTAR HAN [C76191]

SEND Trial Summary Parameter Test Name [CL.STSPRM, C90007]
Permitted Value (Code)
Age Text [C90352]
Age Unit [C50400]
Arm Code [C83216]
Basal Diet [C90364]
Bedding [C90366]
Contributing Scientist [C132489]
Control Type [C49647]
Dose Level [C25488]
Dose Units [C73558]
Dosing Duration [C90378]
Drinking Water [C90377]
End Date/Time of Dose Interval [C90379]
Environmental Temperature [C90380]
Environmental Temperature Units [C90381]
Experimental End Date [C90382]
Experimental Start Date [C90487]
Feeding Regimen [C90383]
GLP Flag [C120944]
Good Laboratory Practice Type [C90389]
Group Label [C90391]
Housing Group [C90394]
Housing Humidity [C90395]
Housing Humidity Units [C90396]
Housing Type [C90397]
Investigational Therapy or Treatment [C41161]
Light Cycle [C90419]
Method of Identification [C90422]
Method of Termination [C90423]
Pharmacologic Class [C98768]
Planned Dose Frequency [C147513]
Planned Number of Female Subjects [C90437]
Planned Number of Male Subjects [C90438]
Planned Number of Subjects [C95106]
Primary Treatment CAS Registry Number [C92645]
Primary Treatment Unique Ingredient ID [C92646]
Route of Administration [C38114]
SEND Controlled Terminology Version [C96370]
SEND Implementation Guide Version [C90458]
Set Label [C90455]
Sex of Participants [C49696]
Species [C96433]
Sponsor's Study Reference ID [C135009]
Sponsor-Defined Group Code [C90456]
Sponsoring Organization [C129946]
Start Date/Time of Dose Interval [C90459]
Strain/Substrain [C96373]
Study Category [C90461]
Study Design [C95082]
Study Director [C129944]
Study End Date [C99156]
Study Is Randomized [C95104]
Study Length [C95105]
Study Start Date [C99157]
Study Title [C95108]
Study Type [C92644]
Test Facility Country [C90467]
Test Facility Location [C90468]
Test Facility Name [C90469]
Test Subject Supplier [C90473]
Test Subject Supplier Site [C90474]
Time to Terminal Sacrifice [C90466]
Total Number of Study Animals Purchased [C130198]
Treatment Vehicle [C927]
Water Delivery [C90486]

SEND Trial Summary Parameter Test Code [CL.STSPRMCD, C90009]
Permitted Value (Code)	Display Value (Decode)
AGETXT [C90352]	Age Text
AGEU [C50400]	Age Unit
ARMCD [C83216]	Arm Code
BEDDING [C90366]	Bedding
CNTRBSC [C132489]	Contributing Scientist
DIET [C90364]	Basal Diet
DOSDUR [C90378]	Dosing Duration
DOSENDTC [C90379]	End Date/Time of Dose Interval
DOSSTDTC [C90459]	Start Date/Time of Dose Interval
ENVTEMP [C90380]	Environmental Temperature
ENVTEMPU [C90381]	Environmental Temperature Units
EXPENDTC [C90382]	Experimental End Date
EXPSTDTC [C90487]	Experimental Start Date
FEEDREG [C90383]	Feeding Regimen
GLPFL [C120944]	GLP Flag
GLPTYP [C90389]	Good Laboratory Practice Type
GRPLBL [C90391]	Group Label
HOUSEGRP [C90394]	Housing Group
HOUSETYP [C90397]	Housing Type
HUMIDT [C90395]	Housing Humidity
HUMIDTU [C90396]	Housing Humidity Units
IDMETH [C90422]	Method of Identification
LIGHT [C90419]	Light Cycle
MTHTRM [C90423]	Method of Termination
PCLASS [C98768]	Pharmacologic Class
PDOSFRQ [C147513]	Planned Dose Frequency
PLANFSUB [C90437]	Planned Number of Female Subjects
PLANMSUB [C90438]	Planned Number of Male Subjects
ROUTE [C38114]	Route of Administration
SDESIGN [C95082]	Study Design
SETLBL [C90455]	Set Label
SEXPOP [C49696]	Sex of Participants
SLENGTH [C95105]	Study Length
SNDCTVER [C96370]	SEND Controlled Terminology Version
SNDIGVER [C90458]	SEND Implementation Guide Version
SPECIES [C96433]	Species
SPGRPCD [C90456]	Sponsor-Defined Group Code
SPLANSUB [C95106]	Planned Number of Subjects
SPLRLOC [C90474]	Test Subject Supplier Site
SPLRNAM [C90473]	Test Subject Supplier
SPREFID [C135009]	Sponsor's Study Reference ID
SRANDOM [C95104]	Study Is Randomized
SSPONSOR [C129946]	Sponsoring Organization
SSTYP [C92644]	Study Type
STCAT [C90461]	Study Category
STDIR [C129944]	Study Director
STENDTC [C99156]	Study End Date
STITLE [C95108]	Study Title
STRAIN [C96373]	Strain/Substrain
STSTDTC [C99157]	Study Start Date
TCNTRL [C49647]	Control Type
TFCNTRY [C90467]	Test Facility Country
TOTANPCH [C130198]	Total Number of Study Animals Purchased
TRMSAC [C90466]	Time to Terminal Sacrifice
TRT [C41161]	Investigational Therapy or Treatment
TRTCAS [C92645]	Primary Treatment CAS Registry Number
TRTDOS [C25488]	Dose Level
TRTDOSU [C73558]	Dose Units
TRTUNII [C92646]	Primary Treatment Unique Ingredient ID
TRTV [C927]	Treatment Vehicle
TSTFLOC [C90468]	Test Facility Location
TSTFNAM [C90469]	Test Facility Name
WATER [C90377]	Drinking Water
WTRDLVRY [C90486]	Water Delivery

Vital Signs Test Name [CL.SVSTST, C67153]
Permitted Value (Code)
Temperature [C25206]

Vital Signs Test Code [CL.SVSTSTCD, C66741]
Permitted Value (Code)	Display Value (Decode)
TEMP [C25206]	Temperature

Unit [CL.UNIT, C71620]
Permitted Value (Code)
% [C25613]
10^12/L [C67308]
10^6/L [C67452]
10^9/L [C67255]
C [C42559]
U/L [C67456]
fL [C64780]
fmol [C68854]
g [C48155]
g/L [C42576]
g/animal/day [C73714]
g/kg [C69104]
kg/L [C64566]
mL/animal/16 h [*]
mL/kg/day [C73758]
mg/L [C64572]
mg/dL [C67015]
mmol/L [C64387]
ng/L [C67327]
sec [C42535]
uL [C48153]
ug/animal [C73728]
umol/L [C48508]

* Extended Value

Unit [CL.VSRESU, C71620]
Permitted Value (Code)
C [C42559]

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Computational Algorithms

Computational Algorithms
Method	Type	Description
Algorithm to derive COMPBLFL	Computation	Y for last non missing record on or before the first dose date (RFSTDTC); otherwise Null
Algorithm to derive COMPDY	Computation	Calculation: = --DTC-RFSTDTC+1 if --DTC is on or after RFSTDTC. Calculation = --DTC - RFSTDTC if --DTC precedes RFSTDTC.
Algorithm to derive COMPENDY	Computation	Calculation: = --ENDTC-RFSTDTC+1 if --ENDTC is on or after RFSTDTC. Calculation = --ENDTC - RFSTDTC if --ENDTC precedes RFSTDTC.
Algorithm to derive COMPIDVAR	Computation	Variable identifying the related record in RDOMAIN.
Algorithm to derive COMPIDVARVAL	Computation	Value of IDVAR in related domain.
Algorithm to derive COMPRDOMAIN	Computation	Domain abbreviation from where data originated
Algorithm to derive COMPSEQ	Computation	Sequential number identifying records within a dataset
Algorithm to derive COMPSTDY	Computation	Calculation: = --STDTC-RFSTDTC+1 if --STDTC is on or after RFSTDTC. Calculation = --STDTC - RFSTDTC if --STDTC precedes RFSTDTC.
Algorithm to derive COMPSTRESN	Computation	When --STRESC contains a quantitative result, the numeric equivalent is derived in -STRESN
Algorithm to derive COMPUSUBJID	Computation	Concatenation of STUDYID-SUBJID

Go to the top of the define.xml

Comments

Comments
CommentOID	Description
COM.DM.AGE	If birth date recorded, animal's start date on the dosing phase (RFSTDTC) - Birth date +1, otherwise this is the age of the animal at the start of the study defined in the study protocol. If an age
COM.DM.RFENDTC	Animal's date of death on the study. If animal did not die during the study, this is the study end date
COM.DM.RFSTDTC	Animal's start date of the dosing phase
COM.DOMAIN.DM	See Reviewer's Guide, Demographic section
COM.TS.TSSEQ	Sequential number identifying records within each TSPARM in the domain.

Go to the top of the define.xml