Date of document generation: 2021-01-19T10:46:38

Stylesheet version: 2013-04-24


Tabulation Data Definition Tables

Tabulation Datasets for Study 20GR142 (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, TSPARMCD, TSSEQ 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
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 per treatment per subject or pool Tabulation STUDYID, USUBJID, EXTRT, EXSTDTC ex.xpt
DS Disposition EVENTS One record per subject Tabulation STUDYID, USUBJID ds.xpt
BG Body Weight Gains FINDINGS One record per test per interval per subject Tabulation STUDYID, USUBJID, BGTESTCD, BGDTC, BGENDTC bg.xpt
BW Body Weights FINDINGS One record per test per observation time per 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, POOLID, FWTESTCD, FWDTC, FWENDTC fw.xpt
LB Laboratory 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, MAORRES, MASPEC, MAANTREG 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 om.xpt
VS Vital Signs FINDINGS One record per measurement per observation time per subject Tabulation STUDYID, USUBJID, VSTESTCD vs.xpt
POOLDEF Pool Definition RELATIONSHIP One record per subject per pool Tabulation STUDYID, USUBJID, POOLID pooldef.xpt
RELREC Related Records RELATIONSHIP One record per related record, related group of records (e.g.,--GRPID), or related dataset Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID relrec.xpt
SUPPBG Supplemental Body Weight Gain RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppbg.xpt
SUPPBW Supplemental Body Weight RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppbw.xpt
SUPPCL Supplemental Clinical Observations RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppcl.xpt
SUPPDS Supplemental Disposition RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppds.xpt
SUPPFW Supplemental Food and Water RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppfw.xpt
SUPPLB Supplemental Laboratory Test RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM supplb.xpt
SUPPMA Supplemental Qualifiers for Gross RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppma.xpt
SUPPMI Supplemental Qualifiers for Micro RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppmi.xpt
SUPPVS Supplemental Vital Signs RELATIONSHIP One record per IDVAR, IDVARVAL, and QNAM value per subject Tabulation STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM suppvs.xpt

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Trial Arms (TA) [Location: ta.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
DOMAIN Domain Abbreviation text 2 ["TA"]

<SEND Domain Abbreviation>

 OTHER
ARMCD Planned Arm Code 2 text 2 OTHER
ARM Description of Planned Arm text 17 OTHER
TAETORD Order of Element within Arm 3 integer 8 OTHER
ETCD Element Code text 5 OTHER
ELEMENT Description of Element text 22 OTHER
EPOCH Trial Epoch text 8 OTHER

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Trial Elements (TE) [Location: te.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
DOMAIN Domain Abbreviation text 2 ["TE"]

<SEND Domain Abbreviation>

 OTHER
ETCD Element Code 2 text 5 OTHER
ELEMENT Description of Element text 22 OTHER
TESTRL Rule for Start of Element text 35 OTHER
TEENRL Rule for End of Element text 19 OTHER
TEDUR Planned Duration of Element durationDatetime ISO8601 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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["TS"]

<SEND Domain Abbreviation>

 OTHER
TSSEQ Sequence Number 3 integer 8 OTHER
TSGRPID Group Identifier text 1 OTHER
TSPARMCD Trial Summary Parameter Short Name 2 text 8 SEND Trial Summary Parameter Test Code OTHER
TSPARM Trial Summary Parameter text 38 SEND Trial Summary Parameter Test Name OTHER
TSVAL Parameter Value text 77 OTHER
TSVALNF Parameter Null Flavor text 7 ["UNKNOWN"]

<Null Flavor Reason>

 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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["TX"]

<SEND Domain Abbreviation>

 OTHER
SETCD Set Code 2 text 2 OTHER
SET Set Description text 26 OTHER
TXSEQ Sequence Number integer 8 OTHER
TXPARMCD Trial Set Parameter Short Name 3 text 7 SEND Trial Summary Parameter Test Code OTHER
TXPARM Trial Set Parameter text 26 SEND Trial Summary Parameter Test Name OTHER
TXVAL Trial Set Parameter Value text 24 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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["CO"]

<SEND Domain Abbreviation>

 OTHER
RDOMAIN Related Domain Abbreviation text 2 OTHER
USUBJID Unique Subject Identifier text 11 OTHER
COSEQ Sequence Number 2 integer 8 OTHER
IDVAR Identifying Variable text 7 OTHER
IDVARVAL Identifying Variable Value text 7 OTHER
COVAL Comment text 124 COLLECTED
CODTC Date/Time of Comment datetime ISO8601 COLLECTED

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["DM"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
SUBJID Subject Identifier for the Study text 3 OTHER
RFSTDTC Subject Reference Start Date/Time datetime ISO8601 COLLECTED
RFENDTC Subject Reference End Date/Time datetime ISO8601 COLLECTED
RFXSTDTC Date/Time of First Study Treatment datetime ISO8601 COLLECTED
RFXENDTC Date/Time of Last Study Treatment datetime ISO8601 COLLECTED
BRTHDTC Date/Time of Birth datetime ISO8601 COLLECTED
AGE Age integer 8 DERIVED
Subject Reference Start/Time – Date of Birth and convert it based on Age units.
AGEU Age Unit text 4 ["DAYS"]

<Age Unit>

 OTHER
SEX Sex text 1 ["F", "M"]

<Sex>

 OTHER
ARMCD Planned Arm Code text 2 OTHER
ARM Description of Planned Arm text 17 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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["SE"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
SESEQ Sequence Number integer 8 OTHER
ETCD Element Code 3 text 5 OTHER
ELEMENT Description of Element text 22 OTHER
SESTDTC Start Date/Time of Element 4 datetime ISO8601 COLLECTED
SEENDTC End Date/Time of Element datetime ISO8601 COLLECTED

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["EX"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
FOCID Focus of Study-Specific Interest text 16 OTHER
EXSEQ Sequence Number integer 8 OTHER
EXTRT Name of Actual Treatment 3 text 12 OTHER
EXDOSE Dose per Administration float 8 COLLECTED
EXDOSU Dose Units text 2 ["ug"]

<Unit>

 OTHER
EXDOSFRM Dose Form text 10 ["SUSPENSION"]

<Pharmaceutical Dosage Form>

 OTHER
EXDOSFRQ Dosing Frequency Per Interval text 2 ["QD"]

<Frequency>

 OTHER
EXROUTE Route of Administration text 13 ["INTRAMUSCULAR"]

<Route of Administration Response>

 OTHER
EXLOT Lot Number text 13 OTHER
EXLOC Location of Dose Administration text 17 OTHER
EXTRTV Treatment Vehicle text 29 OTHER
EXVAMT Amount Administered float 8 COLLECTED
EXVAMTU Amount Administered Units text 2 ["uL"]

<Unit>

 OTHER
EXSTDTC Start Date/Time of Treatment 4 datetime ISO8601 COLLECTED
EXSTDY Study Day of Start of Treatment integer 8 DERIVED
"--STDTC minus RFSTDTC plus 1 if --STDTC is on or after RFSTDTC. --STDTC minus RFSTDTC if --STDTC precedes RFSTDTC."
EXTPT Planned Time Point Name text 21 OTHER
EXTPTNUM Planned Time Point Number integer 8 OTHER

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["DS"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
DSSEQ Sequence Number integer 8 OTHER
DSTERM Reported Term for the Disposition Event text 21 COLLECTED
DSDECOD Standardized Disposition Term text 18 ["RECOVERY SACRIFICE", "TERMINAL SACRIFICE"]

<Standardized Disposition Term>

 COLLECTED
DSUSCHFL Unscheduled Flag text 1 OTHER
VISITDY Planned Study Day of Disposition integer 8 DERIVED
Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
DSSTDTC Date/Time of Disposition datetime ISO8601 COLLECTED
DSSTDY Study Day of Disposition integer 8 DERIVED
"--STDTC minus RFSTDTC plus 1 if --STDTC is on or after RFSTDTC. --STDTC minus RFSTDTC if --STDTC precedes RFSTDTC."
DSNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
Related dataset: Supplemental Disposition (SUPPDS)

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Body Weight Gains (BG) [Location: bg.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
DOMAIN Domain Abbreviation text 2 ["BG"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
BGSEQ Sequence Number integer 8 OTHER
BGTESTCD Test Short Name 3 text 6 ["BWGAIN"]

<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 DERIVED
Body Weight at the end interval minus body weight at the start interval.
BGORRESU Unit of the Original Result text 1 ["g"]

<Unit>

 OTHER
BGSTRESC Standardized Result in Character Format text 5 DERIVED
Body Weight at the end interval minus body weight at the start interval.
BGSTRESN Standardized Result in Numeric Format float 8 DERIVED
Body Weight at the end interval minus body weight at the start interval.
BGSTRESU Unit of the Standardized Result text 1 ["g"]

<Unit>

 OTHER
BGDTC Date/Time Animal Weighed 4 datetime ISO8601 COLLECTED
BGENDTC End Date/Time Animal Weighed 5 datetime ISO8601 COLLECTED
BGDY Study Day of Start of Interval integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
BGENDY Study Day of End of Weight Interval integer 8 DERIVED
"--ENDTC minus RFSTDTC plus 1 if --ENDTC is on or after RFSTDTC. --ENDTC minus RFSTDTC if --ENDTC precedes RFSTDTC."
Related dataset: Supplemental Body Weight Gain (SUPPBG)

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Body Weights (BW) [Location: bw.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
DOMAIN Domain Abbreviation text 2 ["BW"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
BWSEQ Sequence Number integer 8 OTHER
BWTESTCD Test Short Name 3 text 6 ["BW", "TERMBW"]

<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 6 COLLECTED
BWORRESU Unit of the Original Result text 1 ["g"]

<Unit>

 OTHER
BWSTRESC Standardized Result in Character Format text 6 COLLECTED
BWSTRESN Standardized Result in Numeric Format float 8 COLLECTED
BWSTRESU Unit of the Standardized Result text 1 ["g"]

<Unit>

 OTHER
BWBLFL Baseline Flag text 1 OTHER
VISITDY Planned Study Day of Collection integer 8 DERIVED
Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
BWDTC Date/Time Animal Weighed 4 datetime ISO8601 COLLECTED
BWDY Study Day Animal Weighed integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
BWNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
BWNOMLBL Label for Nominal Study Day text 7 DERIVED
Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.
Related dataset: Supplemental Body Weight (SUPPBW)

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["CL"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
CLSEQ Sequence Number integer 8 OTHER
CLGRPID Group Identifier text 7 OTHER
CLTESTCD Test Short Name 3 text 3 CLTESTCD OTHER
CLTEST Test Name text 20 CLTEST OTHER
CLCAT Category for Clinical Observations 4 text 14 ["CLINICAL SIGNS", "DERMAL", "OPHTHALMOLOGY"]

<Category for Clinical Observation>

 OTHER
CLSCAT Subcategory for Clinical Observations text 32 CLSCAT OTHER
CLORRES Result or Findings as Collected 5 text 73 COLLECTED
CLSTRESC Standardized Result in Character Format text 48 COLLECTED
CLLOC Location of a Finding 6 text 9 COLLECTED
CLSEV Severity text 7 COLLECTED
CLUSCHFL Unscheduled Flag text 1 ["Y"]

<No Yes Response>

 OTHER
VISITDY Planned Study Day of Collection integer 8 DERIVED
Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
CLDTC Date/Time of Observation 7 datetime ISO8601 COLLECTED
CLDY Study Day of Observation integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
CLNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
CLNOMLBL Label for Nominal Study Day text 18 DERIVED
Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.
CLTPT Planned Time Point Name text 7 OTHER
CLTPTNUM Planned Time Point Number integer 8 OTHER
Related dataset: Supplemental Clinical Observations (SUPPCL)

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["FW"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 1 OTHER
POOLID Pool Identifier 3 text 6 OTHER
FWSEQ Sequence Number integer 8 OTHER
FWTESTCD Food/Water Consumption Short Name 4 text 2 ["FC"]

<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 ["g"]

<Unit>

 OTHER
FWSTRESC Standardized Result in Character Format text 4 DERIVED
Calculated food consumption and water consumption per animal per day in the standardized unit.
FWSTRESN Standardized Result in Numeric Format float 8 DERIVED
When --STRESC contains a numeric result, the numeric equivalent is reported in --STRESN.
FWSTRESU Unit of the Standardized Result text 12 ["g/animal/day"]

<Unit>

 OTHER
FWDTC Start Date/Time of Observation 5 datetime ISO8601 COLLECTED
FWENDTC End Date/Time of Observation 6 datetime ISO8601 COLLECTED
FWDY Study Day of Start of Observation integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
FWENDY Study Day of End of Observation integer 8 DERIVED
"--ENDTC minus RFSTDTC plus 1 if --ENDTC is on or after RFSTDTC. --ENDTC minus RFSTDTC if --ENDTC precedes RFSTDTC."
Related dataset: Supplemental Food and Water (SUPPFW)

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Laboratory (LB) [Location: lb.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
DOMAIN Domain Abbreviation text 2 ["LB"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
LBSEQ Sequence Number integer 8 OTHER
LBGRPID Group Identifier text 6 OTHER
LBREFID Specimen Identifier text 6 OTHER
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 26 ["Clinical Chemistry", "Hematology and Coagulation", "Urinalysis"]

<LBCAT>

 OTHER
LBORRES Result or Findings as Collected text 11 COLLECTED
LBORRESU Unit of the Original Result text 7 Unit OTHER
LBORNRLO Reference Range Lower Limit-Orig Unit text 4 OTHER
LBORNRHI Reference Range Upper Limit-Orig Unit text 4 OTHER
LBSTRESC Standardized Result in Character Format text 11 COLLECTED
LBSTRESN Standardized Result in Numeric Format float 8 COLLECTED
LBSTRESU Unit of the Standardized Result text 7 Unit OTHER
LBSTNRLO Reference Range Lower Limit-Std Unit float 8 OTHER
LBSTNRHI Reference Range Upper Limit-Std Unit float 8 OTHER
LBNRIND Reference Range Indicator text 8 OTHER
LBSTAT Completion Status text 8 ["NOT DONE"]

<Not Done>

 COLLECTED
LBREASND Reason Not Done text 54 COLLECTED
LBSPEC Specimen Material Type 4 text 11 ["URINE", "WHOLE BLOOD"]

<Specimen>

 OTHER
LBLOC Specimen Collection Location text 7 OTHER
LBMETHOD Method of Test or Examination text 1 OTHER
LBBLFL Baseline Flag text 1 OTHER
LBUSCHFL Unscheduled Flag text 1 OTHER
VISITDY Planned Study Day of Collection integer 8 DERIVED
Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
LBDTC Date/Time of Specimen Collection 5 datetime ISO8601 COLLECTED
LBDY Study Day of Specimen Collection integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
LBNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
LBNOMLBL Label for Nominal Study Day text 6 DERIVED
Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.
LBTPT Planned Time Point Name text 3 OTHER
LBTPTNUM Planned Time Point Number 6 integer 8 OTHER
Related dataset: Supplemental Laboratory Test (SUPPLB)

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["MA"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
FOCID Focus of Study-Specific Interest text 16 OTHER
MASEQ Sequence Number integer 8 OTHER
MAGRPID Group Identifier text 7 OTHER
MAREFID Specimen Reference Identifier text 8 OTHER
MATESTCD Macroscopic Examination Short Name 3 text 8 ["CLSFUP", "GROSPATH"]

<Macroscopic Findings Test Code>

 OTHER
MATEST Macroscopic Examination Name text 30 ["Clinical Signs Follow-up", "Gross Pathological Examination"]

<Macroscopic Findings Test Name>

 OTHER
MAORRES Result or Findings as Collected 4 text 57 COLLECTED
MASTRESC Standardized Result in Character Format text 20 COLLECTED
MASPEC Specimen Material Type 5 text 30 Specimen OTHER
MAANTREG Anatomical Region of Specimen 6 text 12 OTHER
MADTC Date/Time datetime ISO8601 COLLECTED
MADY Study Day integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
Related dataset: Supplemental Qualifiers for Gross (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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["MI"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
MISEQ Sequence Number integer 8 OTHER
MIGRPID Group Identifier text 7 OTHER
MIREFID Specimen Reference Identifier text 8 OTHER
MITESTCD Microscopic Examination Short Name 3 text 8 ["GHISTXQL"]

<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 59 COLLECTED
MISTRESC Standardized Result in Character Format 4 text 27 Non-Neoplastic Finding Type COLLECTED
MIRESCAT Result Category text 14 ["NON-NEOPLASTIC"]

<Microscopic Histopathology Result Category>

 OTHER
MICHRON Chronicity of Finding text 1 COLLECTED
MIDISTR Distribution Pattern of Finding text 5 ["FOCAL"]

<Distribution>

 COLLECTED
MISTAT Completion Status text 8 ["NOT DONE"]

<Not Done>

 COLLECTED
MIREASND Reason Not Done text 7 COLLECTED
MISPEC Specimen Material Type 5 text 30 Specimen OTHER
MIANTREG Anatomical Region of Specimen 6 text 12 OTHER
MISPCCND Specimen Condition text 1 OTHER
MISPCUFL Specimen Usability for the Test text 1 OTHER
MISEV Severity text 6 ["1 OF 5", "2 OF 5", "3 OF 5"]

<SEND Severity>

 COLLECTED
MIDTC Date/Time datetime ISO8601 COLLECTED
MIDY Study Day integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
Related dataset: Supplemental Qualifiers for Micro (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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["OM"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
OMSEQ Sequence Number integer 8 OTHER
OMTESTCD Test Short Name 3 text 6 ["OWBR", "OWBW", "WEIGHT"]

<Organ Measurement Test Code>

 OTHER
OMTEST Test Name text 27 ["Organ to Body Weight Ratio", "Organ to Brain Weight Ratio", "Weight"]

<Organ Measurement Test Name>

 OTHER
OMORRES Result or Findings as Collected text 7 COLLECTED
OMORRESU Unit of the Original Result text 1 ["%", "g"]

<Unit>

 OTHER
OMSTRESC Standardized Result in Character Format text 7 COLLECTED
OMSTRESN Standardized Result in Numeric Format float 8 COLLECTED
OMSTRESU Unit of the Standardized Result text 1 ["%", "g"]

<Unit>

 OTHER
OMSPEC Specimen Material Type 4 text 15 Specimen OTHER
OMEXCLFL Exclusion Flag text 1 ["Y"]

<No Yes Response>

 COLLECTED
OMDTC Date/Time Organ Measured datetime ISO8601 COLLECTED
OMDY Study Day of Measurement integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
OMNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
OMNOMLBL Label for Nominal Study Day text 6 DERIVED
Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.

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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 7 OTHER
DOMAIN Domain Abbreviation text 2 ["VS"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 2 text 11 OTHER
VSSEQ Sequence Number integer 8 OTHER
VSTESTCD Vital Signs Test Short Name 3 text 4 ["TEMP"]

<SEND Vital Signs Test Code>

 OTHER
VSTEST Vital Signs Test Name text 11 ["Temperature"]

<SEND Vital Signs Test Name>

 OTHER
VSCAT Category for Vital Signs text 16 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 COLLECTED
VSSTRESN Standardized Result in Numeric Format float 8 COLLECTED
VSSTRESU Unit of the Standardized Result text 1 ["C"]

<Unit>

 OTHER
VSLOC Location of Vital Signs Measurement text 6 ["RECTAL"]

<VSLOC>

 OTHER
VSBLFL Baseline Flag text 1 OTHER
VISITDY Planned Study Day of Collection integer 8 DERIVED
Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
VSDTC Date/Time of Measurement datetime ISO8601 COLLECTED
VSDY Study Day of Vital Signs Measurement integer 8 DERIVED
"--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
VSNOMDY Nominal Study Day for Tabulations integer 8 DERIVED
Set equal to associated domain VISITDY.
VSNOMLBL Label for Nominal Study Day text 6 DERIVED
Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.
VSTPT Planned Time Point Name text 7 OTHER
VSTPTNUM Planned Time Point Number integer 8 OTHER
Related dataset: Supplemental Vital Signs (SUPPVS)

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Pool Definition (POOLDEF) [Location: pooldef.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
POOLID Pool Identifier 3 text 6 OTHER
USUBJID Unique Subject Identifier 2 text 11 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 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 ["CL", "MA", "MI"]

<SEND Domain Abbreviation>

 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 4 OTHER
RELTYPE Relationship Type text 1 OTHER
RELID Relationship Identifier 6 text 2 OTHER

Go to the top of the define.xml

Supplemental Body Weight Gain (SUPPBG) [Location: suppbg.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 3 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 18 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Body Weight Gains (BG)

Go to the top of the define.xml

Supplemental Body Weight (SUPPBW) [Location: suppbw.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 3 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 12 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Body Weights (BW)

Go to the top of the define.xml

Supplemental Clinical Observations (SUPPCL) [Location: suppcl.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 4 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 12 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Clinical Observations (CL)

Go to the top of the define.xml

Supplemental Disposition (SUPPDS) [Location: suppds.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 2 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 12 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Disposition (DS)

Go to the top of the define.xml

Supplemental Food and Water (SUPPFW) [Location: suppfw.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 1 OTHER
POOLID Pool Identifier text 6 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 3 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 18 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Food and Water Consumption (FW)

Go to the top of the define.xml

Supplemental Laboratory Test (SUPPLB) [Location: supplb.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 4 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 39 OTHER
QVAL Data Value text 8 OTHER
QORIG Origin text 9 OTHER
Related dataset: Laboratory (LB)

Go to the top of the define.xml

Supplemental Qualifiers for Gross (SUPPMA) [Location: suppma.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 4 OTHER
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 OTHER
Related dataset: Macroscopic Findings (MA)

Go to the top of the define.xml

Supplemental Qualifiers for Micro (SUPPMI) [Location: suppmi.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 4 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 16 OTHER
QVAL Data Value text 24 COLLECTED
QORIG Origin text 9 OTHER
Related dataset: Microscopic Findings (MI)

Go to the top of the define.xml

Supplemental Vital Signs (SUPPVS) [Location: suppvs.xpt]
Variable Label Key Type Length Controlled Terms or Format Origin Derivation/Comment
STUDYID Study Identifier 1 text 7 OTHER
RDOMAIN Related Domain Abbreviation 2 text 2 OTHER
USUBJID Unique Subject Identifier 3 text 11 OTHER
IDVAR Identifying Variable 4 text 5 OTHER
IDVARVAL Identifying Variable Value 5 text 3 OTHER
QNAM Qualifier Variable Name 6 text 8 OTHER
QLABEL Qualifier Variable Label text 12 OTHER
QVAL Data Value text 6 OTHER
QORIG Origin text 9 OTHER
Related dataset: Vital Signs (VS)

Go to the top of the define.xml

Value Level Metadata

Value Level Metadata - SUPPLB [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 8 OTHER
QVAL QNAM EQ PHASEDAY
(PHASEDAY) 		integer 8 OTHER

Value Level Metadata - SUPPMI [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ MIRESMOD
(MIRESMOD) 		text 24 COLLECTED

Value Level Metadata - SUPPCL [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 8 OTHER
QVAL QNAM EQ PHASEDAY
(PHASEDAY) 		integer 8 OTHER

Value Level Metadata - SUPPFW [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 8 OTHER
QVAL QNAM EQ PHSEDAY1
(PHSEDAY1) 		integer 8 OTHER
QVAL QNAM EQ PHSEDAY2
(PHSEDAY2) 		integer 8 OTHER

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

Value Level Metadata - TX [TXVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
TXVAL TXPARMCD EQ SPGRPCD
 text 1 OTHER
TXVAL TXPARMCD EQ GRPLBL
 text 24 OTHER
TXVAL TXPARMCD EQ TRTDOSU
 text 2 ["ug"]

<Unit>

 OTHER

Value Level Metadata - SUPPDS [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 8 OTHER
QVAL QNAM EQ PHASEDAY
(PHASEDAY) 		integer 8 OTHER

Value Level Metadata - SUPPBG [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSNAME2
(PHSNAME2) 		text 8 OTHER
QVAL QNAM EQ PHSEDAY2
(PHSEDAY2) 		integer 8 OTHER

Value Level Metadata - TS [TSVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
TSVAL TSPARMCD EQ TRT
 text 12 OTHER
TSVAL TSPARMCD EQ AGEU
 text 5 ["WEEKS"]

<Age Unit>

 OTHER
TSVAL TSPARMCD EQ SDESIGN
 text 8 ["PARALLEL"]

<Study Design>

 OTHER
TSVAL TSPARMCD EQ ROUTE
 text 13 ["INTRAMUSCULAR"]

<Route of Administration Response>

 OTHER
TSVAL TSPARMCD EQ SNDIGVER
 text 37 ["SEND IMPLEMENTATION GUIDE VERSION 3.1"]

<SEND Implementation Guide Version>

 OTHER
TSVAL TSPARMCD EQ SPECIES
 text 3 ["RAT"]

<Species>

 OTHER
TSVAL TSPARMCD EQ SSTYP
 text 20 ["REPEAT DOSE TOXICITY"]

<SEND Study Type>

 OTHER
TSVAL TSPARMCD EQ STCAT
 text 3 ["TOX"]

<Study Category>

 OTHER
TSVAL TSPARMCD EQ STRAIN
 text 10 ["WISTAR HAN"]

<Strain/Substrain>

 OTHER
TSVAL TSPARMCD EQ TFCNTRY
 text 3 ["USA"]

<Country>

 OTHER
TSVAL TSPARMCD EQ SEXPOP
 text 4 ["BOTH"]

<Sex of Participants Response>

 OTHER
TSVAL TSPARMCD EQ GLPFL
 text 1 ["Y"]

<No Yes Response>

 OTHER

Value Level Metadata - SUPPVS [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 6 OTHER
QVAL QNAM EQ PHASEDAY
(PHASEDAY) 		integer 8 OTHER

Value Level Metadata - SUPPBW [QVAL]
Variable Where Type Length / Display Format Controlled Terms or Format Origin Derivation/Comment
QVAL QNAM EQ PHSENAME
(PHSENAME) 		text 8 OTHER
QVAL QNAM EQ PHASEDAY
(PHASEDAY) 		integer 8 OTHER

Go to the top of the define.xml

Controlled Terms

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

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

SEND Domain Abbreviation [BG.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
BG [C95083]

Unit [BG.UNIT.BGORRESU, C71620]
Permitted Value (Code)
g [C48155]

Unit [BG.UNIT.BGSTRESU, C71620]
Permitted Value (Code)
g [C48155]

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

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

SEND Domain Abbreviation [BW.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
BW [C95085]

Unit [BW.UNIT.BWORRESU, C71620]
Permitted Value (Code)
g [C48155]

Unit [BW.UNIT.BWSTRESU, C71620]
Permitted Value (Code)
g [C48155]

Category for Clinical Observation [CL.CLCAT.CLCAT, C89963]
Permitted Value (Code)
CLINICAL SIGNS [C100104]
DERMAL [C25478]
OPHTHALMOLOGY [C16939]

CLSCAT [CL.CLSCAT.CLSCAT]
Permitted Value (Code)
Cornea
General Appearance
General Appearance and Condition
Retina
Skin and Haircoat
Vitreous Body

CLTEST [CL.CLTEST.CLTEST]
Permitted Value (Code)
CLINICAL SIGNS
Edema Grade-Left
Edema Grade-Right
Erythema Grade-Left
Erythema Grade-Right
OPHTHALMOLOGY

CLTESTCD [CL.CLTESTCD.CLTESTCD]
Permitted Value (Code)
CS
EDL
EDR
ERL
ERR
OP

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

SEND Domain Abbreviation [CL.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
CL [C95086]

SEND Domain Abbreviation [CO.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
CO [C49569]

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

SEND Domain Abbreviation [DM.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
DM [C49572]

Sex [DM.SEX.SEX, C66731]
Permitted Value (Code)
F [C16576]
M [C20197]

Standardized Disposition Term [DS.DSDECOD.DSDECOD, C89968]
Permitted Value (Code)
RECOVERY SACRIFICE [C90445]
TERMINAL SACRIFICE [C90465]

SEND Domain Abbreviation [DS.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
DS [C49576]

Frequency [EX.FREQ.EXDOSFRQ, C71113]
Permitted Value (Code)
QD [C25473]

Pharmaceutical Dosage Form [EX.FRM.EXDOSFRM, C66726]
Permitted Value (Code)
SUSPENSION [C42994]

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

SEND Domain Abbreviation [EX.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
EX [C49587]

Unit [EX.UNIT.EXDOSU, C71620]
Permitted Value (Code)
ug [C48152]

Unit [EX.UNIT.EXVAMTU, C71620]
Permitted Value (Code)
uL [C48153]

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

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

SEND Domain Abbreviation [FW.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
FW [C95090]

Unit [FW.UNIT.FWORRESU, C71620]
Permitted Value (Code)
g [C48155]

Unit [FW.UNIT.FWSTRESU, C71620]
Permitted Value (Code)
g/animal/day [C73714]

LBCAT [LB.LBCAT.LBCAT]
Permitted Value (Code)
Clinical Chemistry
Hematology and Coagulation
Urinalysis

Laboratory Test Name [LB.LBTEST.LBTEST, C67154]
Permitted Value (Code)
Acanthocytes [C74699]
Activated Partial Thromboplastin Time [C38462]
Alanine Aminotransferase [C64433]
Albumin [C64431]
Albumin/Globulin [C74894]
Alkaline Phosphatase [C64432]
Alpha-1 Acid Glycoprotein [C100429]
Alpha-2 Macroglobulin [C80168]
Aspartate Aminotransferase [C64467]
Basophilia [*]
Basophilic Stippling [C96567]
Basophils [C64470]
Basophils/Total Cells [C98865]
Bilirubin [C38037]
Burr Cells [C74701]
Calcium [C64488]
Chloride [C64495]
Cholesterol [C105586]
Clarity [C96594]
Color [C64546]
Creatinine [C64547]
Dacryocytes [C64801]
Dohle Bodies [C74610]
Eosinophils [C64550]
Eosinophils/Total Cells [C98720]
Ery. Mean Corpuscular HGB Concentration [C64798]
Ery. Mean Corpuscular Hemoglobin [C64797]
Ery. Mean Corpuscular Volume [C64799]
Erythrocyte Agglutination [C111197]
Erythrocyte Cell Morphology [C92296]
Erythrocytes [C51946]
Erythrocytes Distribution Width [C64800]
Fibrinogen [C64606]
Gamma Glutamyl Transferase [C64847]
Globulin [C74738]
Glucose [C105585]
Hematocrit [C64796]
Hemoglobin [C64848]
Hemoglobin Crystals [*]
Hemolytic Index [C111208]
Howell-Jolly Bodies [C74704]
Hypersegmented Cells [C74612]
Icteric Index [C111232]
Ketones [C64854]
Large Unstained Cells [C74659]
Large Unstained Cells/Leukocytes [C79467]
Leukocytes [C51948]
Lipemic Index [C111242]
Lymphocytes [C51949]
Lymphocytes/Leukocytes [C64820]
Mean Platelet Volume [C74730]
Monocytes [C64823]
Monocytes/Total Cells [C98872]
Neutrophils [C63321]
Neutrophils/Total Cells [C98763]
Occult Blood [C74686]
Other Morphology [*]
Phosphate [C64857]
Platelet Clumps [C96624]
Platelets [C51951]
Poikilocytes [C79602]
Potassium [C64853]
Protein [C64858]
Prothrombin Time [C62656]
Reticulocytes [C51947]
Reticulocytes/Erythrocytes [C64828]
Schistocytes [C74706]
Sediment Examination [C105744]
Siderocyte-like Inclusions [*]
Sodium [C64809]
Specific Gravity [C64832]
Spermatozoa [C74663]
Spherocytes [C74707]
Squamous Epithelial Cells [C74773]
Stomatocytes [C74708]
Target Cells [C96636]
Toxic Granulation [C96641]
Toxic Vacuolation [C127813]
Triglycerides [C64812]
Triple Phosphate Crystals [C74756]
Urea Nitrogen [C125949]
Vacuolated Lymphocytes [C111329]
Volume [C74720]
pH [C45997]

* Extended Value


Laboratory Test Code [LB.LBTESTCD.LBTESTCD, C65047]
Permitted Value (Code)
A1AGLP [C100429]
A2MACG [C80168]
ACANT [C74699]
ALB [C64431]
ALBGLOB [C74894]
ALP [C64432]
ALT [C64433]
APTT [C38462]
AST [C64467]
BASO [C64470]
BASOCE [C98865]
BASOPH [*]
BILI [C38037]
BURRCE [C74701]
CA [C64488]
CHOL [C105586]
CL [C64495]
CLARITY [C96594]
COLOR [C64546]
CREAT [C64547]
CYTRPHOS [C74756]
DOHLE [C74610]
EOS [C64550]
EOSCE [C98720]
EPISQCE [C74773]
FIBRINO [C64606]
GGT [C64847]
GLOBUL [C74738]
GLUC [C105585]
HCT [C64796]
HEMOLYSI [C111208]
HGB [C64848]
HGB_CRYS [*]
HOWJOL [C74704]
HYPSEGCE [C74612]
ICTERUSI [C111232]
K [C64853]
KETONES [C64854]
LGLUCLE [C79467]
LGUNSCE [C74659]
LIPEMIAI [C111242]
LYM [C51949]
LYMLE [C64820]
LYMVAC [C111329]
MCH [C64797]
MCHC [C64798]
MCV [C64799]
MONO [C64823]
MONOCE [C98872]
MPV [C74730]
NEUT [C63321]
NEUTCE [C98763]
OCCBLD [C74686]
OTHERM [*]
PH [C45997]
PHOS [C64857]
PLAT [C51951]
PLATCLMP [C96624]
POIKILO [C79602]
PROT [C64858]
PT [C62656]
RBC [C51946]
RBCAGGLU [C111197]
RBCMORPH [C92296]
RDW [C64800]
RETI [C51947]
RETIRBC [C64828]
SCHISTO [C74706]
SEDEXAM [C105744]
SIDERO [*]
SODIUM [C64809]
SPERM [C74663]
SPGRAV [C64832]
SPHERO [C74707]
STIPBASO [C96567]
STOMCY [C74708]
TEARDCY [C64801]
TOXGRAN [C96641]
TOXVAC [C127813]
TRGTCE [C96636]
TRIG [C64812]
UREAN [C125949]
VOLUME [C74720]
WBC [C51948]

* Extended Value


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

SEND Domain Abbreviation [LB.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
LB [C49592]

Specimen [LB.SPEC.LBSPEC, C77529]
Permitted Value (Code)
URINE [C13283]
WHOLE BLOOD [C41067]

Unit [LB.UNIT.LBORRESU, C71620]
Permitted Value (Code)
% [C25613]
/HPF [C96619]
/LPF [C96620]
10^12/L [C67308]
10^9/L [C67255]
RATIO [C44256]
U/L [C67456]
fL [C64780]
g/dL [C64783]
mL [C28254]
mg/L [C64572]
mg/dL [C67015]
mmol/L [C64387]
pg [C64551]
sec [C42535]

Unit [LB.UNIT.LBSTRESU, C71620]
Permitted Value (Code)
% [C25613]
/HPF [C96619]
/LPF [C96620]
10^12/L [C67308]
10^9/L [C67255]
RATIO [C44256]
U/L [C67456]
fL [C64780]
g/dL [C64783]
mL [C28254]
mg/L [C64572]
mg/dL [C67015]
mmol/L [C64387]
pg [C64551]
sec [C42535]

Macroscopic Findings Test Name [MA.MATEST.MATEST, C89971]
Permitted Value (Code)
Clinical Signs Follow-up [C16033]
Gross Pathological Examination [C90390]

Macroscopic Findings Test Code [MA.MATESTCD.MATESTCD, C89972]
Permitted Value (Code)
CLSFUP [C16033]
GROSPATH [C90390]

SEND Domain Abbreviation [MA.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
MA [C95094]

Specimen [MA.SPEC.MASPEC, C77529]
Permitted Value (Code)
ADIPOSE TISSUE [C12472]
ARTERY, AORTA [C12669]
BONE MARROW, STERNUM [C77690]
BONE, STERNUM [C12793]
BRAIN [C12439]
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, SEMINAL VESICLE [C12787]
GLAND, THYROID [C12400]
GUT-ASSOCIATED LYMPHOID TISSUE [C12936]
HEART [C12727]
JOINT [C13044]
KIDNEY [C12415]
LARGE INTESTINE, CECUM [C12381]
LARGE INTESTINE, COLON [C12382]
LARYNX [C12420]
LIVER [C12392]
LUNG [C12468]
LYMPH NODE, DRAINING [C150905]
LYMPH NODE, INGUINAL [C32801]
LYMPH NODE, MESENTERIC [C77641]
MUSCLE, SKELETAL [C13050]
NERVE, OPTIC [C12761]
NERVE, PERIPHERAL [C12768]
OVARY [C12404]
OVIDUCT [C12403]
PANCREAS [C12393]
SITE, INJECTION [C77680]
SKIN [C12470]
SMALL INTESTINE, DUODENUM [C12263]
SMALL INTESTINE, ILEUM [C12387]
SMALL INTESTINE, JEJUNUM [C12388]
SPINAL CORD [C12464]
SPLEEN [C12432]
STOMACH [C12391]
TESTIS [C12412]
THYMUS [C12433]
TONGUE [C12422]
TRACHEA [C12428]
URETER [C12416]
URINARY BLADDER [C12414]
UTERUS [C12405]
VAGINA [C12407]

Distribution [MI.DSTRBN.MIDISTR, C120530]
Permitted Value (Code)
FOCAL [C28224]

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

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

SEND Microscopic Findings Test Code [MI.MITESTCD.MITESTCD, C89974]
Permitted Value (Code)
GHISTXQL [C147493]

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

Non-Neoplastic Finding Type [MI.NONNEO.MISTRESC, C120531]
Permitted Value (Code)
ATROPHY [C79748]
BASOPHILIC TUBULE [C161544]
CELLULARITY, INCREASED [C41428]
CYST [C2978]
DEGENERATION/NECROSIS [C120875]
DILATATION [C113136]
EDEMA [C3002]
EROSION [C50443]
FIBROSIS [C3044]
HYPERTROPHY [C3124]
INFILTRATE [C42077]
INFLAMMATION [C3137]
MINERALIZATION [C120899]
PHYSIS THICKNESS, INCREASED [C139154]
RETINAL ROSETTE [C161565]
UNREMARKABLE [C000001]
VACUOLATION [C96302]

SEND Domain Abbreviation [MI.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
MI [C95095]

SEND Severity [MI.SEV.MISEV, C90000]
Permitted Value (Code)
1 OF 5 [C147501]
2 OF 5 [C147504]
3 OF 5 [C147507]

Specimen [MI.SPEC.MISPEC, C77529]
Permitted Value (Code)
ADIPOSE TISSUE [C12472]
ARTERY, AORTA [C12669]
BONE MARROW, STERNUM [C77690]
BONE, STERNUM [C12793]
BRAIN [C12439]
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, SEMINAL VESICLE [C12787]
GLAND, THYROID [C12400]
GUT-ASSOCIATED LYMPHOID TISSUE [C12936]
HEART [C12727]
JOINT [C13044]
KIDNEY [C12415]
LARGE INTESTINE, CECUM [C12381]
LARGE INTESTINE, COLON [C12382]
LIVER [C12392]
LUNG [C12468]
LYMPH NODE, DRAINING [C150905]
LYMPH NODE, INGUINAL [C32801]
LYMPH NODE, MESENTERIC [C77641]
MUSCLE, SKELETAL [C13050]
NERVE, OPTIC [C12761]
NERVE, PERIPHERAL [C12768]
OVARY [C12404]
OVIDUCT [C12403]
PANCREAS [C12393]
SITE, INJECTION [C77680]
SKIN [C12470]
SMALL INTESTINE, DUODENUM [C12263]
SMALL INTESTINE, ILEUM [C12387]
SMALL INTESTINE, JEJUNUM [C12388]
SPINAL CORD [C12464]
SPLEEN [C12432]
STOMACH [C12391]
TESTIS [C12412]
THYMUS [C12433]
TONGUE [C12422]
TRACHEA [C12428]
URETER [C12416]
URINARY BLADDER [C12414]
UTERUS [C12405]
VAGINA [C12407]

No Yes Response [OM.NY.OMEXCLFL, C66742]
Permitted Value (Code)
Y [C49488]

Organ Measurement Test Name [OM.OMTEST.OMTEST, C89976]
Permitted Value (Code)
Organ to Body Weight Ratio [C90426]
Organ to Brain Weight Ratio [C90427]
Weight [C25208]

Organ Measurement Test Code [OM.OMTESTCD.OMTESTCD, C89977]
Permitted Value (Code)
OWBR [C90427]
OWBW [C90426]
WEIGHT [C25208]

SEND Domain Abbreviation [OM.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
OM [C49605]

Specimen [OM.SPEC.OMSPEC, C77529]
Permitted Value (Code)
BRAIN [C12439]
EPIDIDYMIS [C12328]
GLAND, ADRENAL [C12666]
GLAND, PROSTATE [C12410]
HEART [C12727]
KIDNEY [C12415]
LIVER [C12392]
OVARY [C12404]
SPLEEN [C12432]
TESTIS [C12412]
THYMUS [C12433]

Unit [OM.UNIT.OMORRESU, C71620]
Permitted Value (Code)
% [C25613]
g [C48155]

Unit [OM.UNIT.OMSTRESU, C71620]
Permitted Value (Code)
% [C25613]
g [C48155]

SEND Domain Abbreviation [RELREC.SDOMAIN.RDOMAIN, C111113]
Permitted Value (Code)
CL [C95086]
MA [C95094]
MI [C95095]

SEND Domain Abbreviation [SE.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
SE [C49616]

SEND Domain Abbreviation [TA.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
TA [C49618]

SEND Domain Abbreviation [TE.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
TE [C49619]

Age Unit [TS.AGEU.AGEU, C66781]
Permitted Value (Code)
WEEKS [C29844]

Country [TS.COUNTRY.TFCNTRY, C66786]
Permitted Value (Code)
USA [C17234]

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

Null Flavor Reason [TS.NULLFLAV.TSVALNF, C150810]
Permitted Value (Code)
UNKNOWN [C17998]

No Yes Response [TS.NY.GLPFL, C66742]
Permitted Value (Code)
Y [C49488]

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

SEND Domain Abbreviation [TS.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
TS [C53483]

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

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

Species [TS.SPECIES.SPECIES, C77808]
Permitted Value (Code)
RAT [C160998]

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

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

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

SEND Trial Summary Parameter Test Name [TS.STSPRM.TSPARM, C90007]
Permitted Value (Code)
Age [C25150]
Age Unit [C50400]
Dosing Duration [C90378]
End Date/Time of Dose Interval [C90379]
Experimental End Date [C90382]
Experimental Start Date [C90487]
GLP Flag [C120944]
Good Laboratory Practice Type [C90389]
Housing Group [C90394]
Investigational Therapy or Treatment [C41161]
Pharmacologic Class [C98768]
Planned Dose Frequency [C147513]
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]
Sex of Participants [C49696]
Species [C96433]
Sponsor's Study Reference ID [C135009]
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 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]
Time to Terminal Sacrifice [C90466]
Treatment Vehicle [C927]

SEND Trial Summary Parameter Test Code [TS.STSPRMCD.TSPARMCD, C90009]
Permitted Value (Code)
AGE [C25150]
AGEU [C50400]
DOSDUR [C90378]
DOSENDTC [C90379]
DOSSTDTC [C90459]
EXPENDTC [C90382]
EXPSTDTC [C90487]
GLPFL [C120944]
GLPTYP [C90389]
HOUSEGRP [C90394]
PCLASS [C98768]
PDOSFRQ [C147513]
ROUTE [C38114]
SDESIGN [C95082]
SEXPOP [C49696]
SLENGTH [C95105]
SNDCTVER [C96370]
SNDIGVER [C90458]
SPECIES [C96433]
SPLANSUB [C95106]
SPLRNAM [C90473]
SPREFID [C135009]
SSPONSOR [C129946]
SSTYP [C92644]
STCAT [C90461]
STDIR [C129944]
STENDTC [C99156]
STITLE [C95108]
STRAIN [C96373]
STSTDTC [C99157]
TFCNTRY [C90467]
TRMSAC [C90466]
TRT [C41161]
TRTCAS [C92645]
TRTUNII [C92646]
TRTV [C927]
TSTFLOC [C90468]
TSTFNAM [C90469]

SEND Domain Abbreviation [TX.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
TX [C95103]

SEND Trial Summary Parameter Test Name [TX.STSPRM.TXPARM, C90007]
Permitted Value (Code)
Arm Code [C83216]
Control Type [C49647]
Dose Level [C25488]
Dose Units [C73558]
Group Label [C90391]
Sponsor-Defined Group Code [C90456]

SEND Trial Summary Parameter Test Code [TX.STSPRMCD.TXPARMCD, C90009]
Permitted Value (Code)
ARMCD [C83216]
GRPLBL [C90391]
SPGRPCD [C90456]
TCNTRL [C49647]
TRTDOS [C25488]
TRTDOSU [C73558]

Unit [TX.UNIT.TRTDOSU, C71620]
Permitted Value (Code)
ug [C48152]

SEND Domain Abbreviation [VS.SDOMAIN.DOMAIN, C111113]
Permitted Value (Code)
VS [C49622]

SEND Vital Signs Test Name [VS.SVSTST.VSTEST, C120537]
Permitted Value (Code)
Temperature [C25206]

SEND Vital Signs Test Code [VS.SVSTSTCD.VSTESTCD, C120536]
Permitted Value (Code)
TEMP [C25206]

Unit [VS.UNIT.VSORRESU, C71620]
Permitted Value (Code)
C [C42559]

Unit [VS.UNIT.VSSTRESU, C71620]
Permitted Value (Code)
C [C42559]

VSLOC [VS.VSLOC.VSLOC]
Permitted Value (Code)
RECTAL

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Computational Algorithms

Computational Algorithms
Method Type Description
Algorithm to derive AGE Computation Subject Reference Start/Time – Date of Birth and convert it based on Age units.
Algorithm to derive --STDY Computation "--STDTC minus RFSTDTC plus 1 if --STDTC is on or after RFSTDTC. --STDTC minus RFSTDTC if --STDTC precedes RFSTDTC."
Algorithm to derive VISITDY Computation Set equal to associated domain --DY except when activity was performed on a different day than planned. Set to null when activity was unscheduled.
Algorithm to derive --NOMDY Computation Set equal to associated domain VISITDY.
Algorithm to derive BG result Computation Body Weight at the end interval minus body weight at the start interval.
Algorithm to derive --DY Computation "--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC."
Algorithm to derive --ENDY Computation "--ENDTC minus RFSTDTC plus 1 if --ENDTC is on or after RFSTDTC. --ENDTC minus RFSTDTC if --ENDTC precedes RFSTDTC."
Algorithm to derive --NOMLBL Computation Set with "Day" concatenated with associated domain --NOMDY for a scheduled activitity. Set with "Day" concatenated with associated domain --NOMDY and "Unscheduled". for an unscheduled activitity.
Algorithm to derive FWSTRESC Computation Calculated food consumption and water consumption per animal per day in the standardized unit.
Algorithm to derive --STRESN Computation When --STRESC contains a numeric result, the numeric equivalent is reported in --STRESN.

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