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1
1 1.1
Clinical Data Interchange Standards ConsortiumCDISCStandard for Exchange of Nonclinical Data (SEND) CDISCStandard for Exchange of Nonclinical Data Implementation GuideSENDIGSENDIGCROFDA SEND IG
SENDIGCDISCCDISC Study Data Tabulation Model (SDTM) Ver. 1.2SDTM SENDIG
SENDIGSDTM
FDASENDSENDFDA12FDA : SEND
1.2
:
1SENDIG
2SDTMSEND SDTMimplementation guideSDTM
3SEND
4
5special-purpose domains
63 general observation classes
7SDTMTrial Design
8 / SDTMSubject Pooling
Appendices
1.3 CDISC
SEND IG V2.3V2.3V2.3SENDSDTMSDTM IGCDISC www.cdisc.orgSDTM V1.2SDTM
Variable Name
Domain or General Observation Class
AGETXT
Demographics
--ANTREG
Findings
--CSTATE
Findings
--DETECT
Findings
--DIR
Findings
--PORTOT
Findings
--EXCLFL
Findings
--LAT
Findings
--LEAD
Findings
POOLID
Identifiers
--REASEX
Findings
SET
Trial Sets
SETCD
Demographics, Trial Sets
--SPCUFL
Findings
SPECIES
Demographics
STRAIN
Demographics
SBSTRAIN
Demographics
Appendix E
1.4 IMPLEMENTATION GUIDE
SENDIGSENDIGSENDSubjectTrialVisit DayInterventions
SENDIG
1. SDTM SDTM
1. 1-3 Appendix B
1. 4
1. SENDIGPDF5-6
1. 7Trial Design
1. 81
1. CDISCSEND Controlled TerminologyCT
1. Appendix
1.5
CDISC SENDhttp://www.cdisc.org/send CDISC SEND
2 SDTMSEND 2.1
3SDTMInterventions()Events()FindingsSDTM
Interventions
Eventsdisposition
FindingsFindings
SDTM
IdentifierTiming3
QualifierSENDSDTM
4
2.2
SENDSDTM3special-purpose
DemographicsDMCommentsCOSubject ElementsSE3 1 5
Trial ElementsTE)Trial ArmsTA)Trial SetsTXTrial Summary TSTrial Design ModelTDM7
Relationship datasets8 RELRECSUPP--
2.3 SENDIG
CDISC SEND Team
Special-Purpose () (5)
Demographics DM
Subject Elements SE
Comments CO
Interventions ()(6.1)
Exposure EX
Events () (6.2)
Disposition DS
Findings () (6.3)
Body Weights BW
Body Weight Gains BG
Clinical Observations CL
Death Diagnosis DD
Food and Water Consumption FW
Laboratory Test Results LB
Macroscopic Findings MA
Microscopic Findings MI
Organ Measurements OM
Palpable Masses PM
Pharmacokinetics Concentrations PC
Pharmacokinetics Parameters PP
Subject Characteristics SC
Tumor Findings TF
Vital Signs VS
ECG Test Results EG
Trial Design (7)
Trial Elements TE
Trial Arms TA
Trial Sets TX
Trial Summary TS
Relationship (8)
Supplemental Qualifiers SUPP
Related RELREC
Pooling POOLDEF
SENDIGDMTXTS3BWBGCLDSEXFWLBMAMIOM
SENDIGSDTM Tables2.2.1-2.2.3IdentifierSDTM Table2.2.4SDTM Table2.2.5Qualifier
Permissible4.1.3
SDTM8Supplemental QualifiersSDTMSDTMCDISC SENDCDISC SEND
2.4
SDTMSENDImplementation guideSDTM RoleRole 5
Identifier
Topic
Timing
Qualifier
RuleTrial Design
Qualifier5
Grouping Qualifiers --CAT--SCAT
Result QualifiersFindings--ORRES--STRESC--STRESN
Synonym Qualifiers --MODIFY--DECOD--TRT--TERM--TEST--TESTCD
Record Qualifiers DMAGESEXSPECIESSTRAINFindings--REASND--BLFL--LOC--SPECNAM
Variable Qualifiers --ORRESU--ORNRHI--ORNRLO--ORRES--DOSU--DOSU--DOSE
2.5
CDISC Submission Data Standards(SDS)SEND SENDIG
3 SEND 3.1
2 2*1 DOMAINSDTM4 8
DOMAIN
RDOMAIN
3.1.1
SEND IG
Variable Name ("STUDYID")
Variable Label (Study Identifier)
Type NumChar()
Controlled Terms, Codelist, or Format (BWTESTCD[BWTESTCD]) DOMAIN("BW") (ISO8601ISO8601)
Role (2.4)
CDISC Notes
Core 3"Req""Exp"Perm "Req"Required"Exp"ExpectedPermPermissible (4.1.3)
3.2DEFINE.XML
SENDdefine.xmlCase Report Tabulation Data Definition Specification [define.xml]FDA Study Data Specification
3.2.1
(Appendix D) 3.2.1
define.xml7
Dataset: ("DM.xpt""DM")
Description: Demographics() Laboratory Test Results() )
Class: InterventionEventsFindingsSpecial-Purpose
Structure: (One record per subject(1) One record per subject per visit(1) One record per subject per event(1 )
Purpose: Tabulation() Analysis() )
Keys : 25 3.2.13.2.1.1.2)
Location :
TABLE 3.2.1 TABLE 3.2.1
Dataset
Description
Class
Structure
Purpose
Keys
Location
DM
Demographics
Special-Purpose Domain
One record per subject
Tabulation
STUDYID, USUBJID
dm.xpt
CO
Comments
Special-Purpose Domain
One record per comment
Tabulation
STUDYID, COSEQ
co.xpt
SE
Subject Elements
Special-Purpose Domain
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 or POOLED, EXTRT, EXSTDTC
ex.xpt
DS
Disposition
Events
One record per subject
Tabulation
STUDYID, USUBJID
ds.xpt
BW
Body Weight
Findings
One record per test per observation time per subject
Tabulation
STUDYID, USUBJID, BWTESTCD, BWDTC
bw.xpt
BG
Body Weight Gains
Findings
One record per test per interval per subject
Tabulation
STUDYID, USUBJID, BGTESTCD, BGDTC, BGENDTC
bg.xpt
CL
Clinical Observations
Findings
One record per finding per observation time per subject or pool
Tabulation
STUDYID, USUBJID or POOLED, CLTESTCD, CLCAT, CLORRES, CLLOC, CLDTC
cl.xpt
DD
Death Diagnosis
Findings
One record per diagnosis per subject
(for unscheduled death only)
Tabulation
STUDYID, USUBJID
dd.xpt
EG
ECG Test Results
Findings
One record per test per observation time per subject
Tabulation
STUDYID, USUBJID, EGTESTCD, EGDTC
eg.xpt
FW
Food and Water Consumptions
Findings
One record per test per interval per subject or pool
Tabulation
STUDYID, USUBJID or POOLED, 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 or POOLED, 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, MALAT, MADIR
ma.xpt
MI
Microscopic Findings
Findings
One record per finding per specimen per subject
Tabulation
STUDYID, USUBJID, MITESTCD, MISTRESC, MISPEC, MIANTREG, MILAT, MIDIR
mi.xpt
OM
Organ Measurements
Findings
One record per test per specimen per subject
Tabulation
STUDYID, USUBJID, OMTESTCD, OMSPEC, OMANTREG< OMLAT, OMDIR
om.xpt
PM
Palpable Masses
Findings
One record per test per palpable mass per observation time per subject
Tabulation
STUDYID, USUBJID, PMTESTCD, PMSPID, PMDTC
pm.xpt
PC
Pharmacokinetics Concentration
Findings
One record per test per specimen per observation time per subject or pool
Tabulation
STUDYID, USUBJID or POOLED, PCTESTCD, PCSPEC, PCDTC
pc.xpt
PP
Pharmacokinetics Parameters
Findings
One record per test per time-concentration profile per specimen per subject or pool
Tabulation
STUDYID, USUBJID or POOLED, PPTESTCD, PPCAT, PPSPEC, PPRFTDTC
pp.xpt
SC
Subject Characteristics
Findings
One record per characteristic per subject
Tabulation
STUDYID, USUBJID, SCTESTCD
sc.xpt
TF
Tumor Findings
Findings
One record per tumor per specimen per subject
Tabulation
STUDYID, USUBJID, TFTESTCD, TFORRES, TFSPEC, TFANTREG, TFLAT, TFDIR
tf.xpt
VS
Vital Signs
Findings
One record per measurement per observation time per subject
Tabulation
STUDYID, USUBJID, VSTESTCD, VSDTC
vs.xpt
TE
Trial Elements
Special-Purpose Domain
One record per planned Element
Tabulation
STUDYID, ETCD
te.xpt
TA
Trial Arms
Special-Purpose Domain
One record per planned Element per Arm
Tabulation
STUDYID, ARMCD, TAETORD
ta.xpt
TX
Trial Sets
Special-Purpose Domain
One record per Trial Set parameter per Trail Set
Tabulation
STUDYID, SETCD, TXPERMCD
tx.xpt
TS
Trial Summary
Special-Purpose Domain
One record per Trial Summary parameter value
Tabulation
STUDYID, TSPERMCD, TSSEQ
ts.xpt
POOLDEF
Pool Definition
Special-Purpose Domain
One record per subject per pool
Tabulation
STUDYID, USUBJID, POOLID
pooldef.xpt
RELREC
Related Records
Relationship Datasets
One record per related record, related group of records (e.g., --GRPID), or related dataset
Tabulation
STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID
relrec.xpt
SUPP--
Supplemental Qualifiers for (domain name)
Relationship Datasets
One record per IDVAR, IDVARVAL, and QNAM, value per subject per related domain
Tabulation
STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM
supp--.xpt
Key Structure
3.2.1.1PRIMARY KEYS
()--SEQSTUDYIDUSUBJIDPOOLIDDOMAIN--SEQ--SEQsurrogate
3.2.1.1.1 SURROGATE KEYS
1 SDTM--SEQ
3.2.1.1.2 NATURAL KEYS
1
positionlocation
Supplemental Qualifier
Clinical Observations ():
ACL
STUDYID, USUBJID, CLTESTCD, CLDTC, CLTPT
B(CLLOC)(VISITDY)(CLDTC)BCL
STUDYID, USUBJID, CLTESTCD, CLLOC, CLDTC
Supplemental Qualifier1 2 Supplemental Qualifiers
Supplemental QualifiersA.B2SUPP-- QNAM SUPP--QNAMSUPP-- XVARQNAMQNAM.XVAR
CL
B B (QNAM=CLMAKE)(QNAM=CLMODEL)
STUDYID, USUBJID, CLTESTCD, CLLOC, CLDTC, QNAM.CLMAKE, QNAM.CLMODEL
Findings--TESTCD TESTCD --TESTCD Controlled Terminology
X MRI --TESTCD 1--TESTCD
X MRI
1 --TESTCD
--TESTCD 8
--TESTCD
qualifier--TESTCD EROSIONQualifier--LOC Supplemental QualifierQNAM.MAKEQNAM.MODEL
--TESTCD EROSION Left MCP IMCP I Ultrasound ACME U 2.1 Supplemental Qualifier
--TESTCD
--TEST
--LOC
--METHOD
QNAM.MAKE
QNAM.MODEL
EROSION
Erosion
LEFT MCP I
ULTRASOUND
ACME
U 2.1
3.2.2
define.xml7
SAS Ver 5 8
40
()
controlled terminologyControlled TermsCodelist Format4.3
Origin
Role SENDRoleIdentifierTopicTiming5Qualifier
CommentsCommentsCDISC Notes
6SENDIGSDTMIdentifierControlled TerminologyCDISC
3.2.2.1
Origin SENDIGOrigin
COLLECTED COLLECTED COLLECTED
DERIVEDDERIVED
OTHEROTHER Trial Design7 STUDYIDUSUBJIDDOMAIN--SEQTESTCD
NOT AVAILABLENOT AVAILABLE Origin Origin
COLLECTEDDERIVEDOTHERNOT AVAILABLE
(--STRESC) COLLECTED
) DERIVED
() COLLECTED DERIVED NOT AVAILABLE
3.2.3
OM () COLLECTED DERIVED define.xml
Source Dataset
Source Variable
Value
Label
Origin
OM
OMTESTCD
OW
Organ Weight
COLLECTED
OM
OMTESTCD
OWBW
Organ to Body Weight Ratio
DERIVED
OM
OMTESTCD
OMBR
Organ to Brain Weight Ratio
DERIVED
3.3 CONFORMANCE
SENDIG
SENDIG
SENDIGControlled Terminology
SENDIG
SENDIG
SDTMSENDIG
SDTMSENDControlled Terminology
RequiredExpectedRequired ()
1TopicIdentifierTiming
CDISC Notes
SAS V5
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
12345
LB
99-123
LBSEQ
3
LBREAS
Reason Test or Examination was Performed
ORIGINAL SAMPLE LOST
44.14.1.1
3 TimingSENDIGSUPP--RELREC8
4.1.2
define.xml SDTM 3 IdentifiersTopic QualifierTimingSDTM 2.2.12.2.5
4.1.3SDTM
3Core
RequiredRequired1
ExpectedExpectedExpectedExpectedExpecteddefine.xml
PermissibleSDTMTimingIdentifierQualifierPermissible
Permissible
4.1.4
SDTM DemographicsDMdm.xpt SEND CTRELREC8.3SUPP8.5POOLDEF8.7
4.24.2.1
SDTM SDTMIG Version 3.1.2 Appendix D Findings--TESTCDQNAM--CD--CD--TESTCD --TEST
--TESTCD QNAM8 SAS v 5 XML
QNAMsupplemental qualifier--TESTCD QNAM--TESTCD
--CD--TESTCD
ETCDELEMENTSETCDTrial Set ()TSPARMCDTSPARM8
ARMCD 20 ARMCD 7 ARMCD 2 ARMCD20
40Title Case
Supplemental Qualifiersformatdecodesterminologydata types1 SENDIG
4.2.22
2
Special-Purpose5 Standard6 Trial Design7 Relationship8 21AZ2AZ09SAS v5 eCTD
1. Identifiers(STUDYIDDOMAINUSUBJIDPOOLID)
1. VISITDYTrial DesignELEMENT ARM
1. DemographicsDMDMDTC DMDY
1. RELREC SUPP-- CommentsTrial Design
(--SEQ) Required IdentifiersOptional Identifiers--SPID--GRPIDREFID RELREC
4.2.3
SubjectSubjectUSUBJID
USUBJIDPOOLIDRequired ()
2USUBJIDUSUBJID
()POOLID
SUBJIDUSUBJID
dm.xpt (pharmacokinetic study)
STUDYID
DOMAIN
USUBJID
SUBJID
CT1234
DM
CT1234-007
007
dm.xpt (toxicology study)
STUDYID
DOMAIN
USUBJID
SUBJID
CT1234LTS
DM
CT1234-007
004
8.7.
4.2.4
Controlled TerminologyControlled Terminology List4.3.2 define.xml
4.2.5
SDTM--STAT--REASND4.5.1.3
4.2.6
Grouping variables--CAT--SCATSDTM IdentifiersQualifiersLBTEST = SODIUM LBCAT = CHEMISTRY LBSCAT = ELECTROLYTES --CAT --SCAT --DECOD --BODSYS
STUDYID
DOMAIN
--CAT
--SCAT
USUBJID
--GRPID
--REFID
1.
A USUBJID
B USUBJID
0. STUDYID
0. DOMAIN
0. --CAT--SCAT--CAT--SCAT MAMI--CAT--SCAT --CAT--SCAT
0.
0.
0. Related RecordsRELRECRELRECPalpable Masses PM
C USUBJID
0. --GRPID USUBJID --GRPID USUBJID --CAT --SCAT --GRPID
0. --SPID --REFID Identifier
2.
A. --CAT--SCAT --GRPID
--CAT--SCAT
--CAT--SCAT
--CAT--SCAT --GRPID
--GRPID
--GRPID
B. --CAT--SCAT --REFID --CAT--SCAT --REFID
Findings--RESCAT --CAT --SCAT 6.3.3.2 CL 3
4.3CONTROLLED TERMINOLOGY4.3.1
SEND (CT) SENDSENDSEND CT56,
4.3.2
Controlled Terminology
0. National Cancer Institute [NCI]
0. mg/dL
0. --TESTTitle Case
4.3.3CONTROLLED TERMINOLOGY
define.xmldefine.xmlRequired4.1.3
4.3.4CONTROLLED TERMINOLOGY
Supplemental Qualifiers
4.3.5YES NO
Yes NoY N Y N N 1 Yes1 Y N Y (--BLFL) N
UnknownNot Applicable Y N U NA
4.3.6
--SPEC1
4.3.6.1--SPECTissues
1--SPEC / TESTIS / EPIDIDYMIS (SPEC) (SPEC)
4.3.6.2 --LAT--DIR--PORTOT
1laterality--LAT, directionality--DIR, and portion or totality of specimen--PORTOT)1 ; ventral () surface () 2 VENTRAL;SURFACE
4.3.7
Preferred TermPreferred TermSEND CTNCIThesauras C degCCDegrees Celsius SENDPreferred Term C 4.5.1.4
Source value21NCI ThesaurusNCI ThesaurusSENDPreferred term
Source units--ORRESUPreferred Term
1 Celsius C
2 microgram per liter ug/L
3 ng/mL ug/L
Row
Source Unit
Submission Value (--ORRESU)
1
Celsius
C
2
microgram per liter
ug/L
3
ng/mL
ug/L
4.4
SDTM2.2.5SDTM31Events () Interventions () Findings) --DTC--DY
SENDIGISO 8601http://www.iso.orgISO 8601
4.4.1DateTime
SDTM--DTCISO 8601
SENDIGISO 8601
YYYY-MM-DDThh:mm:ss
[YYYY] = 4
[MM] = 201-12, 101
[DD] = 201-31
[T] =
[hh] = 200-23AM/PM
[mm] = 200-59
[ss] = 200-59
ISO8601
[-] ():
[:] ():
[/] (): 4.4.3
[P] (): 4.4.3
ISO 8601
ISO 8601
ISO 8601YYYY-MM-DD
ISO 8601 hh:mm:ss
SDTMSENDIG - : ISO 8601ISO 8601SDTM2009162009-01-0620090106
(datetime) YYYY-MM-DDThh:mm:ss T 2001-12-26T00:00:01
ISO 8601SENDDateTime DTC
4.4.2
ISO 8601ISO 8601 / ISO 8601SDTM241
ISO 8601ISO 8601[T
ISO 8601
1
December 15, 2003 13:14:17
2003-12-15T13:14:17
2
December 15, 2003 13:14
2003-12-15T13:14
3
December 15, 2003 13
2003-12-15T13
4
December 15, 2003
2003-12-15
5
December, 2003
2003-12
6
2003
2003
ISO 8601 /
ISO 8601
1
10:00AM 10:30AMDecember 15, 2003
2003-12-15T10:00/2003-12-15T10:30
2
2003February 15, 2003)
2003-01-01T14:30/2003-02-15T12:00
3
200312110
2003-12-01/2003-12-10
4
2003
2003-01-01/2003-06-30
21430
ISO 860111
ISO
1
December 15, 2003 13:15:17
2003-12-15T13:15:17
2
December 15, 2003 ??:15
2003-12-15T-:15
3
December 15, 2003 13:??:17
2003-12-15T13:-:17
4
200315
2003---15
5
1215
--12-15
6
7:15
-----T07:15
ISO 8601
4.4.3--DUR
ISO 86012instantSDTM2--DTC--ENDTC2
--DUR--DTC--ENDTC--DTC--ENDTC
--EVLINT--ELTMISO 8601ISO 8601--DUR
PnYnMnDTnHnMnS PnW
[P] (): Period P
[n] :
[W] : P6W6Calendar Weeks
ISO 8601 P n T
--DTC--ENDTCtime [T
ISO 86012
YYYY-MM-DDThh:mm:ss/YYYY-MM-DDThh:mm:ss
negative
-PnYnMnDTnHnMnS
PnW
IGISO 8601
ISO 8601()lowest-order component ) 121/4 ISO 8601
ISO 8601
2
P2Y
10
P10W
314
P3M14D
3
P3D
6173
P6M17DT3H
14757
P14DT7H57M
4218
PT42M18S
PT0.5H
512
P5DT12.25H
4
P4.5W
10
4.4.4Study Day
--DY--STDYENDY1--DTC and --ENDTCSubject Reference Start DateDemographics (DM)RFSTDTC
Subject Reference Start DateRFSTDTC1RFSTDTC1RFSTDTC1RFSTDTC -100
--DY
--DTCRFSTDTC--DTC RFSTDTC 1
--DTCRFSTDTC--DTC RFSTDTC
VISITDY1
1VISITDY
VISITDYVISITDYSUPPQUALVISDYLOVISDYHI8.5.1.1, 34
4.2.3POOLDEF8.7RFSTDTC
1. VISITDY--DY
1. VISITDY--DY--DY--VISITDY1--DTC
4.4.5
4.4.4SDTM--DTCDMRFSTDTC--DYRFSTDTCdefine.xmlElementEPOCHSubject Elements5.3.1Element
4.4.6FINDINGS
--DTCECGEGDTCFindings--DTCLBLBDTC24LBDTCLBENDTCFindings--STDTC
--DTC
--STDTC
--ENDTC
X
X
X
4.4.7TIME POINT
--TPT--TPTNUM--ELTM--TPTREF--RFSTDTC--TPTNUMVISITDY--DTC--DY4.4.7
FIGURE 4.4.7
306090
CLTPTNUM
CLTPT
CLELTM
CLTPTREF
CLRFTDTC
CLDTC
1
30 MIN
PT30M
DOSE ADMINISTRATION
2006-08-01T08:00
2006-08-01T08:30
2
60 MIN
PT1H
DOSE ADMINISTRATION
2006-08-01T08:00
2006-08-01T09:01
3
90 MIN
PT1H30M
DOSE ADMINISTRATION
2006-08-01T08:00
2006-08-01T09:32
SDTMCLDTC-CLRFTDTC--RFTDTC--TPTREFRFTDTC--TPTREFDOSE ADMINISTRATION
1214
VISITDY
CLTPT
CLTPTNUM
1
PREDOSE
1
1H
2
4H
3
2
PREDOSE
1
1H
2
4H
3
71414--TPTREF--RFTDTC
VISITDY
CLTPT
CLTPTNUM
CLELTM
CLTPTREF
CLRFTDTC
7
PREDOSE
1
DAY 7, AM DOSE
2006-08-01T08:00
1H
2
PT1H
DAY 7, AM DOSE
2006-08-01T08:00
4H
3
PT4H
DAY 7, AM DOSE
2006-08-01T08:00
PREDOSE
1
DAY 7, PM DOSE
2006-08-01T14:00
1H
2
PT1H
DAY 7, PM DOSE
2006-08-01T14:00
4H
3
PT4H
DAY 7, PM DOSE
2006-08-01T14:00
8
24H
4
PT24H
DAY 7, AM DOSE
2006-08-01T08:00
24H
4
PT24H
DAY 7, PM DOSE
2006-08-01T14:00
14
PREDOSE
1
DAY 14, AM DOSE
2006-08-08T08:00
1H
2
PT1H
DAY 14, AM DOSE
2006-08-08T08:00
4H
3
PT4H
DAY 14, AM DOSE
2006-08-08T08:00
PREDOSE
1
DAY 14, PM DOSE
2006-08-08T14:00
1H
2
PT1H
DAY 14, PM DOSE
2006-08-08T14:00
4H
3
PT4H
DAY 14, PM DOSE
2006-08-08T14:00
15
24H
4
PT24H
DAY 14, AM DOSE
2006-08-08T08:00
24H
4
PT24H
DAY 14, PM DOSE
2006-08-08T14:00
VISITDY--TPT--TPTNUM11
--TPT--ELTM11--ELTMISO 8601--ELTMPredose--ELTM--ELTM2DOMAINVISITDY--TPTREF--TPTNUM--ELTM
4612 +/- 2--ELTM46 PT4H --ELTM12 +/- 2 PT12H--ELTM--ELTM2--TPT
--TPTNUM--TPTELTM--ELTM--TPTNUMTPT
4.54.5.14.5.1.1
--ORRES ORRESExpected --STAT NOT DONE.
--ORRES--STRESC--STRESC, --ORRES--ORRESCL --STRESCMIMA--ORRESmodifier --STRESC--STRESC--STRESN--STRESC--STRESN
--ORRES--STRESC--ORRES--STRESC --STRESN
>10,000