Date of Define-XML document generation: 2016-07-08T05:48:25-04:00

Define-XML version: 2.0.0

Stylesheet version: 2016-07-05

Standard
SDTM-IG 3.1.2
Study Name
CDISC01
Study Description
CDISC Test Study
Protocol Name
CDISC01
Metadata Name
Data Definitions for CDISC01, SDTM-IG 3.1.2
Metadata Description
Data Definitions for CDISC01, SDTM-IG 3.1.2

Tabulation Datasets for Study CDISC01 (SDTM-IG 3.1.2)

Tabulation Datasets for Study CDISC01 (SDTM-IG 3.1.2)
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
TATrial ArmsTRIAL DESIGNOne record per planned Element per ArmTabulationSTUDYID, ARMCD, TAETORDta.xpt
TETrial ElementsTRIAL DESIGNOne record per planned ElementTabulationSTUDYID, ETCDte.xpt
TITrial Inclusion/Exclusion CriteriaTRIAL DESIGNOne record per I/E criterionTabulationSTUDYID, IETESTCDti.xpt
TSTrial SummaryTRIAL DESIGNOne record per trial summary parameter valueTabulationSTUDYID, TSPARMCD, TSSEQts.xpt
TVTrial VisitsTRIAL DESIGNOne record per planned Visit per ArmTabulationSTUDYID, VISITNUM, ARMCDtv.xpt
DMDemographicsSPECIAL PURPOSEOne record per subjectTabulationSTUDYID, USUBJIDdm.xpt

See Reviewer's Guide, Section 2.1 Demographics

Study Data Reviewer's Guide

SESubject ElementsSPECIAL PURPOSEOne record per actual Element per subjectTabulationSTUDYID, USUBJID, SESTDTC, SEENDTC, TAETORD, ETCDse.xpt
SVSubject VisitsSPECIAL PURPOSEOne record per actual visit per subjectTabulationSTUDYID, USUBJID, SVSTDTC, VISITNUMsv.xpt
CMConcomitant MedicationsINTERVENTIONSOne record per recorded medication occurrence or constant-dosing interval per subjectTabulationSTUDYID, USUBJID, CMSTDTC, CMENDTC, CMCAT, CMTRT, CMDOSTXT, CMDOSU, CMINDC, CMDOSFRQcm.xpt
EXExposureINTERVENTIONSOne record per constant dosing interval per subjectTabulationSTUDYID, USUBJID, EXSTDTC, EXENDTC, EXTRT, EXDOSEex.xpt
AEAdverse EventsEVENTSOne record per adverse event per subjectTabulationSTUDYID, USUBJID, AEDECOD, AESTDTCae.xpt
DSDispositionEVENTSOne record per disposition status or protocol milestone per subjectTabulationSTUDYID, USUBJID, DSSTDY, DSSTDTC, DSCAT, DSDECODds.xpt
MHMedical HistoryEVENTSOne record per medical history event per subjectTabulationSTUDYID, USUBJID, MHCAT, MHTERM, MHDTC, MHSTDTCmh.xpt
DADrug AccountabilityFINDINGSOne record per drug accountability finding per subjectTabulationSTUDYID, USUBJID, DATESTCD, DADTCda.xpt
EGECG Test ResultsFINDINGSOne record per ECG observation per visit per subjectTabulationSTUDYID, USUBJID, EGTESTCD, EGDTC, VISITNUMeg.xpt
IEInclusion/Exclusion Criteria Not MetFINDINGSOne record per inclusion/exclusion criterion not met per subjectTabulationSTUDYID, USUBJID, IETESTCDie.xpt
LBLaboratory Tests ResultsFINDINGSOne record per analyte per visit per subjectTabulationSTUDYID, USUBJID, LBCAT, LBMETHOD, LBTESTCD, LBDTC, VISITNUMlb.xpt
PEPhysical ExaminationFINDINGSOne record per body system or abnormality per visit per subjectTabulationSTUDYID, USUBJID, PETESTCD, PEDTC, VISITNUMpe.xpt
QSCGQuestionnaire-QSCG (Questionnaires)FINDINGSOne record per questionnaire per question per visit per subjectTabulationSTUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUMqscg.xpt

QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

QSCSQuestionnaire-QSCS (Questionnaires)FINDINGSOne record per questionnaire per question per visit per subjectTabulationSTUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUMqscs.xpt

QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

QSMMQuestionnaire-QSMM (Questionnaires)FINDINGSOne record per questionnaire per question per visit per subjectTabulationSTUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUMqsmm.xpt

QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

SCSubject CharacteristicsFINDINGSOne record per characteristic per subjectTabulationSTUDYID, USUBJID, SCTESTCDsc.xpt
VSVital SignsFINDINGSOne record per vital sign measurement per visit per subjectTabulationSTUDYID, USUBJID, VSTESTCD, VSDTC, VISITNUM, VSPOSvs.xpt
RELRECRelated RecordsRELATIONSHIPOne record per related record, group of records or datasetTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELIDrelrec.xpt
SUPPAESupplemental Qualifiers for AE (Adverse Events)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppae.xpt
SUPPCMSupplemental Qualifiers for CM (Concomitant Medications)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppcm.xpt
SUPPDMSupplemental Qualifiers for DM (Demographics)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppdm.xpt
SUPPEGSupplemental Qualifiers for EG (ECG Test Results)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppeg.xpt
SUPPEXSupplemental Qualifiers for EX (Exposure)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppex.xpt
SUPPLBSupplemental Qualifiers for LB (Laboratory Tests Results)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsupplb.xpt
SUPPQSCGSupplemental Qualifiers for QSCG (Questionnaires)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppqscg.xpt
SUPPQSCSSupplemental Qualifiers for QSCS (Questionnaires)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppqscs.xpt
SUPPQSMMSupplemental Qualifiers for QSMM (Questionnaires)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppqsmm.xpt
SUPPVSSupplemental Qualifiers for VS (Vital Signs)RELATIONSHIPOne record per IDVAR, IDVARVAL, and QNAM value per subjectTabulationSTUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAMsuppvs.xpt

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Trial Arms (TA)

TA (Trial Arms) - TRIAL DESIGN [Location: ta.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (TA)
  • "TA" = "Trial Arms"
Assigned
ARMCDPlanned Arm Code2text8Planned Arm Code
  • "WONDER10" = "Miracle Drug 10 mg"
  • "WONDER20" = "Miracle Drug 20 mg"
  • "PLACEBO" = "Placebo"
  • "SCRNFAIL" = "Screen Failure"
Assigned
ARMDescription of Planned Armtext20Description of Planned Arm
  • "Miracle Drug 10 mg"
  • "Miracle Drug 20 mg"
  • "Placebo"
  • "Screen Failure"
Protocol
TAETORDOrder of Element within Arm3integer1Assigned
ETCDElement Codetext8Assigned
ELEMENTDescription of Elementtext40Protocol
TABRANCHBranchtext35Protocol
TATRANSTransition Ruletext1Protocol
EPOCHEpochtext30Protocol

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Trial Elements (TE)

TE (Trial Elements) - TRIAL DESIGN [Location: te.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (TE)
  • "TE" = "Trial Elements"
Assigned
ETCDElement Code2text8Assigned
ELEMENTDescription of Elementtext40Protocol
TESTRLRule for Start of Elementtext24Protocol
TEDURPlanned Duration of Elementtext4Protocol

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Trial Inclusion/Exclusion Criteria (TI)

TI (Trial Inclusion/Exclusion Criteria) - TRIAL DESIGN [Location: ti.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (TI)
  • "TI" = "Trial Inclusion/Exclusion Criteria"
Assigned
IETESTCDIncl/Excl Criterion Short Name2text6IE Test Codes

[6 Terms]

Assigned
IETESTInclusion/Exclusion Criteriontext92IE Tests

[6 Terms]

[CRF] Annotated Case Report Form 4 - 5
IECATInclusion/Exclusion Categorytext9 [CRF] Annotated Case Report Form 4 - 5

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Trial Summary (TS)

TS (Trial Summary) - TRIAL DESIGN [Location: ts.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (TS)
  • "TS" = "Trial Summary"
Assigned
TSSEQSequence Number3integer1Derived
Sequential number identifying records within each TSPARM in the domain.
TSPARMCDTrial Summary Parameter Short Name2text8Trial Summary Parameter Test Code

[23 Terms]

Assigned
TSPARMTrial Summary Parametertext36Trial Summary Parameter Test Name

[23 Terms]

Assigned
TSVALParameter Valuetext57Protocol

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Trial Visits (TV)

TV (Trial Visits) - TRIAL DESIGN [Location: tv.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (TV)
  • "TV" = "Trial Visits"
Assigned
VISITNUMVisit Number2integer2Assigned
VISITVisit Nametext12Protocol
VISITDYPlanned Study Day of Visitinteger3Protocol
ARMCDPlanned Arm Code3text1Assigned
TVSTRLVisit Start Ruletext30Protocol

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Demographics (DM)

DM (Demographics) - SPECIAL PURPOSE [Location: dm.xpt]
Related dataset: Supplemental Qualifiers for DM (SUPPDM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (DM)
  • "DM" = "Demographics"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
SUBJIDSubject Identifier for the Studytext6 [CRF] Annotated Case Report Form 3
RFSTDTCSubject Reference Start Date/TimedateISO8601Derived
RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures.
RFENDTCSubject Reference End Date/TimedateISO8601Derived
RFENDTC = termination date, for safety subjects. Null for screen failures.
SITEIDStudy Site Identifiertext3 [CRF] Annotated Case Report Form 3
BRTHDTCDate/Time of BirthdateISO8601 [CRF] Annotated Case Report Form 6
AGEAgeinteger2Derived
Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document.

Complex Algorithms

AGEUAge Unitstext5Assigned

Defaulted to YEARS

SEXSextext1Sex
  • "F" = "Female"
  • "M" = "Male"
  • "U" = "Unknown"
[CRF] Annotated Case Report Form 6
RACERacetext40Race

[7 Terms]

[CRF] Annotated Case Report Form 6
ETHNICEthnicitytext22Ethnic Group
  • "HISPANIC OR LATINO"
  • "NOT HISPANIC OR LATINO"
[CRF] Annotated Case Report Form 6
ARMCDPlanned Arm Codetext8Planned Arm Code
  • "WONDER10" = "Miracle Drug 10 mg"
  • "WONDER20" = "Miracle Drug 20 mg"
  • "PLACEBO" = "Placebo"
  • "SCRNFAIL" = "Screen Failure"
Assigned

Assigned based on Randomization Number. See Note 2.1

Study Data Reviewer's Guide

ARMDescription of Planned Armtext20Description of Planned Arm
  • "Miracle Drug 10 mg"
  • "Miracle Drug 20 mg"
  • "Placebo"
  • "Screen Failure"
Assigned

Assigned from TA.ARM based on ARMCD.

COUNTRYCountrytext3ISO3166

ISO3166

Assigned

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Subject Elements (SE)

SE (Subject Elements) - SPECIAL PURPOSE [Location: se.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (SE)
  • "SE" = "Subject Element"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
SESEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
ETCDElement Code6text7Assigned
ELEMENTDescription of Elementtext40Protocol
SESTDTCStart Date/Time of Element3dateISO8601Derived
If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document.

Complex Algorithms

SEENDTCEnd Date/Time of Element4dateISO8601Derived
If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document.

Complex Algorithms

TAETORDPlanned Order of Elements within Arm5integer1Protocol

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Subject Visits (SV)

SV (Subject Visits) - SPECIAL PURPOSE [Location: sv.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (SV)
  • "SV" = "Subject Visits"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
VISITNUMVisit Number4integer2Derived
Derived from visit-based subject-level domains
VISITVisit Nametext8Derived
Derived from visit-based subject-level domains
VISITDYPlanned Study Day of Visitinteger3Protocol
SVSTDTCStart Date/Time of Visit3dateISO8601Derived
Derived from visit-based subject-level domains
SVENDTCEnd Date/Time of VisitdateISO8601Derived
SVENDTC = SVSTDTC
SVSTDYStudy Day of Start of Visitinteger3Derived
SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC.

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Concomitant Medications (CM)

CM (Concomitant Medications) - INTERVENTIONS [Location: cm.xpt]
Related dataset: Supplemental Qualifiers for CM (SUPPCM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (CM)
  • "CM" = "Concomitant Meds"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
CMSEQSequence Numberinteger2Derived
Sequential number identifying records within each USUBJID in the domain.
CMTRTReported Name of Drug, Med, or Therapy6text23 [CRF] Annotated Case Report Form 9 22
CMMODIFYModified Reported Nametext23Assigned
CMDECODStandardized Medication Nametext30Drug Dictionary

WHODRUG 200204

Assigned
CMCATCategory for Medication5text36Category for Medication
  • "CONCOMITANT MEDICATIONS"
  • "PSYCHOTROPHIC DRUG TREATMENT HISTORY"
[CRF] Annotated Case Report Form 9 22
CMINDCIndication9text27 [CRF] Annotated Case Report Form 9 22
CMCLASMedication Classtext45Drug Dictionary

WHODRUG 200204

Assigned

Coded to ATC level 3 Term based on CMINDC

CMCLASCDMedication Class Codetext3Drug Dictionary

WHODRUG 200204

Assigned

Coded to ATC level 3 Code based on CMINDC

CMDOSTXTDose Description7text4 [CRF] Annotated Case Report Form 9 22
CMDOSUDose Units8text6Unit (CM)

[13 Terms]

[CRF] Annotated Case Report Form 9 22
CMDOSFRQDosing Frequency per Interval10text5Frequency

[9 Terms]

[CRF] Annotated Case Report Form 22
CMROUTERoute of Administrationtext12Route of Administration

[9 Terms]

[CRF] Annotated Case Report Form 22

Free text from CRF mapped to CDISC CT

CMSTDTCStart Date/Time of Medication3dateISO8601 [CRF] Annotated Case Report Form 9 22
CMENDTCEnd Date/Time of Medication4dateISO8601 [CRF] Annotated Case Report Form 9 22
CMSTDYStudy Day of Start of Medicationinteger6Derived
CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC
CMENDYStudy Day of End of Medicationinteger4Derived
CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC
CMENRFEnd Relative to Reference Periodtext6Relation to Reference Period (CMENRF)
  • "AFTER"
[CRF] Annotated Case Report Form 22

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Exposure (EX)

EX (Exposure) - INTERVENTIONS [Location: ex.xpt]
Related dataset: Supplemental Qualifiers for EX (SUPPEX)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (EX)
  • "EX" = "Exposure"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
EXSEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
EXTRTName of Actual Treatment5text20Treatment
  • "Miracle Drug"
  • "Placebo"
Derived
Derived from ARM, ARMCD
EXDOSEDose per Administration6integer2Derived
If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0.
EXDOSUDose Unitstext2Derived
Derived from ARM, ARMCD - equal to mg
EXDOSFRMDose Formtext7Pharmaceutical Dosage Form
  • "TABLET" = "tab"
[CRF] Annotated Case Report Form 20
EXSTDTCStart Date/Time of Treatment3dateISO8601 [CRF] Annotated Case Report Form 20
EXENDTCEnd Date/Time of Treatment4dateISO8601 [CRF] Annotated Case Report Form 20
EXSTDYStudy Day of Start of Treatmentinteger2Derived
EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC.
EXENDYStudy Day of End of Treatmentinteger2Derived
EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC.

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Adverse Events (AE)

AE (Adverse Events) - EVENTS [Location: ae.xpt]
Related dataset: Supplemental Qualifiers for AE (SUPPAE)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (AE)
  • "AE" = "Adverse Events"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
AESEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
AESPIDSponsor-Defined Identifiertext4 [CRF] Annotated Case Report Form 21
AETERMReported Term for the Adverse Eventtext25 [CRF] Annotated Case Report Form 21
AEMODIFYModified Reported Termtext9Assigned
AEDECODDictionary-Derived Term3text18Adverse Event Dictionary

MEDDRA 8.0

Assigned
AEBODSYSBody System or Organ Classtext52Adverse Event Dictionary

MEDDRA 8.0

Assigned
AESEVSeverity/Intensitytext8Severity/Intensity Scale for Adverse Events
  • "MILD" = "Grade 1"
  • "MODERATE" = "Grade 2"
  • "SEVERE" = "Grade 3"
[CRF] Annotated Case Report Form 21
AESERSerious Eventtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 21
AEACNAction Taken with Study Treatmenttext30Action Taken with Study Treatment
  • "DOSE NOT CHANGED"
  • "DOSE REDUCED"
  • "DRUG INTERRUPTED"
  • "DRUG WITHDRAWN"
[CRF] Annotated Case Report Form 21
AERELCausalitytext16Causality
  • "NOT RELATED"
  • "POSSIBLY RELATED"
  • "RELATED"
[CRF] Annotated Case Report Form 21
AESTDTCStart Date/Time of Adverse Event4dateISO8601 [CRF] Annotated Case Report Form 21
AEENDTCEnd Date/Time of Adverse EventdateISO8601 [CRF] Annotated Case Report Form 21
AESTDYStudy Day of Start of Adverse Eventinteger3Derived
AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC
AEENDYStudy Day of End of Adverse Eventinteger3Derived
AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC
AEENRFEnd Relative to Reference Periodtext5Relation to Reference Period (AEENRF)
  • "AFTER"
[CRF] Annotated Case Report Form 21

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Disposition (DS)

DS (Disposition) - EVENTS [Location: ds.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (DS)
  • "DS" = "Disposition"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
DSSEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
DSTERMReported Term for the Disposition Eventtext34Reported Term for the Disposition Record

[11 Terms]

[CRF] Annotated Case Report Form 6 16 18
DSDECODStandardized Disposition Term6text21Completion/Reason for Non-Completion

[10 Terms]

[CRF] Annotated Case Report Form 6 16 18

CRF controlled terminology was mapped to match CDISC controlled terminology.

DSCATCategory for Disposition Event5text18Category for Disposition Event
  • "DISPOSITION EVENT" = "Disposition Event"
  • "PROTOCOL MILESTONE" = "Protocol Milestone"
Assigned
EPOCHEpochtext9Epoch
  • "SCREEN"
  • "TREATMENT"
Assigned
DSSTDTCStart Date/Time of Disposition Event4dateISO8601 [CRF] Annotated Case Report Form 6 16 18
DSSTDYStudy Day of Start of Disposition Event3integer3Derived
DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null.

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Medical History (MH)

MH (Medical History) - EVENTS [Location: mh.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (MH)
  • "MH" = "Medical History"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
MHSEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
MHTERMReported Term for the Medical History4text169 [CRF] Annotated Case Report Form 7 - 8
MHCATCategory for Medical History3text28Category for Medical History
  • "MEDICAL AND SURGICAL HISTORY"
  • "PSYCHIATRIC HISTORY"
[CRF] Annotated Case Report Form 7 - 8
MHPRESPMedical History Event Pre-Specifiedtext2No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Assigned
MHOCCURMedical History Occurrencetext2No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Assigned
MHBODSYSBody System or Organ Classtext23Body System or Organ Class
  • "Endocrine-Metabolic"
  • "Eyes-Ears-Nose-Throat"
  • "Genitourinary"
  • "Musculoskeletal"
  • "Neurological"
Assigned

Assigned for Medical History but not Psychiatric History

MHDTCDate/Time of History Collection5dateISO8601 [CRF] Annotated Case Report Form 7 - 8
MHSTDTCStart Date/Time of Medical History Event6dateISO8601 [CRF] Annotated Case Report Form 7 - 8
MHENRFEnd Relative to Reference Periodtext30Relation to Reference Period (MHENRF)
  • "BEFORE"
  • "DURING/AFTER"
[CRF] Annotated Case Report Form 8

CRF controlled terminology was mapped to match CDISC controlled terminology.

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Drug Accountability (DA)

DA (Drug Accountability) - FINDINGS [Location: da.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (DA)
  • "DA" = "Drug Accountability"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
DASEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
DATESTCDShort Name of Accountability Assessment3text7Drug Accountability Test Code
  • "DISPAMT" = "Dispensed Amount"
  • "RETAMT" = "Returned Amount"
Assigned
DATESTName of Accountability Assessmenttext25Drug Accountability Test Name
  • "Dispensed Amount"
  • "Returned Amount"
[CRF] Annotated Case Report Form 19
DAORRESAssessment Result in Original Unitstext2 [CRF] Annotated Case Report Form 19
DAORRESUOriginal Unitstext7 [CRF] Annotated Case Report Form 19
DASTRESCAssessment Result in Std Formattext2Derived
DASTRESC = DAORRES
DASTRESNNumeric Result/Finding in Standard Unitsinteger2Derived
DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data.
DASTRESUAssessment Standard Unitstext7Derived
DASTRESU = DAORRESU
VISITNUMVisit Numberinteger2Derived
Derived from DADTC and SVSTDTC.
VISITVisit Nametext8Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
DADTCDate/Time of Accountability Assessment4dateISO8601 [CRF] Annotated Case Report Form 19
DADYStudy Day of Accountability Assessmentinteger3Derived
DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC.

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ECG Test Results (EG)

EG (ECG Test Results) - FINDINGS [Location: eg.xpt]
Related dataset: Supplemental Qualifiers for EG (SUPPEG)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (EG)
  • "EG" = "Electrocardiogram"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
EGSEQSequence Numberinteger2Derived
Sequential number identifying records within each USUBJID in the domain.
EGSPIDSponsor-Defined Identifiertext6Assigned

ECG parameter ordering variable

EGTESTCDECG Test or Examination Short Name3text6ECG Test Code

[7 Terms]

Assigned
EGTESTECG Test or Examination Nametext40ECG Test Name

[7 Terms]

[CRF] Annotated Case Report Form 12
EGPOSECG Position of Subjecttext6Protocol

Equal to SUPINE

EGORRESResult or Finding in Original Unitstext15 [CRF] Annotated Case Report Form 12
EGORRESUOriginal Unitstext4Unit (EGRESU)
  • "BEATS/MIN" = "Beats per Minute"
  • "msec" = "Millisecond"
[CRF] Annotated Case Report Form 12
EGSTRESCCharacter Result/Finding in Std Formattext15Derived
Data collected in non-standard units is converted using standard conversion factors to standard units.
EGSTRESNNumeric Result/Finding in Standard Unitsfloat5Derived
EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data.
EGSTRESUStandard Unitstext9Unit (EGRESU)
  • "BEATS/MIN" = "Beats per Minute"
  • "msec" = "Millisecond"
Assigned
EGBLFLBaseline Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise
EGDRVFLDerived Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise.

Complex Algorithms

EGEVALEvaluatortext12Assigned

Equal to INVESTIGATOR for CRF data

VISITNUMVisit Number5integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext7Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
EGDTCDate/Time of ECG4dateISO8601 [CRF] Annotated Case Report Form 12
EGDYStudy Day of ECGinteger3Derived
EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC.

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Inclusion/Exclusion Criteria Not Met (IE)

IE (Inclusion/Exclusion Criteria Not Met) - FINDINGS [Location: ie.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (IE)
  • "IE" = "Inclusion/Exclusion"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
IESEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
IETESTCDInclusion/Exclusion Criterion Short Name3text6IE Test Codes

[6 Terms]

Assigned
IETESTInclusion/Exclusion Criteriontext54IE Tests

[6 Terms]

[CRF] Annotated Case Report Form 4 - 5
IECATInclusion/Exclusion Categorytext9 [CRF] Annotated Case Report Form 4 - 5
IEORRESI/E Criterion Original Resulttext1 [CRF] Annotated Case Report Form 4 - 5
IESTRESCI/E Criterion Result in Std Formattext1Derived
IESTRESC = IEORRES
VISITNUMVisit Numberinteger1Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext6Assigned
IEDTCDate/Time of CollectiondateISO8601 [CRF] Annotated Case Report Form 4 - 5

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Laboratory Tests Results (LB)

LB (Laboratory Tests Results) - FINDINGS [Location: lb.xpt]
Related dataset: Supplemental Qualifiers for LB (SUPPLB)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (LB)
  • "LB" = "Laboratory Data"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
LBSEQSequence Numberinteger2Derived
Sequential number identifying records within each USUBJID in the domain.
LBREFIDSpecimen IDtext7eDT

Accession number

LBTESTCDLab Test or Examination Short Name5text7Laboratory Test Code

[10 Terms]

Assigned
LBTESTLab Test or Examination Nametext22Laboratory Test Name

[10 Terms]

eDT
LBCATCategory for Lab Test3text10eDT
LBORRESResult or Finding in Original Unitstext8eDT
LBORRESUOriginal Unitstext7Unit (LBRESU)

[6 Terms]

eDT
LBORNRLOReference Range Lower Limit in Orig Unittext8eDT
LBORNRHIReference Range Upper Limit in Orig Unittext8eDT
LBSTRESCCharacter Result/Finding in Std Formattext8eDT
LBSTRESNNumeric Result/Finding in Standard Unitsfloat5eDT
LBSTRESUStandard Unitstext7eDT
LBSTNRLOReference Range Lower Limit-Std Unitsfloat4eDT
LBSTNRHIReference Range Upper Limit-Std Unitsfloat4eDT
LBSTNRCReference Range for Char Rslt-Std Unitstext19eDT
LBNRINDReference Range Indicatortext20Reference Range Indicator
  • "ABNORMAL"
  • "HIGH"
  • "LOW"
  • "NORMAL"
Derived
Reference Range Indicator based upon standard results and ranges.
LBSPECSpecimen Typetext5Specimen Type
  • "BLOOD"
  • "SERUM"
  • "URINE"
eDT
LBMETHODMethod of Test or Examination4text8Method
  • "DIPSTICK"
  • "QUANT"
eDT
LBBLFLBaseline Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise.
LBFASTFasting Statustext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
eDT
VISITNUMVisit Number7integer2eDT
VISITVisit Nametext7eDT
VISITDYPlanned Study Day of Visitinteger3Protocol
LBDTCDate/Time of Specimen Collection6datetimeISO8601eDT
LBDYStudy Day of Specimen Collectioninteger3Derived
LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC.

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Physical Examination (PE)

PE (Physical Examination) - FINDINGS [Location: pe.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (PE)
  • "PE" = "Physical Exam"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
PESEQSequence Numberinteger2Derived
Sequential number identifying records within each USUBJID in the domain.
PETESTCDBody System Examined Short Name3text4PE Test Codes

[9 Terms]

Assigned
PETESTBody System Examinedtext29PE Tests

[9 Terms]

[CRF] Annotated Case Report Form 10
PEORRESVerbatim Examination Findingtext36 [CRF] Annotated Case Report Form 10
PESTRESCCharacter Result/Finding in Std Formattext26Derived
PESTRESC = PEORRES
VISITNUMVisit Number5integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext7Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
PEDTCDate/Time of Examination4dateISO8601 [CRF] Annotated Case Report Form 10
PEDYStudy Day of Examinationinteger3Derived
PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC.

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Questionnaire-QSCG (QSCG)

QSCG (Questionnaire-QSCG, Questionnaires) - FINDINGS [Location: qscg.xpt]
Related dataset: Supplemental Qualifiers for QSCG (SUPPQSCG)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (QS)
  • "QS" = "Questionnaires"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
QSSEQSequence Numberinteger3Derived
Sequential number identifying records within each USUBJID in the domain.
QSTESTCDQuestion Short Name4text7QS Test Codes

[28 Terms]

Assigned
QSTESTQuestion Nametext37QS Tests

[27 Terms]

[CRF] Annotated Case Report Form 17
QSCATCategory of Question3text50 [CRF] Annotated Case Report Form 17
QSORRESFinding in Original Unitstext20 [CRF] Annotated Case Report Form 17
QSSTRESCCharacter Result/Finding in Std Formattext2Derived
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESNNumeric Finding in Standard Unitsinteger2Derived
When QSORRES is numeric then QSSTRESN equal to numeric result
VISITNUMVisit Number6integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext8Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
QSDTCDate/Time of Finding5dateISO8601 [CRF] Annotated Case Report Form 17
QSDYStudy Day of Findinginteger3Derived
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.

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Questionnaire-QSCS (QSCS)

QSCS (Questionnaire-QSCS, Questionnaires) - FINDINGS [Location: qscs.xpt]
Related dataset: Supplemental Qualifiers for QSCS (SUPPQSCS)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (QS)
  • "QS" = "Questionnaires"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
QSSEQSequence Numberinteger3Derived
Sequential number identifying records within each USUBJID in the domain.
QSTESTCDQuestion Short Name4text7QS Test Codes

[28 Terms]

Assigned
QSTESTQuestion Nametext37QS Tests

[27 Terms]

[CRF] Annotated Case Report Form 17
QSCATCategory of Question3text50 [CRF] Annotated Case Report Form 17
QSSCATSubcategory for Questiontext40 [CRF] Annotated Case Report Form 14 - 15
QSORRESFinding in Original Unitstext20 [CRF] Annotated Case Report Form 17
QSSTRESCCharacter Result/Finding in Std Formattext2Derived
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESNNumeric Finding in Standard Unitsinteger2Derived
When QSORRES is numeric then QSSTRESN equal to numeric result
QSBLFLBaseline Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUMVisit Number6integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext8Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
QSDTCDate/Time of Finding5dateISO8601 [CRF] Annotated Case Report Form 17
QSDYStudy Day of Findinginteger3Derived
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
QSEVLINTEvaluation Intervaltext20 [CRF] Annotated Case Report Form 14

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Questionnaire-QSMM (QSMM)

QSMM (Questionnaire-QSMM, Questionnaires) - FINDINGS [Location: qsmm.xpt]
Related dataset: Supplemental Qualifiers for QSMM (SUPPQSMM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (QS)
  • "QS" = "Questionnaires"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
QSSEQSequence Numberinteger3Derived
Sequential number identifying records within each USUBJID in the domain.
QSTESTCDQuestion Short Name4text7QS Test Codes

[28 Terms]

Assigned
QSTESTQuestion Nametext37QS Tests

[27 Terms]

[CRF] Annotated Case Report Form 17
QSCATCategory of Question3text50 [CRF] Annotated Case Report Form 17
QSORRESFinding in Original Unitstext20 [CRF] Annotated Case Report Form 17
QSSTRESCCharacter Result/Finding in Std Formattext2Derived
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESNNumeric Finding in Standard Unitsinteger2Derived
When QSORRES is numeric then QSSTRESN equal to numeric result
QSBLFLBaseline Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUMVisit Number6integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext8Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
QSDTCDate/Time of Finding5dateISO8601 [CRF] Annotated Case Report Form 17
QSDYStudy Day of Findinginteger3Derived
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.

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Subject Characteristics (SC)

SC (Subject Characteristics) - FINDINGS [Location: sc.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (SC)
  • "SC" = "Subject Characteristics"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
SCSEQSequence Numberinteger1Derived
Sequential number identifying records within each USUBJID in the domain.
SCTESTCDSubject Characteristic Short Name3text8Subject Characteristic Code (SCTESTCD)
  • "EDLEVEL" = "Education Level"
  • "MARISTAT" = "Marital Status"
  • "SUBJINIT" = "Subject Initials"
Assigned
SCTESTSubject Characteristictext16SC Tests
  • "Education Level"
  • "Marital Status"
  • "Subject Initials"
[CRF] Annotated Case Report Form 6
SCORRESResult or Finding in Original Unitstext24 [CRF] Annotated Case Report Form 3 6
SCSTRESCCharacter Result/Finding in Std Formattext24Derived
SCSTRESC = SCORRES
SCDTCDate/Time of CollectiondateISO8601 [CRF] Annotated Case Report Form 6
SCDYStudy Day of Examinationinteger3Derived
SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC.

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Vital Signs (VS)

VS (Vital Signs) - FINDINGS [Location: vs.xpt]
Related dataset: Supplemental Qualifiers for VS (SUPPVS)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
DOMAINDomain Abbreviationtext2Domain Abbreviation (VS)
  • "VS" = "Vital Signs"
Assigned
USUBJIDUnique Subject Identifier2text14Derived
Concatenation of STUDYID and SUBJID
VSSEQSequence Numberinteger2Derived
Sequential number identifying records within each USUBJID in the domain.
VSTESTCDVital Signs Test Short Name3text20Vital Signs Test Code

[6 Terms]

Assigned
VSTESTVital Signs Test Nametext24Vital Signs Test Name

[6 Terms]

[CRF] Annotated Case Report Form 11
VSPOSVital Signs Position of Subject6text7 [CRF] Annotated Case Report Form 11
VSORRESResult or Finding in Original Unitstext30 [CRF] Annotated Case Report Form 11
VSORRESUOriginal Unitstext20 [CRF] Annotated Case Report Form 11
VSSTRESCCharacter Result/Finding in Std Formattext30Derived
Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm).
VSSTRESNNumeric Result/Finding in Standard Unitsfloat5Derived
VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data.
VSSTRESUStandard Unitstext9Units for Vital Signs Results
  • "BEATS/MIN" = "Beats per Minute"
  • "cm" = "Centimeter"
  • "kg" = "Kilogram"
  • "mmHg" = "Millimeter of Mercury"
Assigned

Standard units consistent with CDISC controlled terminology

VSBLFLBaseline Flagtext1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUMVisit Number5integer2Assigned

Assigned from the TV domain based on the VISIT

VISITVisit Nametext8Assigned
VISITDYPlanned Study Day of Visitinteger3Protocol
VSDTCDate/Time of Measurements4dateISO8601 [CRF] Annotated Case Report Form 11
VSDYStudy Day of Vital Signsinteger3Derived
VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC.

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Related Records (RELREC)

RELREC (Related Records) - RELATIONSHIP [Location: relrec.xpt]
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text8Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text2Assigned

Value of identifying variable described in IDVAR.

RELTYPERelationship Typetext4Assigned

All values are null since this is used only when identifying a dataset-level relationship.

RELIDRelationship Identifier6text10Derived
All records for the same USUBJID with the same RELID are considered related.

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Supplemental Qualifiers for AE (SUPPAE)

SUPPAE (Supplemental Qualifiers for AE, Adverse Events) - RELATIONSHIP [Location: suppae.xpt]
Related dataset: Adverse Events (AE)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text1Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext30Assigned
QVALData Valuetext60
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Adverse Events (AE)

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Supplemental Qualifiers for CM (SUPPCM)

SUPPCM (Supplemental Qualifiers for CM, Concomitant Medications) - RELATIONSHIP [Location: suppcm.xpt]
Related dataset: Concomitant Medications (CM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text2Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text8Assigned
QLABELQualifier Variable Labeltext26Assigned
QVALData Valuetext43
QORIGOrigintext10Assigned
QEVALEvaluatortext30Assigned
Related dataset: Concomitant Medications (CM)

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Supplemental Qualifiers for DM (SUPPDM)

SUPPDM (Supplemental Qualifiers for DM, Demographics) - RELATIONSHIP [Location: suppdm.xpt]
Related dataset: Demographics (DM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text1Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text1Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text8Assigned
QLABELQualifier Variable Labeltext26Assigned
QVALData Valuetext30
QORIGOrigintext11Assigned
QEVALEvaluatortext30Assigned
Related dataset: Demographics (DM)

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Supplemental Qualifiers for EG (SUPPEG)

SUPPEG (Supplemental Qualifiers for EG, ECG Test Results) - RELATIONSHIP [Location: suppeg.xpt]
Related dataset: ECG Test Results (EG)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text2Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext2
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: ECG Test Results (EG)

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Supplemental Qualifiers for EX (SUPPEX)

SUPPEX (Supplemental Qualifiers for EX, Exposure) - RELATIONSHIP [Location: suppex.xpt]
Related dataset: Exposure (EX)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text1Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text4Assigned
QLABELQualifier Variable Labeltext25Assigned
QVALData Valuetext2
QORIGOrigintext11Assigned
QEVALEvaluatortext30Assigned
Related dataset: Exposure (EX)

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Supplemental Qualifiers for LB (SUPPLB)

SUPPLB (Supplemental Qualifiers for LB, Laboratory Tests Results) - RELATIONSHIP [Location: supplb.xpt]
Related dataset: Laboratory Tests Results (LB)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text2Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext2
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Laboratory Tests Results (LB)

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Supplemental Qualifiers for QSCG (SUPPQSCG)

SUPPQSCG (Supplemental Qualifiers for QSCG, Questionnaires) - RELATIONSHIP [Location: suppqscg.xpt]
Related dataset: Questionnaire-QSCG (QSCG)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text50Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext3
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Questionnaire-QSCG (QSCG)

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Supplemental Qualifiers for QSCS (SUPPQSCS)

SUPPQSCS (Supplemental Qualifiers for QSCS, Questionnaires) - RELATIONSHIP [Location: suppqscs.xpt]
Related dataset: Questionnaire-QSCS (QSCS)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text50Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext3
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Questionnaire-QSCS (QSCS)

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Supplemental Qualifiers for QSMM (SUPPQSMM)

SUPPQSMM (Supplemental Qualifiers for QSMM, Questionnaires) - RELATIONSHIP [Location: suppqsmm.xpt]
Related dataset: Questionnaire-QSMM (QSMM)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text50Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext3
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Questionnaire-QSMM (QSMM)

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Supplemental Qualifiers for VS (SUPPVS)

SUPPVS (Supplemental Qualifiers for VS, Vital Signs) - RELATIONSHIP [Location: suppvs.xpt]
Related dataset: Vital Signs (VS)
VariableLabelKeyTypeLengthControlled Terms or FormatOriginDerivation / Comment
STUDYIDStudy Identifier1text7Protocol
RDOMAINRelated Domain Abbreviation2text2Derived
Domain abbreviation from where data originated.
USUBJIDUnique Subject Identifier3text14Derived
Concatenation of STUDYID and SUBJID
IDVARIdentifying Variable4text5Assigned

Name of the variables for the related records.

IDVARVALIdentifying Variable Value5text2Assigned

Value of identifying variable described in IDVAR.

QNAMQualifier Variable Name6text7Assigned
QLABELQualifier Variable Labeltext36Assigned
QVALData Valuetext2
QORIGOrigintext7Assigned
QEVALEvaluatortext30Assigned
Related dataset: Vital Signs (VS)

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Value Level Metadata

Value Level Metadata - DA [DAORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
DAORRESDATESTCD = "DISPAMT" (Dispensed Amount)
integer2 [CRF] Annotated Case Report Form 19
DAORRESDATESTCD = "RETAMT" (Returned Amount)
integer2 [CRF] Annotated Case Report Form 19
Value Level Metadata - EG [EGORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
EGORRESEGTESTCD = "INTP" (Interpretation)
text8Interpretation: Original Results
  • "ABNORMAL"
  • "NORMAL"
[CRF] Annotated Case Report Form 12
EGORRESEGTESTCD = "PRMEAN" (Summary (Mean) PR Duration)
integer3 [CRF] Annotated Case Report Form 12
EGORRESEGTESTCD = "QRSDUR" (Summary (Mean) QRS Duration)
integer3 [CRF] Annotated Case Report Form 12
EGORRESEGTESTCD = "QTMEAN" (Summary (Mean) QT Duration)
integer3 [CRF] Annotated Case Report Form 12
EGORRESEGTESTCD = "VRMEAN" (Summary (Mean) Ventricular Rate)
integer2 [CRF] Annotated Case Report Form 12
Value Level Metadata - EG [EGSTRESC]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
EGSTRESCEGTESTCD = "QTCB" (QTcB - Bazett's Correction Formula)
float5.1Derived
QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document.

Complex Algorithms

EGSTRESCEGTESTCD = "QTCF" (QTcF - Fridericia's Correction Formula)
float5.1Derived
QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document.

Complex Algorithms

Value Level Metadata - IE [IEORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
IEORRESIETESTCD = "EXCL01" (Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 5
IEORRESIETESTCD = "EXCL02" (Is unable or unwilling to undergo multiple venipunctures)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 5
IEORRESIETESTCD = "EXCL03" (Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 5
IEORRESIETESTCD = "INCL01" (Is age 18 - 85)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 4
IEORRESIETESTCD = "INCL02" (Has Xyz disease of at least 10 weeks duration confirmed by biopsy)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 4
IEORRESIETESTCD = "INCL03" (Did not respond to a standard course of medication Abc)
text200No Yes Response
  • "N" = "No"
  • "NA" = "Not Applicable"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 4
Value Level Metadata - LB [LBORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
LBORRESLBTESTCD = "BILI" (Bilirubin)
and LBCAT = "CHEMISTRY"
and LBSPEC = "BLOOD"
float3eDT
LBORRESLBTESTCD = "BUN" (Blood Urea Nitrogen)
and LBCAT = "CHEMISTRY"
and LBSPEC = "BLOOD"
float4eDT
LBORRESLBTESTCD = "GLUC" (Glucose)
and LBCAT = "CHEMISTRY"
and LBSPEC = "BLOOD"
float3eDT
LBORRESLBTESTCD = "GLUC" (Glucose)
and LBCAT = "URINALYSIS"
and LBSPEC = "URINE"
and LBMETHOD = "DIPSTICK"
text8eDT
LBORRESLBTESTCD = "GLUC" (Glucose)
and LBCAT = "URINALYSIS"
and LBSPEC = "URINE"
and LBMETHOD = "QUANT"
text8eDT
LBORRESLBTESTCD = "HCT" (Hematocrit)
and LBCAT = "HEMATOLOGY"
and LBSPEC = "BLOOD"
float4eDT
LBORRESLBTESTCD = "HGB" (Hemoglobin)
and LBCAT = "HEMATOLOGY"
and LBSPEC = "BLOOD"
float4eDT
LBORRESLBTESTCD = "LYM" (Lymphocytes)
and LBCAT = "HEMATOLOGY"
and LBSPEC = "BLOOD"
float4eDT
LBORRESLBTESTCD = "OCCBLD" (Occult Blood)
and LBCAT = "URINALYSIS"
and LBSPEC = "URINE"
text8eDT
LBORRESLBTESTCD = "PH" (pH)
and LBCAT = "URINALYSIS"
and LBSPEC = "URINE"
float3eDT
LBORRESLBTESTCD = "VITB12" (Vitamin B12)
and LBCAT = "CHEMISTRY"
and LBSPEC = "SERUM"
integer3eDT
LBORRESLBTESTCD = "VITB9" (Vitamin B9)
and LBCAT = "CHEMISTRY"
and LBSPEC = "BLOOD"
float5eDT
Value Level Metadata - PE [PEORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
PEORRESPETESTCD = "PE01" (Appearance/Skin)
text16 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE02" (Head/Neck (Including Thyroid))
text6 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE03" (Eyes-Ears-Nose-Throat)
text13 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE04" (Cardiovascular)
text20 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE05" (Pulmonary)
text6 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE06" (Abdomen)
text6 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE07" (Neurological)
text26 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE08" (Musculoskeletal)
text6 [CRF] Annotated Case Report Form 10
PEORRESPETESTCD = "PE09" (Other)
text19 [CRF] Annotated Case Report Form 10
Value Level Metadata - QSCG [QSORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QSORRESQSTESTCD = "CGIGLOB" (Global Improvement)
integer1Global Improvement

[7 Terms]

[CRF] Annotated Case Report Form 17
Value Level Metadata - QSCS [QSORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QSORRESQSTESTCD = "CSDD01" (Anxiety)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD02" (Sadness)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD03" (Lack of Reactivity to Pleasant Events)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD04" (Irritability)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD05" (Agitation)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD06" (Retardation)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD07" (Multiple Physical Complaints)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD08" (Loss of Interest)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 14
QSORRESQSTESTCD = "CSDD09" (Appetite Loss)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD10" (Weight Loss)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD11" (Lack of Energy)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD12" (Diurnal Variation of Mood)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD13" (Difficulty Falling Asleep)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD14" (Multiple Awakenings During Sleep)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD15" (Early Morning Awakening)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD16" (Suicide)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD17" (Poor Self-Esteem)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD18" (Pessimism)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDD19" (Mood-Congruent Delusions)
integer1CUE_EXPF_X
  • 0 = "Absent"
  • 1 = "Mild or Intermittent"
  • 2 = "Severe"
[CRF] Annotated Case Report Form 15
QSORRESQSTESTCD = "CSDDTOT" (Total Score)
integer2 [CRF] Annotated Case Report Form 15
Value Level Metadata - QSMM [QSORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QSORRESQSTESTCD = "MMSEA1" (Orientation time score)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSEA2" (Orientation place score)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSEB" (Registration)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSEC" (Attention and Calculation)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSED" (Recall)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSEET" (Language)
integer1 [CRF] Annotated Case Report Form 13
QSORRESQSTESTCD = "MMSETOT" (Total Score)
integer2 [CRF] Annotated Case Report Form 13
Value Level Metadata - SC [SCORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
SCORRESSCTESTCD = "EDLEVEL" (Education Level)
text24 [CRF] Annotated Case Report Form 6
SCORRESSCTESTCD = "MARISTAT" (Marital Status)
text17Marital Status

[6 Terms]

[CRF] Annotated Case Report Form 6
SCORRESSCTESTCD = "SUBJINIT" (Subject Initials)
text3 [CRF] Annotated Case Report Form 3
Value Level Metadata - SUPPAE [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "AETRTEM"
(Treatment Emergent Flag)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise.
QVALQNAM = "HLGT"
(High Level Group Term)
text52Adverse Event Dictionary

MEDDRA 8.0

Assigned
QVALQNAM = "HLT"
(High Level Term)
text60Adverse Event Dictionary

MEDDRA 8.0

Assigned
QVALQNAM = "LLT"
(Lowest Level Term)
text18Adverse Event Dictionary

MEDDRA 8.0

Assigned
Value Level Metadata - SUPPCM [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "ATC4CODE"
(WHODRUG ATC Level 4 Code)
text5Drug Dictionary

WHODRUG 200204

Assigned
QVALQNAM = "ATC4TERM"
(ATC4 Drug Class Term)
text43Drug Dictionary

WHODRUG 200204

Assigned
QVALQNAM = "CPREFCD"
(WHODRUG Drug Code)
text11Drug Dictionary

WHODRUG 200204

Assigned
QVALQNAM = "PDDREAS"
(Reason for Discontinuation)
text21Reason for Discontinuation
  • "ONGOING"
  • "ADVERSE EVENT"
  • "INSUFFICIENT RESPONSE"
  • "SATISFACTORY RESPONSE"
  • "OTHER"
[CRF] Annotated Case Report Form 9
QVALQNAM = "PDRESP"
(Response)
text4PSRESPF
  • "GOOD"
  • "NO CHANGE"
  • "POOR"
[CRF] Annotated Case Report Form 9
Value Level Metadata - SUPPDM [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "RACE1"
(Race 1)
text5Race

[7 Terms]

[CRF] Annotated Case Report Form 6
QVALQNAM = "RACE2"
(Race 2)
text25Race

[7 Terms]

[CRF] Annotated Case Report Form 6
QVALQNAM = "RACE3"
(Race 3)
text5Race

[7 Terms]

[CRF] Annotated Case Report Form 6
QVALQNAM = "RACEOTH"
(Race, Other)
text14 [CRF] Annotated Case Report Form 6
QVALQNAM = "RAND"
(Randomized Population Flag)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 16
QVALQNAM = "RANDNO"
(Randomization Number)
text4 [CRF] Annotated Case Report Form 16
QVALQNAM = "SAFETY"
(Safety Population Flag)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise.
Value Level Metadata - SUPPEG [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "EGCLSIG"
(Clinically Significant)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
[CRF] Annotated Case Report Form 12
Value Level Metadata - SUPPEX [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "SMNO"
(Number of Tablets Per Day)
integer2 [CRF] Annotated Case Report Form 20
Value Level Metadata - SUPPLB [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "LBCLSIG"
(Clinically Significant)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.
Value Level Metadata - SUPPQSCG [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "RTRINIT"
(Rater Initials)
text3 [CRF] Annotated Case Report Form 13 14 17

QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17

Value Level Metadata - SUPPQSCS [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "RTRINIT"
(Rater Initials)
text3 [CRF] Annotated Case Report Form 13 14 17

QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17

Value Level Metadata - SUPPQSMM [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "RTRINIT"
(Rater Initials)
text3 [CRF] Annotated Case Report Form 13 14 17

QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17

Value Level Metadata - SUPPVS [QVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
QVALQNAM = "VSCLSIG"
(Clinically Significant)
text1No Yes Response Subset
  • "N" = "No"
  • "U" = "Unknown"
  • "Y" = "Yes"
Derived
Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.
Value Level Metadata - TS [TSVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
TSVALTSPARMCD = "ADDON" (Added on to Existing Treatments)
text57Protocol
TSVALTSPARMCD = "AGEMAX" (Planned Maximum Age of Subjects)
integer2Protocol
TSVALTSPARMCD = "AGEMIN" (Planned Minimum Age of Subjects)
integer2Protocol
TSVALTSPARMCD = "AGESPAN" (Age Span)
text57Protocol
TSVALTSPARMCD = "AGEU" (Age Unit)
text57Protocol
TSVALTSPARMCD = "DOSE" (Dose per Administration)
integer2Protocol
TSVALTSPARMCD = "DOSFRQ" (Dosing Frequency)
text57Protocol
TSVALTSPARMCD = "DOSU" (Dose Units)
text57Protocol
TSVALTSPARMCD = "LENGTH" (Trial Length)
text57Protocol
TSVALTSPARMCD = "OBJPRIM" (Trial Primary Objective)
text57Protocol
TSVALTSPARMCD = "OBJSEC" (Trial Secondary Objective)
text57Protocol
TSVALTSPARMCD = "PLANSUB" (Planned Number of Subjects)
integer2Protocol
TSVALTSPARMCD = "RANDOM" (Trial is Randomized)
text57Protocol
TSVALTSPARMCD = "ROUTE" (Route of Administration)
text57Protocol
TSVALTSPARMCD = "SEXPOP" (Sex of Participants)
text57Protocol
TSVALTSPARMCD = "SPONSOR" (Clinical Study Sponsor)
text57Protocol
TSVALTSPARMCD = "TBLIND" (Trial Blinding Schema)
text57Protocol
TSVALTSPARMCD = "TCNTRL" (Control Type)
text57Protocol
TSVALTSPARMCD = "TINDTP" (Trial Indication Type)
text57Protocol
TSVALTSPARMCD = "TITLE" (Trial Title)
text57Protocol
TSVALTSPARMCD = "TPHASE" (Trial Phase Classification)
text57Protocol
TSVALTSPARMCD = "TRT" (Investigational Therapy or Treatment)
text57Protocol
TSVALTSPARMCD = "TTYPE" (Trial Type)
text57Protocol
Value Level Metadata - VS [VSORRES]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
VSORRESVSTESTCD = "DIABP" (Diastolic Blood Pressure)
integer2 [CRF] Annotated Case Report Form 11
VSORRESVSTESTCD = "FRMSIZE" (Body Frame Size)
text6Size
  • "SMALL"
  • "MEDIUM"
  • "LARGE"
[CRF] Annotated Case Report Form 11
VSORRESVSTESTCD = "HEIGHT" (Height)
float5.1 [CRF] Annotated Case Report Form 11
VSORRESVSTESTCD = "PULSE" (Pulse Rate)
integer2 [CRF] Annotated Case Report Form 11
VSORRESVSTESTCD = "SYSBP" (Systolic Blood Pressure)
integer3 [CRF] Annotated Case Report Form 11
VSORRESVSTESTCD = "WEIGHT" (Weight)
float5.1 [CRF] Annotated Case Report Form 11
Value Level Metadata - VS [VSORRESU]
VariableWhereTypeLength or Display FormatControlled Terms or FormatOriginDerivation / Comment
VSORRESUVSTESTCD = "HEIGHT" (Height)
text5Unit (UH)
  • "IN" = "Inch"
  • "cm" = "Centimeter"
[CRF] Annotated Case Report Form 11
VSORRESUVSTESTCD = "WEIGHT" (Weight)
text4Unit (UW)
  • "LB" = "Pound"
  • "kg" = "Kilogram"
[CRF] Annotated Case Report Form 11

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Controlled Terms

Action Taken with Study Treatment [CL.ACN, C66767]
Permitted Value (Code)
DOSE NOT CHANGED [C49504]
DOSE REDUCED [C49505]
DRUG INTERRUPTED [C49501]
DRUG WITHDRAWN [C49502]
Domain Abbreviation (AE) [CL.AEDOM, C66734]
Permitted Value (Code)Display Value (Decode)
AE [C49562]Adverse Events
Relation to Reference Period (AEENRF) [CL.AEENRF, C66728]
Permitted Value (Code)
AFTER [C38008]
Causality [CL.AEREL]
Permitted Value (Code)
NOT RELATED
POSSIBLY RELATED
RELATED
Severity/Intensity Scale for Adverse Events [CL.AESEV, C66769]
Permitted Value (Code)Display Value (Decode)
MILD [C41338]Grade 1
MODERATE [C41339]Grade 2
SEVERE [C41340]Grade 3
Description of Planned Arm [CL.ARM]
Permitted Value (Code)
Miracle Drug 10 mg
Miracle Drug 20 mg
Placebo
Screen Failure
Planned Arm Code [CL.ARMCD]
Permitted Value (Code)Display Value (Decode)
WONDER10Miracle Drug 10 mg
WONDER20Miracle Drug 20 mg
PLACEBOPlacebo
SCRNFAILScreen Failure
Global Improvement [CL.CGIIMP_X]
Permitted Value (Code)Display Value (Decode)
1Very much improved
2Much Improved
3Minimally Improved
4No change
5Minimally worse
6Much worse
7Very much worse
Category for Medication [CL.CMCAT]
Permitted Value (Code)
CONCOMITANT MEDICATIONS
PSYCHOTROPHIC DRUG TREATMENT HISTORY
Domain Abbreviation (CM) [CL.CMDOM, C66734]
Permitted Value (Code)Display Value (Decode)
CM [C49568]Concomitant Meds
Relation to Reference Period (CMENRF) [CL.CMENRF, C66728]
Permitted Value (Code)
AFTER [C38008]
Unit (CM) [CL.CMUNIT, C71620]
Permitted Value (Code)
CAPSULE [C48480]
IU [C48579]
TABLET [C48542]
VIAL [C48551]
g [C48155]
mL [C28254]
mL/hr [*]
mL/kg [C67411]
mg [C28253]
mg/kg [C67401]
ug [C48152]
ug/kg [C67396]
Other [*]

* Extended Value

CUE_EXPF_X [CL.CUE_EXPF]
Permitted Value (Code)Display Value (Decode)
0Absent
1Mild or Intermittent
2Severe
Domain Abbreviation (DA) [CL.DADOM, C66734]
Permitted Value (Code)Display Value (Decode)
DA [C49578]Drug Accountability
Drug Accountability Test Name [CL.DATEST, C78731]
Permitted Value (Code)
Dispensed Amount [C78721]
Returned Amount [C78722]
Drug Accountability Test Code [CL.DATESTC, C78732]
Permitted Value (Code)Display Value (Decode)
DISPAMT [C78721]Dispensed Amount
RETAMT [C78722]Returned Amount
Reason for Discontinuation [CL.DDISCNT]
Permitted Value (Code)
ONGOING
ADVERSE EVENT
INSUFFICIENT RESPONSE
SATISFACTORY RESPONSE
OTHER
Domain Abbreviation (DM) [CL.DMDOM, C66734]
Permitted Value (Code)Display Value (Decode)
DM [C49572]Demographics
Category for Disposition Event [CL.DSCAT, C74558]
Permitted Value (Code)Display Value (Decode)
DISPOSITION EVENT [C74590]Disposition Event
PROTOCOL MILESTONE [C74588]Protocol Milestone
Domain Abbreviation (DS) [CL.DSDOM, C66734]
Permitted Value (Code)Display Value (Decode)
DS [C49576]Disposition
Domain Abbreviation (EG) [CL.EGDOM, C66734]
Permitted Value (Code)Display Value (Decode)
EG [C49626]Electrocardiogram
Unit (EGRESU) [CL.EGRESU, C71620]
Permitted Value (Code)Display Value (Decode)
BEATS/MIN [C49673]Beats per Minute
msec [C41140]Millisecond
ECG Test Name [CL.EGTEST, C71152]
Permitted Value (Code)
Interpretation [C41255]
QTcB - Bazett's Correction Formula [*]
QTcF - Fridericia's Correction Formula [*]
Summary (Mean) PR Duration [*]
Summary (Mean) QRS Duration [*]
Summary (Mean) QT Duration [*]
Summary (Mean) Ventricular Rate [*]

* Extended Value

ECG Test Code [CL.EGTESTC, C71153]
Permitted Value (Code)Display Value (Decode)
INTP [C41255]Interpretation
PRMEAN [*]Summary (Mean) PR Duration
QRSDUR [*]Summary (Mean) QRS Duration
QTCB [*]QTcB - Bazett's Correction Formula
QTCF [*]QTcF - Fridericia's Correction Formula
QTMEAN [*]Summary (Mean) QT Duration
VRMEAN [*]Summary (Mean) Ventricular Rate

* Extended Value

Epoch [CL.EPOCH, C99079]
Permitted Value (Code)
SCREEN [*]
TREATMENT [C101526]

* Extended Value

Ethnic Group [CL.ETHNIC, C66790]
Permitted Value (Code)
HISPANIC OR LATINO [C17459]
NOT HISPANIC OR LATINO [C41222]
Domain Abbreviation (EX) [CL.EXDOM, C66734]
Permitted Value (Code)Display Value (Decode)
EX [C49587]Exposure
Treatment [CL.EXTRT]
Permitted Value (Code)
Miracle Drug
Placebo
Frequency [CL.FREQ, C71113]
Permitted Value (Code)Display Value (Decode)
BID [C64496]BD
ONCE [C64576]Once
OTHER [C17649]Other
PRN [C64499]As needed
Q24H [C64515]Every 24 hours
QID [C64530]4 times per day
QOD [C64525]Every other day
QS [*]Every week
TID [C64527]3 times per day

* Extended Value

Pharmaceutical Dosage Form [CL.FRM, C66726]
Permitted Value (Code)Display Value (Decode)
TABLET [C42998]tab
Domain Abbreviation (IE) [CL.IEDOM, C66734]
Permitted Value (Code)Display Value (Decode)
IE [C61536]Inclusion/Exclusion
IE Tests [CL.IETEST]
Permitted Value (Code)
Did not respond to a standard course of medication Abc
Has Xyz disease of at least 10 weeks duration confirmed by biopsy
Is age 18 - 85
Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years
Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment
Is unable or unwilling to undergo multiple venipunctures
IE Test Codes [CL.IETESTC]
Permitted Value (Code)Display Value (Decode)
EXCL01Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment
EXCL02Is unable or unwilling to undergo multiple venipunctures
EXCL03Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years
INCL01Is age 18 - 85
INCL02Has Xyz disease of at least 10 weeks duration confirmed by biopsy
INCL03Did not respond to a standard course of medication Abc
Domain Abbreviation (LB) [CL.LBDOM, C66734]
Permitted Value (Code)Display Value (Decode)
LB [C49592]Laboratory Data
Unit (LBRESU) [CL.LBRESU, C71620]
Permitted Value (Code)
% [C25613]
X10^9/L [*]
g/dL [C64783]
mg/dL [C67015]
ng/dL [C67326]
pg/mL [*]

* Extended Value

Laboratory Test Name [CL.LBTEST, C67154]
Permitted Value (Code)
Bilirubin [C38037]
Blood Urea Nitrogen [C61019]
Glucose [C105585]
Hematocrit [C64796]
Hemoglobin [C64848]
Lymphocytes [C51949]
Occult Blood [C74686]
Vitamin B12 [C64817]
Vitamin B9 [C74676]
pH [C45997]
Laboratory Test Code [CL.LBTESTC, C65047]
Permitted Value (Code)Display Value (Decode)
BILI [C38037]Bilirubin
BUN [C61019]Blood Urea Nitrogen
GLUC [C105585]Glucose
HCT [C64796]Hematocrit
HGB [C64848]Hemoglobin
LYM [C51949]Lymphocytes
OCCBLD [C74686]Occult Blood
PH [C45997]pH
VITB12 [C64817]Vitamin B12
VITB9 [C74676]Vitamin B9
Marital Status [CL.MARISTT, C76348]
Permitted Value (Code)
DIVORCED [C51776]
DOMESTIC PARTNER [C53262]
LEGALLY SEPARATED [C51777]
MARRIED [C51773]
NEVER MARRIED [C51774]
WIDOWED [C51775]
Method [CL.METHOD, C85492]
Permitted Value (Code)
DIPSTICK [*]
QUANT [*]

* Extended Value

Body System or Organ Class [CL.MHBODSS]
Permitted Value (Code)
Endocrine-Metabolic
Eyes-Ears-Nose-Throat
Genitourinary
Musculoskeletal
Neurological
Category for Medical History [CL.MHCAT]
Permitted Value (Code)
MEDICAL AND SURGICAL HISTORY
PSYCHIATRIC HISTORY
Domain Abbreviation (MH) [CL.MHDOM, C66734]
Permitted Value (Code)Display Value (Decode)
MH [C49603]Medical History
Relation to Reference Period (MHENRF) [CL.MHENRF, C66728]
Permitted Value (Code)
BEFORE [C25629]
DURING/AFTER [C49640]
Interpretation: Original Results [CL.NABCLN]
Permitted Value (Code)
ABNORMAL
NORMAL
Completion/Reason for Non-Completion [CL.NOCOMPL, C66727]
Permitted Value (Code)
ADVERSE EVENT [C41331]
COMPLETED [C25250]
INFORMED CONSENT [*]
LACK OF EFFICACY [C48226]
LOST TO FOLLOW-UP [C48227]
PHYSICIAN DECISION [C48250]
PROTOCOL DEVIATION [C48251]
RANDOMIZED [*]
SCREEN FAILURE [C49628]
WITHDRAWAL BY SUBJECT [C49634]

* Extended Value

Reference Range Indicator [CL.NRIND, C78736]
Permitted Value (Code)
ABNORMAL [C78802]
HIGH [C78800]
LOW [C78801]
NORMAL [C78727]
No Yes Response Subset [CL.NY, C66742]
Permitted Value (Code)Display Value (Decode)
N [C49487]No
U [C17998]Unknown
Y [C49488]Yes
No Yes Response [CL.NYNA, C66742]
Permitted Value (Code)Display Value (Decode)
N [C49487]No
NA [C48660]Not Applicable
Y [C49488]Yes
Domain Abbreviation (PE) [CL.PEDOM, C66734]
Permitted Value (Code)Display Value (Decode)
PE [C49608]Physical Exam
PE Tests [CL.PETEST]
Permitted Value (Code)
Abdomen
Appearance/Skin
Cardiovascular
Eyes-Ears-Nose-Throat
Head/Neck (Including Thyroid)
Musculoskeletal
Neurological
Pulmonary
Other
PE Test Codes [CL.PETESTC]
Permitted Value (Code)Display Value (Decode)
PE01Appearance/Skin
PE02Head/Neck (Including Thyroid)
PE03Eyes-Ears-Nose-Throat
PE04Cardiovascular
PE05Pulmonary
PE06Abdomen
PE07Neurological
PE08Musculoskeletal
PE09Other
PSRESPF [CL.PSRESP]
Permitted Value (Code)
GOOD
NO CHANGE
POOR
Domain Abbreviation (QS) [CL.QSDOM, C66734]
Permitted Value (Code)Display Value (Decode)
QS [C49609]Questionnaires
QS Tests [CL.QSTEST]
Permitted Value (Code)
Agitation
Anxiety
Appetite Loss
Attention and Calculation
Difficulty Falling Asleep
Diurnal Variation of Mood
Early Morning Awakening
Global Improvement
Irritability
Lack of Energy
Lack of Reactivity to Pleasant Events
Language
Loss of Interest
Mood-Congruent Delusions
Multiple Awakenings During Sleep
Multiple Physical Complaints
Orientation place score
Orientation time score
Pessimism
Poor Self-Esteem
Recall
Registration
Retardation
Sadness
Suicide
Total Score
Weight Loss
QS Test Codes [CL.QSTESTC]
Permitted Value (Code)Display Value (Decode)
CGIGLOBGlobal Improvement
CSDD01Anxiety
CSDD02Sadness
CSDD03Lack of Reactivity to Pleasant Events
CSDD04Irritability
CSDD05Agitation
CSDD06Retardation
CSDD07Multiple Physical Complaints
CSDD08Loss of Interest
CSDD09Appetite Loss
CSDD10Weight Loss
CSDD11Lack of Energy
CSDD12Diurnal Variation of Mood
CSDD13Difficulty Falling Asleep
CSDD14Multiple Awakenings During Sleep
CSDD15Early Morning Awakening
CSDD16Suicide
CSDD17Poor Self-Esteem
CSDD18Pessimism
CSDD19Mood-Congruent Delusions
CSDDTOTTotal Score
MMSEA1Orientation time score
MMSEA2Orientation place score
MMSEBRegistration
MMSECAttention and Calculation
MMSEDRecall
MMSEETLanguage
MMSETOTTotal Score
Race [CL.RACE, C74457]
Permitted Value (Code)
WHITE [C41261]
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
BLACK OR AFRICAN AMERICAN [C16352]
ASIAN [C41260]
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]
OTHER [*]
MULTIPLE [*]

* Extended Value

Route of Administration [CL.ROUTE, C66729]
Permitted Value (Code)
ORAL [C38288]
SUBCUTANEOUS [C38299]
INTRAMUSCULAR [C28161]
INTRAVENOUS [C38276]
RECTAL [C38295]
TOPICAL [C38304]
NASAL [C38284]
INTRASINAL [C38262]
OTHER [*]

* Extended Value

Domain Abbreviation (SC) [CL.SCDOM, C66734]
Permitted Value (Code)Display Value (Decode)
SC [C49610]Subject Characteristics
SC Tests [CL.SCTEST, C103330]
Permitted Value (Code)
Education Level [*]
Marital Status [C25188]
Subject Initials [*]

* Extended Value

Subject Characteristic Code (SCTESTCD) [CL.SCTESTC, C74559]
Permitted Value (Code)Display Value (Decode)
EDLEVEL [*]Education Level
MARISTAT [C25188]Marital Status
SUBJINIT [*]Subject Initials

* Extended Value

Domain Abbreviation (SE) [CL.SEDOM, C66734]
Permitted Value (Code)Display Value (Decode)
SE [C49616]Subject Element
Sex [CL.SEX, C66731]
Permitted Value (Code)Display Value (Decode)
F [C16576]Female
M [C20197]Male
U [C17998]Unknown
Size [CL.SIZE, C66733]
Permitted Value (Code)
SMALL [C25376]
MEDIUM [C49507]
LARGE [C49508]
Specimen Type [CL.SPECTYP, C78734]
Permitted Value (Code)
BLOOD [C12434]
SERUM [C13325]
URINE [C13283]
Domain Abbreviation (SV) [CL.SVDOM, C66734]
Permitted Value (Code)Display Value (Decode)
SV [C49617]Subject Visits
Domain Abbreviation (TA) [CL.TADOM, C66734]
Permitted Value (Code)Display Value (Decode)
TA [C49618]Trial Arms
Domain Abbreviation (TE) [CL.TEDOM, C66734]
Permitted Value (Code)Display Value (Decode)
TE [C49619]Trial Elements
Domain Abbreviation (TI) [CL.TIDOM, C66734]
Permitted Value (Code)Display Value (Decode)
TI [C49620]Trial Inclusion/Exclusion Criteria
Reported Term for the Disposition Record [CL.TREASF]
Permitted Value (Code)
COMPLETED
DID NOT MEET INCLUSION CRITERIA #3
DISCONTINUED DUE TO ADVERSE EVENT
DISCONTINUED DUE TO CONSENT WITHDRAWEL
DISCONTINUED DUE TO LACK OF THERAPEUTIC RESPONSE
DISCONTINUED DUE TO LOST TO FOLLOW UP
DISCONTINUED DUE TO SPONSOR/INVESTIGATOR DECISION
INFORMED CONSENT OBTAINED
PATIENT DID NOT MEET INCLUSION/EXCLUSION CRITERIA AT SCREENING
PROTOCOL VIOLATION
RANDOMIZED
Domain Abbreviation (TS) [CL.TSDOM, C66734]
Permitted Value (Code)Display Value (Decode)
TS [C53483]Trial Summary
Trial Summary Parameter Test Name [CL.TSPARM, C67152]
Permitted Value (Code)
Added on to Existing Treatments [C49703]
Age Span [*]
Age Unit [*]
Clinical Study Sponsor [C70793]
Control Type [C49647]
Dose Units [C73558]
Dose per Administration [C25488]
Dosing Frequency [C89081]
Investigational Therapy or Treatment [C41161]
Planned Maximum Age of Subjects [C49694]
Planned Minimum Age of Subjects [C49693]
Planned Number of Subjects [C49692]
Route of Administration [C38114]
Sex of Participants [C49696]
Trial Blinding Schema [C49658]
Trial Indication Type [C49652]
Trial Length [C49697]
Trial Phase Classification [C48281]
Trial Primary Objective [C85826]
Trial Secondary Objective [C85827]
Trial Title [C49802]
Trial Type [C49660]
Trial is Randomized [C25196]

* Extended Value

Trial Summary Parameter Test Code [CL.TSPARMC, C66738]
Permitted Value (Code)Display Value (Decode)
ADDON [C49703]Added on to Existing Treatments
AGEMAX [C49694]Planned Maximum Age of Subjects
AGEMIN [C49693]Planned Minimum Age of Subjects
AGESPAN [*]Age Span
AGEU [*]Age Unit
DOSE [C25488]Dose per Administration
DOSFRQ [C89081]Dosing Frequency
DOSU [C73558]Dose Units
LENGTH [C49697]Trial Length
OBJPRIM [C85826]Trial Primary Objective
OBJSEC [C85827]Trial Secondary Objective
PLANSUB [C49692]Planned Number of Subjects
RANDOM [C25196]Trial is Randomized
ROUTE [C38114]Route of Administration
SEXPOP [C49696]Sex of Participants
SPONSOR [C70793]Clinical Study Sponsor
TBLIND [C49658]Trial Blinding Schema
TCNTRL [C49647]Control Type
TINDTP [C49652]Trial Indication Type
TITLE [C49802]Trial Title
TPHASE [C48281]Trial Phase Classification
TRT [C41161]Investigational Therapy or Treatment
TTYPE [C49660]Trial Type

* Extended Value

Domain Abbreviation (TV) [CL.TVDOM, C66734]
Permitted Value (Code)Display Value (Decode)
TV [C49621]Trial Visits
Unit (UH) [CL.UH, C71620]
Permitted Value (Code)Display Value (Decode)
IN [C48500]Inch
cm [C49668]Centimeter
Unit (UW) [CL.UW, C71620]
Permitted Value (Code)Display Value (Decode)
LB [C48531]Pound
kg [C28252]Kilogram
Domain Abbreviation (VS) [CL.VSDOM, C66734]
Permitted Value (Code)Display Value (Decode)
VS [C49622]Vital Signs
Units for Vital Signs Results [CL.VSRESU, C66770]
Permitted Value (Code)Display Value (Decode)
BEATS/MIN [C49673]Beats per Minute
cm [C49668]Centimeter
kg [C28252]Kilogram
mmHg [C49670]Millimeter of Mercury
Vital Signs Test Name [CL.VSTEST, C67153]
Permitted Value (Code)
Body Frame Size [C49680]
Diastolic Blood Pressure [C25299]
Height [C25347]
Pulse Rate [C49676]
Systolic Blood Pressure [C25298]
Weight [C25208]
Vital Signs Test Code [CL.VSTESTC, C66741]
Permitted Value (Code)Display Value (Decode)
DIABP [C25299]Diastolic Blood Pressure
FRMSIZE [C49680]Body Frame Size
HEIGHT [C25347]Height
PULSE [C49676]Pulse Rate
SYSBP [C25298]Systolic Blood Pressure
WEIGHT [C25208]Weight

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External Dictionaries

External Dictionaries
Reference NameExternal DictionaryDictionary Version
ISO3166 (CL.IS3166F) ISO3166
Adverse Event Dictionary (CL.AEDICT) MEDDRA8.0
Drug Dictionary (CL.DRUGDCT) WHODRUG200204

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Computational Algorithms

Computational Algorithms
MethodTypeDescription
MT.AE.AEENDYComputation
AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC
MT.AE.AESEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.AE.AESTDYComputation
AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC
MT.AE.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.CM.CMENDYComputation
CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC
MT.CM.CMSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.CM.CMSTDYComputation
CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC
MT.CM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.DA.DADYComputation
DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC.
MT.DA.DASEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.DA.DASTRESCComputation
DASTRESC = DAORRES
MT.DA.DASTRESNComputation
DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data.
MT.DA.DASTRESUComputation
DASTRESU = DAORRESU
MT.DA.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.DA.VISITNUMComputation
Derived from DADTC and SVSTDTC.
MT.DM.AGEComputation
Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document.

Complex Algorithms

MT.DM.RFENDTCComputation
RFENDTC = termination date, for safety subjects. Null for screen failures.
MT.DM.RFSTDTCComputation
RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures.
MT.DM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.DS.DSSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.DS.DSSTDYComputation
DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null.
MT.DS.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.EG.EGBLFLComputation
Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise
MT.EG.EGDRVFLComputation
EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise.

Complex Algorithms

MT.EG.EGDYComputation
EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC.
MT.EG.EGSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.EG.EGSTRESCComputation
Data collected in non-standard units is converted using standard conversion factors to standard units.
MT.EG.EGSTRESNComputation
EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data.
MT.EG.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.EX.EXDOSEComputation
If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0.
MT.EX.EXDOSUComputation
Derived from ARM, ARMCD - equal to mg
MT.EX.EXENDYComputation
EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC.
MT.EX.EXSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.EX.EXSTDYComputation
EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC.
MT.EX.EXTRTComputation
Derived from ARM, ARMCD
MT.EX.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.IE.IESEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.IE.IESTRESCComputation
IESTRESC = IEORRES
MT.IE.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.LB.LBBLFLComputation
Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise.
MT.LB.LBDYComputation
LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC.
MT.LB.LBNRINDComputation
Reference Range Indicator based upon standard results and ranges.
MT.LB.LBSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.LB.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.MH.MHSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.MH.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.PE.PEDYComputation
PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC.
MT.PE.PESEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.PE.PESTRESCComputation
PESTRESC = PEORRES
MT.PE.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.QSCG.QSDYComputation
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
MT.QSCG.QSSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.QSCG.QSSTRESCComputation
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
MT.QSCG.QSSTRESNComputation
When QSORRES is numeric then QSSTRESN equal to numeric result
MT.QSCG.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.QSCS.QSBLFLComputation
Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
MT.QSCS.QSDYComputation
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
MT.QSCS.QSSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.QSCS.QSSTRESCComputation
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
MT.QSCS.QSSTRESNComputation
When QSORRES is numeric then QSSTRESN equal to numeric result
MT.QSCS.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.QSMM.QSBLFLComputation
Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
MT.QSMM.QSDYComputation
QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
MT.QSMM.QSSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.QSMM.QSSTRESCComputation
If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
MT.QSMM.QSSTRESNComputation
When QSORRES is numeric then QSSTRESN equal to numeric result
MT.QSMM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.RELREC.RDOMAINComputation
Domain abbreviation from where data originated.
MT.RELREC.RELIDComputation
All records for the same USUBJID with the same RELID are considered related.
MT.RELREC.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SC.SCDYComputation
SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC.
MT.SC.SCSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.SC.SCSTRESCComputation
SCSTRESC = SCORRES
MT.SC.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SE.SEENDTCComputation
If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document.

Complex Algorithms

MT.SE.SESEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.SE.SESTDTCComputation
If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document.

Complex Algorithms

MT.SE.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPAE.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPAE.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPCM.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPCM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPDM.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPDM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPEG.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPEG.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPEX.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPEX.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPLB.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPLB.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPQSCG.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPQSCG.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPQSCS.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPQSCS.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPQSMM.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPQSMM.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SUPPVS.RDOMAINComputation
Domain abbreviation from where data originated.
MT.SUPPVS.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SV.SVENDTCComputation
SVENDTC = SVSTDTC
MT.SV.SVSTDTCComputation
Derived from visit-based subject-level domains
MT.SV.SVSTDYComputation
SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC.
MT.SV.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.SV.VISITComputation
Derived from visit-based subject-level domains
MT.SV.VISITNUMComputation
Derived from visit-based subject-level domains
MT.TS.TSSEQComputation
Sequential number identifying records within each TSPARM in the domain.
MT.VS.USUBJIDComputation
Concatenation of STUDYID and SUBJID
MT.VS.VSBLFLComputation
Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise.
MT.VS.VSDYComputation
VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC.
MT.VS.VSSEQComputation
Sequential number identifying records within each USUBJID in the domain.
MT.VS.VSSTRESCComputation
Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm).
MT.VS.VSSTRESNComputation
VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data.
MT.EG.EGSTRESC.WC.EG.EGSTRESC.00008Computation
QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document.

Complex Algorithms

MT.EG.EGSTRESC.WC.EG.EGSTRESC.00009Computation
QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document.

Complex Algorithms

MT.SUPPAE.QVAL.WC.SUPPAE.QVAL.00068Computation
AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise.
MT.SUPPDM.QVAL.WC.SUPPDM.QVAL.00083Computation
SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise.
MT.SUPPLB.QVAL.WC.SUPPLB.QVAL.00086Computation
Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.
MT.SUPPVS.QVAL.WC.SUPPVS.QVAL.00090Computation
Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.

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Comments

Comments
CommentOIDDescription
COM.DMSee Reviewer's Guide, Section 2.1 Demographics

Study Data Reviewer's Guide

COM.QSCGQS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

COM.QSCSQS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

COM.QSMMQS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section.

Study Data Reviewer's Guide

COM.CM.CMCLASCoded to ATC level 3 Term based on CMINDC
COM.CM.CMCLASCDCoded to ATC level 3 Code based on CMINDC
COM.CM.CMROUTEFree text from CRF mapped to CDISC CT
COM.DM.AGEUDefaulted to YEARS
COM.DM.ARMAssigned from TA.ARM based on ARMCD.
COM.DM.ARMCDAssigned based on Randomization Number. See Note 2.1

Study Data Reviewer's Guide

COM.DS.DSDECODCRF controlled terminology was mapped to match CDISC controlled terminology.
COM.EG.EGEVALEqual to INVESTIGATOR for CRF data
COM.EG.EGPOSEqual to SUPINE
COM.EG.EGSPIDECG parameter ordering variable
COM.EG.VISITNUMAssigned from the TV domain based on the VISIT
COM.IE.VISITNUMAssigned from the TV domain based on the VISIT
COM.LB.LBREFIDAccession number
COM.MH.MHBODSYSAssigned for Medical History but not Psychiatric History
COM.MH.MHENRFCRF controlled terminology was mapped to match CDISC controlled terminology.
COM.PE.VISITNUMAssigned from the TV domain based on the VISIT
COM.QSCG.VISITNUMAssigned from the TV domain based on the VISIT
COM.QSCS.VISITNUMAssigned from the TV domain based on the VISIT
COM.QSMM.VISITNUMAssigned from the TV domain based on the VISIT
COM.RELREC.IDVARName of the variables for the related records.
COM.RELREC.IDVARVALValue of identifying variable described in IDVAR.
COM.RELREC.RELTYPEAll values are null since this is used only when identifying a dataset-level relationship.
COM.SUPPAE.IDVARName of the variables for the related records.
COM.SUPPAE.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPCM.IDVARName of the variables for the related records.
COM.SUPPCM.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPDM.IDVARName of the variables for the related records.
COM.SUPPDM.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPEG.IDVARName of the variables for the related records.
COM.SUPPEG.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPEX.IDVARName of the variables for the related records.
COM.SUPPEX.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPLB.IDVARName of the variables for the related records.
COM.SUPPLB.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPQSCG.IDVARName of the variables for the related records.
COM.SUPPQSCG.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPQSCS.IDVARName of the variables for the related records.
COM.SUPPQSCS.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPQSMM.IDVARName of the variables for the related records.
COM.SUPPQSMM.IDVARVALValue of identifying variable described in IDVAR.
COM.SUPPVS.IDVARName of the variables for the related records.
COM.SUPPVS.IDVARVALValue of identifying variable described in IDVAR.
COM.VS.VISITNUMAssigned from the TV domain based on the VISIT
COM.VS.VSSTRESUStandard units consistent with CDISC controlled terminology
COM.SUPPQSCG.QVAL.WC.SUPPQSCG.QVAL.00087QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17
COM.SUPPQSCS.QVAL.WC.SUPPQSCS.QVAL.00088QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17
COM.SUPPQSMM.QVAL.WC.SUPPQSMM.QVAL.00089QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17

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