ID

8592

Description

a set of data elements recommended for mapping the electronic fields for the ADEERS system for data collection. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D9131777-7F1F-3B56-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D9131777-7F1F-3B56-E034-0003BA12F5E7

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Adverse Event Toxicity - AdEERs Screen Labels - 2264300v3.0

No Instruction available.

  1. StudyEvent: AdEERs Screen Labels
    1. No Instruction available.
AE report
Description

AE report

Alias
UMLS CUI-1
C1706741
AE_REPORT
Description

AdverseEventReportText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
Ticket Number
Description

TicketNumber

Data type

text

Amendment Number
Description

AmendmentNumber

Data type

text

REPORT_TYPE
Description

ReportType

Data type

text

Present Status
Description

AdverseEventStatusText

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25688
UMLS 2011AA Property
C0449438
Assessment Comments
Description

AdverseEventAssessmentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Review
Description

NameofReviewer

Data type

text

Death Unrelated to an AE
Description

UnrelatedAdverseEventDeathReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ObjectClass
C25328
UMLS 2011AA ObjectClass
C0445356
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
Sent to FDA?
Description

AdverseEventReportSentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
IS_24_HOUR_REPORT
Description

AdverseEvent24ReportSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
Report Created Date
Description

ReportCreatedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25375
NCI Thesaurus Property
C42620
UMLS CUI-1
C1302584
Date Submitted to Group
Description

GroupSubmittedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25695
UMLS 2011AA Property
C1515023
Date Submitted to NCI
Description

NCIFormSubmittedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25695
UMLS 2011AA Property
C1515023
Date Submitted to FDA
Description

FDAFormSubmittedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25695
UMLS 2011AA Property
C1515023
AE_CREATED_USER
Description

AdverseEventSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
ELECTRONIC_REPORT
Description

ElectronicProtocolReportSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
LEAD_OGN_ID
Description

LeadOrganizationIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19711
UMLS 2011AA ObjectClass
C1522486
NCI Thesaurus ObjectClass-2
C25552
UMLS 2011AA ObjectClass-2
C1522538
PI_ID
Description

PrincipalInvestigatorIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Reporter_information
Description

Reporter_information

First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Middle Name
Description

PersonMiddleName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Email
Description

ResponsiblePersonE-mailAddressText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Fax
Description

ResponsiblePersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Physician_information
Description

Physician_information

First Name
Description

TreatingMDFirstName

Data type

text

Last Name
Description

TreatingMDLastName

Data type

text

Middle Name
Description

PersonMiddleName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Phone
Description

TreatingMDPhone

Data type

text

Email
Description

TreatingPhysicianE-mail

Data type

text

Alias
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ValueDomain
C25170
UMLS 2011AA ValueDomain
C0013849
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Fax
Description

TreatingPhyisicanFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Submitter_information
Description

Submitter_information

First Name
Description

SubmittedByFirstName

Data type

text

Last Name
Description

SubmittedByLastName

Data type

text

Middle Name
Description

PersonMiddleName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Email
Description

ResponsiblePersonE-mailAddressText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Fax
Description

PersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
NCI Thesaurus ValueDomain-2
C25210
UMLS 2011AA ValueDomain-2
C0085205
Course_information
Description

Course_information

Treatment Assignment Code
Description

TreatmentAssignmentCode

Data type

text

Description
Description

DESCRIPTION

Data type

text

Other Treatment Assignment
Description

TreatmentAssignment

Data type

text

Start date of first course (MM/DD/YYYY)
Description

CourseStartDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25379
UMLS 2011AA ObjectClass
C0750729
NCI Metathesaurus ObjectClass
CL219258
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus Property-2
C25431
UMLS 2011AA Property-2
C0439659
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Start Date of course associated with Expedited
Description

StartDateofcourseassociatedwithExpedited

Data type

text

Start Date of Primary AE
Description

StartDateofPrimaryAE

Data type

text

End Date of Primary AE
Description

EndDateofPrimaryAE

Data type

text

Course Number on which AE occurred
Description

CourseNumberonwhichAEoccurred

Data type

text

Total number of courses to date
Description

AgentCourseCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Description_of_event
Description

Description_of_event

Description and Treatment of Event(s)
Description

DescriptionandTreatmentofEvent(s)

Data type

text

Present Status
Description

AdverseEventStatusText

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25688
UMLS 2011AA Property
C0449438
Date of Recovery or Death
Description

Recoveryordeathdate

Data type

text

Retreated
Description

Retreated

Data type

text

Removed from Protocol Treatment
Description

RemovedfromProtocolTreatment

Data type

text

Date Removed from Protocol Treatment
Description

Off-TreatmentStudyFollow-UpEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C15206
UMLS 2011AA ObjectClass-2
C0008972
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Cause of Death
Description

PatientCauseofDeathText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus ObjectClass
C28554
UMLS 2011AA ObjectClass
C0011065
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
Primary Organ System failure Causing Death
Description

PrimaryOrganSystemfailureCausingDeath

Data type

text

Death Date
Description

DeathDocumentedDate

Data type

date

Autopsy Performed
Description

AutopsyPerformed

Data type

text

Institution_information
Description

Institution_information

Institution
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
CTEP ID
Description

CTEPID

Data type

text

INSTITUTION_ID
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Protocol_information
Description

Protocol_information

NCI_PROTOCOL_NUMBER_ID
Description

Protocol ID NCI

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1513882
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19202
Title
Description

Protocol Title

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Phase
Description

Phase

Data type

text

Protocol Status
Description

CurrentProtocolStatus

Data type

text

Type of Study
Description

TypeofStudy

Data type

text

Lead Institution
Description

LeadInstitution

Data type

text

Principal Investigator
Description

PrincipalInvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Lead Drug Monitor
Description

LeadDrugMonitor

Data type

text

CTCAE Version
Description

CTCAEVersion

Data type

text

NCI_PROTOCOL_NUMBER_ID
Description

Protocol ID NCI

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1513882
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19202
Patient_information
Description

Patient_information

Patient ID
Description

Patient'sIDNumber

Data type

text

Birth Date (MM/YYYY)
Description

Patient Birth Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Race
Description

PatientRaceCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Gender
Description

PatientGenderCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Ethnicity
Description

PatientEthnicityCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C29933
Height
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Baseline Performance status at Initiation of protocol ECOG/Zubrod scale
Description

PerformanceStatusScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Disease Name
Description

DiseaseName

Data type

text

Disease Category
Description

DiseaseCategory

Data type

text

Disease Name Not Listed
Description

DiseaseNameNotListed

Data type

text

Primary Site of Disease
Description

PrimarySiteofDisease

Data type

text

Date of Initial Diagnosis
Description

CancerInitialDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Other Primary Site of Disease
Description

OtherPrimarySiteofDisease

Data type

text

Prior_therapy
Description

Prior_therapy

Therapy
Description

Therapy Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1299575
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Therapy Start Date
Description

Treatment Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25509
UMLS CUI-1
C3173309
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Therapy End Date
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Chemoagents
Description

Chemoagents

Agent
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Pre_existing_condition
Description

Pre_existing_condition

Pre-Existing Condition
Description

Pre-ExistingCondition

Data type

text

Other Pre-Existing Condition
Description

OtherPre-ExistingCondition

Data type

text

Site_name
Description

Site_name

Site of Metastatic Disease
Description

SiteofMetastaticDisease

Data type

text

Other Body Site
Description

OtherBodySiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Protocol_agent
Description

Protocol_agent

Agent
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
NSC
Description

AgentNSC/GPIIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C41244
Total Dose Administered this course
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Last Administered Date
Description

DateofLastAdministrationpriortoSAE

Data type

text

Total Dose UOM
Description

Units

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1519795
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25709
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Agent Adjustment
Description

AgentAdjustment

Data type

text

Agent Delayed
Description

DoseDelayedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Delay
Description

Delay

Data type

text

Delay UOM
Description

DelayUOM

Data type

text

Concomitant_medication
Description

Concomitant_medication

Name of Concomitant Medication
Description

NameofConcomitantMedication

Data type

text

CONCOM_REPORTED_BY
Description

CONCOM_REPORTED_BY

Data type

text

Other_contributing_cause
Description

Other_contributing_cause

Other Contributing Cause
Description

OtherContributingCause

Data type

text

Cause Reported by
Description

CauseReportedby

Data type

text

Adverse_event_ctc
Description

Adverse_event_ctc

Category
Description

Category

Data type

text

Adverse Event (Latest CTCAE Version)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
MedDRA Code (Latest CTCAE Version)
Description

MedDRACode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Grade (Latest CTCAE Version)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Adverse Event (Latest CTCAE Version)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
Adverse Event (Latest CTCAE Version)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTCAE Category (Latest CTCAE Version)
Description

CTCAdverseEventCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Adverse Event (Latest CTCAE Version)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
MedDRA Code (Latest CTCAE Version)
Description

MedDRACode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Grade (Latest CTCAE Version)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Other Adverse Event (specify)
Description

CTCAdverseEventTerm,Specify

Data type

text

Hospitalization/Prolongation of Hospitalization
Description

Hospitalization or Prolongation of Hospitalization

Data type

boolean

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
AE_REPORTED_BY
Description

AE_REPORTED_BY

Data type

text

LATEST_VERSION_GRADE_ID
Description

LATEST_VERSION_GRADE_ID

Data type

text

Attribution_for_ae
Description

Attribution_for_ae

ATTRIBUTED_TO_TYPE
Description

ATTRIBUTED_TO_TYPE

Data type

text

ATTRIBUTED_TO
Description

ATTRIBUTED_TO

Data type

text

ATTRIBUTED_TO_BY
Description

ATTRIBUTED_TO_BY

Data type

text

Attribution
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Attribution By
Description

AttributionBy

Data type

text

Lab_result
Description

Lab_result

Lab Category
Description

LabCategory

Data type

text

Lab
Description

Lab

Data type

text

Other Lab
Description

OtherLab

Data type

text

Baseline Date
Description

BaselineDate

Data type

text

Baseline Value
Description

BaselineValue

Data type

text

Baseline UOM
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Recovery Latest Date
Description

RecoveryLatestDate

Data type

text

Recovery Latest Value
Description

RecoveryLatestValue

Data type

text

Recovery Latest UOM
Description

RecoveryLatestUOM

Data type

text

Worst Date
Description

WorstDate

Data type

text

Worst Value
Description

WorstValue

Data type

text

Worst UOM
Description

WorstUOM

Data type

text

Site
Description

Site

Data type

text

Microbiology Date
Description

Microbiology Date

Data type

date

Infectious Agent
Description

InfectiousAgentName

Data type

text

Alias
NCI Metathesaurus ObjectClass
CL031041
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Additional_info
Description

Additional_info

Additional Information
Description

AdditionalInformation

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: AdEERs Screen Labels
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
AE report
C1706741 (UMLS CUI-1)
AdverseEventReportText
Item
AE_REPORT
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
TicketNumber
Item
Ticket Number
text
AmendmentNumber
Item
Amendment Number
text
ReportType
Item
REPORT_TYPE
text
AdverseEventStatusText
Item
Present Status
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus Property)
C0449438 (UMLS 2011AA Property)
AdverseEventAssessmentText
Item
Assessment Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
NameofReviewer
Item
Review
text
UnrelatedAdverseEventDeathReason
Item
Death Unrelated to an AE
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25328 (NCI Thesaurus ObjectClass)
C0445356 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
AdverseEventReportSentSpecify
Item
Sent to FDA?
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
AdverseEvent24ReportSpecify
Item
IS_24_HOUR_REPORT
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
Report Created Date
Item
Report Created Date
date
C25164 (NCI Thesaurus ValueDomain)
C25375 (NCI Thesaurus ObjectClass)
C42620 (NCI Thesaurus Property)
C1302584 (UMLS CUI-1)
GroupSubmittedDate
Item
Date Submitted to Group
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)
NCIFormSubmittedDate
Item
Date Submitted to NCI
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)
FDAFormSubmittedDate
Item
Date Submitted to FDA
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)
AdverseEventSpecify
Item
AE_CREATED_USER
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
ElectronicProtocolReportSpecify
Item
ELECTRONIC_REPORT
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
LeadOrganizationIdentifierNumber
Item
LEAD_OGN_ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19711 (NCI Thesaurus ObjectClass)
C1522486 (UMLS 2011AA ObjectClass)
C25552 (NCI Thesaurus ObjectClass-2)
C1522538 (UMLS 2011AA ObjectClass-2)
PrincipalInvestigatorIdentifierNumber
Item
PI_ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
Item Group
Reporter_information
PersonCompletingForm,FirstName
Item
First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Person Completing Form Last Name
Item
Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
PersonMiddleName
Item
Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
ResponsiblePersonE-mailAddressText
Item
Email
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
ResponsiblePersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
Item Group
Physician_information
TreatingMDFirstName
Item
First Name
text
TreatingMDLastName
Item
Last Name
text
PersonMiddleName
Item
Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
TreatingMDPhone
Item
Phone
text
TreatingPhysicianE-mail
Item
Email
text
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25170 (NCI Thesaurus ValueDomain)
C0013849 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
TreatingPhyisicanFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
Item Group
Submitter_information
SubmittedByFirstName
Item
First Name
text
SubmittedByLastName
Item
Last Name
text
PersonMiddleName
Item
Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
ResponsiblePersonE-mailAddressText
Item
Email
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
PersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
C25210 (NCI Thesaurus ValueDomain-2)
C0085205 (UMLS 2011AA ValueDomain-2)
Item Group
Course_information
TreatmentAssignmentCode
Item
Treatment Assignment Code
text
DESCRIPTION
Item
Description
text
TreatmentAssignment
Item
Other Treatment Assignment
text
CourseStartDate
Item
Start date of first course (MM/DD/YYYY)
date
C25379 (NCI Thesaurus ObjectClass)
C0750729 (UMLS 2011AA ObjectClass)
CL219258 (NCI Metathesaurus ObjectClass)
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property-2)
C0439659 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
StartDateofcourseassociatedwithExpedited
Item
Start Date of course associated with Expedited
text
StartDateofPrimaryAE
Item
Start Date of Primary AE
text
EndDateofPrimaryAE
Item
End Date of Primary AE
text
CourseNumberonwhichAEoccurred
Item
Course Number on which AE occurred
text
AgentCourseCount
Item
Total number of courses to date
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Item Group
Description_of_event
DescriptionandTreatmentofEvent(s)
Item
Description and Treatment of Event(s)
text
AdverseEventStatusText
Item
Present Status
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus Property)
C0449438 (UMLS 2011AA Property)
Recoveryordeathdate
Item
Date of Recovery or Death
text
Retreated
Item
Retreated
text
RemovedfromProtocolTreatment
Item
Removed from Protocol Treatment
text
Off-TreatmentStudyFollow-UpEndDate
Item
Date Removed from Protocol Treatment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
PatientCauseofDeathText
Item
Cause of Death
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ObjectClass)
C0011065 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
PrimaryOrganSystemfailureCausingDeath
Item
Primary Organ System failure Causing Death
text
DeathDocumentedDate
Item
Death Date
date
AutopsyPerformed
Item
Autopsy Performed
text
Item Group
Institution_information
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Code List
Institution
CL Item
CTEP Enterprise (CTEP Enterprise)
CTEPID
Item
CTEP ID
text
Institution Number
Item
INSTITUTION_ID
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Item Group
Protocol_information
Protocol ID NCI
Item
NCI_PROTOCOL_NUMBER_ID
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1513882 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19202 (NCI Thesaurus Property-2)
Protocol Title
Item
Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Phase
Item
Phase
text
CurrentProtocolStatus
Item
Protocol Status
text
TypeofStudy
Item
Type of Study
text
LeadInstitution
Item
Lead Institution
text
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
LeadDrugMonitor
Item
Lead Drug Monitor
text
CTCAEVersion
Item
CTCAE Version
text
Protocol ID NCI
Item
NCI_PROTOCOL_NUMBER_ID
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1513882 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19202 (NCI Thesaurus Property-2)
Item Group
Patient_information
Patient'sIDNumber
Item
Patient ID
text
Patient Birth Date
Item
Birth Date (MM/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment (American Indian or Alaska Native)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
More than one race (More than one race)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
Code List
Gender
CL Item
Male (Male)
CL Item
Female (Female)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29933 (NCI Thesaurus Property)
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race (Hispanic or Latino)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Patient Refused Or Data Not Available (Not Reported)
CL Item
Patient Is Unsure Of Their Ethnicity (Unknown)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
Baseline Performance status at Initiation of protocol ECOG/Zubrod scale
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Baseline Performance status at Initiation of protocol ECOG/Zubrod scale
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
Item
Disease Name
text
Code List
Disease Name
CL Item
Based on MedDRA v6.0 (Based on MedDRA v6.0)
DiseaseCategory
Item
Disease Category
text
DiseaseNameNotListed
Item
Disease Name Not Listed
text
Item
Primary Site of Disease
text
Code List
Primary Site of Disease
CL Item
CTEP Enterprise (CTEP Enterprise)
CancerInitialDiagnosisDate
Item
Date of Initial Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
OtherPrimarySiteofDisease
Item
Other Primary Site of Disease
text
Item Group
Prior_therapy
Item
Therapy
text
C25191 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Code List
Therapy
CL Item
Based on MedDRA v6.0 (Based on MedDRA v6.0)
Treatment Start Date
Item
Therapy Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C3173309 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
Therapy End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Chemoagents
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Code List
Agent
CL Item
CTEP Enterprise (CTEP Enterprise)
Item Group
Pre_existing_condition
Pre-ExistingCondition
Item
Pre-Existing Condition
text
Item
Other Pre-Existing Condition
text
Code List
Other Pre-Existing Condition
CL Item
Based on MedDRA v6.0 (Based on MedDRA v6.0)
Item Group
Site_name
Item
Site of Metastatic Disease
text
Code List
Site of Metastatic Disease
CL Item
CTEP Enterprise (CTEP Enterprise)
OtherBodySiteText
Item
Other Body Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Item Group
Protocol_agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Code List
Agent
CL Item
CTEP Enterprise (CTEP Enterprise)
AgentNSC/GPIIdentifierNumber
Item
NSC
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C41244 (NCI Thesaurus Property-2)
Agent Total Dose
Item
Total Dose Administered this course
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
DateofLastAdministrationpriortoSAE
Item
Last Administered Date
text
Item
Total Dose UOM
text
C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
Code List
Total Dose UOM
CL Item
Curie (Ci)
C0700085 (NCI Metathesaurus)
CL Item
Gram-equivalent Weight (Eq)
CL Item
Hertz (Hz)
CL Item
International Unit (IU)
C28255 (NCI Thesaurus)
CL Item
Joules Per Centimeter Square (JCM2)
CL Item
Liter (L)
CL Item
Meter (MHz)
C0475209 (NCI Metathesaurus)
CL Item
Millimeter (MMM)
C28251 (NCI Thesaurus)
C0439200 (UMLS 2011AA)
CL Item
Million Electron Volts (MeV)
CL Item
Megarad (Mrad)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Osmole (Osmol)
CL Item
Pascal (Pa)
C42547 (NCI Thesaurus)
C0439473 (UMLS 2011AA)
CL Item
Percent (Percent)
C48570 (NCI Thesaurus)
C0439165 (UMLS 2011AA)
CL Item
Tissue Culture Infections Dose (TCID)
CL Item
Viral Particles (VP)
CL Item
Billion Pfu (billion pfu)
CL Item
Cells (cells)
CL Item
Centimeter (cm)
C49668 (NCI Thesaurus)
C0475210 (UMLS 2011AA)
CL Item
Deciliter (dL)
CL Item
Decimeter (dm)
CL Item
Gram (g)
C0439208 (NCI Metathesaurus)
CL Item
Gravity (in Centrifugation) (gravity)
CL Item
Kilohertz (kHz)
CL Item
Kilopascal (kPa)
CL Item
Kilo-electron Volt (keV)
CL Item
Kilogram (kg)
C28252 (NCI Thesaurus)
C0439209 (UMLS 2011AA)
CL Item
Meter (m)
C0475209 (NCI Metathesaurus)
CL Item
Millicurie (mCi)
CL Item
Milliequivalent (mEq)
CL Item
Milliliter (mL)
C28254 (NCI Thesaurus)
C0439242 (UMLS 2011AA)
CL Item
Milliosmole (mOsmol)
CL Item
Million Unit (mU)
CL Item
Millivolt (mV)
C0456691 (NCI Metathesaurus)
CL Item
mVP (mVP)
CL Item
Microcurie (mcCi)
CL Item
Microliter (mcL)
CL Item
Microgram (mcg)
CL Item
Micrometer (mcm)
CL Item
Micromole (mcmol)
C48509 (NCI Thesaurus)
C0439194 (UMLS 2011AA)
CL Item
Milligram (mg)
C28253 (NCI Thesaurus)
C0439210 (UMLS 2011AA)
CL Item
Million International Units (million IU)
CL Item
Million Pfu (million pfu)
CL Item
Milliunit (milliunit)
CL Item
Millimeter (mm)
C28251 (NCI Thesaurus)
C0439200 (UMLS 2011AA)
CL Item
Millimole (mmol)
CL Item
Gram-molecular Weight (mole) (mol)
CL Item
Nanocurie (nCi)
C0560007 (NCI Metathesaurus)
CL Item
Nanogram (ng)
CL Item
Nanometer (nm)
C0439202 (NCI Metathesaurus)
CL Item
Nanometers Of Light (nm light)
CL Item
Plaque Forming Unit (pfu)
CL Item
Picogram (pg)
C0439213 (NCI Metathesaurus)
CL Item
Pounds Per Square Inch (psi)
C0439472 (NCI Metathesaurus)
CL Item
Unit (unit)
C44278 (NCI Thesaurus)
C0439148 (UMLS 2011AA)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item
Agent Adjustment
text
Code List
Agent Adjustment
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose reduced (Dose reduced)
CL Item
Drug withdrawn (Drug withdrawn)
CL Item
Not applicable (Not applicable)
DoseDelayedInd-3
Item
Agent Delayed
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
Delay
Item
Delay
text
DelayUOM
Item
Delay UOM
text
Item Group
Concomitant_medication
NameofConcomitantMedication
Item
Name of Concomitant Medication
text
CONCOM_REPORTED_BY
Item
CONCOM_REPORTED_BY
text
Item Group
Other_contributing_cause
OtherContributingCause
Item
Other Contributing Cause
text
CauseReportedby
Item
Cause Reported by
text
Item Group
Adverse_event_ctc
Category
Item
Category
text
CTC Adverse Event Term
Item
Adverse Event (Latest CTCAE Version)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
MedDRACode
Item
MedDRA Code (Latest CTCAE Version)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTC Adverse Event Grade
Item
Grade (Latest CTCAE Version)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
CTC Adverse Event Term
Item
Adverse Event (Latest CTCAE Version)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Term
Item
Adverse Event (Latest CTCAE Version)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTCAdverseEventCategory
Item
CTCAE Category (Latest CTCAE Version)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CTC Adverse Event Term
Item
Adverse Event (Latest CTCAE Version)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
MedDRACode
Item
MedDRA Code (Latest CTCAE Version)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTC Adverse Event Grade
Item
Grade (Latest CTCAE Version)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
CTCAdverseEventTerm,Specify
Item
Other Adverse Event (specify)
text
Hospitalization or Prolongation of Hospitalization
Item
Hospitalization/Prolongation of Hospitalization
boolean
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
AE_REPORTED_BY
Item
AE_REPORTED_BY
text
LATEST_VERSION_GRADE_ID
Item
LATEST_VERSION_GRADE_ID
text
Item Group
Attribution_for_ae
ATTRIBUTED_TO_TYPE
Item
ATTRIBUTED_TO_TYPE
text
ATTRIBUTED_TO
Item
ATTRIBUTED_TO
text
ATTRIBUTED_TO_BY
Item
ATTRIBUTED_TO_BY
text
Item
Attribution
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
Attribution
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
AttributionBy
Item
Attribution By
text
Item Group
Lab_result
Item
Lab Category
text
Code List
Lab Category
CL Item
Bone Marrow Biopsy (Bone Marrow Biopsy)
CL Item
Chemistry (Chemistry)
CL Item
Coagulation (Coagulation)
CL Item
Hematologic (Hematologic)
CL Item
Microbiology (Microbiology)
CL Item
Respiratory (Respiratory)
Item
Lab
text
Code List
Lab
CL Item
ANC (ANC)
CL Item
Activated partial thromboplastin time (APTT) (Activated partial thromboplastin time (APTT))
CL Item
Albumin - blood (Albumin - blood)
CL Item
Alkaline phosphates NOS (Alkaline phosphates NOS)
CL Item
Amylase - blood (Amylase - blood)
CL Item
Bacterial infection NOS (Bacterial infection NOS)
CL Item
Bilirubin direct - blood (Bilirubin direct - blood)
CL Item
Bilirubin total - blood (Bilirubin total - blood)
CL Item
Blood Urea Nitrogen (BUN) (Blood Urea Nitrogen (BUN))
CL Item
Blood bicarbonate (Blood bicarbonate)
CL Item
Blood carbon dioxide (Blood carbon dioxide)
CL Item
Blood neutrophils (ANC) (Blood neutrophils (ANC))
CL Item
Bone Marrow Cellularity (Bone Marrow Cellularity)
CL Item
Bone Marrow blasts (Bone Marrow blasts)
CL Item
Calcium - blood (Ca) (Calcium - blood (Ca))
CL Item
Carbon dioxide - blood (CO2) (Carbon dioxide - blood (CO2))
CL Item
Chloride - blood (Chloride - blood)
CL Item
Cholesterol - blood (Cholesterol - blood)
CL Item
Creatine phosphokinase - blood (CK) (Creatine phosphokinase - blood (CK))
CL Item
Creatinine - serum (Cr) (Creatinine - serum (Cr))
CL Item
Creatinine clearance (CrCl) (Creatinine clearance (CrCl))
CL Item
Fibrin D-dimer (Fibrin D-dimer)
CL Item
Fibrin degradation products (FDP) (Fibrin degradation products (FDP))
CL Item
Fibrinogen - blood (Fibrinogen - blood)
CL Item
Fungal infection NOS (Fungal infection NOS)
CL Item
Glucose - blood (Glucose - blood)
CL Item
Glutamic-oxaloacetic transferase (AST, SGOT) (Glutamic-oxaloacetic transferase (AST, SGOT))
CL Item
Glutamic-pyruvate transferase (ALT, SGPT) (Glutamic-pyruvate transferase (ALT, SGPT))
CL Item
Hematocrit (Hct) (Hematocrit (Hct))
CL Item
Hemoglobin (Hb) (Hemoglobin (Hb))
CL Item
International normalised ratio (INR) (International normalised ratio (INR))
CL Item
Lactate dehydrogenase - blood (LDH) (Lactate dehydrogenase - blood (LDH))
CL Item
Lipase (Lipase)
CL Item
Magnesium - blood (Mg) (Magnesium - blood (Mg))
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
Peripheral Blasts count (Peripheral Blasts count)
CL Item
Phosphorus (Phosphorus)
CL Item
Platelet count (PLT) (Platelet count (PLT))
CL Item
Potassium - blood (K) (Potassium - blood (K))
CL Item
Protein NOS (Total) (Protein NOS (Total))
CL Item
Prothrombin time (PT) (Prothrombin time (PT))
CL Item
Sodium - blood (Sodium - blood)
CL Item
Triglycerides (Triglycerides)
CL Item
Urine analysis (Urine analysis)
CL Item
Viral infection NOS (Viral infection NOS)
CL Item
White blood cell count (WBC) (White blood cell count (WBC))
CL Item
pH NOS (pH NOS)
CL Item
pO2 (pO2)
OtherLab
Item
Other Lab
text
BaselineDate
Item
Baseline Date
text
BaselineValue
Item
Baseline Value
text
Item
Baseline UOM
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
Code List
Baseline UOM
CL Item
Percent (%)
CL Item
1000 Per Cubic Millimiter (1000/mm3)
CL Item
10^3 Per Microliter (1000/uL)
CL Item
Cubic Centimeters Per Minute (cc/min)
CL Item
Cells Per Liter (cells/L)
CL Item
Grams Per Deciliter (g/dL)
CL Item
Grams Per Liter (g/L)
CL Item
Grams (gm)
CL Item
Grams Per Deciliter (gm/dl)
CL Item
International Units Per Liter (iU/L)
CL Item
Kilopascal (kPa)
CL Item
Milliequivalent Per Liter (mEq/L)
CL Item
Milligrams Per Deciliter (mg/dL)
CL Item
mg/dl (mg/dl)
CL Item
Milligrams Per Liter (mg/L)
CL Item
Minutes (min)
CL Item
Milliliters Per Minute (mL/Min/1.73m2)
CL Item
Cubic Millimeters (mm3)
CL Item
Millimeters Of Mercury (mmHg)
CL Item
Millimole Per Liter (mmol/L)
CL Item
Not Applicable (n/a)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Number (number)
C25337 (NCI Thesaurus)
C0237753 (UMLS 2011AA)
CL Item
Seconds (seconds)
C0457385 (NCI Metathesaurus)
CL Item
Units Per Liter (U/L)
CL Item
ug/mL (ug/mL)
CL Item
ul (ul)
CL Item
umol/L (umol/L)
CL Item
Vol Frac (Vol Frac)
RecoveryLatestDate
Item
Recovery Latest Date
text
RecoveryLatestValue
Item
Recovery Latest Value
text
RecoveryLatestUOM
Item
Recovery Latest UOM
text
WorstDate
Item
Worst Date
text
WorstValue
Item
Worst Value
text
WorstUOM
Item
Worst UOM
text
Site
Item
Site
text
Microbiology Date
Item
Microbiology Date
date
InfectiousAgentName
Item
Infectious Agent
text
CL031041 (NCI Metathesaurus ObjectClass)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item Group
Additional_info
Item
Additional Information
text
Code List
Additional Information
CL Item
Autopsy Report (Autopsy Report)
CL Item
Consults (Consults)
CL Item
Discharge Summary (Discharge Summary)
CL Item
Flow Sheets/ Case Report Forms (Flow Sheets/ Case Report Forms)
CL Item
Laboratory Reports (Laboratory Reports)
CL Item
OBA Form (OBA Form)
CL Item
Other (Other)
CL Item
Pathology Report (Pathology Report)
CL Item
Progress Notes (Progress Notes)
CL Item
Radiology Reports (Radiology Reports)
CL Item
Referral Letters (Referral Letters)
CL Item
Summary Report Sent to IRB (Summary Report Sent to IRB)
CL Item
Operative Report (Operative Report)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial