Adverse Event Toxicity - AdEERs Screen Labels - 2264300v3.0 - Portal för medicinska datamodeller (MDM-portal)

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)
C0439064 (UMLS 2011AA ObjectClass)

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)
C0877248 (UMLS 2011AA ObjectClass)

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)
C0439064 (UMLS 2011AA ObjectClass)

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)
C0439064 (UMLS 2011AA ObjectClass)

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)
C1522538 (UMLS 2011AA ObjectClass)

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)

PersonCompletingForm,FirstName

Item

First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ResponsiblePersonLastName

Item

Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA 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)

ResponsiblePersonPhoneNumber

Item

Phone

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA 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)
C1273518 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)

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)

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)

ResponsiblePersonPhoneNumber

Item

Phone

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA 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)
C0085205 (UMLS 2011AA ValueDomain)

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)
C0439659 (UMLS 2011AA Property)
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

double

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

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)
C0008972 (UMLS 2011AA ObjectClass)
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)
C0205225 (UMLS 2011AA Property)

PrimaryOrganSystemfailureCausingDeath

Item

Primary Organ System failure Causing Death

text

DeathDocumentedDate

Item

Death Date

date

AutopsyPerformed

Item

Autopsy Performed

text

InstitutionName

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CL.1

Code List

Institution

CL Item

CTEP Enterprise (CTEP Enterprise)

CTEPID

Item

CTEP ID

text

InstitutionIdentifierNumber

Item

INSTITUTION_ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolNCIIdentifierNumber

Item

NCI_PROTOCOL_NUMBER_ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus Property)
C1513882 (UMLS 2011AA Property)

ProtocolTitleName

Item

Title

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA 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

ProtocolNCIIdentifierNumber

Item

NCI_PROTOCOL_NUMBER_ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus Property)
C1513882 (UMLS 2011AA Property)

Patient'sIDNumber

Item

Patient ID

text

PatientBirthDate

Item

Birth Date (MM/YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

PatientRaceCategory

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)

CL.2

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)

PatientGenderCategory

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)

CL.3

Code List

Gender

CL Item

Male (Male)

CL Item

Female (Female)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientEthnicityCategory

Item

Ethnicity

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29933 (NCI Thesaurus Property)

CL.4

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)

PatientHeightMeasurement

Item

Height

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PerformanceStatusScale

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)

CL.5

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)

DiseaseName

Item

Disease Name

text

CL.6

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

PrimarySiteofDisease

Item

Primary Site of Disease

text

CL.7

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)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

OtherPrimarySiteofDisease

Item

Other Primary Site of Disease

text

TherapyModificationName

Item

Therapy

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

CL.8

Code List

Therapy

CL Item

Based on MedDRA v6.0 (Based on MedDRA v6.0)

FirstTreatmentBeginDate

Item

Therapy Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

TreatmentEndDate

Item

Therapy End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

AgentName

Item

Agent

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.11

Code List

Agent

CL Item

CTEP Enterprise (CTEP Enterprise)

Pre-ExistingCondition

Item

Pre-Existing Condition

text

OtherPre-ExistingCondition

Item

Other Pre-Existing Condition

text

CL.9

Code List

Other Pre-Existing Condition

CL Item

Based on MedDRA v6.0 (Based on MedDRA v6.0)

SiteofMetastaticDisease

Item

Site of Metastatic Disease

text

CL.10

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)

AgentName

Item

Agent

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.11

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)

AgentCourseTotalDose

Item

Total Dose Administered this course

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

DateofLastAdministrationpriortoSAE

Item

Last Administered Date

text

AgentDoseUOM

Item

Total Dose UOM

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.12

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)

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

AgentAdjustment

Item

Agent Adjustment

text

CL.13

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

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)

CL.14

Code List

Agent Delayed

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Delay

Item

Delay

text

DelayUOM

Item

Delay UOM

text

NameofConcomitantMedication

Item

Name of Concomitant Medication

text

CONCOM_REPORTED_BY

Item

CONCOM_REPORTED_BY

text

OtherContributingCause

Item

Other Contributing Cause

text

CauseReportedby

Item

Cause Reported by

text

ID

Beskrivning

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

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