ID

11379

Beskrivning

PRL1013: Adverse Event Form NCT01268605 Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial (POH RCERT) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A651C58C-D9BC-9A03-E040-BB89AD4309CC

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A651C58C-D9BC-9A03-E040-BB89AD4309CC

Nyckelord

Versioner (3)
  1. 2012-08-27 2012-08-27 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-07-03 2015-07-03 -
Uppladdad den

3 juli 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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PRL1013: Adverse Event Form NCT01268605

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: PRL1013: Adverse Event Form
    1. No Instruction available.
Header Module
Beskrivning

Header Module

Site Number
Beskrivning

PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus ObjectClass-2
C37901
UMLS 2011AA ObjectClass-2
C0205145
NCI Thesaurus ObjectClass-3
C52664
UMLS 2011AA ObjectClass-3
C1709628
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient ID
Beskrivning

PatientIdentifier

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Date of visit
Beskrivning

PatientDentistVisitDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C52654
UMLS 2011AA Property
C0011441
NCI Thesaurus Property-2
C25716
UMLS 2011AA Property-2
C0545082
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Adverse event assessment
Beskrivning

Adverse event assessment

Adverse Event description
Beskrivning

AdverseEventTreatingDescriptionText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25705
UMLS 2011AA Property
C1522326
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Adverse Event Onset Date
Beskrivning

Adverse Event Onset Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Severity of event
Beskrivning

AdverseEventSeverityType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Relation of event to restoration on study tooth/teeth
Beskrivning

AdverseEventDentalRestorationAttributionScale

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C60718
UMLS 2011AA Property
C0399059
NCI Thesaurus Property-2
C25358
UMLS 2011AA Property-2
C0596130
Was this event expected or anticipated
Beskrivning

AdverseEventExpectedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25501
UMLS 2011AA Property
C1517001
Restoration replaced
Beskrivning

Resin-BasedCompositeTherapyReplacementPerformedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C52586
UMLS 2011AA ObjectClass
C1711229
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C53610
UMLS 2011AA Property-2
C0559956
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Restoration replaced with temporary or sedative dressing
Beskrivning

Resin-BasedCompositeTherapySedativeFillingPerformedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C52586
UMLS 2011AA ObjectClass
C1711229
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C62295
UMLS 2011AA Property-2
C1947975
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pulpectomy and temporization
Beskrivning

Resin-BasedCompositeTherapyPulpectomyPerformedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C52586
UMLS 2011AA ObjectClass
C1711229
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C52550
UMLS 2011AA Property-2
C1705872
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Endodontic therapy or referral
Beskrivning

EndodonticTreatmentPerformedIndicator

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C52575
UMLS 2011AA ObjectClass
C0700632
Extraction
Beskrivning

ToothExtractionPerformedIndicator

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C12506
UMLS 2011AA ObjectClass
C0040426
NCI Thesaurus ObjectClass-2
C61575
UMLS 2011AA ObjectClass-2
C0185115
New medication taken
Beskrivning

NewAgentAdministeredInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Hospitalization
Beskrivning

AdverseEventRequiredHospitalizationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property-2
C25179
UMLS 2011AA Property-2
C0019993
Other
Beskrivning

AdverseEventOtherResultInd-3

Datatyp

boolean

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
Specify
Beskrivning

AdverseEventOtherResultSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
Outcome of event
Beskrivning

AdverseEventDentalResultType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C41136
UMLS 2011AA Property-2
C0226984
Date of resolution (If "Resolved",)
Beskrivning

AdverseEventResolutionDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
Was this considered a Serious Adverse Event
Beskrivning

SeriousAdverseEventReportInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C54035
UMLS 2011AA ObjectClass-2
C0205404
Death
Beskrivning

SeriousAdverseEventDeathResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Life-threatening
Beskrivning

SeriousAdverseEventLifeThreateningorDisablingResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus Property-2
C41337
UMLS 2011AA Property-2
C1517874
Disability/Incapacity
Beskrivning

SeriousAdverseEventDisabilityResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C21007
UMLS 2011AA Property
C0231170
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Congenital abnormality
Beskrivning

SeriousAdverseEventCongenitalAbnormalityResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus Property-2
C2849
UMLS 2011AA Property-2
C0000768
Required intervention to prevent permanent impairment/damage
Beskrivning

SeriousAdverseEventRequiredInterventionorProcedureResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus Property
C25218
UMLS 2011AA Property
C1948041
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25652
UMLS 2011AA Property-3
C1514873
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Hospitalization, initial or prolonged
Beskrivning

SeriousAdverseEventHospitalizationResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
NCI Thesaurus Property-2
C25179
UMLS 2011AA Property-2
C0019993
Other
Beskrivning

SeriousAdverseEventOtherResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Specify
Beskrivning

SeriousAdverseEventOtherResultSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Comments
Beskrivning

Comments

Comments
Beskrivning

Research Comments

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 Formulär
  1. StudyEvent: PRL1013: Adverse Event Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header Module
PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber
Item
Site Number
text
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass-2)
C0205145 (UMLS 2011AA ObjectClass-2)
C52664 (NCI Thesaurus ObjectClass-3)
C1709628 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PatientIdentifier
Item
Patient ID
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
PatientDentistVisitDate
Item
Date of visit
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C52654 (NCI Thesaurus Property)
C0011441 (UMLS 2011AA Property)
C25716 (NCI Thesaurus Property-2)
C0545082 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Adverse event assessment
AdverseEventTreatingDescriptionText
Item
Adverse Event description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus Property)
C1522326 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Adverse Event Onset Date
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
Item
Severity of event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.1
Code List
Severity of event
CL Item
Mild Adverse Event (Mild)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (Moderate)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (Severe)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life Threatening Or Disabling Adverse Event (Life-threatening)
C41337 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (Fatal)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
Relation of event to restoration on study tooth/teeth
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C60718 (NCI Thesaurus Property)
C0399059 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)
CL.2
Code List
Relation of event to restoration on study tooth/teeth
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)
AdverseEventExpectedInd-2
Item
Was this event expected or anticipated
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25501 (NCI Thesaurus Property)
C1517001 (UMLS 2011AA Property)
Resin-BasedCompositeTherapyReplacementPerformedInd-2
Item
Restoration replaced
boolean
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass-2)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property-2)
C0559956 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Resin-BasedCompositeTherapySedativeFillingPerformedInd-2
Item
Restoration replaced with temporary or sedative dressing
boolean
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass-2)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C62295 (NCI Thesaurus Property-2)
C1947975 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Resin-BasedCompositeTherapyPulpectomyPerformedInd-2
Item
Pulpectomy and temporization
boolean
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass-2)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C52550 (NCI Thesaurus Property-2)
C1705872 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EndodonticTreatmentPerformedIndicator
Item
Endodontic therapy or referral
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C52575 (NCI Thesaurus ObjectClass)
C0700632 (UMLS 2011AA ObjectClass)
ToothExtractionPerformedIndicator
Item
Extraction
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C12506 (NCI Thesaurus ObjectClass)
C0040426 (UMLS 2011AA ObjectClass)
C61575 (NCI Thesaurus ObjectClass-2)
C0185115 (UMLS 2011AA ObjectClass-2)
NewAgentAdministeredInd-2
Item
New medication taken
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdverseEventRequiredHospitalizationInd-2
Item
Hospitalization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property-2)
AdverseEventOtherResultInd-3
Item
Other
boolean
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
AdverseEventOtherResultSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
Item
Outcome of event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41136 (NCI Thesaurus Property-2)
C0226984 (UMLS 2011AA Property-2)
CL.12
Code List
Outcome of event
CL Item
Resolved (RESOLVED)
C0750521 (NCI Metathesaurus)
CL Item
Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
CL Item
Unresolved At Protocol Completion (Unresolved at protocol completion)
AdverseEventResolutionDate
Item
Date of resolution (If "Resolved",)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
SeriousAdverseEventReportInd-2
Item
Was this considered a Serious Adverse Event
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)
SeriousAdverseEventDeathResultInd-2
Item
Death
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
SeriousAdverseEventLifeThreateningorDisablingResultInd-2
Item
Life-threatening
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C41337 (NCI Thesaurus Property-2)
C1517874 (UMLS 2011AA Property-2)
SeriousAdverseEventDisabilityResultInd-2
Item
Disability/Incapacity
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C21007 (NCI Thesaurus Property)
C0231170 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
SeriousAdverseEventCongenitalAbnormalityResultInd-2
Item
Congenital abnormality
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C2849 (NCI Thesaurus Property-2)
C0000768 (UMLS 2011AA Property-2)
SeriousAdverseEventRequiredInterventionorProcedureResultInd-2
Item
Required intervention to prevent permanent impairment/damage
boolean
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25652 (NCI Thesaurus Property-3)
C1514873 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SeriousAdverseEventHospitalizationResultInd-2
Item
Hospitalization, initial or prolonged
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property-2)
SeriousAdverseEventOtherResultInd-2
Item
Other
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
SeriousAdverseEventOtherResultSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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