ID

1542

Descrizione

PRL1013: Adverse Event Form 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

collegamento

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

Keywords

versioni (3)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 03/07/15 03/07/15 -
Caricato su

27 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Dental Caries NCT01268605 Toxicity - PRL1013: Adverse Event Form - 3246990v1.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: PRL1013: Adverse Event Form
    1. No Instruction available.
Header Module
Descrizione

Header Module

Site Number
Descrizione

PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber

Tipo di dati

text

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

PatientIdentifier

Tipo di dati

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
Descrizione

PatientDentistVisitDate

Tipo di dati

date

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

PatientInitialsName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Unnamed1
Descrizione

Unnamed1

Adverse Event description
Descrizione

AdverseEventTreatingDescriptionText

Tipo di dati

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
C25365
UMLS 2011AA Property
C0678257
Adverse Event Onset Date
Descrizione

CTCAdverseEventOnsetDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Unnamed2
Descrizione

Unnamed2

Severity of event
Descrizione

AdverseEventSeverityType

Tipo di dati

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
Descrizione

AdverseEventDentalRestorationAttributionScale

Tipo di dati

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
C25358
UMLS 2011AA Property
C0596130
Was this event expected or anticipated
Descrizione

AdverseEventExpectedInd-2

Tipo di dati

text

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
Descrizione

Resin-BasedCompositeTherapyReplacementPerformedInd-2

Tipo di dati

text

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

Resin-BasedCompositeTherapySedativeFillingPerformedInd-2

Tipo di dati

text

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

Resin-BasedCompositeTherapyPulpectomyPerformedInd-2

Tipo di dati

text

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

EndodonticTreatmentPerformedIndicator

Tipo di dati

text

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
Descrizione

ToothExtractionPerformedIndicator

Tipo di dati

text

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
C61575
UMLS 2011AA ObjectClass
C0185115
New medication taken
Descrizione

NewAgentAdministeredInd-2

Tipo di dati

text

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

AdverseEventRequiredHospitalizationInd-2

Tipo di dati

text

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
C25179
UMLS 2011AA Property
C0019993
Other
Descrizione

AdverseEventOtherResultInd-3

Tipo di dati

text

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
C20200
UMLS 2011AA Property
C1274040
Specify
Descrizione

AdverseEventOtherResultSpecify

Tipo di dati

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
C20200
UMLS 2011AA Property
C1274040
Outcome of event
Descrizione

AdverseEventDentalResultType

Tipo di dati

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
C41136
UMLS 2011AA Property
C0226984
Date of resolution (If "Resolved",)
Descrizione

AdverseEventResolutionDate

Tipo di dati

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
Descrizione

SeriousAdverseEventReportInd-2

Tipo di dati

text

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
C54035
UMLS 2011AA ObjectClass
C0205404
Death
Descrizione

SeriousAdverseEventDeathResultInd-2

Tipo di dati

text

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

SeriousAdverseEventLifeThreateningorDisablingResultInd-2

Tipo di dati

text

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
C41337
UMLS 2011AA Property
C1517874
Disability/Incapacity
Descrizione

SeriousAdverseEventDisabilityResultInd-2

Tipo di dati

text

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

SeriousAdverseEventCongenitalAbnormalityResultInd-2

Tipo di dati

text

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
C2849
UMLS 2011AA Property
C0000768
Required intervention to prevent permanent impairment/damage
Descrizione

SeriousAdverseEventRequiredInterventionorProcedureResultInd-2

Tipo di dati

text

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

SeriousAdverseEventHospitalizationResultInd-2

Tipo di dati

text

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
C25179
UMLS 2011AA Property
C0019993
Other
Descrizione

SeriousAdverseEventOtherResultInd-2

Tipo di dati

text

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

SeriousAdverseEventOtherResultSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Unnamed4
Descrizione

Unnamed4

Comments
Descrizione

ResearchCommentsText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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  1. StudyEvent: PRL1013: Adverse Event Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header Module
PractitionersEngagedinAppliedResearchandLearningNetworkClinicalStudySiteIdentifierNumber
Item
Site Number
text
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass)
C0205145 (UMLS 2011AA ObjectClass)
C52664 (NCI Thesaurus ObjectClass)
C1709628 (UMLS 2011AA ObjectClass)
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)
C0545082 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Unnamed1
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)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item Group
Unnamed2
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)
C0596130 (UMLS 2011AA Property)
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)
Item
Was this event expected or anticipated
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25501 (NCI Thesaurus Property)
C1517001 (UMLS 2011AA Property)
CL.3
Code List
Was this event expected or anticipated
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Restoration replaced
text
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property)
C0559956 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
Restoration replaced
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Restoration replaced with temporary or sedative dressing
text
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C62295 (NCI Thesaurus Property)
C1947975 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Restoration replaced with temporary or sedative dressing
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pulpectomy and temporization
text
C15368 (NCI Thesaurus ObjectClass)
C52586 (NCI Thesaurus ObjectClass)
C1711229 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C52550 (NCI Thesaurus Property)
C1705872 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Pulpectomy and temporization
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Endodontic therapy or referral
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C52575 (NCI Thesaurus ObjectClass)
C0700632 (UMLS 2011AA ObjectClass)
CL.7
Code List
Endodontic therapy or referral
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Extraction
text
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)
C0185115 (UMLS 2011AA ObjectClass)
CL.8
Code List
Extraction
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
New medication taken
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.9
Code List
New medication taken
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Hospitalization
text
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)
C0019993 (UMLS 2011AA Property)
CL.10
Code List
Hospitalization
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Other
text
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)
C1274040 (UMLS 2011AA Property)
CL.11
Code List
Other
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1274040 (UMLS 2011AA Property)
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)
C0226984 (UMLS 2011AA Property)
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)
Item
Was this considered a Serious Adverse Event
text
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)
C0205404 (UMLS 2011AA ObjectClass)
CL.13
Code List
Was this considered a Serious Adverse Event
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Death
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
CL.14
Code List
Death
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Life-threatening
text
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)
C1517874 (UMLS 2011AA Property)
CL.15
Code List
Life-threatening
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Disability/Incapacity
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C21007 (NCI Thesaurus Property)
C0231170 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
CL.16
Code List
Disability/Incapacity
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Congenital abnormality
text
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)
C0000768 (UMLS 2011AA Property)
CL.17
Code List
Congenital abnormality
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Required intervention to prevent permanent impairment/damage
text
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.18
Code List
Required intervention to prevent permanent impairment/damage
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Hospitalization, initial or prolonged
text
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)
C0019993 (UMLS 2011AA Property)
CL.19
Code List
Hospitalization, initial or prolonged
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Other
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
CL.20
Code List
Other
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
SeriousAdverseEventOtherResultSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
Item Group
Unnamed4
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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