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  1. StudyEvent: PRL1013: Adverse Event Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
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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