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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Adverse Event Onset Date
Item
Date of Onset
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
AdverseEventDescriptiveText
Item
Event description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Segment
Item
Segment
text
Item Group
Study Product/suspect Medication Data
StudyProductName
Item
Study Product Name
text
DoseofStudyProduct(s)atSAEonset
Item
Dose of Study Product(s) at SAE onset
text
RouteofStudyProduct(s)atSAEonset
Item
Route of Study Product(s) at SAE onset
text
ScheduleofStudyProduct(s)atSAEonset
Item
Schedule of Study Product(s) at SAE onset
text
Item Group
Concomitant Medications
ConcomitantMedicationUseInd-3
Item
Non-concomitant medications
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Concomitant Medication
Item
Medications
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
ConcomitantMedicationStartDate
Item
Start Date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus ObjectClass)
C0750729 (UMLS 2011AA ObjectClass)
CL219258 (NCI Metathesaurus Property)
ConcomitantMedicationStopDate
Item
Stop Date
date
C25164 (NCI Thesaurus ObjectClass)
C0011008 (UMLS 2011AA ObjectClass)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0723457 (NCI Metathesaurus Property)
ConcomitantMedicationAdministeredDose
Item
Dose, Route, Schedule
float
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdverseEventAssessmentText
Item
Comment
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)

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