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)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Segment
Item
Segment
text
Hasthiseventbeendeterminedtobeanunexpected,grade3-5adverseevent
Item
Has this event been determined to be an unexpected, grade 3-5 adverse event
boolean
DoesthisrequireexpeditedreportingtotheFDA
Item
Does this require expedited reporting to the FDA
boolean
DoesthisrequireexpeditedreportingtotheDSMB
Item
Does this require expedited reporting to the DSMB
boolean
Doyourecommendthepatientbewithdrawnfromfurtherprotocoltherapy
Item
Do you recommend the patient be withdrawn from further protocol therapy
boolean
Isthisreviewcomplete
Item
Is this review complete
boolean
IfNo,whatadditionalinformationisrequired
Item
If No, what additional information is required
text