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Information:
Fel:
ID
1987
Beskrivning
AE6 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF18A8F9-ECF8-0F73-E034-0003BA3F9857
Länk
Nyckelord
Versioner (3)
- 2012-09-19 2012-09-19 -
- 2015-01-09 2015-01-09 - Martin Dugas
- 2015-07-03 2015-07-03 -
Uppladdad den
19 september 2012
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Leukemia, Myelocytic, Acute null Treatment - AE6 - 2394530v3.0
Similar models
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- StudyEvent: AE6
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
CTCAdverseEventOnsetDate
Item
Date of Onset
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)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA 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)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Segment
Item
Segment
text
Item
Has this event been determined to be an unexpected, grade 3-5 adverse event
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does this require expedited reporting to the FDA
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does this require expedited reporting to the DSMB
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Do you recommend the patient be withdrawn from further protocol therapy
text
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
No (No)
IfNo,whatadditionalinformationisrequired
Item
If No, what additional information is required
text