ID

1987

Beschrijving

AE6 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF18A8F9-ECF8-0F73-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF18A8F9-ECF8-0F73-E034-0003BA3F9857

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 03-07-15 03-07-15 -
Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Leukemia, Myelocytic, Acute null Treatment - AE6 - 2394530v3.0

No Instruction available.

Unnamed 1
Beschrijving

Unnamed 1

Date of Onset
Beschrijving

CTCAdverseEventOnsetDate

Datatype

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
Event description
Beschrijving

AdverseEventDescriptiveText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0678257
Comments
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Segment
Beschrijving

Segment

Datatype

text

Has this event been determined to be an unexpected, grade 3-5 adverse event
Beschrijving

Hasthiseventbeendeterminedtobeanunexpected,grade3-5adverseevent

Datatype

text

Does this require expedited reporting to the FDA
Beschrijving

DoesthisrequireexpeditedreportingtotheFDA

Datatype

text

Does this require expedited reporting to the DSMB
Beschrijving

DoesthisrequireexpeditedreportingtotheDSMB

Datatype

text

Do you recommend the patient be withdrawn from further protocol therapy
Beschrijving

Doyourecommendthepatientbewithdrawnfromfurtherprotocoltherapy

Datatype

text

Is this review complete
Beschrijving

Isthisreviewcomplete

Datatype

text

If No, what additional information is required
Beschrijving

IfNo,whatadditionalinformationisrequired

Datatype

text

Similar models

No Instruction available.

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed 1
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)
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)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
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
Code List
Has this event been determined to be an unexpected, grade 3-5 adverse event
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does this require expedited reporting to the FDA
text
Code List
Does this require expedited reporting to the FDA
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does this require expedited reporting to the DSMB
text
Code List
Does this require expedited reporting to the DSMB
CL Item
Yes (Yes)
CL Item
No (No)
Item
Do you recommend the patient be withdrawn from further protocol therapy
text
Code List
Do you recommend the patient be withdrawn from further protocol therapy
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is this review complete
text
Code List
Is this review complete
CL Item
Yes (Yes)
CL Item
No (No)
IfNo,whatadditionalinformationisrequired
Item
If No, what additional information is required
text

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