ID

1987

Descrição

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

Palavras-chave

  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 03/07/2015 03/07/2015 -
Transferido a

19 de setembro de 2012

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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

No Instruction available.

Unnamed 1
Descrição

Unnamed 1

Date of Onset
Descrição

CTCAdverseEventOnsetDate

Tipo de dados

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
Descrição

AdverseEventDescriptiveText

Tipo de dados

text

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

ResearchCommentsText

Tipo de dados

text

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

Segment

Tipo de dados

text

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

Hasthiseventbeendeterminedtobeanunexpected,grade3-5adverseevent

Tipo de dados

text

Does this require expedited reporting to the FDA
Descrição

DoesthisrequireexpeditedreportingtotheFDA

Tipo de dados

text

Does this require expedited reporting to the DSMB
Descrição

DoesthisrequireexpeditedreportingtotheDSMB

Tipo de dados

text

Do you recommend the patient be withdrawn from further protocol therapy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

Doyourecommendthepatientbewithdrawnfromfurtherprotocoltherapy

Tipo de dados

text

Is this review complete
Descrição

Isthisreviewcomplete

Tipo de dados

text

If No, what additional information is required
Descrição

IfNo,whatadditionalinformationisrequired

Tipo de dados

text

Similar models

No Instruction available.

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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