ID

11432

Description

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

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
Uploaded on

July 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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AE6

No Instruction available.

Miscellaneous Information
Description

Miscellaneous Information

Date of Onset
Description

Adverse Event Onset Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Event description
Description

AdverseEventDescriptiveText

Data type

text

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

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Segment
Description

Segment

Data type

text

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

Hasthiseventbeendeterminedtobeanunexpected,grade3-5adverseevent

Data type

boolean

Does this require expedited reporting to the FDA
Description

DoesthisrequireexpeditedreportingtotheFDA

Data type

boolean

Does this require expedited reporting to the DSMB
Description

DoesthisrequireexpeditedreportingtotheDSMB

Data type

boolean

Do you recommend the patient be withdrawn from further protocol therapy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

Doyourecommendthepatientbewithdrawnfromfurtherprotocoltherapy

Data type

boolean

Is this review complete
Description

Isthisreviewcomplete

Data type

boolean

If No, what additional information is required
Description

IfNo,whatadditionalinformationisrequired

Data type

text

Similar models

No Instruction available.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Miscellaneous Information
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

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