ID

11562

Descrizione

AE1 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF17F5D5-D70B-0080-E034-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF17F5D5-D70B-0080-E034-0003BA3F9857

Keywords

versioni (4)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 08/07/15 08/07/15 -
Caricato su

8 luglio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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AE1

Inglese

No Instruction available.

1 moduli  
Miscellaneous Information
Descrizione

Miscellaneous Information

Date of Onset
Descrizione

AdverseEventOnsetDate

Tipo di dati

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25279
UMLS 2011AA Property-2
C0332162
Event description
Descrizione

AdverseEventDescriptiveText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0678257
Was this event expected or anticipated
Descrizione

ExpectedEventIndicator

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25501
UMLS 2011AA Property
C1517001
NCI Metathesaurus ValueDomain
C0021212
Record the severity of event
Descrizione

SeverityName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25499
UMLS 2011AA ObjectClass
C0441471
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
What is the relationship to study therapy/intervention
Descrizione

CTC Adverse Event Attribution Category

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Record the most severe outcome of the event
Descrizione

AdverseEventOutcomeType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Record the date of resolution
Descrizione

Adverse Event Resolution Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985918
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25655
Was this event associated with
Descrizione

AdverseEventSeriousnessAttributionScale

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Comments
Descrizione

Research Comments

Tipo di dati

text

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

Segment

Tipo di dati

text

Report activation status
Descrizione

Reportactivationstatus

Tipo di dati

text

If Other, specify reason for deactivation
Descrizione

IfOther,specifyreasonfordeactivation

Tipo di dati

text

Record date transplant center became aware of the event
Descrizione

Recorddatetransplantcenterbecameawareoftheevent

Tipo di dati

text

Indicate weight at time of the event
Descrizione

Indicateweightattimeoftheevent

Tipo di dati

text

Is there an alternative etiology
Descrizione

Isthereanalternativeetiology

Tipo di dati

text

What is the effect on study therapy/intervention schedule
Descrizione

Whatistheeffectonstudytherapy/interventionschedule

Tipo di dati

text

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Similar models

No Instruction available.

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Miscellaneous Information
AdverseEventOnsetDate
Item
Date of Onset
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property-2)
C0332162 (UMLS 2011AA Property-2)
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)
ExpectedEventIndicator
Item
Was this event expected or anticipated
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25501 (NCI Thesaurus Property)
C1517001 (UMLS 2011AA Property)
C0021212 (NCI Metathesaurus ValueDomain)
Item
Record the severity of event
text
C25499 (NCI Thesaurus ObjectClass)
C0441471 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
CL.3
Code List
Record the severity of event
CL Item
Mild (Mild)
C70666 (NCI Thesaurus)
C2945599 (UMLS 2011AA)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Life Threatening (Life Threatening)
CL Item
Fatal (Fatal)
Item
What is the relationship to study therapy/intervention
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.4
Code List
What is the relationship to study therapy/intervention
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
Item
Record the most severe outcome of the event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.7
Code List
Record the most severe outcome of the event
CL Item
Adverse Event Is Resolved (Resolved, No Residual Effects)
CL Item
Adverse Event Is Resolved With Sequelae (Resolved with Sequelae)
CL Item
Adverse Event Is Ongoing (Persistent Condition)
CL Item
Adverse Event Was Fatal (Resolved by Death)
Adverse Event Resolution Date
Item
Record the date of resolution
date
C25164 (NCI Thesaurus ValueDomain)
C2985918 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25655 (NCI Thesaurus Property)
Item
Was this event associated with
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.8
Code List
Was this event associated with
CL Item
None of the following (None of the following)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life-threatening event)
CL Item
Disability (Disability)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment or damage)
CL Item
Hospitalized (Hospitalization (initial or prolonged))
CL Item
Other (Other SAE)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
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
Item
Report activation status
text
CL.1
Code List
Report activation status
CL Item
Keep report active (Keep report active)
CL Item
Deactive - Report filed in error (Deactive - Report filed in error)
CL Item
Deactive - Key field error (Deactive - Key field error)
CL Item
Deactive - Other reason (Deactive - Other reason)
IfOther,specifyreasonfordeactivation
Item
If Other, specify reason for deactivation
text
Recorddatetransplantcenterbecameawareoftheevent
Item
Record date transplant center became aware of the event
text
Indicateweightattimeoftheevent
Item
Indicate weight at time of the event
text
Item
Is there an alternative etiology
text
CL.5
Code List
Is there an alternative etiology
CL Item
None apparent (None apparent)
CL Item
Study Disease (Study Disease)
CL Item
Other Pre-Existing Disease or Condition (Other Pre-Existing Disease or Condition)
CL Item
Accident, Trauma, or External Factors (Accident, Trauma, or External Factors)
CL Item
Concurrent Illness/Condition (Not Pre-Existing) (Concurrent Illness/Condition (Not Pre-Existing))
Item
What is the effect on study therapy/intervention schedule
text
CL.6
Code List
What is the effect on study therapy/intervention schedule
CL Item
No Change - Completed (No Change - Completed)
CL Item
No Change - Ongoing (No Change - Ongoing)
CL Item
Dose Modified (Dose Modified)
CL Item
Temporarily Stopped (Temporarily Stopped)
CL Item
Permanently Stopped (Permanently Stopped)
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