ID

9230

Beskrivning

Adverse Events (AE) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1267264-7F67-522F-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1267264-7F67-522F-E034-0003BA12F5E7

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Melanoma (Skin) null Toxicity - Adverse Events (AE) - 2074863v3.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: Adverse Events (AE)
    1. No Instruction available.
Ccrr Module For Adverse Events (ae)
Beskrivning

Ccrr Module For Adverse Events (ae)

Patient ID (Pt. ID issued during registration or previously issued patient ID)
Beskrivning

Pt.ID

Datatyp

text

Institution ID
Beskrivning

InstitutionNo.

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Initials (F ML)
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution:
Beskrivning

InstitutionName

Datatyp

text

Date of patient evaluation (Month Year Day)
Beskrivning

AssessmentDate

Datatyp

date

Has the patient experienced any adverse events since the last visit (Adverse Event Text)
Beskrivning

LateAdverseEventInd

Datatyp

boolean

Grade
Beskrivning

CTCAdverseEventGrade

Datatyp

text

Serious (If AE is serious, also report through AdEERS)
Beskrivning

Serious

Datatyp

boolean

Relationship to Study Intervention
Beskrivning

CTCAdverseEventAttributionCode

Datatyp

text

Present Status
Beskrivning

CTCAdverseEventOutcome

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Other (specify in Comments)
Beskrivning

OtherInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Action Taken:
Beskrivning

CTCAdverseEvent,ActionTaken

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Other (specify in Comments)
Beskrivning

Other

Datatyp

text

MedDRA Code
Beskrivning

MedDRACode

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Onset (DATE):
Beskrivning

AdverseEventOnsetDate

Datatyp

text

Resolution (DATE):
Beskrivning

AdverseEventSymptomEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Onset Date reported at a prior visit
Beskrivning

OnsetDatereportedatapriorvisit

Datatyp

text

still present at this visit (Month Year Day)
Beskrivning

stillpresentatthisvisit

Datatyp

text

Comments:
Beskrivning

Comments

Datatyp

text

Completed by:
Beskrivning

CompletedBy

Datatyp

text

Date:
Beskrivning

FormCompletionDate,Original

Datatyp

date

Month Year Day
Beskrivning

MonthYearDay

Datatyp

text

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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Adverse Events (AE)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Ccrr Module For Adverse Events (ae)
Pt.ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
InstitutionNo.
Item
Institution ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Patient Initials
Item
Patient Initials (F ML)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
InstitutionName
Item
Institution:
text
AssessmentDate
Item
Date of patient evaluation (Month Year Day)
date
LateAdverseEventInd
Item
Has the patient experienced any adverse events since the last visit (Adverse Event Text)
boolean
Item
Grade
text
CL.2
Code List
Grade
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Life-threatening or disabling (Life-threatening or disabling)
CL Item
Fatal (Fatal)
Serious
Item
Serious (If AE is serious, also report through AdEERS)
boolean
Item
Relationship to Study Intervention
text
CL.4
Code List
Relationship to Study Intervention
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possibly (Possibly)
CL Item
Probably (Probably)
CL Item
Definitely (Definitely)
CL Item
Unknown/Not Applicable (Unknown/Not Applicable)
Item
Present Status
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.5
Code List
Present Status
CL Item
Adverse Event Was Fatal (Fatal/Died)
CL Item
Adverse Event Is Ongoing (Intervention for AE continues)
CL Item
Adverse Event Is Unchanged (Not recovered/Not resolved)
CL Item
Adverse Event Is Resolved With Sequelae (Recovered/Resolved with sequelae)
CL Item
Adverse Event Is Resolved (Recovered/Resolved without sequelae)
CL Item
Adverse Event Has Improved (Recovering/Resolving)
CL Item
Other (specify in Comments) (Other (specify in Comments))
OtherInd-3
Item
Other (specify in Comments)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
Item
Action Taken:
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
CL.6
Code List
Action Taken:
CL Item
There Was No Action Taken Based On The Adverse Event (None)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (Early termination)
CL Item
Concomitant medications (Concomitant medications)
CL Item
Hospitalization (Hospitalization)
CL Item
Other (specify in Comments) (Other (specify in Comments))
Other
Item
Other (specify in Comments)
text
MedDRACode
Item
MedDRA Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
AdverseEventOnsetDate
Item
Onset (DATE):
text
AdverseEventSymptomEndDate
Item
Resolution (DATE):
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
OnsetDatereportedatapriorvisit
Item
Onset Date reported at a prior visit
text
stillpresentatthisvisit
Item
still present at this visit (Month Year Day)
text
Comments
Item
Comments:
text
CompletedBy
Item
Completed by:
text
FormCompletionDate,Original
Item
Date:
date
MonthYearDay
Item
Month Year Day
text
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