ID

9230

Description

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

Link

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

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

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

English

No Instruction available.

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

Ccrr Module For Adverse Events (ae)

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

Pt.ID

Data type

text

Institution ID
Description

InstitutionNo.

Data type

text

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

Patient Initials

Data type

text

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

InstitutionName

Data type

text

Date of patient evaluation (Month Year Day)
Description

AssessmentDate

Data type

date

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

LateAdverseEventInd

Data type

boolean

Grade
Description

CTCAdverseEventGrade

Data type

text

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

Serious

Data type

boolean

Relationship to Study Intervention
Description

CTCAdverseEventAttributionCode

Data type

text

Present Status
Description

CTCAdverseEventOutcome

Data type

text

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

OtherInd-3

Data type

text

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

CTCAdverseEvent,ActionTaken

Data type

text

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

Other

Data type

text

MedDRA Code
Description

MedDRACode

Data type

text

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

AdverseEventOnsetDate

Data type

text

Resolution (DATE):
Description

AdverseEventSymptomEndDate

Data type

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
Description

OnsetDatereportedatapriorvisit

Data type

text

still present at this visit (Month Year Day)
Description

stillpresentatthisvisit

Data type

text

Comments:
Description

Comments

Data type

text

Completed by:
Description

CompletedBy

Data type

text

Date:
Description

FormCompletionDate,Original

Data type

date

Month Year Day
Description

MonthYearDay

Data type

text

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Adverse Events (AE)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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