ID

9521

Description

NSABP PROTOCOL R-04: ADVERSE EVENT FORM Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822175-F6A3-24E0-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822175-F6A3-24E0-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 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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Colorectal Cancer NCT00058474 Toxicity - NSABP PROTOCOL R-04: ADVERSE EVENT FORM - 2082776v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP PROTOCOL R-04: ADVERSE EVENT FORM
    1. No Instruction available.
Ccrr Module For Nsabp Protocol R-04: Adverse Event Form
Description

Ccrr Module For Nsabp Protocol R-04: Adverse Event Form

First Three Letters of Patients Last Name
Description

FirstThreeLettersofPatient'sLastName

Data type

text

Patient Study ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution Name / Affiliate Name
Description

Affiliate Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form, Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form, First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form, Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Are Data Amended?
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
AE report date
Description

CTCAdverseEventInitialReportDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
Any grade 2, 3, 4, or 5 adverse event?
Description

Anygrade2,3,4or5AdverseEvent?

Data type

boolean

Was the patient hospitalized for 24 hours or more?
Description

PatientHospitalizationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C1516728
NCI Thesaurus Property
C25703
UMLS CUI-2
C2826934
Other CTC Adverse Event Term(s) not listed
Description

CTCAdverseEventTermSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25703
UMLS 2011AA Property
C1515273
4-Character NSABP Code
Description

4-CharacterNSABPCode

Data type

text

CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C2985911
NCI Thesaurus Property
C25365
CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C2985911
NCI Thesaurus Property
C25365
Attirubtion
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Attirubtion
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Did the patient experience an episode of Grade 3 or greater diarrhea with Grade 4 granulocytopenia (neutropenia)?
Description

DidthepatientexperienceanepisodeofGrade3orgreaterdiarrheawithGrade4granulocytopenia(neutropenia)?

Data type

boolean

Was the patient hospitalized for the management of diarrhea or dehydration, with radiographic or colonoscopic evidence of bowel wall injury?
Description

Wasthepatienthospitalizedforthemanagementofdiarrheaordehydration,withradiographicorcolonoscopicevidenceofbowelwallinjury?

Data type

boolean

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: NSABP PROTOCOL R-04: ADVERSE EVENT FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Nsabp Protocol R-04: Adverse Event Form
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
Patient ID NSABP
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Affiliate Name
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are Data Amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
CTCAdverseEventInitialReportDate
Item
AE report date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
Anygrade2,3,4or5AdverseEvent?
Item
Any grade 2, 3, 4, or 5 adverse event?
boolean
PatientHospitalizationInd-2
Item
Was the patient hospitalized for 24 hours or more?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C25703 (NCI Thesaurus Property)
C2826934 (UMLS CUI-2)
CTCAdverseEventTermSpecify
Item
Other CTC Adverse Event Term(s) not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
4-CharacterNSABPCode
Item
4-Character NSABP Code
text
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C41331 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C41331 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
Item
Attirubtion
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.7
Code List
Attirubtion
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Definite (related)
CL209464 (NCI Metathesaurus)
Item
Attirubtion
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.7
Code List
Attirubtion
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Definite (related)
CL209464 (NCI Metathesaurus)
DidthepatientexperienceanepisodeofGrade3orgreaterdiarrheawithGrade4granulocytopenia(neutropenia)?
Item
Did the patient experience an episode of Grade 3 or greater diarrhea with Grade 4 granulocytopenia (neutropenia)?
boolean
Wasthepatienthospitalizedforthemanagementofdiarrheaordehydration,withradiographicorcolonoscopicevidenceofbowelwallinjury?
Item
Was the patient hospitalized for the management of diarrhea or dehydration, with radiographic or colonoscopic evidence of bowel wall injury?
boolean
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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