ID

10059

Descripción

NSABP PROTOCOL C-08 ADVERSE EVENT FORM Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF511EA4-0C5D-199B-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF511EA4-0C5D-199B-E034-0003BA3F9857

Palabras clave

  1. 27/8/12 27/8/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 23/3/15 23/3/15 - Martin Dugas
Subido en

23 de marzo de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer (NSABP NCT00096278)

Fax to 412-622-2111

  1. StudyEvent: NSABP PROTOCOL C-08 ADVERSE EVENT FORM
    1. Fax to 412-622-2111
Header
Descripción

Header

Patient Initials (Last, First Middle)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Descripción

Patient ID NSABP

Tipo de datos

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
Descripción

Institution Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Affiliate Name
Descripción

Affiliate Name

Tipo de datos

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
Descripción

Person Completing Form Last Name

Tipo de datos

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
Descripción

Person Completing Form First Name

Tipo de datos

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
Descripción

Person Completing Form Phone

Tipo de datos

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? (check box if yes, and circle amended items)
Descripción

Data amended

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Reporting Period START DATE (month day year)
Descripción

Reporting Period Start Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period END DATE (month day year)
Descripción

Reporting Period End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Comments
Descripción

Research Comments

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Adverse event
Descripción

Adverse event

Alias
UMLS CUI-1
C0877248
Type of Report
Descripción

Typeofreport

Tipo de datos

text

No. of bevacizumab doses given this report period
Descripción

BevacizumabAgentAdministeredCount

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C2039
UMLS 2011AA ObjectClass
C0796392
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was patient hospitalized for 24 hours or more?
Descripción

PatientHospitalizationInd-2

Tipo de datos

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
Any grade 3, 4, or 5 adverse event (AE) or any grade >= 2 neurologic AE?
Descripción

AdverseEventGradeInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE v3.0 Short Name
Descripción

CommonToxicityCriteriaAdverseEventShortNameType

Tipo de datos

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C49704
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS CUI-1
C1516728
CTCAE v3.0 "Select" Term (if applicable)
Descripción

CTC Adverse Event Term

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C38024
NCI Thesaurus Property-2
C45559
CTCAE v3.0 Grade
Descripción

CTCAE v3.0 Grade

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
UMLS CUI-1
C2985911

Similar models

Fax to 412-622-2111

  1. StudyEvent: NSABP PROTOCOL C-08 ADVERSE EVENT FORM
    1. Fax to 412-622-2111
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient 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)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
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? (check box if yes, and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Reporting Period Start Date
Item
Reporting Period START DATE (month day year)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period END DATE (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Type of Report
text
Code List
Type of Report
CL Item
Chemotherapy With Or Without Bevacizumab (Chemotherapy with or without bevacizumab)
CL Item
Bevacizumab Following Completion Or Discontinuation Of Chemotherapy (Bevacizumab following completion or discontinuation of chemotherapy)
CL Item
Post Treatment (Post treatment)
BevacizumabAgentAdministeredCount
Item
No. of bevacizumab doses given this report period
float
C2039 (NCI Thesaurus ObjectClass)
C0796392 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PatientHospitalizationInd-2
Item
Was 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)
AdverseEventGradeInd-2
Item
Any grade 3, 4, or 5 adverse event (AE) or any grade >= 2 neurologic AE?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTC Adverse Event
Item
CTCAE v3.0 Short Name
text
C25364 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1516728 (UMLS CUI-1)
CTC Adverse Event Term
Item
CTCAE v3.0 "Select" Term (if applicable)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
CTC Adverse Event Grade
Item
CTCAE v3.0 Grade
text
C49704 (NCI Thesaurus ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
C2985911 (UMLS CUI-1)

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