ID

6385

Description

NSABP PROTOCOL B-38FORM ALERT - Form ALERT Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD8A2825-7101-4099-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD8A2825-7101-4099-E034-0003BA12F5E7

Keywords

Versions (5)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/10/15 1/10/15 - Martin Dugas
  5. 7/8/15 7/8/15 -
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December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00093795 Toxicity - NSABP PROTOCOL B-38FORM ALERT - Form ALERT - 2281168v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP PROTOCOL B-38FORM ALERT - Form ALERT
    1. No Instruction available.
Unnamed 1
Description

Unnamed 1

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NSABP Patient ID
Description

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Institution Name
Description

InstitutionName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Affiliate Name
Description

AffiliatedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass
C25413
UMLS 2011AA ObjectClass
C1510826
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Treating MD, Last Name
Description

TreatingMDLastName

Data type

text

Treating MD, First Name
Description

TreatingMDFirstName

Data type

text

Treating MD, Phone
Description

TreatingPhysicianPhoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Person completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Person completing Form, First Name
Description

ResponsiblePersonFirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Person completing Form, Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Are data amended? (check box if yes, and circle amended items)
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed 2
Description

Unnamed 2

Date of this Report
Description

ReportCreatedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus Property
C42620
UMLS 2011AA Property
C1706214
Patient's Age at Time of AE
Description

PatientAdverseEventAssessmentAgeYearCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Currrent Cycle Number
Description

TreatmentCurrentCourseNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Was patient hospitalized for 24 hours or more?
Description

PatientHospitalizationInd-2

Data type

text

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
CTCAE v3.0 Short Name
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property
C25249
UMLS 2011AA Property
C1806781
"Select" Term
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
Unnamed question 1
Description

SpecifyTypeofAdverseEvent(AE)

Data type

text

Adverse Event Onset Date
Description

CTCAdverseEventOnsetDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Protocol Therapy
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Date of Most Recent Treatment
Description

DateofMostRecentTreatment

Data type

text

CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Briefly describe the AE (provide supporting documentation)
Description

BrieflydescribetheAE

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: NSABP PROTOCOL B-38FORM ALERT - Form ALERT
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed 1
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
AffiliatedInstitutionName
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass)
C1510826 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
TreatingMDLastName
Item
Treating MD, Last Name
text
TreatingMDFirstName
Item
Treating MD, First Name
text
TreatingPhysicianPhoneNumber
Item
Treating MD, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
ResponsiblePersonLastName
Item
Person completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonFirstName
Item
Person completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonPhoneNumber
Item
Person completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
Item
Are data amended? (check box if yes, and circle amended items)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (check box if yes, and circle amended items)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed 2
ReportCreatedDate
Item
Date of this Report
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C42620 (NCI Thesaurus Property)
C1706214 (UMLS 2011AA Property)
PatientAdverseEventAssessmentAgeYearCount
Item
Patient's Age at Time of AE
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
TreatmentCurrentCourseNumber
Item
Currrent Cycle Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Was patient hospitalized for 24 hours or more?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
CL.2
Code List
Was patient hospitalized for 24 hours or more?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CommonToxicityCriteriaAdverseEventShortNameType
Item
CTCAE v3.0 Short Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)
CTCAdverseEventSpecifiedTermType
Item
"Select" Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
Unnamed question 1
text
CL.3
Code List
Unnamed question 1
CL Item
Grade 2 Unexpected (Grade 2 unexpected)
CL Item
Grade 3 Unexpected (Grade 3 unexpected)
CL Item
Grade 4 Unexpected (Grade 4 unexpected)
CL Item
Grade 4 Expected (Grade 4 expected)
CL Item
Grade 5 (Grade 5)
CL211380 (NCI Metathesaurus)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item
Protocol Therapy
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CL.4
Code List
Protocol Therapy
CL Item
Doxorubicin (Doxorubicin)
CL Item
Cyclophosphamide (Cyclophosphamide)
CL Item
Docetaxel (Docetaxel)
CL Item
Paclitaxel (Paclitaxel)
CL Item
Gemcitabine (Gemcitabine)
DateofMostRecentTreatment
Item
Date of Most Recent Treatment
text
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.5
Code List
CTC Adverse Event Attribution Code
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)
BrieflydescribetheAE
Item
Briefly describe the AE (provide supporting documentation)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
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