ID

778

Beschrijving

NSABP B-35 Form ALERT Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0587E1D-38C6-3AA5-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0587E1D-38C6-3AA5-E034-080020C9C0E0

Trefwoorden

Versies (4)
  1. 26-08-12 26-08-12 -
  2. 08-07-15 08-07-15 -
  3. 08-07-15 08-07-15 -
  4. 20-09-21 20-09-21 -
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26 augustus 2012

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053898 Toxicity - NSABP B-35 Form ALERT - 2034153v3.0

Engels

Form ALERT Instructions: *Use NCI's Common Toxicity Criteria (CTC) Version 2.0 to assess the adverse event (AE). *Report any grade 3 unexpected AE, or any grade 4 AE, or any grade 5 AE (as listed below). *Complete and FAX this form with all available supporting documentation to the NSABP Biostatistical Center (412/624-1082) within 24 hours of learning about the AE. *Report the AE regardless of attribution (relationship) to protocol therapy (tamoxifen/anastrozole). *Do not fax this report to the NCI, FDA or HPFB.

1 Formulieren  
Unnamed1
Beschrijving

Unnamed1

First Three Letters of Patient's Last Name
Beschrijving

FirstThreeLettersofPatient'sLastName

Datatype

text

Patient Study ID
Beschrijving

PatientStudyID

Datatype

text

Institution Name
Beschrijving

InstitutionName

Datatype

text

Affiliate Name
Beschrijving

AffiliateName

Datatype

text

Treating MD First Name
Beschrijving

RegisteredInvestigator

Datatype

text

Treating MD First Name
Beschrijving

RegisteredInvestigator

Datatype

text

Treating MD Phone
Beschrijving

TreatingMDPhone

Datatype

text

Person Completing Form Last Name
Beschrijving

PersonCompletingForm,LastName

Datatype

text

Person Completing Form First Name
Beschrijving

PersonCompletingForm,FirstName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Person Completing Form Phone
Beschrijving

PersonCompletingForm,Phone

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Are data amended? (If Yes, circle the amended items in red.)
Beschrijving

AmendedDataInd

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Beschrijving

Unnamed2

Date of this report (Month Day Year)
Beschrijving

FormCompletionDate,Original

Datatype

date

Patient's Age at Time of AE
Beschrijving

PatientAdverseEventAssessmentAgeYearCount

Datatype

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
Notify Local IRB?
Beschrijving

LocalInstitutionalReviewBoardAdverseEventNotificationInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25388
UMLS 2011AA ObjectClass
C1947913
NCI Thesaurus ObjectClass
C16741
UMLS 2011AA ObjectClass
C0086911
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25297
UMLS 2011AA Property
C0422202
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Institution Number
Beschrijving

NCIInstitutionNumber

Datatype

text

Specify Type of Adverse Event (AE)
Beschrijving

SpecifyTypeofAdverseEvent(AE)

Datatype

text

AE (CTC Term)
Beschrijving

CTCAdverseEventTerm

Datatype

text

4-Character NSABP Code
Beschrijving

4-CharacterNSABPCode

Datatype

text

Date of Adverse Event (Month Day Year)
Beschrijving

CTCAdverseEvent,InitialReportDate

Datatype

date

Was the patient hospitalized for 24 hours or more?
Beschrijving

PatientHospitalizationInd-2

Datatype

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
Attribution (relationship) of the AE to protocol therapy?
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

Tamoxifen/Anastrozole Start Date (Month Day Year)
Beschrijving

TreatmentStartDate

Datatype

date

Tamoxifen/Anastrozole Date of Most Recent Dose (Month Day Year)
Beschrijving

DateofMostRecentTreatment

Datatype

text

Briefly describe the AE (provide supporting documentation)
Beschrijving

BrieflydescribetheAE

Datatype

text

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

Form ALERT Instructions: *Use NCI's Common Toxicity Criteria (CTC) Version 2.0 to assess the adverse event (AE). *Report any grade 3 unexpected AE, or any grade 4 AE, or any grade 5 AE (as listed below). *Complete and FAX this form with all available supporting documentation to the NSABP Biostatistical Center (412/624-1082) within 24 hours of learning about the AE. *Report the AE regardless of attribution (relationship) to protocol therapy (tamoxifen/anastrozole). *Do not fax this report to the NCI, FDA or HPFB.

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patient's Last Name
text
PatientStudyID
Item
Patient Study ID
text
InstitutionName
Item
Institution Name
text
AffiliateName
Item
Affiliate Name
text
RegisteredInvestigator
Item
Treating MD First Name
text
RegisteredInvestigator
Item
Treating MD First Name
text
TreatingMDPhone
Item
Treating MD Phone
text
PersonCompletingForm,LastName
Item
Person Completing Form Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonCompletingForm,Phone
Item
Person Completing Form Phone
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Are data amended? (If Yes, circle the amended items in red.)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If Yes, circle the amended items in red.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed2
FormCompletionDate,Original
Item
Date of this report (Month Day Year)
date
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)
Item
Notify Local IRB?
text
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
C16741 (NCI Thesaurus ObjectClass)
C0086911 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25297 (NCI Thesaurus Property)
C0422202 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
Notify Local IRB?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
NCIInstitutionNumber
Item
Institution Number
text
Item
Specify Type of Adverse Event (AE)
text
CL.3
Code List
Specify Type of Adverse Event (AE)
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** Unexpected* (Grade 5** unexpected*)
CL Item
Grade 5** Expected (Grade 5** expected)
CTCAdverseEventTerm
Item
AE (CTC Term)
text
4-CharacterNSABPCode
Item
4-Character NSABP Code
text
CTCAdverseEvent,InitialReportDate
Item
Date of Adverse Event (Month Day Year)
date
Item
Was the 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.4
Code List
Was the 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)
Item
Attribution (relationship) of the AE to protocol therapy?
text
CL.5
Code List
Attribution (relationship) of the AE to protocol therapy?
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Definitely (Related)
TreatmentStartDate
Item
Tamoxifen/Anastrozole Start Date (Month Day Year)
date
DateofMostRecentTreatment
Item
Tamoxifen/Anastrozole Date of Most Recent Dose (Month Day Year)
text
BrieflydescribetheAE
Item
Briefly describe the AE (provide supporting documentation)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
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