ID

43191

Description

NSABP B-35 Form ALERT NCT00053898 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

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 7/8/15 7/8/15 -
  3. 7/8/15 7/8/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NSABP B-35 Form ALERT NCT00053898

English

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 forms  
Patient Demographics
Description

Patient Demographics

Alias
UMLS CUI-1
C1704791
First Three Letters of Patient's Last Name
Description

First Three Letters of Patient's Last Name

Data type

text

Alias
UMLS CUI-1
C0421448
Patient Study ID
Description

Patient Study ID

Data type

float

Alias
UMLS CUI-1
C2826693
UMLS CUI-2
C0030705
Institution Name
Description

Institution Name

Data type

float

Alias
UMLS CUI-1
C1301943
Affiliate Name
Description

Affiliate Name

Data type

text

Alias
UMLS CUI-1
C1510825
UMLS CUI-2
C0027365
Treating MD First Name
Description

Treating MD First Name

Data type

float

Alias
UMLS CUI-1
C1710470
Treating MD Last Name
Description

Treating MD Last Name

Data type

float

Alias
UMLS CUI-1
C1710470
UMLS CUI-2
C1301584
Treating MD Phone
Description

Treating MD Phone

Data type

integer

Alias
UMLS CUI-1
C1710470
UMLS CUI-2
C1515258
Person Completing Form Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
UMLS CUI-1
C3262828
Person Completing Form First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25364
UMLS CUI-1
C3262828
UMLS CUI-2
C1443235
Person Completing Form Phone
Description

Person Completing Form Phone

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C3262828
UMLS CUI-2
C1515258
Are data amended? (If Yes, circle the amended items in red.)
Description

Are data amended? (If Yes, circle the amended items in red.)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI-1
C1511726
UMLS CUI-2
C1691222
AE Evaluation
Description

AE Evaluation

Date of this report (Month Day Year)
Description

Date of this report (Month Day Year)

Data type

date

Alias
UMLS CUI-1
C1302584
Patient's Age at Time of AE
Description

Patient's Age at Time of AE

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C41331
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-1
C0030705
UMLS CUI-2
C0001779
Notify Local IRB?
Description

Notify Local IRB?

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25388
NCI Thesaurus ObjectClass-2
C16741
NCI Thesaurus Property
C41331
NCI Thesaurus Property-2
C25297
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0086911
UMLS CUI-2
C0422202
UMLS CUI-3
C1512698
Institution Number
Description

Institution Number

Data type

float

Alias
UMLS CUI-1
C1272753
UMLS CUI-2
C0237753
Specify Type of Adverse Event (AE)
Description

Specify Type of Adverse Event (AE)

Data type

text

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1521902
AE (CTC Term)
Description

AE (CTC Term)

Data type

text

Alias
UMLS CUI-1
C1879645
4-Character NSABP Code
Description

4-Character NSABP Code

Data type

text

Alias
UMLS CUI-1
C1513905
UMLS CUI-2
C0805701
Date of Adverse Event (Month Day Year)
Description

Date of Adverse Event (Month Day Year)

Data type

date

Alias
UMLS CUI-1
C2985916
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
Attribution (relationship) of the AE to protocol therapy?
Description

Attribution (relationship) of the AE to protocol therapy?

Data type

text

Alias
UMLS CUI-1
C1510821
UMLS CUI-2
C0054605
TamoxifenAnastrozole /Start Date (Month Day Year)
Description

TamoxifenAnastrozole /Start Date (Month Day Year)

Data type

date

Alias
UMLS CUI-1
C0039286
UMLS CUI-2
C0290883
UMLS CUI-3
C2708155
Tamoxifen/Anastrozole Date of Most Recent Dose (Month Day Year)
Description

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

Data type

date

Alias
UMLS CUI-1
C0039286
UMLS CUI-2
C0290883
UMLS CUI-3
C1762893
Briefly describe the AE (provide supporting documentation)
Description

Briefly describe the AE (provide supporting documentation)

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0877248
UMLS CUI-2
C0678257
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Demographics
C1704791 (UMLS CUI-1)
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patient's Last Name
text
C0421448 (UMLS CUI-1)
PatientStudyID
Item
Patient Study ID
float
C2826693 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
InstitutionName
Item
Institution Name
float
C1301943 (UMLS CUI-1)
AffiliateName
Item
Affiliate Name
text
C1510825 (UMLS CUI-1)
C0027365 (UMLS CUI-2)
Treating MD First Name
Item
Treating MD First Name
float
C1710470 (UMLS CUI-1)
Treating MD Last Name
Item
Treating MD Last Name
float
C1710470 (UMLS CUI-1)
C1301584 (UMLS CUI-2)
TreatingMDPhone
Item
Treating MD Phone
integer
C1710470 (UMLS CUI-1)
C1515258 (UMLS CUI-2)
PersonCompletingForm,LastName
Item
Person Completing Form Last Name
text
C3262828 (UMLS CUI-1)
PersonCompletingForm,FirstName
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C3262828 (UMLS CUI-1)
C1443235 (UMLS CUI-2)
PersonCompletingForm,Phone
Item
Person Completing Form Phone
integer
C25704 (NCI Thesaurus ValueDomain)
C3262828 (UMLS CUI-1)
C1515258 (UMLS CUI-2)
AmendedDataInd
Item
Are data amended? (If Yes, circle the amended items in red.)
boolean
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C1511726 (UMLS CUI-1)
C1691222 (UMLS CUI-2)
Item Group
AE Evaluation
FormCompletionDate,Original
Item
Date of this report (Month Day Year)
date
C1302584 (UMLS CUI-1)
PatientAdverseEventAssessmentAgeYearCount
Item
Patient's Age at Time of AE
float
C16960 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C41331 (NCI Thesaurus Property-2)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0030705 (UMLS CUI-1)
C0001779 (UMLS CUI-2)
LocalInstitutionalReviewBoardAdverseEventNotificationInd-2
Item
Notify Local IRB?
boolean
C25388 (NCI Thesaurus ObjectClass)
C16741 (NCI Thesaurus ObjectClass-2)
C41331 (NCI Thesaurus Property)
C25297 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0086911 (UMLS CUI-1)
C0422202 (UMLS CUI-2)
C1512698 (UMLS CUI-3)
NCIInstitutionNumber
Item
Institution Number
float
C1272753 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Specify Type of Adverse Event (AE)
text
C0877248 (UMLS CUI-1)
C1521902 (UMLS CUI-2)
CL.3
Code List
Specify Type of Adverse Event (AE)
CL Item
Grade 3 Unexpected* (Grade 3 unexpected*)
C1519275 (UMLS CUI-1)
C1519789 (UMLS CUI-2)
CL Item
Grade 4 Unexpected* (Grade 4 unexpected*)
C1519789 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
CL Item
Grade 4 Expected (Grade 4 expected)
C1517002 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
CL Item
Grade 5** Unexpected* (Grade 5** unexpected*)
C1519789 (UMLS CUI-1)
C1705232 (UMLS CUI-2)
CL Item
Grade 5** Expected (Grade 5** expected)
C1517002 (UMLS CUI-1)
C1705232 (UMLS CUI-2)
CTCAdverseEventTerm
Item
AE (CTC Term)
text
C1879645 (UMLS CUI-1)
4-CharacterNSABPCode
Item
4-Character NSABP Code
text
C1513905 (UMLS CUI-1)
C0805701 (UMLS CUI-2)
CTCAdverseEvent,InitialReportDate
Item
Date of Adverse Event (Month Day Year)
date
C2985916 (UMLS CUI-1)
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)
Item
Attribution (relationship) of the AE to protocol therapy?
text
C1510821 (UMLS CUI-1)
C0054605 (UMLS CUI-2)
CL.5
Code List
Attribution (relationship) of the AE to protocol therapy?
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS CUI-1)
CL Item
Definitely (Related)
C1704787 (UMLS CUI-1)
TreatmentStartDate
Item
TamoxifenAnastrozole /Start Date (Month Day Year)
date
C0039286 (UMLS CUI-1)
C0290883 (UMLS CUI-2)
C2708155 (UMLS CUI-3)
DateofMostRecentTreatment
Item
Tamoxifen/Anastrozole Date of Most Recent Dose (Month Day Year)
date
C0039286 (UMLS CUI-1)
C0290883 (UMLS CUI-2)
C1762893 (UMLS CUI-3)
BrieflydescribetheAE
Item
Briefly describe the AE (provide supporting documentation)
text
C25704 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
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