NSABP B-35 Form ALERT NCT00053898

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

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.

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)
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)
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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