ID
9003
Description
Adverse Event Form (Form 24-AE) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7
Link
Keywords
Versions (2)
- 8/26/12 8/26/12 -
- 1/9/15 1/9/15 - Martin Dugas
Uploaded on
January 9, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 Toxicity - Adverse Event Form (Form 24-AE) - 2072124v3.0
Instructions: Indicate whether or not the patient experienced any of the adverse events listed below by marking an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done. This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 & 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No AE Forms are required after first relapse/recurrence.
Description
Vasomotor Menopausal
Description
CTCAdverseEventHotflashes/flushesGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventAttributionCode
Data type
text
Description
Waspatienttreatedforhotflashes/nightsweats?
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
Musculoskeletal
Description
BoneMineralDensityTestPerformedPerformed
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
- NCI Thesaurus Property
- C38000
- UMLS 2011AA Property
- C0884358
- NCI Thesaurus ObjectClass
- C61545
- UMLS 2011AA ObjectClass
- C0177804
Description
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
BoneFractures
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
BoneFractureDate
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ObjectClass
- C12366
- UMLS 2011AA ObjectClass
- C0262950
- NCI Thesaurus Property
- C3046
- UMLS 2011AA Property
- C0016658
Description
Maincauseofbonefracture
Data type
text
Description
Other,sourceofsurvivalinformation
Data type
text
Description
Siteofbonefracture
Data type
text
Description
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
Psychological
Description
CTCAdverseEventMoodalteration-depressionGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventAttributionCode
Data type
text
Description
Cardiovascular/cerebrovascular
Description
Hypertension(treated?)
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventCardiac-ischemia/infarctionGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventThrombosis/embolismGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventCNScerebrovascularischemiaGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
Constitutional Symptoms
Description
CTCAdverseEventInsomniaGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventNauseaGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Description
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
CTCAdverseEventAttributionCode
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:
Data type
text
Description
Other,
Data type
text
Description
CTCAdverseEventInjectionsitereactionGrade
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
Other Adverse Events
Description
CTCAdverseEventTerm,Other
Data type
text
Description
CTCAdverseEventAttributionCode
Data type
text
Description
InvestigatorSignature
Data type
text
Alias
- NCI Thesaurus Property
- C25678
- UMLS 2011AA Property
- C1519316
- NCI Thesaurus ObjectClass
- C17089
- UMLS 2011AA ObjectClass
- C0035173
Description
InvestigatorSignatureDate
Data type
date
Description
Ccrr Module For Adverse Event Form (form 24-ae)
Description
MonthNumber
Data type
text
Description
PatientStudyID,CoordinatingGroup
Data type
text
Description
Patient Initials
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Description
PatientBirthDate
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25275
- UMLS 2011AA Property
- C2745955
Description
MainMemberInstitution/Affiliate
Data type
text
Description
ParticipatingGroupCode
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25162
- UMLS 2011AA ValueDomain
- C0805701
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Instructions: Indicate whether or not the patient experienced any of the adverse events listed below by marking an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done. This form is to be completed: -> Prior to starting any protocol therapy (Tamoxifen, Exemestane, OFS), and -> On the same schedule as the Follow-Up Form (24-E) (every 3 months in Year 1, every six months in Years 2-5) (during Tamoxifen, Exemestane, OFS), and -> At 6 & 12 months after the last dose of all protocol therapy (Tamoxifen, Exemestane, OFS). -> No AE Forms are required after first relapse/recurrence.
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C1512698 (UMLS 2011AA ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C1512698 (UMLS 2011AA ValueDomain)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C1512698 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
C0027627 (UMLS 2011AA)
C0029456 (UMLS 2011AA)
C0019552 (UMLS 2011AA)
C0549207 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0549184 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0039286 (UMLS 2011AA)
C0060116 (UMLS 2011AA)
C0077275 (UMLS 2011AA)
C0120107 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)