ID
1088
Beschrijving
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
Trefwoorden
Versies (2)
- 26-08-12 26-08-12 -
- 09-01-15 09-01-15 - Martin Dugas
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26 augustus 2012
DOI
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Licentie
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.
Beschrijving
Vasomotor Menopausal
Beschrijving
CTCAdverseEventHotflashes/flushesGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
Waspatienttreatedforhotflashes/nightsweats?
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
Musculoskeletal
Beschrijving
BoneMineralDensityTestPerformedPerformed
Datatype
text
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
Beschrijving
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
BoneFractures
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschrijving
BoneFractureDate
Datatype
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
Beschrijving
Maincauseofbonefracture
Datatype
text
Beschrijving
Other,sourceofsurvivalinformation
Datatype
text
Beschrijving
Siteofbonefracture
Datatype
text
Beschrijving
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
Psychological
Beschrijving
CTCAdverseEventMoodalteration-depressionGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
Cardiovascular/cerebrovascular
Beschrijving
Hypertension(treated?)
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventCardiac-ischemia/infarctionGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventThrombosis/embolismGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventCNScerebrovascularischemiaGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
Constitutional Symptoms
Beschrijving
CTCAdverseEventInsomniaGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventNauseaGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Beschrijving
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:
Datatype
text
Beschrijving
Other,
Datatype
text
Beschrijving
CTCAdverseEventInjectionsitereactionGrade
Datatype
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschrijving
Other Adverse Events
Beschrijving
CTCAdverseEventTerm,Other
Datatype
text
Beschrijving
CTCAdverseEventAttributionCode
Datatype
text
Beschrijving
InvestigatorSignature
Datatype
text
Alias
- NCI Thesaurus Property
- C25678
- UMLS 2011AA Property
- C1519316
- NCI Thesaurus ObjectClass
- C17089
- UMLS 2011AA ObjectClass
- C0035173
Beschrijving
InvestigatorSignatureDate
Datatype
date
Beschrijving
Ccrr Module For Adverse Event Form (form 24-ae)
Beschrijving
MonthNumber
Datatype
text
Beschrijving
PatientStudyID,CoordinatingGroup
Datatype
text
Beschrijving
PatientInitialsName
Datatype
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
Beschrijving
PatientBirthDate
Datatype
date
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25275
- UMLS 2011AA Property
- C2745955
Beschrijving
MainMemberInstitution/Affiliate
Datatype
text
Beschrijving
ParticipatingGroupCode
Datatype
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)
C2945599 (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)
C1512698 (UMLS 2011AA ValueDomain)
C1298908 (UMLS 2011AA)
C1705108 (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)
C1512698 (UMLS 2011AA ValueDomain)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C1512698 (UMLS 2011AA ValueDomain)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
C1512698 (UMLS 2011AA ValueDomain)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
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)
C2945599 (UMLS 2011AA)
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)
C0155626 (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)
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)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)