ID
9003
Beschreibung
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
Stichworte
Versionen (2)
- 26.08.12 26.08.12 -
- 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am
9. Januar 2015
DOI
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Lizenz
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.
Beschreibung
Vasomotor Menopausal
Beschreibung
CTCAdverseEventHotflashes/flushesGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
Waspatienttreatedforhotflashes/nightsweats?
Datentyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschreibung
Musculoskeletal
Beschreibung
BoneMineralDensityTestPerformedPerformed
Datentyp
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
Beschreibung
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Datentyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
BoneFractures
Datentyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschreibung
BoneFractureDate
Datentyp
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
Beschreibung
Maincauseofbonefracture
Datentyp
text
Beschreibung
Other,sourceofsurvivalinformation
Datentyp
text
Beschreibung
Siteofbonefracture
Datentyp
text
Beschreibung
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
Psychological
Beschreibung
CTCAdverseEventMoodalteration-depressionGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
Cardiovascular/cerebrovascular
Beschreibung
Hypertension(treated?)
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventCardiac-ischemia/infarctionGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventThrombosis/embolismGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventCNScerebrovascularischemiaGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
Constitutional Symptoms
Beschreibung
CTCAdverseEventInsomniaGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventNauseaGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Beschreibung
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:
Datentyp
text
Beschreibung
Other,
Datentyp
text
Beschreibung
CTCAdverseEventInjectionsitereactionGrade
Datentyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beschreibung
Other Adverse Events
Beschreibung
CTCAdverseEventTerm,Other
Datentyp
text
Beschreibung
CTCAdverseEventAttributionCode
Datentyp
text
Beschreibung
InvestigatorSignature
Datentyp
text
Alias
- NCI Thesaurus Property
- C25678
- UMLS 2011AA Property
- C1519316
- NCI Thesaurus ObjectClass
- C17089
- UMLS 2011AA ObjectClass
- C0035173
Beschreibung
InvestigatorSignatureDate
Datentyp
date
Beschreibung
Ccrr Module For Adverse Event Form (form 24-ae)
Beschreibung
MonthNumber
Datentyp
text
Beschreibung
PatientStudyID,CoordinatingGroup
Datentyp
text
Beschreibung
Patient Initials
Datentyp
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Beschreibung
PatientBirthDate
Datentyp
date
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25275
- UMLS 2011AA Property
- C2745955
Beschreibung
MainMemberInstitution/Affiliate
Datentyp
text
Beschreibung
ParticipatingGroupCode
Datentyp
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)