ID
9003
Descripción
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
Palabras clave
Versiones (2)
- 26/8/12 26/8/12 -
- 9/1/15 9/1/15 - Martin Dugas
Subido en
9 de enero de 2015
DOI
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Licencia
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.
Descripción
Vasomotor Menopausal
Descripción
CTCAdverseEventHotflashes/flushesGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
Waspatienttreatedforhotflashes/nightsweats?
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
Musculoskeletal
Descripción
BoneMineralDensityTestPerformedPerformed
Tipo de datos
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
Descripción
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
BoneFractures
Tipo de datos
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Descripción
BoneFractureDate
Tipo de datos
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
Descripción
Maincauseofbonefracture
Tipo de datos
text
Descripción
Other,sourceofsurvivalinformation
Tipo de datos
text
Descripción
Siteofbonefracture
Tipo de datos
text
Descripción
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
Psychological
Descripción
CTCAdverseEventMoodalteration-depressionGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
Cardiovascular/cerebrovascular
Descripción
Hypertension(treated?)
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventCardiac-ischemia/infarctionGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventThrombosis/embolismGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventCNScerebrovascularischemiaGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
Constitutional Symptoms
Descripción
CTCAdverseEventInsomniaGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventNauseaGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Descripción
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:
Tipo de datos
text
Descripción
Other,
Tipo de datos
text
Descripción
CTCAdverseEventInjectionsitereactionGrade
Tipo de datos
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descripción
Other Adverse Events
Descripción
CTCAdverseEventTerm,Other
Tipo de datos
text
Descripción
CTCAdverseEventAttributionCode
Tipo de datos
text
Descripción
InvestigatorSignature
Tipo de datos
text
Alias
- NCI Thesaurus Property
- C25678
- UMLS 2011AA Property
- C1519316
- NCI Thesaurus ObjectClass
- C17089
- UMLS 2011AA ObjectClass
- C0035173
Descripción
InvestigatorSignatureDate
Tipo de datos
date
Descripción
Ccrr Module For Adverse Event Form (form 24-ae)
Descripción
MonthNumber
Tipo de datos
text
Descripción
PatientStudyID,CoordinatingGroup
Tipo de datos
text
Descripción
Patient Initials
Tipo de datos
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Descripción
PatientBirthDate
Tipo de datos
date
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25275
- UMLS 2011AA Property
- C2745955
Descripción
MainMemberInstitution/Affiliate
Tipo de datos
text
Descripción
ParticipatingGroupCode
Tipo de datos
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)