ID
9003
Beskrivning
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
Länk
Nyckelord
Versioner (2)
- 2012-08-26 2012-08-26 -
- 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den
9 januari 2015
DOI
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Licens
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.
Beskrivning
Vasomotor Menopausal
Beskrivning
CTCAdverseEventHotflashes/flushesGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
Waspatienttreatedforhotflashes/nightsweats?
Datatyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beskrivning
Musculoskeletal
Beskrivning
BoneMineralDensityTestPerformedPerformed
Datatyp
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
Beskrivning
Ifyes,wasbonemineraldensityT-scoreatleast1.5standarddeviationsbelowtheyoungadultnormalmeaninatleastonesite?
Datatyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
BoneFractures
Datatyp
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beskrivning
BoneFractureDate
Datatyp
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
Beskrivning
Maincauseofbonefracture
Datatyp
text
Beskrivning
Other,sourceofsurvivalinformation
Datatyp
text
Beskrivning
Siteofbonefracture
Datatyp
text
Beskrivning
CTCAdverseEventMusculoskeletal-Other(Specify,______)Grade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
Psychological
Beskrivning
CTCAdverseEventMoodalteration-depressionGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
Cardiovascular/cerebrovascular
Beskrivning
Hypertension(treated?)
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventCardiac-ischemia/infarctionGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventThrombosis/embolismGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventCNScerebrovascularischemiaGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
Constitutional Symptoms
Beskrivning
CTCAdverseEventInsomniaGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventFatigue(lethargy,malaise,asthenia)Grade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventNauseaGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
Allergic Reaction / Hypersensitivity / Injection Site Reaction
Beskrivning
CTCAdverseEventAllergicreaction/hypersensitivity(includingdrugfever)Grade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
Ifpossibly,probablyordefinitelyrelatedtostudytreatment,intheInvestigator?sopinion,theeventwasmostlikelydueto:
Datatyp
text
Beskrivning
Other,
Datatyp
text
Beskrivning
CTCAdverseEventInjectionsitereactionGrade
Datatyp
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Beskrivning
Other Adverse Events
Beskrivning
CTCAdverseEventTerm,Other
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
InvestigatorSignature
Datatyp
text
Alias
- NCI Thesaurus Property
- C25678
- UMLS 2011AA Property
- C1519316
- NCI Thesaurus ObjectClass
- C17089
- UMLS 2011AA ObjectClass
- C0035173
Beskrivning
InvestigatorSignatureDate
Datatyp
date
Beskrivning
Ccrr Module For Adverse Event Form (form 24-ae)
Beskrivning
MonthNumber
Datatyp
text
Beskrivning
PatientStudyID,CoordinatingGroup
Datatyp
text
Beskrivning
Patient Initials
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Beskrivning
PatientBirthDate
Datatyp
date
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25275
- UMLS 2011AA Property
- C2745955
Beskrivning
MainMemberInstitution/Affiliate
Datatyp
text
Beskrivning
ParticipatingGroupCode
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C25162
- UMLS 2011AA ValueDomain
- C0805701
Similar models
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)