ID
9115
Beskrivning
Serious Adverse Event Form (Form 24-SAE-A) 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=B111F21A-A960-319C-E034-0003BA12F5E7
Länk
Nyckelord
Versioner (2)
- 2012-08-27 2012-08-27 -
- 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 - Serious Adverse Event Form (Form 24-SAE-A) - 2072974v3.0
SERIOUS ADVERSE EVENT FORM (Form 24-SAE-A) Instructions: Fax Section A within 24 hours in the case of a serious adverse event. Fax Section B within 15 days of initial report and/or for definitive SAE outcome. Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done.
- StudyEvent: Serious Adverse Event Form (Form 24-SAE-A)
Beskrivning
Concomitant Therapy:
Beskrivning
TypeofTherapy
Datatyp
text
Alias
- NCI Thesaurus ObjectClass
- C15368 (undefined)
- NCI Metathesaurus Property
- C0332307 (Type - attribute)
- SNOMED
- 261664005
Beskrivning
AgentName
Datatyp
text
Beskrivning
AgentTotalDose(perday)
Datatyp
float
Beskrivning
AgentAdminRoute
Datatyp
text
Beskrivning
AgentBeginDate
Datatyp
date
Beskrivning
SignificantMedicalHistory,ConcomitantDiseasesand/orRelevantMedicalConditions
Datatyp
text
Beskrivning
Reasonforseriousness
Datatyp
text
Beskrivning
Otherspecify(seriousness)
Datatyp
text
Beskrivning
CTCAdverseEventAttributionCode
Datatyp
text
Beskrivning
ToxicityGradeforEventsthoughttobeatleastpossiblyrelated
Datatyp
text
Beskrivning
IntheInvestigator'sopinion,theEventwasmostlikelydueto:
Datatyp
text
Beskrivning
InvestigatorSignature
Datatyp
text
Alias
- NCI Thesaurus Property
- C25678 (undefined)
- UMLS 2011AA Property
- C1519316 (Signature)
- LOINC
- LP248948-4
- NCI Thesaurus ObjectClass
- C17089 (undefined)
- UMLS 2011AA ObjectClass
- C0035173 (Research Personnel)
- SNOMED
- 769038007
- LOINC
- LA23773-7
Beskrivning
InvestigatorSignature
Datatyp
text
Alias
- NCI Thesaurus Property
- C25678 (undefined)
- UMLS 2011AA Property
- C1519316 (Signature)
- LOINC
- LP248948-4
- NCI Thesaurus ObjectClass
- C17089 (undefined)
- UMLS 2011AA ObjectClass
- C0035173 (Research Personnel)
- SNOMED
- 769038007
- LOINC
- LA23773-7
Beskrivning
TreatingPhysician
Datatyp
text
Alias
- NCI Thesaurus Property
- C25364 (undefined)
- UMLS 2011AA Property
- C0600091 (Identifier)
- SNOMED
- 118522005
- LOINC
- LP31795-5
- NCI Thesaurus ObjectClass
- C25741 (undefined)
- UMLS 2011AA ObjectClass
- C0031831 (Physicians)
- SNOMED
- 158965000
- LOINC
- LA18968-0
- NCI Thesaurus ObjectClass-2
- C25705 (undefined)
- UMLS 2011AA ObjectClass-2
- C1522326 (Treating)
Beskrivning
PhoneNumber
Datatyp
float
Beskrivning
FaxNumber
Datatyp
float
Beskrivning
InvestigatorSignatureDate
Datatyp
date
Beskrivning
Ccrr Module For Serious Adverse Event Form (form 24-sae-a)
Beskrivning
PatientStudyID,CoordinatingGroup
Datatyp
text
Beskrivning
Patient Initials
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C25191 (undefined)
- UMLS CUI-1
- C2986440 (Person Initials)
- NCI Thesaurus ObjectClass
- C16960 (undefined)
- NCI Thesaurus Property
- C25536 (undefined)
Beskrivning
PatientBirthDate
Datatyp
date
Alias
- NCI Thesaurus ObjectClass
- C16960 (undefined)
- UMLS 2011AA ObjectClass
- C0030705 (Patients)
- SNOMED
- 116154003
- NCI Thesaurus Property
- C25275 (undefined)
- UMLS 2011AA Property
- C2745955 (Occurrence)
- SNOMED
- 246454002
Beskrivning
MainMemberInstitution/Affiliate
Datatyp
text
Beskrivning
ParticipatingGroupCode
Datatyp
text
Alias
- NCI Thesaurus ValueDomain
- C25162 (undefined)
- UMLS 2011AA ValueDomain
- C0805701 (Code)
Beskrivning
Dateofinitialreport
Datatyp
text
Beskrivning
PatientFollow-upAssessmentReportDate
Datatyp
date
Alias
- NCI Thesaurus ObjectClass
- C16960 (undefined)
- UMLS 2011AA ObjectClass
- C0030705 (Patients)
- SNOMED
- 116154003
- NCI Thesaurus Property
- C20989 (undefined)
- UMLS 2011AA Property
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
- NCI Thesaurus Property-2
- C16033 (undefined)
- UMLS 2011AA Property-2
- C1522577 (follow-up)
- NCI Thesaurus Property-3
- C25375 (undefined)
- UMLS 2011AA Property-3
- C0684224 (Report (document))
- SNOMED
- 229059009
- LOINC
- LP183761-8
- NCI Thesaurus ValueDomain
- C25164 (undefined)
- UMLS 2011AA ValueDomain
- C0011008 (Date in time)
- SNOMED
- 410671006
Similar models
SERIOUS ADVERSE EVENT FORM (Form 24-SAE-A) Instructions: Fax Section A within 24 hours in the case of a serious adverse event. Fax Section B within 15 days of initial report and/or for definitive SAE outcome. Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done.
- StudyEvent: Serious Adverse Event Form (Form 24-SAE-A)
C0011008 (UMLS 2011AA ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C0332307 (NCI Metathesaurus Property)
C0445356 (UMLS 2011AA)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
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)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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