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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

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B111F21A-A960-319C-E034-0003BA12F5E7

Nyckelord

  1. 2012-08-27 2012-08-27 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
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9 januari 2015

DOI

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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.

    Section A - Serious Adverse Event Onset
    Beskrivning

    Section A - Serious Adverse Event Onset

    Date of onset (day month year)
    Beskrivning

    LateAdverseEventOnsetDate

    Datatyp

    date

    Date Section A filled in (date) (within 24 hours of SAE)
    Beskrivning

    DateSectionAfilledin(date)

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    Main Event
    Beskrivning

    CTCAdverseEventTerm

    Datatyp

    text

    Brief Description
    Beskrivning

    BriefDescription

    Datatyp

    text

    Daily Dosage
    Beskrivning

    AgentTotalDose(perday)

    Datatyp

    float

    Trial Phase (select all that apply)
    Beskrivning

    TrialPhase

    Datatyp

    text

    Admin. (e.g., i.v., p.o.)
    Beskrivning

    AgentAdminRoute

    Datatyp

    text

    Trial Phase, Other specify
    Beskrivning

    TrialPhase,Otherspecify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS 2011AA ValueDomain
    C1521902 (To specify)
    Start date of first cycle (chemotheraphy) (day month year)
    Beskrivning

    FirstDoseStartDate,FirstCycle

    Datatyp

    date

    Date Started (day month year)
    Beskrivning

    TreatmentBeginDate

    Datatyp

    date

    Date Started (day month year)
    Beskrivning

    TreatmentBeginDate

    Datatyp

    date

    Date Started (day month year)
    Beskrivning

    TreatmentBeginDate

    Datatyp

    date

    Date Started (day month year)
    Beskrivning

    TreatmentBeginDate

    Datatyp

    date

    Date Started (day month year)
    Beskrivning

    TreatmentBeginDate

    Datatyp

    date

    Trial Therapy
    Beskrivning

    TrialTherapy

    Datatyp

    text

    Date of Last Administration prior to SAE (day month year)
    Beskrivning

    DateofLastAdministrationpriortoSAE

    Datatyp

    text

    Concomitant Therapy:
    Beskrivning

    Concomitant Therapy:

    Type of Therapy
    Beskrivning

    TypeofTherapy

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Metathesaurus Property
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Name of Medication
    Beskrivning

    AgentName

    Datatyp

    text

    Daily Dosage
    Beskrivning

    AgentTotalDose(perday)

    Datatyp

    float

    Admin. (e.g., i.v., p.o.)
    Beskrivning

    AgentAdminRoute

    Datatyp

    text

    Date Started
    Beskrivning

    AgentBeginDate

    Datatyp

    date

    Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
    Beskrivning

    SignificantMedicalHistory,ConcomitantDiseasesand/orRelevantMedicalConditions

    Datatyp

    text

    Reason for seriousness (select one only)
    Beskrivning

    Reasonforseriousness

    Datatyp

    text

    Other specify (seriousness)
    Beskrivning

    Otherspecify(seriousness)

    Datatyp

    text

    Causality assessment regarding protocol treatment:
    Beskrivning

    CTCAdverseEventAttributionCode

    Datatyp

    text

    Toxicity Grade for Events thought to be at least possibly related
    Beskrivning

    ToxicityGradeforEventsthoughttobeatleastpossiblyrelated

    Datatyp

    text

    In the Investigator?s opinion, the Event was most likely due to:
    Beskrivning

    IntheInvestigator'sopinion,theEventwasmostlikelydueto:

    Datatyp

    text

    Investigator/Designee Signature
    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
    Investigator/Designee Signature
    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
    MD Name (please print:)
    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)
    Phone number
    Beskrivning

    PhoneNumber

    Datatyp

    float

    Fax number
    Beskrivning

    FaxNumber

    Datatyp

    float

    Date (day month year)
    Beskrivning

    InvestigatorSignatureDate

    Datatyp

    date

    Ccrr Module For Serious Adverse Event Form (form 24-sae-a)
    Beskrivning

    Ccrr Module For Serious Adverse Event Form (form 24-sae-a)

    Patient ID Number (Study No.)
    Beskrivning

    PatientStudyID,CoordinatingGroup

    Datatyp

    text

    Patient Initials (f m fl sl)
    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)
    Patient's Date of Birth (day)
    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
    Participating Center/Affiliate
    Beskrivning

    MainMemberInstitution/Affiliate

    Datatyp

    text

    Center Code (Ver.#1)
    Beskrivning

    ParticipatingGroupCode

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    Date of initial report (within 24 hours of SAE:)
    Beskrivning

    Dateofinitialreport

    Datatyp

    text

    Date of follow-up report (within 15 days of initial report:)
    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.

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Section A - Serious Adverse Event Onset
    LateAdverseEventOnsetDate
    Item
    Date of onset (day month year)
    date
    DateSectionAfilledin(date)
    Item
    Date Section A filled in (date) (within 24 hours of SAE)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    CTCAdverseEventTerm
    Item
    Main Event
    text
    BriefDescription
    Item
    Brief Description
    text
    AgentTotalDose(perday)
    Item
    Daily Dosage
    float
    Item
    Trial Phase (select all that apply)
    text
    Code List
    Trial Phase (select all that apply)
    CL Item
    On Chemotherapy (On chemotherapy)
    CL Item
    On Endocrine Therapy (On endocrine therapy)
    CL Item
    On Immunotherapy (On immunotherapy)
    CL Item
    On Radiation Therapy (On radiation therapy)
    CL Item
    Other, Specify (Other, specify)
    CL Item
    On Follow-up Phase (On follow-up phase)
    AgentAdminRoute
    Item
    Admin. (e.g., i.v., p.o.)
    text
    TrialPhase,Otherspecify
    Item
    Trial Phase, Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    FirstDoseStartDate,FirstCycle
    Item
    Start date of first cycle (chemotheraphy) (day month year)
    date
    TreatmentBeginDate
    Item
    Date Started (day month year)
    date
    TreatmentBeginDate
    Item
    Date Started (day month year)
    date
    TreatmentBeginDate
    Item
    Date Started (day month year)
    date
    TreatmentBeginDate
    Item
    Date Started (day month year)
    date
    TreatmentBeginDate
    Item
    Date Started (day month year)
    date
    TrialTherapy
    Item
    Trial Therapy
    text
    DateofLastAdministrationpriortoSAE
    Item
    Date of Last Administration prior to SAE (day month year)
    text
    Item Group
    Concomitant Therapy:
    Item
    Type of Therapy
    text
    C15368 (NCI Thesaurus ObjectClass)
    C0332307 (NCI Metathesaurus Property)
    Code List
    Type of Therapy
    CL Item
    Antidepressants (Antidepressants)
    CL Item
    Antihypertensives (Antihypertensives)
    CL Item
    Oral Hypoglycemic / Insulin (Oral Hypoglycemic / Insulin)
    CL Item
    Anticoagulants (Anticoagulants)
    CL Item
    Antibiotics (Antibiotics)
    CL Item
    Radiotherapy (Radiotherapy)
    CL Item
    Other(s) (Other(s))
    AgentName
    Item
    Name of Medication
    text
    AgentTotalDose(perday)
    Item
    Daily Dosage
    float
    AgentAdminRoute
    Item
    Admin. (e.g., i.v., p.o.)
    text
    AgentBeginDate
    Item
    Date Started
    date
    SignificantMedicalHistory,ConcomitantDiseasesand/orRelevantMedicalConditions
    Item
    Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
    text
    Item
    Reason for seriousness (select one only)
    text
    Code List
    Reason for seriousness (select one only)
    CL Item
    Fatal. (Fatal.)
    CL Item
    Life-threatening (Life-threatening)
    CL Item
    Required Or Prolonged Hospitalization (Required or prolonged hospitalization)
    CL Item
    Resulted In Severe Or Permanent Disability (Resulted in severe or permanent disability)
    CL Item
    Unexpected Grade 4 Toxicity (Unexpected grade 4 toxicity)
    CL Item
    Overdose (Overdose)
    CL Item
    Second Primary Cancer (Second primary cancer)
    CL Item
    Congenital Anomaly (Congenital anomaly)
    CL Item
    Other, Specify (Other, specify)
    Otherspecify(seriousness)
    Item
    Other specify (seriousness)
    text
    Item
    Causality assessment regarding protocol treatment:
    text
    Code List
    Causality assessment regarding protocol treatment:
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (Definite)
    CL Item
    Cannot be classified (Cannot be classified)
    ToxicityGradeforEventsthoughttobeatleastpossiblyrelated
    Item
    Toxicity Grade for Events thought to be at least possibly related
    text
    IntheInvestigator'sopinion,theEventwasmostlikelydueto:
    Item
    In the Investigator?s opinion, the Event was most likely due to:
    text
    InvestigatorSignature
    Item
    Investigator/Designee Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignature
    Item
    Investigator/Designee Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    TreatingPhysician
    Item
    MD Name (please print:)
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    PhoneNumber
    Item
    Phone number
    float
    FaxNumber
    Item
    Fax number
    float
    InvestigatorSignatureDate
    Item
    Date (day month year)
    date
    Item Group
    Ccrr Module For Serious Adverse Event Form (form 24-sae-a)
    PatientStudyID,CoordinatingGroup
    Item
    Patient ID Number (Study No.)
    text
    Patient Initials
    Item
    Patient Initials (f m fl sl)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    PatientBirthDate
    Item
    Patient's Date of Birth (day)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    MainMemberInstitution/Affiliate
    Item
    Participating Center/Affiliate
    text
    ParticipatingGroupCode
    Item
    Center Code (Ver.#1)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    Dateofinitialreport
    Item
    Date of initial report (within 24 hours of SAE:)
    text
    PatientFollow-upAssessmentReportDate
    Item
    Date of follow-up report (within 15 days of initial report:)
    date
    C16960 (NCI Thesaurus ObjectClass)
    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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