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ID

11593

Descrizione

AMC-048 Adverse Events Form (ADV) NCT00392834 Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-31FB-4AF2-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-31FB-4AF2-E044-0003BA3F9857

Keywords

  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 09/01/15 09/01/15 - Martin Dugas
  5. 08/07/15 08/07/15 -
Caricato su

8 luglio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy

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    AMC-048 Adverse Events Form (ADV) NCT00392834

    No Instruction available.

    1. StudyEvent: AMC-048 Adverse Events Form (ADV)
      1. No Instruction available.
    Header
    Descrizione

    Header

    CTC Adverse Event Category
    Descrizione

    CTCAdverseEventCategory

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25161
    UMLS 2011AA Property
    C0008902
    CTC Adverse Event Term
    Descrizione

    CTC Adverse Event Term

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC Adverse Event Grade
    Descrizione

    CTC Adverse Event Grade

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    Adverse Event Onset Date
    Descrizione

    Adverse Event Onset Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985916
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25279
    Adverse event assessment
    Descrizione

    Adverse event assessment

    MedDRA Code
    Descrizione

    MedDRACode

    Tipo di dati

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    If other CTC event selected, please provide description of event
    Descrizione

    AdverseEventDescriptionText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Metathesaurus Property
    C0678257
    Was this event expected or anticipated
    Descrizione

    AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus ObjectClass-3
    C71104
    UMLS 2011AA ObjectClass-3
    C0008976
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    NCI Thesaurus Property-2
    C54156
    UMLS 2011AA Property-2
    C0681842
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Agent Name
    Descrizione

    Agent

    Tipo di dati

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    CTC AE Attribution Code
    Descrizione

    CTC Adverse Event Attribution Category

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Alternative etiology
    Descrizione

    AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25415
    UMLS 2011AA Property
    C1523987
    NCI Thesaurus Property-2
    C25358
    UMLS 2011AA Property-2
    C0596130
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Action Taken at Time of Adverse Event
    Descrizione

    AcquiredImmunodeficiencySyndromeAdverseEventActionType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Other, specify
    Descrizione

    AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    If modification was made to study therapy, who initiated modification
    Descrizione

    AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass
    C0001175
    NCI Thesaurus Property
    C25657
    UMLS 2011AA Property
    C1273518
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Outcome of Adverse Event
    Descrizione

    AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    AE Resolution Date
    Descrizione

    Adverse Event Resolution Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985918
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25655
    If resolved with sequelae, specify
    Descrizione

    AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C49495
    UMLS 2011AA Property-2
    C1709862
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Seriousness Attributed to Adverse Event
    Descrizione

    AdverseEventSeriousnessAttributionScale

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Comments
    Descrizione

    Comments

    Comments
    Descrizione

    Research Comments

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393

    Similar models

    No Instruction available.

    1. StudyEvent: AMC-048 Adverse Events Form (ADV)
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header
    CTCAdverseEventCategory
    Item
    CTC Adverse Event Category
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25161 (NCI Thesaurus Property)
    C0008902 (UMLS 2011AA Property)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Onset Date
    Item
    Adverse Event Onset Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985916 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C25279 (NCI Thesaurus Property)
    Item Group
    Adverse event assessment
    MedDRACode
    Item
    MedDRA Code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    AdverseEventDescriptionText
    Item
    If other CTC event selected, please provide description of event
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C0678257 (NCI Metathesaurus Property)
    AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2
    Item
    Was this event expected or anticipated
    boolean
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C71104 (NCI Thesaurus ObjectClass-3)
    C0008976 (UMLS 2011AA ObjectClass-3)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    C54156 (NCI Thesaurus Property-2)
    C0681842 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    Alternative etiology
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25415 (NCI Thesaurus Property)
    C1523987 (UMLS 2011AA Property)
    C25358 (NCI Thesaurus Property-2)
    C0596130 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Alternative etiology
    CL Item
    Accident, Trauma, Or External Factors (Accident, trauma, or external factors)
    CL Item
    Concurrent Illness/condition (not Pre-existing) (Concurrent illness/condition (not pre-existing))
    CL Item
    None Apparent (None apparent)
    CL Item
    Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
    CL Item
    Study Disease (Study disease)
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    Hospitalization For Ae (Hospitalization)
    CL Item
    Otc/non-rx (OTC/non-Rx)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Prescription (Prescription)
    C28180 (NCI Thesaurus)
    C1521941 (UMLS 2011AA)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    Item
    If modification was made to study therapy, who initiated modification
    text
    C15368 (NCI Thesaurus ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus Property)
    C1273518 (UMLS 2011AA Property)
    C25572 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    If modification was made to study therapy, who initiated modification
    CL Item
    Patient Initiated (Patient initiated)
    CL Item
    Physician Initiated (Physician initiated)
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (Resolved)
    CL Item
    Adverse Event Is Resolved With Sequelae (Resolved with sequelae)
    CL Item
    Unresolved At Protocol Completion (Unresolved at protocol completion)
    CL Item
    Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
    Adverse Event Resolution Date
    Item
    AE Resolution Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985918 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C25655 (NCI Thesaurus Property)
    AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify
    Item
    If resolved with sequelae, specify
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C49495 (NCI Thesaurus Property-2)
    C1709862 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Item
    Seriousness Attributed to Adverse Event
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    Code List
    Seriousness Attributed to Adverse Event
    CL Item
    Congenital Anomaly (Congenital anomaly)
    CL Item
    Death (Death)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    CL Item
    Disability (Disability/incapacity)
    C21007 (NCI Thesaurus)
    C0231170 (UMLS 2011AA)
    CL Item
    Hospitalized (Hospitalization, initial or prolonged)
    CL Item
    Life Threatening (Life threatening)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Intervention Required (Required intervention to prevent permanent impairment/damage)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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