ID

7810

Descripción

E4A03 Thrombotic Event Prior September 14, 2005 Summary Form Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0615D022-651B-5424-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0615D022-651B-5424-E044-0003BA3F9857

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 16/6/15 16/6/15 -
Subido en

9 de enero de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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    Multiple Myeloma and Plasma Cell Neoplasm NCT00098475 Treatment - E4A03 Thrombotic Event Prior September 14, 2005 Summary Form - 2432193v1.0

    Inglés

    ONLY if patient?s disease is still stable or in partial or complete remission and has not progressed/relapsed from protocol therapy.

    1 formularios  
    Header
    Descripción

    Header

    ECOG Protocol Number
    Descripción

    Protocol Number ECOG

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    DCI Name
    Descripción

    Generic drug form

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step
    Descripción

    Registration Number

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    ECOG Patient ID
    Descripción

    Patient ID ECOG

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Reporting Period
    Descripción

    Clinical Trial Period

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Unnamed2
    Descripción

    Unnamed2

    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Descripción

    Protocol Number ECOG

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Protocol Number
    Descripción

    Study Number Participating Group

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Descripción

    Institution Name

    Tipo de datos

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    ECOG Patient ID
    Descripción

    Patient ID ECOG

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Patient ID
    Descripción

    Trial subject ID Participating Group

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Unnamed3
    Descripción

    Unnamed3

    Please mark an 'X' if data have been amended
    Descripción

    Data amended

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended
    Descripción

    Data amended date

    Tipo de datos

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25416
    NCI Thesaurus ValueDomain-2
    C25367
    Unnamed 4
    Descripción

    Unnamed 4

    Did patient recieve DVT prophylaxis (prior to September 14, 2005)
    Descripción

    Deep Vein Thrombosis prophylaxis

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0853245
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus ValueDomain
    C38147
    Start date of first (prophylactic) treatment
    Descripción

    DVT prophylaxis start date

    Tipo de datos

    date

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0853245
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    UMLS CUI-2
    C0808070
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Date of most recent (prophylactic) treatment
    Descripción

    DVT prophylaxis most recent date

    Tipo de datos

    date

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0853245
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    UMLS CUI-2
    C1513491
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-3
    C0011008
    NCI Thesaurus ValueDomain-2
    C25577
    Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
    Descripción

    Aspirin 81 mg

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0783425
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C49341
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus ValueDomain
    C38147
    Aspirin (325 mg)
    Descripción

    Aspirin 325 mg

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0714615
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C287
    NCI Thesaurus Property-3
    C49342
    NCI Thesaurus ValueDomain
    C38147
    Aspirin (other dose)
    Descripción

    Aspirin, other dose

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0004057
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C17649
    NCI Thesaurus Property-2
    C25639
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C38147
    If other dose of Aspirin given, specify dose
    Descripción

    Aspirin dose

    Tipo de datos

    float

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0004057
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C17649
    UMLS CUI-2
    C0178602
    NCI Thesaurus Property-2
    C25639
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    Coumadin
    Descripción

    Warfarin

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0043031
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C945
    NCI Thesaurus ValueDomain
    C38147
    If Coumadin given, specify dose
    Descripción

    Warfarin dose

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0366686
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C945
    NCI Thesaurus ValueDomain
    C25488
    Low molecular weight heparin (enoxaparin; Lovenox)
    Descripción

    Heparin, Low-Molecular-Weight

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0019139
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C2578
    NCI Thesaurus ValueDomain
    C38147
    Other, specify
    Descripción

    DVT prevention, specify

    Tipo de datos

    text

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0853245
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    UMLS CUI-2
    C1521902
    NCI Thesaurus ValueDomain
    C25685
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
    Descripción

    Erythropoietin-type agents

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0014822
    NCI Thesaurus ObjectClass
    C20429
    NCI Thesaurus ObjectClass-2
    C37902
    NCI Thesaurus Property
    C25382
    Unnamed 5
    Descripción

    Unnamed 5

    Did patient experience a thrombotic event (NOTE: Event must be reported through AdEERS and on the E4A03 Adverse Event Form)
    Descripción

    ThrombosisAdverseEventObservedInd-3

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C26891
    UMLS 2011AA ObjectClass-2
    C0040053
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    Date of thrombotic event (If yes, - List Date of thrombotic events this report period. Mark an ¿X¿ in the box on the right if not applicable.)
    Descripción

    ThrombosisAdverseEventObservedDate

    Tipo de datos

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C26891
    UMLS 2011AA ObjectClass-2
    C0040053
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    Mark an 'X' if N/A
    Descripción

    DataUnknownText

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C17998
    UMLS 2011AA Property
    C0439673
    Was the patient on thrombotic prophylaxis (NOTE: If more then one thrombotic event this report period, answer question below with regards to the first thrombotic event this report period.)
    Descripción

    ThrombosisPreventionTherapyReceivedInd-2

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C26891
    UMLS 2011AA ObjectClass
    C0040053
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    UMLS 2011AA Property
    C1514756
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
    Descripción

    Aspirin 81 mg

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0783425
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C49341
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus ValueDomain
    C38147
    Aspirin (325 mg)
    Descripción

    Aspirin 325 mg

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0714615
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C287
    NCI Thesaurus Property-3
    C49342
    NCI Thesaurus ValueDomain
    C38147
    Aspirin (other dose)
    Descripción

    Aspirin, other dose

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0004057
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C17649
    NCI Thesaurus Property-2
    C25639
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C38147
    If other dose of Aspirin given, specify dose
    Descripción

    Aspirin dose

    Tipo de datos

    float

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0004057
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C17649
    UMLS CUI-2
    C0178602
    NCI Thesaurus Property-2
    C25639
    NCI Thesaurus Property-3
    C287
    NCI Thesaurus Property-4
    C25256
    NCI Thesaurus ValueDomain
    C25488
    Coumadin
    Descripción

    Warfarin

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0043031
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C945
    NCI Thesaurus ValueDomain
    C38147
    If Coumadin given, specify dose
    Descripción

    Warfarin dose

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0366686
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C945
    NCI Thesaurus ValueDomain
    C25488
    Low molecular weight heparin (enoxaparin; Lovenox)
    Descripción

    Heparin, Low-Molecular-Weight

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0019139
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    NCI Thesaurus Property-2
    C2578
    NCI Thesaurus ValueDomain
    C38147
    Other, specify
    Descripción

    DVT prevention, specify

    Tipo de datos

    text

    Alias
    NCI Thesaurus ObjectClass
    C49343
    UMLS CUI-1
    C0853245
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus ObjectClass-3
    C15405
    NCI Thesaurus Property
    C25639
    UMLS CUI-2
    C1521902
    NCI Thesaurus ValueDomain
    C25685
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
    Descripción

    Erythropoietin-type agents

    Tipo de datos

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0014822
    NCI Thesaurus ObjectClass
    C20429
    NCI Thesaurus ObjectClass-2
    C37902
    NCI Thesaurus Property
    C25382
    Comments
    Descripción

    Comments

    Investigator Signature
    Descripción

    Investigator Signature

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Descripción

    Investigator Signature Date

    Tipo de datos

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089
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    Similar models

    ONLY if patient?s disease is still stable or in partial or complete remission and has not progressed/relapsed from protocol therapy.

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Header
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    CL.1
    Code List
    Reporting Period
    CL Item
    Deep Vein Thrombosis (DVT)
    Item Group
    Unnamed2
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Unnamed3
    Data amended
    Item
    Please mark an 'X' if data have been amended
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Unnamed 4
    Deep Vein Thrombosis prophylaxis
    Item
    Did patient recieve DVT prophylaxis (prior to September 14, 2005)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0853245 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    DVT prophylaxis start date
    Item
    Start date of first (prophylactic) treatment
    date
    C49343 (NCI Thesaurus ObjectClass)
    C0853245 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C0808070 (UMLS CUI-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    DVT prophylaxis most recent date
    Item
    Date of most recent (prophylactic) treatment
    date
    C49343 (NCI Thesaurus ObjectClass)
    C0853245 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C1513491 (UMLS CUI-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS CUI-3)
    C25577 (NCI Thesaurus ValueDomain-2)
    Aspirin 81 mg
    Item
    Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0783425 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C49341 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin 325 mg
    Item
    Aspirin (325 mg)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0714615 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C287 (NCI Thesaurus Property-2)
    C49342 (NCI Thesaurus Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin, other dose
    Item
    Aspirin (other dose)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0004057 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C25639 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin dose
    Item
    If other dose of Aspirin given, specify dose
    float
    C49343 (NCI Thesaurus ObjectClass)
    C0004057 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C0178602 (UMLS CUI-2)
    C25639 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    Warfarin
    Item
    Coumadin
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0043031 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C945 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Warfarin dose
    Item
    If Coumadin given, specify dose
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0366686 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C945 (NCI Thesaurus Property-2)
    C25488 (NCI Thesaurus ValueDomain)
    Heparin, Low-Molecular-Weight
    Item
    Low molecular weight heparin (enoxaparin; Lovenox)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0019139 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C2578 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    DVT prevention, specify
    Item
    Other, specify
    text
    C49343 (NCI Thesaurus ObjectClass)
    C0853245 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-2)
    C25685 (NCI Thesaurus ValueDomain)
    Erythropoietin-type agents
    Item
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0014822 (UMLS CUI-1)
    C20429 (NCI Thesaurus ObjectClass)
    C37902 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Item Group
    Unnamed 5
    ThrombosisAdverseEventObservedInd-3
    Item
    Did patient experience a thrombotic event (NOTE: Event must be reported through AdEERS and on the E4A03 Adverse Event Form)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C26891 (NCI Thesaurus ObjectClass-2)
    C0040053 (UMLS 2011AA ObjectClass-2)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    ThrombosisAdverseEventObservedDate
    Item
    Date of thrombotic event (If yes, - List Date of thrombotic events this report period. Mark an ¿X¿ in the box on the right if not applicable.)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C26891 (NCI Thesaurus ObjectClass-2)
    C0040053 (UMLS 2011AA ObjectClass-2)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    DataUnknownText
    Item
    Mark an 'X' if N/A
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C17998 (NCI Thesaurus Property)
    C0439673 (UMLS 2011AA Property)
    ThrombosisPreventionTherapyReceivedInd-2
    Item
    Was the patient on thrombotic prophylaxis (NOTE: If more then one thrombotic event this report period, answer question below with regards to the first thrombotic event this report period.)
    boolean
    C26891 (NCI Thesaurus ObjectClass)
    C0040053 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C1514756 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Aspirin 81 mg
    Item
    Aspirin (81 mg) (Were any of the following given prior to the first thrombotic event this report period? answer no 1 or yes 2 for each of the following)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0783425 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C49341 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin 325 mg
    Item
    Aspirin (325 mg)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0714615 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C287 (NCI Thesaurus Property-2)
    C49342 (NCI Thesaurus Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin, other dose
    Item
    Aspirin (other dose)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0004057 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C25639 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    Aspirin dose
    Item
    If other dose of Aspirin given, specify dose
    float
    C49343 (NCI Thesaurus ObjectClass)
    C0004057 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C0178602 (UMLS CUI-2)
    C25639 (NCI Thesaurus Property-2)
    C287 (NCI Thesaurus Property-3)
    C25256 (NCI Thesaurus Property-4)
    C25488 (NCI Thesaurus ValueDomain)
    Warfarin
    Item
    Coumadin
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0043031 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C945 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Warfarin dose
    Item
    If Coumadin given, specify dose
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0366686 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C945 (NCI Thesaurus Property-2)
    C25488 (NCI Thesaurus ValueDomain)
    Heparin, Low-Molecular-Weight
    Item
    Low molecular weight heparin (enoxaparin; Lovenox)
    boolean
    C49343 (NCI Thesaurus ObjectClass)
    C0019139 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C2578 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    DVT prevention, specify
    Item
    Other, specify
    text
    C49343 (NCI Thesaurus ObjectClass)
    C0853245 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass-2)
    C15405 (NCI Thesaurus ObjectClass-3)
    C25639 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-2)
    C25685 (NCI Thesaurus ValueDomain)
    Erythropoietin-type agents
    Item
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (prior to the first thrombotic event?)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0014822 (UMLS CUI-1)
    C20429 (NCI Thesaurus ObjectClass)
    C37902 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Item Group
    Comments
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)
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