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ID

22135

Beschrijving

Study part: Patient death report. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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Versies (1)
  1. 20-05-17 20-05-17 -
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Roche

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20 mei 2017

DOI

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Creative Commons BY-NC 3.0
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    PATIENT DEATH REPORT Roche H0650g Breast Cancer

    Engels

    PATIENT DEATH REPORT

    1 Formulieren  
    1. StudyEvent: ODM
      1. PATIENT DEATH REPORT
    PATIENT DEATH REPORT
    Beschrijving

    PATIENT DEATH REPORT

    Alias
    UMLS CUI-1
    C0011065
    UMLS CUI-2
    C1516308
    PATIENT INT.
    Beschrijving

    Patient initial

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440
    PATIENT NUMBER
    Beschrijving

    Patient id

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1269815
    DATE OF DEATH:
    Beschrijving

    DATE OF DEATH

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1148348
    PRIMARY CAUSE OF DEATH:
    Beschrijving

    cause of death

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0007465
    PROVIDE DETAILS:
    Beschrijving

    cause of death

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0007465
    RELATIONSHIP OF DEATH TO STUDY DRUG
    Beschrijving

    cause of death study drug

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0304229
    RELATIONSHIP OF DEATH TO DISEASE
    Beschrijving

    Cause of Death disease

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0012634
    AUTOPSY PERFORMED?
    Beschrijving

    AUTOPSY

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004398
    IF YES
    Beschrijving

    AUTOPSY

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0004398
    I HAVE REVIEWED ALL RELEVANT DATA AND AGREE WITH THE ASSESSMENTS PROVIDED.
    Beschrijving

    consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    SIGNATURE OF PRINCIPAL INVESTIGATOR
    Beschrijving

    SIGNATURE OF INVESTIGATOR

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826892
    DATE
    Beschrijving

    DATE

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Terug naar het begin van de pagina

    Similar models

    PATIENT DEATH REPORT

    1 Formulieren
    1. StudyEvent: ODM
      1. PATIENT DEATH REPORT
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    PATIENT DEATH REPORT
    C0011065 (UMLS CUI-1)
    C1516308 (UMLS CUI-2)
    Patient initial
    Item
    PATIENT INT.
    text
    C2986440 (UMLS CUI [1])
    Patient id
    Item
    PATIENT NUMBER
    integer
    C1269815 (UMLS CUI [1])
    DATE OF DEATH
    Item
    DATE OF DEATH:
    date
    C1148348 (UMLS CUI [1])
    cause of death
    Item
    PRIMARY CAUSE OF DEATH:
    text
    C0007465 (UMLS CUI [1])
    cause of death
    Item
    PROVIDE DETAILS:
    text
    C0007465 (UMLS CUI [1])
    Item
    RELATIONSHIP OF DEATH TO STUDY DRUG
    integer
    C0007465 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    study drug
    Code List
    RELATIONSHIP OF DEATH TO STUDY DRUG
    CL Item
    NOT RELATED  (1)
    CL Item
    POSSIBLE (2)
    CL Item
    PROBABLE (3)
    Item
    RELATIONSHIP OF DEATH TO DISEASE
    integer
    C0007465 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    study drug
    Code List
    RELATIONSHIP OF DEATH TO DISEASE
    CL Item
    NOT RELATED  (1)
    CL Item
    POSSIBLE (2)
    CL Item
    PROBABLE (3)
    AUTOPSY
    Item
    AUTOPSY PERFORMED?
    boolean
    C0004398 (UMLS CUI [1])
    Item
    IF YES
    integer
    C0004398 (UMLS CUI [1])
    AUTOPSY
    Code List
    IF YES
    CL Item
    A COPY OF THE REPORT IS ATTACHED (1)
    CL Item
    A COPY OF THE REPORT IS NOT ATTACHED OR UNAVAILABLE (2)
    consent
    Item
    I HAVE REVIEWED ALL RELEVANT DATA AND AGREE WITH THE ASSESSMENTS PROVIDED.
    boolean
    C0021430 (UMLS CUI [1])
    SIGNATURE OF INVESTIGATOR
    Item
    SIGNATURE OF PRINCIPAL INVESTIGATOR
    text
    C2826892 (UMLS CUI [1])
    DATE
    Item
    DATE
    date
    C0011008 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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