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ID

41494

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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Versions (2)
  1. 10/28/20 10/28/20 -
  2. 10/28/20 10/28/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 28, 2020

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License

Creative Commons BY 4.0
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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Screening - Physical Examination (Annex Report 2 Final)

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Physical Examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Has a complete physical examination been performed?
    Description

    Has a complete physical examination been performed?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    Physical Examination Result
    Description

    Tick all that apply. At least one box must be ticked.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0456984
    Other Physical Examination Result
    Description

    Other Physical Examination Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0456984
    UMLS CUI [2]
    C0205394
    General Medical History/ Physical Examination
    Description

    General Medical History/ Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
    Description

    Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0012634
    Conditions, signs, diseases
    Description

    Conditions, signs, diseases

    Alias
    UMLS CUI-1
    C0521987
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0012634
    MeDRA System Organ Class
    Description

    MeDRA System Organ Class

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347091
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Condition, sign or disease status
    Description

    Condition, sign or disease status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521987
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0449438
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0449438
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    Similar models

    Screening - Physical Examination (Annex Report 2 Final)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Physical Examination
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Has a complete physical examination been performed?
    Item
    Has a complete physical examination been performed?
    boolean
    C0031809 (UMLS CUI [1])
    Item
    Physical Examination Result
    integer
    C0031809 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Physical Examination Result
    Code List
    Physical Examination Result
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    SAE (Record in SAE section) (3)
    CL Item
    Pre-existing medical condition (Complete General Medical History page) (4)
    CL Item
    Other, specify (5)
    Other Physical Examination Result
    Item
    Other Physical Examination Result
    text
    C0031809 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2])
    Item Group
    General Medical History/ Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
    Item
    Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
    boolean
    C0521987 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0012634 (UMLS CUI [3])
    Item Group
    Conditions, signs, diseases
    C0521987 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0012634 (UMLS CUI-3)
    Item
    MeDRA System Organ Class
    integer
    C2347091 (UMLS CUI [1])
    MeDRA System Organ Class
    Code List
    MeDRA System Organ Class
    CL Item
    Skin and subcutaneous tissue (1)
    CL Item
    Musculoskeletal and connective tissue (2)
    CL Item
    Cardiac (3)
    CL Item
    Vascular (4)
    CL Item
    Respiratory, thoracic and mediastinal (5)
    CL Item
    Gastrointestinal (6)
    CL Item
    Hepatobiliary (7)
    CL Item
    Renal and urinary (8)
    CL Item
    Nervous system (9)
    CL Item
    Eye (10)
    CL Item
    Ear and labyrinth (11)
    CL Item
    Endocrine (12)
    CL Item
    Metabolism and nutrition (13)
    CL Item
    Blood and lymphatic system (14)
    CL Item
    Immune system (Incl. allergies, autoimmune disorders) (15)
    CL Item
    Infections and infestations (16)
    CL Item
    Neoplasms benign, malignant and unspecified (incl. cysts, polyps) (17)
    CL Item
    Surgical and medical procedures (18)
    CL Item
    Psychiatric (20)
    CL Item
    Other (99)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Condition, sign or disease status
    integer
    C0521987 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0449438 (UMLS CUI [2,2])
    C0012634 (UMLS CUI [3,1])
    C0449438 (UMLS CUI [3,2])
    Condition, sign or disease status
    Code List
    Condition, sign or disease status
    CL Item
    Past (1)
    CL Item
    Current (2)
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