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ID

41494

Descrição

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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Versões (2)
  1. 28/10/2020 28/10/2020 -
  2. 28/10/2020 28/10/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

28 de outubro de 2020

DOI

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Licença

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

    Inglês

    Screening - Physical Examination (Annex Report 2 Final)

    1 Formulários  
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient Number
    Descrição

    Physical Examination

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Physical Examination
    Descrição

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Has a complete physical examination been performed?
    Descrição

    Has a complete physical examination been performed?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination Result
    Descrição

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

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    Other Physical Examination Result
    Descrição

    Other Physical Examination Result

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    General Medical History/ Physical Examination
    Descrição

    General Medical History/ Physical Examination

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Are you aware of any relevant pre-existing conditions, signs or diseases (excluding study disease) prior to the start of the study?
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0521987 (Pre-existing condition)
    SNOMED
    102478008
    UMLS CUI [2]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [3]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Conditions, signs, diseases
    Descrição

    Conditions, signs, diseases

    Alias
    UMLS CUI-1
    C0521987 (Pre-existing condition)
    SNOMED
    102478008
    UMLS CUI-2
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI-3
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    MeDRA System Organ Class
    Descrição

    MeDRA System Organ Class

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2347091 (MedDRA System Organ Class)
    Diagnosis
    Descrição

    Diagnosis

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Condition, sign or disease status
    Descrição

    Condition, sign or disease status

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0521987 (Pre-existing condition)
    SNOMED
    102478008
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    UMLS CUI [3,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [3,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
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    Similar models

    Screening - Physical Examination (Annex Report 2 Final)

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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