0 Evaluaciones
ID

35662

Descripción

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

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Versiones (1)
  1. 14/03/19 14/03/19 -
Titular de derechos de autor

GSK group of companies

Subido en

14 marzo 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369

    Inglés

    Drug Dose Form

    1 formularios  
    1. StudyEvent: ODM
      1. Drug Dose Form
    Administrative data
    Descripción

    Administrative data

    Last Name
    Descripción

    Last Name

    Tipo de datos

    text

    First Name
    Descripción

    First Name

    Tipo de datos

    text

    GOG#
    Descripción

    Inst.,Prot.,Seq.

    Tipo de datos

    integer

    Section
    Descripción

    Section

    Tipo de datos

    integer

    Investigational Product
    Descripción

    Investigational Product

    Date of Course
    Descripción

    Date of Course

    Tipo de datos

    date

    Course Number
    Descripción

    Course Number

    Tipo de datos

    integer

    Course Timing
    Descripción

    Course Timing

    Tipo de datos

    text

    Number of delayed days
    Descripción

    Number of delayed days

    Tipo de datos

    integer

    Report reason for delay
    Descripción

    Comment

    Tipo de datos

    text

    Drug Dose
    Descripción

    Drug Dose

    Sequence Number
    Descripción

    Sequence Number

    Tipo de datos

    integer

    Drugs and Dose Level
    Descripción

    Drugs and Dose Level

    Tipo de datos

    text

    Change
    Descripción

    P/U

    Tipo de datos

    text

    Total dose for this course
    Descripción

    Total dose for this course

    Tipo de datos

    text

    Units
    Descripción

    Units

    Tipo de datos

    text

    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    kg
    Surface Area
    Descripción

    Surface Area

    Tipo de datos

    integer

    Unidades de medida
    • m2
    m2
    Performance Status
    Descripción

    Performance Status

    Tipo de datos

    text

    Tumor Measurements
    Descripción

    Tumor Measurements

    Location
    Descripción

    Location

    Tipo de datos

    integer

    Method of Tumor Measurement
    Descripción

    Method

    Tipo de datos

    text

    Date of assessment
    Descripción

    Date of assessment

    Tipo de datos

    date

    Tumor measurements
    Descripción

    Tumor measurements

    Tipo de datos

    text

    Unidades de medida
    • cm
    cm
    Best Tumor Response
    Descripción

    Best Tumor Response

    Best Tumor Response
    Descripción

    Best Tumor Response

    Tipo de datos

    text

    Date of Progression
    Descripción

    Date of Progression

    Tipo de datos

    date

    Date of Best Response
    Descripción

    Date of Best Response

    Tipo de datos

    date

    Pre-treatment Hematologies and Chemistries
    Descripción

    Pre-treatment Hematologies and Chemistries

    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Other (Specify)
    Descripción

    Other

    Tipo de datos

    text

    Comments
    Descripción

    Comments

    Tipo de datos

    text

    HGB
    Descripción

    Hemoglobin

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0019046
    Haematocrit (HCT)
    Descripción

    Haematocrit (HCT)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0018935
    WBC
    Descripción

    WBC

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0023508
    Granulocytes (%)
    Descripción

    LaboratoryProcedureGranulocyteResultPercentageValue

    Tipo de datos

    float

    Unidades de medida
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C12530
    UMLS 2011AA Property-2
    C0018183
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    %
    Platelets
    Descripción

    Platelets

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0005821
    [BUN] BUN
    Descripción

    BUN

    Tipo de datos

    float

    Unidades de medida
    • mg/dL
    mg/dL
    Creatinine
    Descripción

    Chemistry, Clinical, Creatinine measurement

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201975
    Creatinine Clearance
    Descripción

    Creatinine Clearance

    Tipo de datos

    float

    Unidades de medida
    • mL/min
    Alias
    UMLS CUI [1]
    C0373595
    mL/min
    AST (SGOT)
    Descripción

    AST

    Tipo de datos

    float

    Unidades de medida
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    Bilirubin
    Descripción

    Bilirubin

    Tipo de datos

    float

    Unidades de medida
    • mg/dL
    Alias
    UMLS CUI [1]
    C0005437
    mg/dL
    CA125
    Descripción

    LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

    Tipo de datos

    float

    Alias
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C325
    UMLS 2011AA Property
    C0006610
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C17220
    UMLS 2011AA Property-3
    C0041365
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
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    Drug Dose Form

    1 formularios
    1. StudyEvent: ODM
      1. Drug Dose Form
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    Last Name
    Item
    Last Name
    text
    First Name
    Item
    First Name
    text
    Gynecologic Oncology Group
    Item
    GOG#
    integer
    Section
    Item
    Section
    integer
    Item Group
    Investigational Product
    Date of Course
    Item
    Date of Course
    date
    Course Number
    Item
    Course Number
    integer
    Item
    Course Timing
    text
    Course Timing
    Code List
    Course Timing
    CL Item
    On time (1)
    CL Item
    Delayed (2)
    CL Item
    Taken off study treatment (3)
    Number of delayed days
    Item
    Number of delayed days
    integer
    Comment
    Item
    Report reason for delay
    text
    Item Group
    Drug Dose
    Sequence Number
    Item
    Sequence Number
    integer
    Drugs and Dose Level
    Item
    Drugs and Dose Level
    text
    Change
    Item
    Change
    text
    Total dose for this course
    Item
    Total dose for this course
    text
    Units
    Item
    Units
    text
    Weight
    Item
    Weight
    float
    Surface Area
    Item
    Surface Area
    integer
    Performance Status
    Item
    Performance Status
    text
    Item Group
    Tumor Measurements
    Item
    Location
    integer
    Location
    Code List
    Location
    CL Item
    Location #1 (1)
    CL Item
    Location #2 (2)
    CL Item
    Location #3 (3)
    Method
    Item
    Method of Tumor Measurement
    text
    Date of assessment
    Item
    Date of assessment
    date
    Tumor measurements
    Item
    Tumor measurements
    text
    Item Group
    Best Tumor Response
    Item
    Best Tumor Response
    text
    Best Tumor Response
    Code List
    Best Tumor Response
    CL Item
    Complete Response (NED) (1)
    CL Item
    Partial (>50% decrease each lesion followed) (2)
    CL Item
    Stable (3)
    CL Item
    Increasing Disease (>50% increase in any tumor) (4)
    CL Item
    Not evaluated this course (5)
    Date of Progression
    Item
    Date of Progression
    date
    Date of Best Response
    Item
    Date of Best Response
    date
    Item Group
    Pre-treatment Hematologies and Chemistries
    Assessment Date
    Item
    Assessment Date
    date
    Other
    Item
    Other (Specify)
    text
    Comments
    Item
    Comments
    text
    Hemoglobin
    Item
    HGB
    float
    C0019046 (UMLS CUI [1])
    Haematocrit (HCT)
    Item
    Haematocrit (HCT)
    float
    C0018935 (UMLS CUI [1])
    WBC
    Item
    WBC
    text
    C0023508 (UMLS CUI [1])
    LaboratoryProcedureGranulocyteResultPercentageValue
    Item
    Granulocytes (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12530 (NCI Thesaurus Property-2)
    C0018183 (UMLS 2011AA Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Platelets
    Item
    Platelets
    text
    C0005821 (UMLS CUI [1])
    BUN
    Item
    [BUN] BUN
    float
    Chemistry, Clinical, Creatinine measurement
    Item
    Creatinine
    float
    C0008000 (UMLS CUI [1,1])
    C0201975 (UMLS CUI [1,2])
    Creatinine Clearance
    Item
    Creatinine Clearance
    float
    C0373595 (UMLS CUI [1])
    AST
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    Bilirubin
    Item
    Bilirubin
    float
    C0005437 (UMLS CUI [1])
    LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
    Item
    CA125
    float
    C0022885 (UMLS 2011AA ObjectClass)
    C325 (NCI Thesaurus Property)
    C0006610 (UMLS 2011AA Property)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property-2)
    C17220 (NCI Thesaurus Property-3)
    C0041365 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
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