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ID

35662

Description

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 

Keywords

Versions (1)
  1. 14-03-19 14-03-19 -
Copyright Holder

GSK group of companies

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14 maart 2019

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

    English

    Drug Dose Form

    1 forms  
    1. StudyEvent: ODM
      1. Drug Dose Form
    Administrative data
    Description

    Administrative data

    Last Name
    Description

    Last Name

    Data type

    text

    First Name
    Description

    First Name

    Data type

    text

    GOG#
    Description

    Inst.,Prot.,Seq.

    Data type

    integer

    Section
    Description

    Section

    Data type

    integer

    Investigational Product
    Description

    Investigational Product

    Date of Course
    Description

    Date of Course

    Data type

    date

    Course Number
    Description

    Course Number

    Data type

    integer

    Course Timing
    Description

    Course Timing

    Data type

    text

    Number of delayed days
    Description

    Number of delayed days

    Data type

    integer

    Report reason for delay
    Description

    Comment

    Data type

    text

    Drug Dose
    Description

    Drug Dose

    Sequence Number
    Description

    Sequence Number

    Data type

    integer

    Drugs and Dose Level
    Description

    Drugs and Dose Level

    Data type

    text

    Change
    Description

    P/U

    Data type

    text

    Total dose for this course
    Description

    Total dose for this course

    Data type

    text

    Units
    Description

    Units

    Data type

    text

    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    kg
    Surface Area
    Description

    Surface Area

    Data type

    integer

    Measurement units
    • m2
    m2
    Performance Status
    Description

    Performance Status

    Data type

    text

    Tumor Measurements
    Description

    Tumor Measurements

    Location
    Description

    Location

    Data type

    integer

    Method of Tumor Measurement
    Description

    Method

    Data type

    text

    Date of assessment
    Description

    Date of assessment

    Data type

    date

    Tumor measurements
    Description

    Tumor measurements

    Data type

    text

    Measurement units
    • cm
    cm
    Best Tumor Response
    Description

    Best Tumor Response

    Best Tumor Response
    Description

    Best Tumor Response

    Data type

    text

    Date of Progression
    Description

    Date of Progression

    Data type

    date

    Date of Best Response
    Description

    Date of Best Response

    Data type

    date

    Pre-treatment Hematologies and Chemistries
    Description

    Pre-treatment Hematologies and Chemistries

    Assessment Date
    Description

    Assessment Date

    Data type

    date

    Other (Specify)
    Description

    Other

    Data type

    text

    Comments
    Description

    Comments

    Data type

    text

    HGB
    Description

    Hemoglobin

    Data type

    float

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

    Haematocrit (HCT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0018935
    WBC
    Description

    WBC

    Data type

    text

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

    LaboratoryProcedureGranulocyteResultPercentageValue

    Data type

    float

    Measurement units
    • %
    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
    Description

    Platelets

    Data type

    text

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

    BUN

    Data type

    float

    Measurement units
    • mg/dL
    mg/dL
    Creatinine
    Description

    Chemistry, Clinical, Creatinine measurement

    Data type

    float

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

    Creatinine Clearance

    Data type

    float

    Measurement units
    • mL/min
    Alias
    UMLS CUI [1]
    C0373595
    mL/min
    AST (SGOT)
    Description

    AST

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    Bilirubin
    Description

    Bilirubin

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0005437
    mg/dL
    CA125
    Description

    LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

    Data type

    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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    Similar models

    Drug Dose Form

    1 forms
    1. StudyEvent: ODM
      1. Drug Dose Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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