0 Evaluaciones
ID

37261

Descripción

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Palabras clave

Versiones (1)
  1. 12/7/19 12/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de julio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

    Inglés

    Cycle 3

    1 formularios  
    1. StudyEvent: ODM
      1. Cycle 3
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Local Laboratory - Haematology
    Descripción

    Local Laboratory - Haematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Laboratory name
    Descripción

    Performing laboratory name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3258037
    Address
    Descripción

    Performing Laboratory, Street Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1882331
    UMLS CUI [1,2]
    C1301826
    Lab ID
    Descripción

    Laboratory Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986056
    Date sample taken
    Descripción

    Laboratory Procedures, Hematology finding, Sampling, Date in time

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Planned Relative Time
    Descripción

    Laboratory Procedures, Hematology finding, Relative time, Planned

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0439564
    UMLS CUI [1,4]
    C1301732
    Haematology Test
    Descripción

    Laboratory Procedures, Hematology finding

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    Result
    Descripción

    Laboratory Procedures, Hematology finding, Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1274040
    Local Laboratory - Clinical Chemistry
    Descripción

    Local Laboratory - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Laboratory name
    Descripción

    Performing laboratory name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3258037
    Address
    Descripción

    Performing Laboratory, Street Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1882331
    UMLS CUI [1,2]
    C1301826
    Lab ID
    Descripción

    Laboratory Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986056
    Date sample taken
    Descripción

    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Planned Relative Time
    Descripción

    Laboratory Procedures, Chemistry, Clinical, Relative time, Planned

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0439564
    UMLS CUI [1,4]
    C1301732
    Clinical Chemistry Test
    Descripción

    Laboratory Procedures, Chemistry, Clinical

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    Result
    Descripción

    Laboratory Procedures, Chemistry, Clinical, Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1274040
    Volver a la parte superior de la página

    Similar models

    Cycle 3

    1 formularios
    1. StudyEvent: ODM
      1. Cycle 3
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Local Laboratory - Haematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Performing laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Performing Laboratory, Street Address
    Item
    Address
    text
    C1882331 (UMLS CUI [1,1])
    C1301826 (UMLS CUI [1,2])
    Laboratory Identifier
    Item
    Lab ID
    text
    C2986056 (UMLS CUI [1])
    Laboratory Procedures, Hematology finding, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Relative time, Planned
    Item
    Planned Relative Time
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Item
    Haematology Test
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Haematology Test
    CL Item
    Haemoglobin (1)
    CL Item
    Haematocrit (2)
    CL Item
    Red Blood Cell (3)
    CL Item
    White Blood Cell (4)
    CL Item
    Platelet (5)
    CL Item
    Neutrophils (6)
    CL Item
    Bands (7)
    CL Item
    Lymphocytes (8)
    CL Item
    Monocytes (9)
    CL Item
    Eosinophils (10)
    CL Item
    Basophils (11)
    Laboratory Procedures, Hematology finding, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Item Group
    Local Laboratory - Clinical Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Performing laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Performing Laboratory, Street Address
    Item
    Address
    text
    C1882331 (UMLS CUI [1,1])
    C1301826 (UMLS CUI [1,2])
    Laboratory Identifier
    Item
    Lab ID
    text
    C2986056 (UMLS CUI [1])
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
    Item
    Date sample taken
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Chemistry, Clinical, Relative time, Planned
    Item
    Planned Relative Time
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Item
    Clinical Chemistry Test
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Laboratory Procedures, Chemistry, Clinical
    Code List
    Clinical Chemistry Test
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Chloride (3)
    CL Item
    Bicarbonate (4)
    CL Item
    Calcium (5)
    CL Item
    Phosphorus (6)
    CL Item
    Magnesium (7)
    CL Item
    Blood Urea Nitrogen (BUN) (8)
    CL Item
    Urea (9)
    CL Item
    Uric acid (10)
    CL Item
    Creatinine (11)
    CL Item
    LDH (12)
    CL Item
    Aspartate Aminotransferase (AST) (13)
    CL Item
    Alanine Transaminase (ALT) (14)
    CL Item
    Bilirubin (total) (15)
    CL Item
    Protein (total) (16)
    CL Item
    Albumin (17)
    CL Item
    Creatinine Clearance (calculated) (18)
    CL Item
    CA125 (19)
    Laboratory Procedures, Chemistry, Clinical, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
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