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37213

Beskrivning

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Nyckelord

Versioner (1)
  1. 2019-07-08 2019-07-08 -
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GlaxoSmithKline

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8 juli 2019

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Creative Commons BY-NC 3.0
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    Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

    Engelsk

    Laboratory Tests

    1 Formulär  
    1. StudyEvent: ODM
      1. Laboratory Tests
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Beskrivning

    Patient number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Beskrivning

    Person Initials

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Laboratory Tests - Hematology
    Beskrivning

    Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Visit
    Beskrivning

    Laboratory Procedures, Hematology finding, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0545082
    Sample Date
    Beskrivning

    Laboratory Procedures, Hematology finding, Specimen Collection Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1302413
    Sample Time
    Beskrivning

    Laboratory Procedures, Hematology finding, Sampling, Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Laboratory Name
    Beskrivning

    Laboratory Procedures, Hematology finding, Performing Laboratory

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1882331
    Test
    Beskrivning

    Laboratory Procedures, Hematology finding

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    Value
    Beskrivning

    Laboratory Procedures, Hematology finding, Numerical Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1522609
    Are there clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Hematology finding, Abnormality

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1704258
    Laboratory Tests - Blood Chemistry
    Beskrivning

    Laboratory Tests - Blood Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0005774
    Visit
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C0545082
    Sample Date
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Specimen Collection Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C1302413
    Sample Time
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Sampling, Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Laboratory Name
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Performing Laboratory

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C1882331
    Test
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    Value
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Numerical Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C1522609
    Are there clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Blood Chemical Analysis, Abnormality

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0005774
    UMLS CUI [1,3]
    C1704258
    Laboratory Tests - Urinalysis
    Beskrivning

    Laboratory Tests - Urinalysis

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0042014
    Visit
    Beskrivning

    Laboratory Procedures, Urinalysis, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0545082
    Sample Date
    Beskrivning

    Laboratory Procedures, Urinalysis, Specimen Collection Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1302413
    Laboratory Name
    Beskrivning

    Laboratory Procedures, Urinalysis, Performing Laboratory

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1882331
    Test
    Beskrivning

    Laboratory Procedures, Urinalysis

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    Value
    Beskrivning

    Laboratory Procedures, Urinalysis, Numerical Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1522609
    Complete microscopy if protein and/or blood results are ’Positive’: Was microscopy performed?
    Beskrivning

    Laboratory Procedures, Urinalysis, Microscopic urinalysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0430397
    Microscopy
    Beskrivning

    Laboratory Procedures, Urinalysis, Microscopic urinalysis

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0430397
    Value
    Beskrivning

    Laboratory Procedures, Urinalysis, Microscopic urinalysis, Numerical Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0430397
    UMLS CUI [1,4]
    C1522609
    Are there clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Urinalysis, Abnormality

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1704258
    Tillbaka till toppen

    Similar models

    Laboratory Tests

    1 Formulär
    1. StudyEvent: ODM
      1. Laboratory Tests
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Laboratory Tests - Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Laboratory Procedures, Hematology finding, Visit
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Specimen Collection Date
    Item
    Sample Date
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Sampling, Time
    Item
    Sample Time
    time
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Performing Laboratory
    Item
    Laboratory Name
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1882331 (UMLS CUI [1,3])
    Item
    Test
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Test
    CL Item
    Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    RBC (3)
    CL Item
    WBC (4)
    CL Item
    Neutrophils - segmented (5)
    CL Item
    Bands (6)
    CL Item
    Lymphocytes (7)
    CL Item
    Monocytes (8)
    CL Item
    Eosinophils (9)
    CL Item
    Basophils (10)
    CL Item
    Platelets (11)
    Laboratory Procedures, Hematology finding, Numerical Value
    Item
    Value
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1522609 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Abnormality
    Item
    Are there clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item Group
    Laboratory Tests - Blood Chemistry
    C0022885 (UMLS CUI-1)
    C0005774 (UMLS CUI-2)
    Laboratory Procedures, Blood Chemical Analysis, Visit
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Blood Chemical Analysis, Specimen Collection Date
    Item
    Sample Date
    date
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Laboratory Procedures, Blood Chemical Analysis, Sampling, Time
    Item
    Sample Time
    time
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Blood Chemical Analysis, Performing Laboratory
    Item
    Laboratory Name
    text
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C1882331 (UMLS CUI [1,3])
    Item
    Test
    text
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Test
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Chloride (3)
    CL Item
    Bicarbonate (4)
    CL Item
    Calcium (5)
    CL Item
    BUN (6)
    CL Item
    Creatinine (7)
    CL Item
    Alkaline Phosphatase (8)
    CL Item
    SGOT/AST (9)
    CL Item
    SGPT/ALT (10)
    CL Item
    Total Bilirubin (11)
    CL Item
    Total Protein (12)
    CL Item
    Albumine (13)
    CL Item
    Creatinine Clearance (14)
    CL Item
    Serum Beta HCG (15)
    Laboratory Procedures, Blood Chemical Analysis, Numerical Value
    Item
    Value
    text
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C1522609 (UMLS CUI [1,3])
    Laboratory Procedures, Blood Chemical Analysis, Abnormality
    Item
    Are there clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0005774 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Item Group
    Laboratory Tests - Urinalysis
    C0022885 (UMLS CUI-1)
    C0042014 (UMLS CUI-2)
    Laboratory Procedures, Urinalysis, Visit
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Specimen Collection Date
    Item
    Sample Date
    date
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Performing Laboratory
    Item
    Laboratory Name
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1882331 (UMLS CUI [1,3])
    Item
    Test
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Test
    CL Item
    Protein  (1)
    CL Item
    Glucose  (2)
    CL Item
    Blood (3)
    Item
    Value
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1522609 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Numerical Value
    Code List
    Value
    CL Item
    Neg (1)
    CL Item
    Trace (2)
    CL Item
    Pos (3)
    CL Item
    Not Done (4)
    Laboratory Procedures, Urinalysis, Microscopic urinalysis
    Item
    Complete microscopy if protein and/or blood results are ’Positive’: Was microscopy performed?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0430397 (UMLS CUI [1,3])
    Item
    Microscopy
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0430397 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Microscopic urinalysis
    Code List
    Microscopy
    CL Item
    RBC/HPF  (1)
    CL Item
    WBC/HPF  (2)
    CL Item
    Casts/LPF  (3)
    CL Item
    Crystals/LPF (4)
    Item
    Value
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0430397 (UMLS CUI [1,3])
    C1522609 (UMLS CUI [1,4])
    Laboratory Procedures, Urinalysis, Microscopic urinalysis
    Code List
    Value
    CL Item
    Neg (1)
    CL Item
    Few (2)
    CL Item
    Moderate (3)
    CL Item
    Many (4)
    Laboratory Procedures, Urinalysis, Abnormality
    Item
    Are there clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Tillbaka till toppen 

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