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ID

30135

Description

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

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Versions (2)
  1. 5/13/18 5/13/18 -
  2. 5/14/18 5/14/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 14, 2018

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License

Creative Commons BY-NC 3.0
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    Oral GW786034 treatment for ovarian cancer NCT00281632

    English

    Visit description: Treatment Period 1. Day 8

    1 forms  
    Header
    Description

    Header

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Vital signs
    Description

    Vital signs

    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood pressure, systolic
    Description

    Blood pressure, systolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Blood pressure, diastolic
    Description

    Blood pressure, diastolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • ° C
    Alias
    UMLS CUI [1]
    C0039476
    ° C
    Local Laboratory - Haematology
    Description

    Local Laboratory - Haematology

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C0022885
    Lab ID
    Description

    Lab ID

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Laboratory name
    Description

    Laboratory name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1882331
    Address
    Description

    Laboratory Address

    Data type

    text

    Alias
    UMLS CUI [1]
    C3262820
    Date Sample taken Haematology
    Description

    Date Sample taken Haematology

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C1302413
    Haematocrit (HCT)
    Description

    Haematocrit (HCT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0018935
    Haemoglobin (Hb)
    Description

    Haemoglobin (Hb)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0518015
    Platelet count (absolute)
    Description

    Platelet count (absolute)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0032181
    White blood cell count (WBC) (Absolute)
    Description

    White blood cell count (WBC) (Absolute)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophil count (absolute)
    Description

    Neutrophil count (absolute)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0948762
    Lymphocyte count (absolute)
    Description

    Lymphocyte count (absolute)

    Data type

    float

    Alias
    UMLS CUI [1]
    C3544087
    Local Laboratory - Clinical Chemistry
    Description

    Local Laboratory - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0022885
    Lab ID
    Description

    Lab ID

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0600091
    Laboratory name
    Description

    Laboratory name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1882331
    Address
    Description

    Laboratory Address

    Data type

    text

    Alias
    UMLS CUI [1]
    C3262820
    Date sample taken clinical chemistry
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1302413
    Alkaline phosphatase
    Description

    Alkaline phosphatase

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201850
    ALT (SGPT)
    Description

    ALT (SGPT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201836
    AST (SGOT)
    Description

    AST (SGOT)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201899
    Albumin
    Description

    Albumin

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201838
    Total bilirubin
    Description

    Total bilirubin

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201913
    Blood Urea Nitrogen
    Description

    BUN

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005845
    Calcium
    Description

    Calcium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201925
    Serum Creatinine
    Description

    Serum Creatinine

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201976
    Glucose (fasting)
    Description

    Glucose (fasting)

    Data type

    float

    Alias
    UMLS CUI [1]
    C0583513
    LDH
    Description

    LDH

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202113
    Potassium
    Description

    Potassium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202194
    Sodium
    Description

    Sodium

    Data type

    float

    Alias
    UMLS CUI [1]
    C0337443
    Investigational Product
    Description

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Investigational Product
    Description

    investigational product

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Start Date
    Description

    investigational product start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Stop Date
    Description

    investigational product stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0304229
    Dose
    Description

    investigational product dosage

    Data type

    integer

    Measurement units
    • mg/day
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0304229
    mg/day
    If there were any dosing deviations / changes, give reason
    Description

    reason for dosing deviations changes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515926
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0392360
    Back to the top of the page

    Similar models

    Visit description: Treatment Period 1. Day 8

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Vital signs
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Blood pressure, systolic
    Item
    Blood pressure, systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure, diastolic
    Item
    Blood pressure, diastolic
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Item Group
    Local Laboratory - Haematology
    C0474523 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    text
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Laboratory name
    Item
    Laboratory name
    text
    C1882331 (UMLS CUI [1])
    Laboratory Address
    Item
    Address
    text
    C3262820 (UMLS CUI [1])
    Date Sample taken Haematology
    Item
    Date Sample taken Haematology
    date
    C0005834 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Haematocrit (HCT)
    Item
    Haematocrit (HCT)
    float
    C0018935 (UMLS CUI [1])
    Haemoglobin (Hb)
    Item
    Haemoglobin (Hb)
    float
    C0518015 (UMLS CUI [1])
    Platelet count (absolute)
    Item
    Platelet count (absolute)
    float
    C0032181 (UMLS CUI [1])
    White blood cell count (WBC) (Absolute)
    Item
    White blood cell count (WBC) (Absolute)
    float
    C0023508 (UMLS CUI [1])
    Neutrophil count (absolute)
    Item
    Neutrophil count (absolute)
    float
    C0948762 (UMLS CUI [1])
    Lymphocyte count (absolute)
    Item
    Lymphocyte count (absolute)
    float
    C3544087 (UMLS CUI [1])
    Item Group
    Local Laboratory - Clinical Chemistry
    C0008000 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Lab ID
    Item
    Lab ID
    integer
    C0022877 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Laboratory name
    Item
    Laboratory name
    text
    C1882331 (UMLS CUI [1])
    Laboratory Address
    Item
    Address
    text
    C3262820 (UMLS CUI [1])
    Date sample taken
    Item
    Date sample taken clinical chemistry
    date
    C0005834 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Alkaline phosphatase
    Item
    Alkaline phosphatase
    float
    C0201850 (UMLS CUI [1])
    ALT (SGPT)
    Item
    ALT (SGPT)
    float
    C0201836 (UMLS CUI [1])
    AST (SGOT)
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    Total bilirubin
    Item
    Total bilirubin
    float
    C0201913 (UMLS CUI [1])
    BUN
    Item
    Blood Urea Nitrogen
    float
    C0005845 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Serum Creatinine
    Item
    Serum Creatinine
    float
    C0201976 (UMLS CUI [1])
    Glucose (fasting)
    Item
    Glucose (fasting)
    float
    C0583513 (UMLS CUI [1])
    LDH
    Item
    LDH
    float
    C0202113 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Item
    Investigational Product
    text
    C0304229 (UMLS CUI [1])
    investigational product
    Code List
    Investigational Product
    CL Item
    GW786034 (1)
    investigational product start date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    investigational product stop date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    investigational product dosage
    Item
    Dose
    integer
    C0178602 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    If there were any dosing deviations / changes, give reason
    text
    C1515926 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    reason for dosing deviations changes
    Code List
    If there were any dosing deviations / changes, give reason
    CL Item
    Hypertension (17)
    CL Item
    Proteinuria (18)
    CL Item
    Fatigue (19)
    CL Item
    Diarrhea (20)
    CL Item
    Mucositis (21)
    CL Item
    Other Toxicity (22)
    CL Item
    Recovered from Toxicity (23)
    CL Item
    lntercurrent Illness (24)
    CL Item
    Subject Non-compliance (25)
    CL Item
    Investigator Error (26)
    CL Item
    Other, specify (CT)
    Back to the top of the page 

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