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ID

22298

Beschrijving

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Non-measurable Disease (Non-target Lesions) Assessment Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Trefwoorden

Versies (1)
  1. 29/5/17 29/5/17 -
Geüploaded op

29 de mayo de 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

    Engels

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

    1 Formulieren  
    Non-measurable Disease (Non-target Lesions) Assessment
    Beschrijving

    Non-measurable Disease (Non-target Lesions) Assessment

    Alias
    UMLS CUI-1
    C2986547
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C1518373
    UMLS CUI-4
    C0012634
    Did this subject have non-measurable disease at Screening?
    Beschrijving

    non-measurable disease at screening

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1518373
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2]
    C1710477
    Lesion number
    Beschrijving

    Lesion number

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0221198
    Lesion location
    Beschrijving

    Lesion location: Provide a brief description of the location of each lesion within the organ. If it is not possible to describe the location further, line through the lesion location box in the lesion location column. If an organ contains more than one lesion, lesion location descriptions must be recorded.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0450429
    Organ code
    Beschrijving

    code

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0178784
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0450429
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0221198
    Longest Diameter
    Beschrijving

    Longest Diameter

    Datatype

    float

    Maateenheden
    • mm
    Alias
    UMLS CUI [1,1]
    C0552406
    UMLS CUI [1,2]
    C0221198
    mm
    Method
    Beschrijving

    Method

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0871511
    UMLS CUI [1,2]
    C0221198
    Assessment 2
    Beschrijving

    Assessment 2

    Alias
    UMLS CUI-1
    C2986547
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C1518373
    UMLS CUI-4
    C0012634
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0221198
    Longest Diameter
    Beschrijving

    Longest Diameter

    Datatype

    float

    Maateenheden
    • mm
    Alias
    UMLS CUI [1,1]
    C0552406
    UMLS CUI [1,2]
    C0221198
    mm
    Method
    Beschrijving

    Method

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0871511
    UMLS CUI [1,2]
    C0221198
    Lesion Status
    Beschrijving

    Lesion Status

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C0221198
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    Similar models

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-measurable Disease NCT00078572

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Non-measurable Disease (Non-target Lesions) Assessment
    C2986547 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C1518373 (UMLS CUI-3)
    C0012634 (UMLS CUI-4)
    Item
    Did this subject have non-measurable disease at Screening?
    text
    C1518373 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C1710477 (UMLS CUI [2])
    measurable disease at screening
    Code List
    Did this subject have non-measurable disease at Screening?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Lesion number
    Item
    Lesion number
    text
    C0237753 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Lesion location
    Item
    Lesion location
    text
    C0237753 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Item
    Organ code
    text
    C0178784 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [2,1])
    C0450429 (UMLS CUI [2,2])
    Organ code
    Code List
    Organ code
    CL Item
    Abdomen/viscera AD = Adrenals (AB)
    CL Item
    Breast (BT)
    CL Item
    CNS  (CS)
    CL Item
    Heart  (HT)
    CL Item
    Liver  (LV)
    CL Item
    Lung (LG)
    CL Item
    Lymph nodes  (LN)
    CL Item
    Pancreas (PS)
    CL Item
    Skin (SK)
    CL Item
    Chest Wall (CW)
    CL Item
    Peritoneum  (PM)
    CL Item
    Pleura (PA)
    CL Item
    Stomach  (SH)
    CL Item
    Kidney (KID)
    CL Item
    Other (XX)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    Longest Diameter
    Item
    Longest Diameter
    float
    C0552406 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    Method
    text
    C0871511 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Method
    Code List
    Method
    CL Item
    Conventional CT scan (C)
    CL Item
    Direct measure by physical exam (D)
    CL Item
    Lymphangiogram (L)
    CL Item
    Magnetic resonance imaging (M)
    CL Item
    X-ray (X)
    CL Item
    Spiral CT  (SC)
    CL Item
    Endoscopy (E)
    CL Item
    Medical photography  (P)
    CL Item
    Nuclear scan (NS)
    CL Item
    Not done (ND)
    Item Group
    Assessment 2
    C2986547 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C1518373 (UMLS CUI-3)
    C0012634 (UMLS CUI-4)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    Longest Diameter
    Item
    Longest Diameter
    float
    C0552406 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    Method
    text
    C0871511 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Method
    Code List
    Method
    CL Item
    Conventional CT scan (C)
    CL Item
    Direct measure by physical exam (D)
    CL Item
    Lymphangiogram (L)
    CL Item
    Magnetic resonance imaging (M)
    CL Item
    X-ray (X)
    CL Item
    Spiral CT  (SC)
    CL Item
    Endoscopy (E)
    CL Item
    Medical photography  (P)
    CL Item
    Nuclear scan (NS)
    CL Item
    Not done (ND)
    Item
    Lesion Status
    text
    C0449438 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Lesion Status
    Code List
    Lesion Status
    CL Item
    New Measurable Lesion (N)
    CL Item
    Lesion Split or Divided (S)
    CL Item
    Lesion Merged or Coalesced (M)
    CL Item
    Not Done (ND)
    CL Item
    Not Assessable (disease assessment performed but lesion could not be sufficiently assessed to determine the status) (NA)
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