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ID

22296

Description

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: Measurable Disease (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

Keywords

Versions (1)
  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

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License

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

    English

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Measurable Disease NCT00078572

    1 forms  
    Measurable Disease (Target Lesions) Assessment
    Description

    Measurable Disease (Target Lesions) Assessment

    Alias
    UMLS CUI-1
    C1513041
    UMLS CUI-2
    C2986546
    UMLS CUI-3
    C0220825
    Did this subject have measurable disease at screening?
    Description

    NOTE: Subjects must have measurable disease to be eligible for the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2]
    C1710477
    Lesion number
    Description

    Lesion number

    Data type

    text

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

    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.

    Data type

    text

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

    code

    Data type

    text

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

    Date

    Data type

    date

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

    Longest Diameter

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0552406
    UMLS CUI [1,2]
    C0221198
    mm
    Method
    Description

    Method

    Data type

    text

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

    Assessment 2

    Alias
    UMLS CUI-1
    C1513041
    UMLS CUI-2
    C2986546
    UMLS CUI-3
    C0220825
    Date
    Description

    Date

    Data type

    date

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

    Longest Diameter

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0552406
    UMLS CUI [1,2]
    C0221198
    mm
    Method
    Description

    Method

    Data type

    text

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

    Lesion Status

    Data type

    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 Measurable Disease NCT00078572

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Measurable Disease (Target Lesions) Assessment
    C1513041 (UMLS CUI-1)
    C2986546 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Item
    Did this subject have measurable disease at screening?
    text
    C1513041 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C1710477 (UMLS CUI [2])
    measurable disease at screening
    Code List
    Did this subject have 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
    C1513041 (UMLS CUI-1)
    C2986546 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    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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