0 Ratings

ID

40268

Description

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the survey of the vital signs once at the screening, study visit at day-1, weeks 1-3 and the follow-up visit and if required as often as needed for logs/repeats. Week 3 assessments can be used as Follow-up assessments for subjects who have completed the 24 hour PK blood draw at the Week 3 visit and are proceeding into the continuing study EGF111767. If this applies, do NOT reenter the same data twice; leave a form comment instead.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Keywords

  1. 3/26/20 3/26/20 - Christian Arras
  2. 3/26/20 3/26/20 - Christian Arras
Copyright Holder

GlaxoSmithKline

Uploaded on

March 26, 2020

DOI

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License

Creative Commons BY-NC 4.0

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    Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

    Vital Signs

    1. StudyEvent: ODM
      1. Vital Signs
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Description

    Visit type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual Date
    Description

    Date in time

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time relative to dosing
    Description

    only to be filled in at Visits Week 1 to 3

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C3469597
    Height
    Description

    only to be filled in at screening visit

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    only to be filled in at screening visit

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Systolic blood pressure
    Description

    Systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm

    Similar models

    Vital Signs

    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of Visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit type
    CL Item
    Screen (Screen)
    CL Item
    Day-1 (Day-1)
    CL Item
    F/U (F/U)
    CL Item
    Week 1 (Week 1)
    CL Item
    Week2 (Week 2)
    CL Item
    Week 3 (Week 3)
    CL Item
    Logs/Repeats (Logs/Rpts)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date in time
    Item
    Actual Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Time relative to dosing
    integer
    C0439564 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    Code List
    Time relative to dosing
    CL Item
    Predose (1)
    CL Item
    0.5 Hr post dose (2)
    CL Item
    1 Hr post dose (3)
    CL Item
    4 Hrs post dose (4)
    CL Item
    24 hrs post dose (5)
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])

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