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ID

41731

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 documents any repeating Pharmacokinetics Blood measurements.

Link

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

Keywords

Versions (1)
  1. 1/9/21 1/9/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2021

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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

    English

    Pharmacokinetics Repeat

    1 forms  
    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 ID
    Description

    subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pharmacokinetics Repeat
    Description

    Pharmacokinetics Repeat

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0205341
    sequence number
    Description

    Pharmacokinetics, sequence number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C2348184
    week number
    Description

    Pharmacokinetics, week number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439230
    UMLS CUI [1,3]
    C0237753
    actual date/time
    Description

    Pharmacokinetics, actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C1264639
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    Similar models

    Pharmacokinetics Repeat

    1 forms
    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 ID
    Item
    subject ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pharmacokinetics Repeat
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Pharmacokinetics, sequence number
    Item
    sequence number
    text
    C0031328 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item
    week number
    text
    C0031328 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    week number
    Code List
    week number
    CL Item
    week 1 (1)
    CL Item
    week 2 (2)
    CL Item
    week 3 (3)
    Pharmacokinetics, actual date/time
    Item
    actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Back to the top of the page 

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