0 Ratings
ID

41825

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 This document documents if a consent for PGx-Pharmacogenetic Research has been given and/or withdrawn.

Link

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

Keywords

Versions (1)
  1. 1/23/21 1/23/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 23, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

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

    English

    Pharmacogenetic Research

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    subject ID
    Description

    subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    date of visit
    Description

    date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    PGx-Pharmacogenetic Research Consent
    Description

    PGx-Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    informed consent for pharmacogenetic research

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
    Description

    pharmacogenetic research consent, date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

    pharmacogenetic research, blood sample

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C2347500
    if blood sample taken, please record date
    Description

    date blood sample taken, pharmacogenetic test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C2347500
    if no, please check reason:
    Description

    pharmacogenetic tests, no consent, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [1,4]
    C0566251
    if other, please specify:
    Description

    pharmacogenetic tests, no consent, other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [1,4]
    C3840932
    PGx-Pharmacogenetic Research Withdrawal of Consent
    Description

    PGx-Pharmacogenetic Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C2349954
    has subject withdrawn consent for PGx-Pharmacogenetic research?
    Description

    withdrawn consent for PGx-Pharmacogenetic research

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    if yes, please record the date the informed consent has been withdrawn
    Description

    pharmacogenetic tests, date informed consent has been withdrawn

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    UMLS CUI [1,4]
    C0011008
    has a request been made for sample destruction?
    Description

    pharmacogenetic research, request for sample destruction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    if yes, please check reason:
    Description

    pharmacogenetic research, request for sample destruction, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0566251
    if other, please specify:
    Description

    pharmacogenetic research, request for sample destruction, other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C3840932
    Back to the top of the page

    Similar models

    Pharmacogenetic Research

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject ID
    Item
    subject ID
    text
    C2348585 (UMLS CUI [1])
    date of visit
    Item
    date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    PGx-Pharmacogenetic Research Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    informed consent for pharmacogenetic research
    Item
    has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    pharmacogenetic research consent, date
    Item
    if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    pharmacogenetic research, blood sample
    Item
    if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C1277698 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    date blood sample taken, pharmacogenetic test
    Item
    if blood sample taken, please record date
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    Item
    if no, please check reason:
    text
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    pharmacogenetic research, no consent, reason
    Code List
    if no, please check reason:
    CL Item
    subject declined (1)
    CL Item
    subject not asked by Investigator (2)
    CL Item
    other (z)
    pharmacogenetic tests, no consent, other reason
    Item
    if other, please specify:
    text
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C3840932 (UMLS CUI [1,4])
    Item Group
    PGx-Pharmacogenetic Research Withdrawal of Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C2349954 (UMLS CUI-3)
    withdrawn consent for PGx-Pharmacogenetic research
    Item
    has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    pharmacogenetic tests, date informed consent has been withdrawn
    Item
    if yes, please record the date the informed consent has been withdrawn
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    pharmacogenetic research, request for sample destruction
    Item
    has a request been made for sample destruction?
    boolean
    C2347500 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    if yes, please check reason:
    text
    C2347500 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    pharmacogenetic research, request for sample destruction, reason
    Code List
    if yes, please check reason:
    CL Item
    subject withdrew consent for PGx (3)
    CL Item
    other (Z)
    pharmacogenetic research, request for sample destruction, other reason
    Item
    if other, please specify:
    text
    C2347500 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C3840932 (UMLS CUI [1,4])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial