ID

41226

Beschrijving

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 Local Laboratory for clinical chemistry and haematology which have to be filled in once for Screening, Day-1, Week 1-3, the Follow-up visit and as often as necessary in logs and 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.

Link

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

Trefwoorden

Versies (1)
  1. 20-07-20 20-07-20 - Christian Arras
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 juli 2020

DOI

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Licentie

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

    Engels

    Local Laboratory

    1 Formulieren  
    1. StudyEvent: ODM
      1. Local Laboratory
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Beschrijving

    Date of Visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Beschrijving

    Subject number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Beschrijving

    Visit type

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Clinical Chemistry
    Beschrijving

    Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Laboratory ID
    Beschrijving

    not required/read only

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2986056
    Laboratory name and address
    Beschrijving

    Not applicable for Screening Visit.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C1442065
    UMLS CUI [1,3]
    C0022877
    Laboratory name
    Beschrijving

    After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3258037
    Address
    Beschrijving

    After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0022877
    Date and time sample taken
    Beschrijving

    Date and time sample taken

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [2,1]
    C0040223
    UMLS CUI [2,2]
    C0200345
    Clinical Chemistry Analytes
    Beschrijving

    Please answer the following questions for each Clinical Chemistry Analytes.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0022885
    Clinical Chemistry, type of result
    Beschrijving

    Type of result, Clinical Chemistry

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0332307
    If Numeric Result, value:
    Beschrijving

    If Numeric Result, value:

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2347373
    If Character Result, value:
    Beschrijving

    If Character Result, value:

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2350015
    Haematology
    Beschrijving

    Haematology

    Alias
    UMLS CUI-1
    C0018941
    Laboratory ID
    Beschrijving

    not required/read only

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2986056
    Laboratory name and address
    Beschrijving

    Not applicable for Screening Visit.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C1442065
    UMLS CUI [1,3]
    C0022877
    Laboratory name
    Beschrijving

    After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3258037
    Address
    Beschrijving

    After once filled in at Screening visit, only to be filled in if Laboratory name has changed.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0022877
    Date and time sample taken
    Beschrijving

    Date and time sample taken

    Datatype

    partialDatetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [2,1]
    C0040223
    UMLS CUI [2,2]
    C0200345
    Haematology Analytes
    Beschrijving

    Please answer the following questions for each Haematology Analytes.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology, type of result
    Beschrijving

    Type of result, Haematology finding

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0332307
    If Numeric Result, value:
    Beschrijving

    If Numeric Result, value:

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2347373
    If Character Result, value:
    Beschrijving

    If Character Result, value:

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2350015
    Terug naar het begin van de pagina

    Similar models

    Local Laboratory

    1 Formulieren
    1. StudyEvent: ODM
      1. Local Laboratory
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Visit type
    Code List
    Visit type
    CL Item
    Screen (Screen)
    CL Item
    Day-1 (Day-1)
    CL Item
    Week 1 (Week 1)
    CL Item
    Week 2 (Week 2)
    CL Item
    Week 3 (Week 3)
    CL Item
    F/U (F/U)
    CL Item
    Logs/Repeats (Logs/Rpts)
    Item Group
    Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Laboratory ID
    Item
    Laboratory ID
    integer
    C2986056 (UMLS CUI [1])
    Item
    Laboratory name and address
    integer
    C3258037 (UMLS CUI [1,1])
    C1442065 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Laboratory name and address
    Code List
    Laboratory name and address
    CL Item
    Results from the same lab as in the previous visit (98)
    CL Item
    If not, please provide: (99)
    Laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Laboratory address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    Date and time sample taken
    Item
    Date and time sample taken
    partialDatetime
    C0011008 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    Item
    Clinical Chemistry Analytes
    integer
    C0008000 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Clinical Chemistry Analytes
    Code List
    Clinical Chemistry Analytes
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Chloride (3)
    CL Item
    Carbon Dioxide (4)
    CL Item
    Urea (5)
    CL Item
    Creatinine (6)
    CL Item
    Calcium (7)
    CL Item
    Albumin (8)
    CL Item
    Total Bilirubin (9)
    CL Item
    Direct Bilirubin (10)
    CL Item
    Alkaline Phosphatase (11)
    CL Item
    AST (12)
    CL Item
    ALT (13)
    Item
    Clinical Chemistry, type of result
    integer
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Type of result
    Code List
    Clinical Chemistry, type of result
    CL Item
    Numeric result (97)
    CL Item
    Character result (98)
    CL Item
    No result (99)
    If Numeric Result, value:
    Item
    If Numeric Result, value:
    text
    C2347373 (UMLS CUI [1])
    If Character Result, value:
    Item
    If Character Result, value:
    text
    C2350015 (UMLS CUI [1])
    Item Group
    Haematology
    C0018941 (UMLS CUI-1)
    Laboratory ID
    Item
    Laboratory ID
    integer
    C2986056 (UMLS CUI [1])
    Item
    Laboratory name and address
    integer
    C3258037 (UMLS CUI [1,1])
    C1442065 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    Laboratory name and address
    Code List
    Laboratory name and address
    CL Item
    Results from the same lab as in the previous visit (98)
    CL Item
    If not, please provide: (99)
    Laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Laboratory address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    Date and time sample taken
    Item
    Date and time sample taken
    partialDatetime
    C0011008 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    Item
    Haematology Analytes
    integer
    C0018941 (UMLS CUI [1])
    Clinical Chemistry Analytes
    Code List
    Haematology Analytes
    CL Item
    Haemoglobin (1)
    CL Item
    RBC (2)
    CL Item
    Platelets (3)
    CL Item
    WBC (4)
    CL Item
    Neutrophils (absolute) (5)
    CL Item
    Lymphocytes (absolute) (6)
    CL Item
    Monocytes (absolute) (7)
    CL Item
    Eosinophils (absolute) (8)
    CL Item
    Basophils (absolute) (9)
    CL Item
    INR (10)
    Item
    Haematology, type of result
    integer
    C0474523 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Type of result
    Code List
    Haematology, type of result
    CL Item
    Numeric result (97)
    CL Item
    Character result (98)
    CL Item
    No result (99)
    If Numeric Result, value:
    Item
    If Numeric Result, value:
    text
    C2347373 (UMLS CUI [1])
    If Character Result, value:
    Item
    If Character Result, value:
    text
    C2350015 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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