0 Ratings
ID

40154

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 medical conditions of the patient. It has to be filled in for screening.

Link

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

Keywords

Versions (2)
  1. 3/16/20 3/16/20 - Christian Arras
  2. 3/17/20 3/17/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 17, 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

    English

    Medical conditions

    1 forms  
    1. StudyEvent: ODM
      1. Medical conditions
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Visit Date
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Medical conditions
    Description

    Medical conditions

    Alias
    UMLS CUI-1
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Does the subject have any current or past cancer or non-cancer related medical conditions?
    Description

    If Yes, specify below:

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Medical conditions entry
    Description

    Medical conditions entry

    Alias
    UMLS CUI-1
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Sequence number
    Description

    hidden/not required

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184 (Sequence Number)
    Specific condition
    Description

    Specific condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C2348235 (Specification)
    Modified term
    Description

    hidden/not required

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826302 (Reported Term)
    Status
    Description

    Status of Disease

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Medical condition classification code
    Description

    Medical condition, classification code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008902 (Classification)
    SNOMED
    73504009
    UMLS CUI [1,2]
    C0805701 (Code)
    UMLS CUI [1,3]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Toxicity code
    Description

    Toxicity code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040539 (Toxicity aspects)
    UMLS CUI [1,2]
    C0805701 (Code)
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    Similar models

    Medical conditions

    1 forms
    1. StudyEvent: ODM
      1. Medical conditions
    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 Group
    Medical conditions
    C0012634 (UMLS CUI-1)
    Item
    Does the subject have any current or past cancer or non-cancer related medical conditions?
    text
    C0012634 (UMLS CUI [1])
    Medical conditions
    Code List
    Does the subject have any current or past cancer or non-cancer related medical conditions?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Medical conditions entry
    C0012634 (UMLS CUI-1)
    Sequence number
    Item
    Sequence number
    text
    C2348184 (UMLS CUI [1])
    Specific condition
    Item
    Specific condition
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    reported term
    Item
    Modified term
    text
    C2826302 (UMLS CUI [1])
    Item
    Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Status
    Code List
    Status
    CL Item
    current (1)
    CL Item
    past (2)
    Item
    Medical condition classification code
    text
    C0008902 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [1,3])
    Disease classification code
    Code List
    Medical condition classification code
    CL Item
    Cancer related (24)
    CL Item
    toxicities related to previous therapy (29)
    CL Item
    Other (general) (OT)
    Item
    Toxicity code
    text
    C0040539 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Toxicity code
    Code List
    Toxicity code
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2  (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    not applicable (X)
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