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ID

29869

Description

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

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Versions (1)
  1. 4/24/18 4/24/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 24, 2018

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License

Creative Commons BY-NC 3.0
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    GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

    English

    Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

    1 forms  
    Relevant concomitant / treatment medications
    Description

    Relevant concomitant / treatment medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0087111
    UMLS CUI-3
    C1519255
    CM Sequence Number
    Description

    CM Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348184
    Drug name
    Description

    (Trade Name preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Description

    units of medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C2347852
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Description

    Route of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0808070
    Ongoing?
    Description

    Ongoing medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    If no ongoing medication, specify end date
    Description

    End date medication

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0806020
    Primary Indication
    Description

    Primary Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    Drug Type
    Description

    Drug Type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457591
    UMLS CUI [1,2]
    C2347852
    Relevant medical conditions/Risk factors
    Description

    Relevant medical conditions/Risk factors

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0035648
    UMLS CUI-3
    C1519255
    MHx Sequence Number
    Description

    MHx Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348184
    Specific Condition Name
    Description

    Specific Condition Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634
    Date of onset
    Description

    Date of onset

    Data type

    date

    Alias
    UMLS CUI [1]
    C0574845
    Specific Condition Continuing?
    Description

    Specific Condition Continuing

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0012634
    Specific Condition Continuing? If No, specify date of last occurrence
    Description

    Date of last occurrence

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2745955
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0011008
    Relevant medical conditions/Risk factors not noted above
    Description

    Relevant medical conditions/Risk factors

    Data type

    text

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0035648
    Relevant diagnostic results
    Description

    Relevant diagnostic results

    Alias
    UMLS CUI-1
    C0430022
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C1519255
    Lab Sequence Number
    Description

    Lab Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C2348184
    Test Name
    Description

    Test Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0022885
    Test Date
    Description

    Test Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826641
    Test Result
    Description

    Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0587081
    Test Units
    Description

    Test Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0587081
    Normal Low Range
    Description

    Normal Low Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C0086715
    Normal High Range
    Description

    Normal High Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C0086715
    Relevant diagnostic results not noted above
    Description

    Relevant diagnostic results not noted above

    Data type

    text

    Alias
    UMLS CUI [1]
    C0587081
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    Description

    event recurrence

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0034897
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    Similar models

    Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Relevant concomitant / treatment medications
    C2347852 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    CM Sequence Number
    Item
    CM Sequence Number
    integer
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1])
    units of medication
    Item
    Unit
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Route of medication
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C2347852 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Ongoing medication
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    End date medication
    Item
    If no ongoing medication, specify end date
    date
    C2347852 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Primary Indication
    Item
    Primary Indication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Drug Type
    Item
    Drug Type
    text
    C0457591 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Relevant medical conditions/Risk factors
    C0262926 (UMLS CUI-1)
    C0035648 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    MHx Sequence Number
    Item
    MHx Sequence Number
    integer
    C2348184 (UMLS CUI [1])
    Specific Condition Name
    Item
    Specific Condition Name
    text
    C0012634 (UMLS CUI [1])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1])
    Item
    Specific Condition Continuing?
    integer
    C0012634 (UMLS CUI [1])
    Specific Condition Continuing
    Code List
    Specific Condition Continuing?
    CL Item
    Yes (1)
    CL Item
    No, specify date of last occurrence  (2)
    CL Item
    Unknown (3)
    Date of last occurrence
    Item
    Specific Condition Continuing? If No, specify date of last occurrence
    date
    C2745955 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Relevant medical conditions/Risk factors
    Item
    Relevant medical conditions/Risk factors not noted above
    text
    C0262926 (UMLS CUI [1])
    C0035648 (UMLS CUI [2])
    Item Group
    Relevant diagnostic results
    C0430022 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Lab Sequence Number
    Item
    Lab Sequence Number
    text
    C0022885 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Test Name
    Item
    Test Name
    text
    C0022885 (UMLS CUI [1])
    Test Date
    Item
    Test Date
    date
    C2826641 (UMLS CUI [1])
    Test Result
    Item
    Test Result
    text
    C0587081 (UMLS CUI [1])
    Test Units
    Item
    Test Units
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal Low Range
    Item
    Normal Low Range
    text
    C0086715 (UMLS CUI [1])
    Normal High Range
    Item
    Normal High Range
    text
    C0086715 (UMLS CUI [1])
    Relevant diagnostic results not noted above
    Item
    Relevant diagnostic results not noted above
    text
    C0587081 (UMLS CUI [1])
    Item
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    integer
    C0877248 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0034897 (UMLS CUI [1,3])
    Rechallenge
    Code List
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown at this time (3)
    CL Item
    Not applicable (4)
    Back to the top of the page 

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