0 Ratings
ID

34725

Description

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any concomitant medication the subject used during the study. It should be filled out at screening (, transcribed to the main form) and updated every visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Keywords

Versions (4)
  1. 12/1/18 12/1/18 -
  2. 12/9/18 12/9/18 -
  3. 1/21/19 1/21/19 -
  4. 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 2019

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Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    English

    Concomitant Medication

    1 forms  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Description

    Subject Screening No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0220908
    UMLS CUI [1,2]
    C0600091
    Subject no.
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date Information Collected
    Description

    Date Information Collected

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3244127
    UMLS CUI [1,2]
    C0011008
    Study Visit
    Description

    Study Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    Description

    If yes, record details below. Paracetamol for mild analgesia may be permitted This item only applies to the screening visit.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C3166216
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C0013231
    UMLS CUI [3,1]
    C0332257
    UMLS CUI [3,2]
    C0042890
    UMLS CUI [4,1]
    C0332257
    UMLS CUI [4,2]
    C1360419
    UMLS CUI [5,1]
    C0332257
    UMLS CUI [5,2]
    C0003138
    Did the subject take any Concomitant Medication?
    Description

    Only applicable for the source document.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Staff Initials
    Description

    Only applicable for the source document.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089
    Concomitant Medication Details
    Description

    Concomitant Medication Details

    Alias
    UMLS CUI-1
    C2347852
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    Start Time
    Description

    If known

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C2347852
    Medication
    Description

    Generic/Brand

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2347852
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C2347852
    Units
    Description

    Units

    Data type

    text

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

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C2347852
    Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C2347852
    Medication Ongoing
    Description

    Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Conclusion
    Description

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Physician's Initials
    Description

    Only applicable for the screening document.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Transcribed from source data by (enter staff initials)
    Description

    Only applicable for the source document.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089
    UMLS CUI [1,3]
    C4554264
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    Similar models

    Concomitant Medication

    1 forms
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Date Information Collected
    Item
    Date Information Collected
    date
    C3244127 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Study Visit
    text
    C0545082 (UMLS CUI [1])
    Study Visit
    Code List
    Study Visit
    CL Item
    Screening (Screening)
    CL Item
    Source Document (Source Document)
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Item
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    text
    C0332185 (UMLS CUI [1,1])
    C3166216 (UMLS CUI [1,2])
    C0332185 (UMLS CUI [2,1])
    C0013231 (UMLS CUI [2,2])
    C0332257 (UMLS CUI [3,1])
    C0042890 (UMLS CUI [3,2])
    C0332257 (UMLS CUI [4,1])
    C1360419 (UMLS CUI [4,2])
    C0332257 (UMLS CUI [5,1])
    C0003138 (UMLS CUI [5,2])
    Prescribed or Non-Prescribed Medication, including Vitamins, Herbal Remedies and Antacids
    Code List
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    CL Item
    N/A (N/A)
    Concomiant Medication
    Item
    Did the subject take any Concomitant Medication?
    boolean
    C2347852 (UMLS CUI [1])
    Staff Initials
    Item
    Staff Initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    Item Group
    Concomitant Medication Details
    C2347852 (UMLS CUI-1)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Start Time
    Item
    Start Time
    datetime
    C1301880 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication
    Item
    Medication
    text
    C0013227 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication Ongoing
    Item
    Medication Ongoing
    boolean
    C2826666 (UMLS CUI [1])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Transcription, Staff Initials
    Item
    Transcribed from source data by (enter staff initials)
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    C4554264 (UMLS CUI [1,3])
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