ID

32399

Description

This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every visit. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Keywords

Versions (2)
  1. 10/28/18 10/28/18 -
  2. 10/30/18 10/30/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 30, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    English

    Concomitant Medication

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Description

    MONITOR DATA VALIDATION CHECKS • Check that either ’Yes’ or ’No’ box at the top of the page has been completed. If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    List of Concomitant Medication
    Description

    List of Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Description

    MONITOR DATA VALIDATION CHECKS Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred).

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Reason for Medication
    Description

    MONITOR DATA VALIDATION CHECKS • Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: • Medical Conditions • Non-Serious Adverse Events • Serious Adverse Events Form

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Start Date
    Description

    MONITOR DATA VALIDATION CHECKS • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826734
    Taken Prior to Study?
    Description

    Taken Prior to Study?

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826667
    Stop Date
    Description

    MONITOR DATA VALIDATION CHECKS • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826744
    Ongoing Medication
    Description

    Ongoing Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826666
    Back to the top of the page

    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 Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1])
    Concomitant medications
    Code List
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    List of Concomitant Medication
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C2826696 (UMLS CUI [1])
    Start Date of Medication
    Item
    Start Date
    partialDate
    C2826734 (UMLS CUI [1])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1])
    Taken Prior to Study?
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Stop Date of Medication
    Item
    Stop Date
    partialDate
    C2826744 (UMLS CUI [1])
    Item
    Ongoing Medication
    text
    C2826666 (UMLS CUI [1])
    Ongoing Medication
    Code List
    Ongoing Medication
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Back to the top of the page 

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