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ID

32377

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: 101199 Clinical Study ID: 101199 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

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Versions (2)
  1. 2018-10-28 2018-10-28 -
  2. 2018-10-30 2018-10-30 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

28 oktober 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101199

    Anglais

    Concomitant Medication

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Type de données

    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.

    Type de données

    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).

    Type de données

    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

    Type de données

    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.

    Type de données

    partialDate

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

    Taken Prior to Study?

    Type de données

    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’.

    Type de données

    partialDate

    Alias
    UMLS CUI [1]
    C2826744
    Ongoing Medication
    Description

    Ongoing Medication

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826666
    Retour au début de la page

    Similar models

    Concomitant Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Retour au début de la page 

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