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ID

32377

Descrizione

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

Keywords

versioni (2)
  1. 28/10/18 28/10/18 -
  2. 30/10/18 30/10/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

28 ottobre 2018

DOI

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Licenza

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

    Inglese

    Concomitant Medication

    1 moduli  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medication
    Descrizione

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Descrizione

    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.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    List of Concomitant Medication
    Descrizione

    List of Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Drug Name
    Descrizione

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

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Reason for Medication
    Descrizione

    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

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826696 (Concomitant Medication Use Indication)
    Start Date
    Descrizione

    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.

    Tipo di dati

    partialDate

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Taken Prior to Study?
    Descrizione

    Taken Prior to Study?

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Stop Date
    Descrizione

    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’.

    Tipo di dati

    partialDate

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    Ongoing Medication
    Descrizione

    Ongoing Medication

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
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    Similar models

    Concomitant Medication

    1 moduli
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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)
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