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ID

32477

Beschrijving

This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final 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

Trefwoorden

Versies (1)
  1. 02-11-18 02-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

2 november 2018

DOI

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Licentie

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

    Engels

    Investigatioinal Product Use and Status of Treatment Blind

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Beschrijving

    Visit Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Identifier
    Beschrijving

    Subject Identifier

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Investigational Product Use
    Beschrijving

    Investigational Product Use

    Alias
    UMLS CUI-1
    C0304229
    Did the subject take investigational product?
    Beschrijving

    Did the subject take investigational product?

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0304229
    Status of Treatment Blind
    Beschrijving

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Beschrijving

    Was the treatment blind broken during the study?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    Date blind broken
    Beschrijving

    If the treatment blind was broken, complete the following

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason blind broken, ✔one
    Beschrijving

    If the treatment blind was broken, complete the following Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    If "Other" was checked: Specify
    Beschrijving

    Other reason blind broken, specification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C3845569
    Terug naar het begin van de pagina

    Similar models

    Investigatioinal Product Use and Status of Treatment Blind

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Investigational Product Use
    C0304229 (UMLS CUI-1)
    Item
    Did the subject take investigational product?
    text
    C0304229 (UMLS CUI [1])
    Did the subject take investigational product?
    Code List
    Did the subject take investigational product?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Item
    Was the treatment blind broken during the study?
    text
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    Was the treatment blind broken during the study?
    Code List
    Was the treatment blind broken during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date blind broken
    Item
    Date blind broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason blind broken, ✔one
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken, ✔one
    CL Item
    Medical emergency requiring identification of investigational product for further treatment  (1)
    CL Item
    Other (Z)
    Other reason blind broken, specification
    Item
    If "Other" was checked: Specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C3845569 (UMLS CUI [1,3])
    Terug naar het begin van de pagina 

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