0 Evaluaciones
ID

34734

Descripción

Study ID: 101998 Clinical Study ID: 101998 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 The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

Palabras clave

Versiones (2)
  1. 23/1/19 23/1/19 -
  2. 25/1/19 25/1/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de enero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Inglés

    Investigational Product Use/Status of Treatment Blind

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Investigational Product Use
    Descripción

    Investigational Product Use

    Alias
    UMLS CUI-1
    C0304229
    Investigational Product Use
    Descripción

    Investigational Product Use

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0304229
    Status Of Treatment Blind
    Descripción

    Status Of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken during the study?
    Descripción

    If Yes, complete the following and Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C0449438
    Date Blind Broken
    Descripción

    If Treatment blind was broken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason Blind Broken
    Descripción

    If treatment blind was broken, Tick one

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    If other, specify
    Descripción

    If treatment blind was broken

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Volver a la parte superior de la página

    Similar models

    Investigational Product Use/Status of Treatment Blind

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Investigational Product Use
    C0304229 (UMLS CUI-1)
    Item
    Investigational Product Use
    text
    C0304229 (UMLS CUI [1])
    Investigational Product Use
    Code List
    Investigational Product Use
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Status Of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Item
    Was the treatment blind broken during the study?
    text
    C2347038 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Status of Treatmet Blind
    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
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason Blind Broken
    Code List
    Reason Blind Broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other (2)
    Other Specification
    Item
    If other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

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