ID

34866

Beskrivning

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 if the subject became pregnant during the study.

Nyckelord

  1. 2019-01-26 2019-01-26 -
  2. 2019-02-01 2019-02-01 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

1 februari 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Pregnancy Information

    1. StudyEvent: ODM
      1. Pregnancy Information
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Beskrivning

    Date of Visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Pregnancy Information
    Beskrivning

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Beskrivning

    If Yes, complete Pregnancy Notification form. Not applicable: Not of childbearing potential or male

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C1533716

    Similar models

    Pregnancy Information

    1. StudyEvent: ODM
      1. Pregnancy Information
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (X)

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