0 Ratings
ID

34058

Description

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 current medical condition of the subject.

Keywords

Versions (3)
  1. 1/11/19 1/11/19 -
  2. 1/13/19 1/13/19 -
  3. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 13, 2019

DOI

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License

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

    English

    Medical Condition

    1 forms  
    1. StudyEvent: ODM
      1. Medical Condition
    Administrative Data
    Description

    Administrative Data

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

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0009488 (Comorbidity)
    MedDRA System Organ Class
    Description

    MedDRA System Organ Class

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347091 (MedDRA System Organ Class)
    Medical Condition
    Description

    Tick only one response for each system organ class

    Data type

    text

    Alias
    UMLS CUI [1]
    C1699700 (medical condition category)
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    Similar models

    Medical Condition

    1 forms
    1. StudyEvent: ODM
      1. Medical Condition
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Medical Conditions
    C0262926 (UMLS CUI-1)
    C0009488 (UMLS CUI-2)
    Item
    MedDRA System Organ Class
    text
    C2347091 (UMLS CUI [1])
    MedDRA System Organ Class
    Code List
    MedDRA System Organ Class
    CL Item
    Blood and lymphatic system disorders (1)
    CL Item
    Cardiac disorders (2)
    CL Item
    Ear and labyrinth disorders (3)
    CL Item
    Endocrine disorders (4)
    CL Item
    Eye disorders (5)
    CL Item
    Gastrointestinal disorders (6)
    CL Item
    Hepatobiliary disorders (7)
    CL Item
    Immune system disorders (8)
    CL Item
    Metabolism and nutrition disorders (9)
    CL Item
    Musculoskeletal and connective tissue disorders (10)
    CL Item
    Nervous system disorders (11)
    CL Item
    Psychiatric disorders (12)
    CL Item
    Renal and urinary disorders (13)
    CL Item
    Reproductive system and breast disorders (14)
    CL Item
    Respiratory, thoracic and mediastinal disorders (15)
    CL Item
    Skin and subcutaneous tissue disorders (16)
    CL Item
    Vascular disorders (17)
    Item
    Medical Condition
    text
    C1699700 (UMLS CUI [1])
    Medical Condition
    Code List
    Medical Condition
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
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