0 Avaliações
ID

34419

Descrição

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 This document asks if the subject is of child-bearing potential and which birth control methods the subject is using to prevent pregnancy during the study. This form should be filled out for female subjects at the screening visit.

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Versões (3)
  1. 11/01/2019 11/01/2019 -
  2. 13/01/2019 13/01/2019 -
  3. 17/01/2019 17/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

17 de janeiro de 2019

DOI

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Licença

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

    Inglês

    Child Bearing Potential and Birth Control

    1 Formulários  
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descrição

    Visit Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Child-Bearing Potential
    Descrição

    Child-Bearing Potential

    Alias
    UMLS CUI-1
    C3831118
    Tick one
    Descrição

    Complete for female subjects only - Pre-menarcheal: Females who have not begun to menstruate. - Post-menopausal: Women who have completed menopause at least one year ago. - Sterile: Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) - Potentially able to bear children: Women of child-bearing age who are not sterile. Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be ticked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be ticked.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C3831118
    Birth Control Methods
    Descrição

    Birth Control Methods

    Alias
    UMLS CUI-1
    C0700589
    Oral contraceptive
    Descrição

    Oral contraceptive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009905
    Intrauterine contraceptive device
    Descrição

    Intrauterine contraceptive device

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021900
    Depot contraceptive (implants, injectables)
    Descrição

    Depot contraceptive (implants, injectables)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0086129
    Spermicide plus physical barrier
    Descrição

    Spermicide plus physical barrier

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0037862
    UMLS CUI [1,2]
    C0004764
    Physical Barrier (condom, diaphragm)
    Descrição

    Barrier method only if used in combination with any of the other acceptable contraception methods.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0004764
    UMLS CUI [2]
    C0042241
    UMLS CUI [3]
    C3873750
    Abstinence
    Descrição

    Abstinence

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3843422
    Sterilization of male partner
    Descrição

    Sterilization of male partner

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0024559
    Other
    Descrição

    Other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    Other, specify
    Descrição

    Other Specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
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    Similar models

    Child Bearing Potential and Birth Control

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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
    Child-Bearing Potential
    C3831118 (UMLS CUI-1)
    Item
    Tick one
    integer
    C3831118 (UMLS CUI [1])
    Child-Bearig Potential
    Code List
    Tick one
    CL Item
    Pre-menarcheal (1)
    CL Item
    Post-menopausal (2)
    CL Item
    Sterile (of child-bearing age) (3)
    CL Item
    Potentially able to bear children (4)
    Item Group
    Birth Control Methods
    C0700589 (UMLS CUI-1)
    Oral contraceptive
    Item
    Oral contraceptive
    boolean
    C0009905 (UMLS CUI [1])
    Intrauterine contraceptive device
    Item
    Intrauterine contraceptive device
    boolean
    C0021900 (UMLS CUI [1])
    Depot contraceptive (implants, injectables)
    Item
    Depot contraceptive (implants, injectables)
    boolean
    C0700589 (UMLS CUI [1,1])
    C0086129 (UMLS CUI [1,2])
    Spermicide plus physical barrier
    Item
    Spermicide plus physical barrier
    boolean
    C0037862 (UMLS CUI [1,1])
    C0004764 (UMLS CUI [1,2])
    Physical Barrier (condom, diaphragm)
    Item
    Physical Barrier (condom, diaphragm)
    boolean
    C0004764 (UMLS CUI [1])
    C0042241 (UMLS CUI [2])
    C3873750 (UMLS CUI [3])
    Abstinence
    Item
    Abstinence
    boolean
    C3843422 (UMLS CUI [1])
    Sterilization of male partner
    Item
    Sterilization of male partner
    boolean
    C0024559 (UMLS CUI [1])
    Other
    Item
    Other
    boolean
    C0205394 (UMLS CUI [1])
    Other Specification
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
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