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34419

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 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.

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 17, 2019

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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

    Child Bearing Potential and Birth Control

    1 forms  
    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
    Child-Bearing Potential
    Description

    Child-Bearing Potential

    Alias
    UMLS CUI-1
    C3831118 (Childbearing Potential)
    Tick one
    Description

    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.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    Birth Control Methods
    Description

    Birth Control Methods

    Alias
    UMLS CUI-1
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Oral contraceptive
    Description

    Oral contraceptive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009905 (Contraceptives, Oral)
    LOINC
    LA16247-1
    Intrauterine contraceptive device
    Description

    Intrauterine contraceptive device

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021900 (Intrauterine Devices)
    SNOMED
    268460000
    Depot contraceptive (implants, injectables)
    Description

    Depot contraceptive (implants, injectables)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [1,2]
    C0086129 (Depot Preparations)
    Spermicide plus physical barrier
    Description

    Spermicide plus physical barrier

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037862 (Spermatocidal Agents)
    UMLS CUI [1,2]
    C0004764 (Contraception, Barrier)
    SNOMED
    225370004
    Physical Barrier (condom, diaphragm)
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004764 (Contraception, Barrier)
    SNOMED
    225370004
    UMLS CUI [2]
    C0042241 (Vaginal contraceptive diaphragm (device))
    SNOMED
    20359006
    UMLS CUI [3]
    C3873750 (Latex condom)
    SNOMED
    706507009
    Abstinence
    Description

    Abstinence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3843422 (Abstinence)
    LOINC
    LA14550-0
    Sterilization of male partner
    Description

    Sterilization of male partner

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024559 (Male sterilization)
    SNOMED
    399141000
    Other
    Description

    Other

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other, specify
    Description

    Other Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C2348235 (Specification)
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    Similar models

    Child Bearing Potential and Birth Control

    1 forms
    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
    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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