ID

34419

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 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.

Nyckelord

Versioner (3)
  1. 2019-01-11 2019-01-11 -
  2. 2019-01-13 2019-01-13 -
  3. 2019-01-17 2019-01-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

    Engelsk

    Child Bearing Potential and Birth Control

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

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

    Child-Bearing Potential

    Alias
    UMLS CUI-1
    C3831118
    Tick one
    Beskrivning

    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.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3831118
    Birth Control Methods
    Beskrivning

    Birth Control Methods

    Alias
    UMLS CUI-1
    C0700589
    Oral contraceptive
    Beskrivning

    Oral contraceptive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009905
    Intrauterine contraceptive device
    Beskrivning

    Intrauterine contraceptive device

    Datatyp

    boolean

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

    Depot contraceptive (implants, injectables)

    Datatyp

    boolean

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

    Spermicide plus physical barrier

    Datatyp

    boolean

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

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

    Datatyp

    boolean

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

    Abstinence

    Datatyp

    boolean

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

    Sterilization of male partner

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0024559
    Other
    Beskrivning

    Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    Other, specify
    Beskrivning

    Other Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Tillbaka till toppen

    Similar models

    Child Bearing Potential and Birth Control

    1 Formulär
    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])
    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])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial