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30810

Beschreibung

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

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  1. 21.06.18 21.06.18 -
  2. 21.06.18 21.06.18 -
  3. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

21. Juni 2018

DOI

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Creative Commons BY-NC 3.0
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    TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

    Englisch

    Attack 1 Diary

    1 Formulare  
    1. StudyEvent: ODM
      1. Attack 1 Diary
    Date of Visit/Assessment
    Beschreibung

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit/Assessment
    Beschreibung

    Date of Visit

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Migraine attack 1 symptoms
    Beschreibung

    Migraine attack 1 symptoms

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C1457887
    Enter the date and time your migraine headache pain started
    Beschreibung

    start date migraine attack

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0808070
    Did you wake up with your migraine headache pain?
    Beschreibung

    woke up with migraine headache pain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0442696
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [1,3]
    C0018681
    Did you have aura?
    Beschreibung

    migraine with aura

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0154723
    Pain worsened by physical activity?
    Beschreibung

    pain worsened by physical activity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C4054844
    What best describes the quality of your migraine headache pain?
    Beschreibung

    migraine headache pain quality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C1148406
    What best describes the location of your migraine headache pain?
    Beschreibung

    migraine headache pain location

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0030193
    UMLS CUI [1,4]
    C0450429
    Investigational Product
    Beschreibung

    Investigational Product

    Start date
    Beschreibung

    Start date

    Datentyp

    date

    Maßeinheiten
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0808070
    DDMONYYYY
    Start time
    Beschreibung

    Start time

    Datentyp

    time

    Maßeinheiten
    • hh:mm
    Alias
    UMLS CUI [1]
    C1301880
    hh:mm
    Stop Date
    Beschreibung

    Stop Date

    Datentyp

    date

    Maßeinheiten
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0806020
    DDMONYYYY
    Migraine attack 1 headache pain and symptoms
    Beschreibung

    Migraine attack 1 headache pain and symptoms

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C0018681
    UMLS CUI-3
    C0030193
    UMLS CUI-4
    C1457887
    Time since drug intake
    Beschreibung

    time since drug intake

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C1512806
    How severe is your migraine headache pain?
    Beschreibung

    migraine headache pain with scale

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C1504479
    Nausea symptoms
    Beschreibung

    Nausea

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027497
    Vomiting symptom
    Beschreibung

    Vomiting

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0042963
    Light sensitivity symptom
    Beschreibung

    Light sensitivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085636
    Sound sensitivity symptom
    Beschreibung

    Sound sensitivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2938899
    Medications taken
    Beschreibung

    Medications taken

    Alias
    UMLS CUI-1
    C2347852
    Sequence Number
    Beschreibung

    Sequence Number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348184
    Drug name (Trade name preferred)
    Beschreibung

    Drug name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Modified reported term
    Beschreibung

    Modified reported term

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826819
    Date and time medication taken
    Beschreibung

    Date and time medication taken

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Primary Reason Medication Taken
    Beschreibung

    Primary Reason Medication Taken

    Datentyp

    text

    Specify other reason
    Beschreibung

    Specify other reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826696
    Ability to function
    Beschreibung

    Ability to function

    Alias
    UMLS CUI-1
    C0441655
    UMLS CUI-2
    C0085732
    Time since drug intake
    Beschreibung

    time since drug intake

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C1512806
    How do you rate your ability to do school work or perform you usual activities?
    Beschreibung

    ability to perform usual activities

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0441655
    UMLS CUI [1,2]
    C0085732
    Investigational product accountability
    Beschreibung

    Investigational product accountability

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0078889
    Investigational product container numbers assigned
    Beschreibung

    investigational product container number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    Total Number of Tablets Dispensed
    Beschreibung

    total number of tablets dispensed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Total Number of Tablets taken
    Beschreibung

    total number of tablets taken

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0039225
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C1883727
    Returned Date
    Beschreibung

    Returned Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0180098
    UMLS CUI [1,3]
    C0332156
    UMLS CUI [1,4]
    C0011008
    Sequence Number
    Beschreibung

    Sequence Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Total Number of Tablets Returned
    Beschreibung

    total number of tablets returned

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0039225
    Investigational Product
    Beschreibung

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Date and time of second tablet
    Beschreibung

    Date and time of second tablet

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1717740
    Stop Date
    Beschreibung

    Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0806020
    Language used in diary assessment
    Beschreibung

    Language used in diary assessment

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0023008
    ISO language
    Beschreibung

    ISO language

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1708640
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    Ähnliche Modelle

    Attack 1 Diary

    1 Formulare
    1. StudyEvent: ODM
      1. Attack 1 Diary
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Migraine attack 1 symptoms
    C0149931 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    start date migraine attack
    Item
    Enter the date and time your migraine headache pain started
    datetime
    C0149931 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    woke up with migraine headache pain
    Item
    Did you wake up with your migraine headache pain?
    boolean
    C0442696 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0018681 (UMLS CUI [1,3])
    migraine with aura
    Item
    Did you have aura?
    boolean
    C0154723 (UMLS CUI [1])
    pain worsened by physical activity
    Item
    Pain worsened by physical activity?
    boolean
    C0018681 (UMLS CUI [1,1])
    C4054844 (UMLS CUI [1,2])
    Item
    What best describes the quality of your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1148406 (UMLS CUI [1,3])
    migraine headache pain quality
    Code List
    What best describes the quality of your migraine headache pain?
    CL Item
    Pulsing, throbbing, or pounding pain (1)
    CL Item
    Pressure/tightening (2)
    Item
    What best describes the location of your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    C0450429 (UMLS CUI [1,4])
    migraine headache pain quality
    Code List
    What best describes the location of your migraine headache pain?
    CL Item
    Only one side of head (1)
    CL Item
    On both sides of head (2)
    Item Group
    Investigational Product
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Migraine attack 1 headache pain and symptoms
    C0149931 (UMLS CUI-1)
    C0018681 (UMLS CUI-2)
    C0030193 (UMLS CUI-3)
    C1457887 (UMLS CUI-4)
    Item
    Time since drug intake
    text
    C0011008 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1512806 (UMLS CUI [1,3])
    time since drug intake
    Code List
    Time since drug intake
    CL Item
    0 hour (at time of dosing) (1)
    (Comment:en)
    CL Item
    1 hour after dose (2)
    (Comment:en)
    CL Item
    2 hous after dose (3)
    (Comment:en)
    CL Item
    4 hours after dose (4)
    (Comment:en)
    Item
    How severe is your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1504479 (UMLS CUI [1,3])
    migraine headache pain with scale
    Code List
    How severe is your migraine headache pain?
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Nausea
    Item
    Nausea symptoms
    boolean
    C0027497 (UMLS CUI [1])
    Vomiting
    Item
    Vomiting symptom
    integer
    C0042963 (UMLS CUI [1])
    Light sensitivity
    Item
    Light sensitivity symptom
    boolean
    C0085636 (UMLS CUI [1])
    Sound sensitivity
    Item
    Sound sensitivity symptom
    boolean
    C2938899 (UMLS CUI [1])
    Item Group
    Medications taken
    C2347852 (UMLS CUI-1)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name (Trade name preferred)
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1])
    Date and time medication taken
    Item
    Date and time medication taken
    datetime
    C0013227 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Primary Reason Medication Taken
    text
    Primary Reason Medication Taken
    Code List
    Primary Reason Medication Taken
    CL Item
    Mild Migraine Headache Pain (1)
    CL Item
    Moderate Migraine Headache Pain (2)
    CL Item
    Severe Migraine Headache Pain (3)
    CL Item
    Other Reason, Specify (4)
    Specify other reason
    Item
    Specify other reason
    text
    C2826696 (UMLS CUI [1])
    Item Group
    Ability to function
    C0441655 (UMLS CUI-1)
    C0085732 (UMLS CUI-2)
    Item
    Time since drug intake
    text
    C0011008 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1512806 (UMLS CUI [1,3])
    time since drug intake
    Code List
    Time since drug intake
    CL Item
    0 hour (at time of dosing) (1)
    (Comment:en)
    CL Item
    1 hour after dose (2)
    (Comment:en)
    CL Item
    2 hous after dose (3)
    (Comment:en)
    CL Item
    4 hours after dose (4)
    (Comment:en)
    Item
    How do you rate your ability to do school work or perform you usual activities?
    text
    C0441655 (UMLS CUI [1,1])
    C0085732 (UMLS CUI [1,2])
    ability to perform usual activities
    Code List
    How do you rate your ability to do school work or perform you usual activities?
    CL Item
    Normal (1)
    CL Item
    Mildly impaired (2)
    CL Item
    Moderately impaired (3)
    CL Item
    Severely impaired (4)
    CL Item
    Required bedrest (5)
    Item Group
    Investigational product accountability
    C0304229 (UMLS CUI-1)
    C0078889 (UMLS CUI-2)
    investigational product container number
    Item
    Investigational product container numbers assigned
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    total number of tablets dispensed
    Item
    Total Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    total number of tablets taken
    Item
    Total Number of Tablets taken
    integer
    C0039225 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1883727 (UMLS CUI [1,3])
    Returned Date
    Item
    Returned Date
    date
    C0013227 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0332156 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Sequence Number
    Item
    Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    total number of tablets returned
    Item
    Total Number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Date and time of second tablet
    Item
    Date and time of second tablet
    datetime
    C0013227 (UMLS CUI [1,1])
    C1717740 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Language used in diary assessment
    C3890583 (UMLS CUI-1)
    C0023008 (UMLS CUI-2)
    ISO language
    Item
    ISO language
    text
    C1708640 (UMLS CUI [1])
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