ID

32672

Beskrivning

This ODM file contains the form for the subject diary. To be filled out throughout the study. Study ID: 101999 Clinical Study ID: 101999 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

Nyckelord

Versioner (3)
  1. 2018-11-11 2018-11-11 -
  2. 2018-11-14 2018-11-14 -
  3. 2019-01-15 2019-01-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 november 2018

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    Engelsk

    Subject Diary

    1 Formulär  
    1. StudyEvent: ODM
      1. Subject Diary
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Subject Diary Instructions
    Beskrivning

    Subject Diary Instructions

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C1442085
    Reminder to Site Personnel
    Beskrivning

    Reminder to Site Personnel

    Alias
    UMLS CUI-1
    C1709896
    UMLS CUI-2
    C2985654
    Migraine Symptoms
    Beskrivning

    Migraine Symptoms

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

    Enter the date your migraine headache pain started.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0332189
    UMLS CUI [1,4]
    C0808070
    Enter the time your migraine headache pain started
    Beskrivning

    Enter the time your migraine headache pain started.

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0332189
    UMLS CUI [1,4]
    C1301880
    Did you wake up with your migraine headache pain?
    Beskrivning

    Did you wake up with your migraine headache pain?

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0442696
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [1,3]
    C0018681
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Aura
    Beskrivning

    Aura during migraine

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0154723
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Pain worsened by routine physical activity
    Beskrivning

    Migraine pain worsened by routine physical activity

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0018681
    UMLS CUI [1,2]
    C4054844
    UMLS CUI [1,3]
    C0149931
    Which best describes the quality of your migraine headache pain? Tick only one:
    Beskrivning

    Quality of migraine headache pain

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C1148406
    Which best describes the location of your migraine headache pain? Tick only one:
    Beskrivning

    Llocation of your migraine headache pain

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0030193
    UMLS CUI [1,4]
    C0450429
    Subject Reminder
    Beskrivning

    Subject Reminder

    Alias
    UMLS CUI-1
    C0681850
    UMLS CUI-2
    C1709896
    Date and Time Study Medication Taken
    Beskrivning

    Date and Time Study Medication Taken

    Alias
    UMLS CUI-1
    C0011008
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C0040223
    UMLS CUI-4
    C0013227
    Date study medication taken
    Beskrivning

    Date study medication taken

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013227
    Time study medication taken :
    Beskrivning

    Time study medication taken :

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
    Details of Migraine Headache Pain and Symptoms
    Beskrivning

    Details of Migraine Headache Pain and Symptoms

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C0018681
    UMLS CUI-3
    C0030193
    UMLS CUI-4
    C1457887
    Planned Timepoint
    Beskrivning

    Planned Timepoint of Medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348792
    UMLS CUI [1,3]
    C1301732
    How severe is your migraine headache pain? Tick one at each timepoint:
    Beskrivning

    Severity of migraine headache pain

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0439793
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Nausea
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0027497
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Vomiting
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0042963
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Light Sensitivity
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0085636
    Do you have any of the following symptoms? Sound Sensitivity
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2938899
    UMLS CUI [1,2]
    C0149931
    Do you have any of the following symptoms? Neck Pain/Discomfort
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0863104
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [2,1]
    C0007859
    UMLS CUI [2,2]
    C0149931
    Do you have any of the following symptoms? Sinus (facial) Pain/Pressure
    Beskrivning

    Tick Yes or No for each symptom at each timepoint:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0015468
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [2,1]
    C0522251
    UMLS CUI [2,2]
    C0149931
    ALLODYNIA QUESTIONNAIRE (Complete at time of dosing)
    Beskrivning

    ALLODYNIA QUESTIONNAIRE (Complete at time of dosing)

    Alias
    UMLS CUI-1
    C0034394
    UMLS CUI-2
    C0458247
    UMLS CUI-3
    C0149931
    UMLS CUI-4
    C0439564
    UMLS CUI-5
    C3469597
    Details of Work Ability
    Beskrivning

    Details of Work Ability

    Alias
    UMLS CUI-1
    C4274891
    Planned Relative Time
    Beskrivning

    Planned Relative Time

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0439564
    How do you rate your ability to work or perform your normal/usual activities?
    Beskrivning

    Tick one appropriate response at each timepoint:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0441655
    UMLS CUI [1,2]
    C0085732
    UMLS CUI [1,3]
    C0149931
    UMLS CUI [2,1]
    C4274891
    UMLS CUI [2,2]
    C0149931
    ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing)
    Beskrivning

    ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing)

    Alias
    UMLS CUI-1
    C0034394
    UMLS CUI-2
    C0458247
    UMLS CUI-3
    C0149931
    UMLS CUI-4
    C0439564
    UMLS CUI-5
    C1548614
    UMLS CUI-6
    C3469597
    Recurrence
    Beskrivning

    Recurrence

    Alias
    UMLS CUI-1
    C0034897
    If your migraine headache pain was NONE at 2 hours, did any pain return between 2 and 24 hours after first treating?
    Beskrivning

    Return of Pain after Treatment

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C1882428
    UMLS CUI [1,4]
    C0149931
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: Date your pain first returned
    Beskrivning

    Date of Migraine Headache Pain Recurrence

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0807712
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C0149931
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: Time your pain first returned
    Beskrivning

    Time of Migraine Headache pain recurrence

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C0030193
    UMLS CUI [1,4]
    C0149931
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: How severe was your migraine headache pain at the time your pain first returned?
    Beskrivning

    Tick one:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034897
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1507013
    UMLS CUI [1,4]
    C0149931
    If your migraine headache pain was MILD or NONE at 2 hours, did MODERATE or SEVERE pain return up to 24 hours after treating?
    Beskrivning

    Recurrence of Moderate or Severe Migraine Headache Pain

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2957106
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C1882428
    UMLS CUI [1,4]
    C0149931
    UMLS CUI [2,1]
    C0278139
    UMLS CUI [2,2]
    C0018681
    UMLS CUI [2,3]
    C0034897
    UMLS CUI [2,4]
    C1882428
    UMLS CUI [2,5]
    C0149931
    If Yes was ticked (moderate or severe headache pain returned after the migraine headache pain had been none or mild 2 hours), complete the following: Date your pain became MODERATE or SEVERE
    Beskrivning

    Date of Moderate or Severe Migraine Headache Pain Recurrence

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0807712
    UMLS CUI [1,2]
    C2957106
    UMLS CUI [1,3]
    C0149931
    UMLS CUI [2,1]
    C0807712
    UMLS CUI [2,2]
    C0278139
    UMLS CUI [2,3]
    C0018681
    UMLS CUI [2,4]
    C0149931
    If Yes was ticked (moderate or severe headache pain returned after the migraine headache pain had been none or mild 2 hours), complete the following: How severe was your migraine headache pain at the time it became moderate or severe?
    Beskrivning

    Tick one:

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034897
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1507013
    UMLS CUI [1,4]
    C0149931
    Medications Taken
    Beskrivning

    Medications Taken

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0087111
    Drug Name Record one medication per row:
    Beskrivning

    Drug Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2360065
    Date Taken
    Beskrivning

    Date Medication Taken

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013227
    Time Taken
    Beskrivning

    (24 hour clock)

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
    Primary Reason Medication Taken: Migraine Headache Pain
    Beskrivning

    Tick one to indicate migraine headache pain severity ONLY if you took this medication for migraine headache pain:

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C1507013
    Primary Reason Medication Taken: Other Reason
    Beskrivning

    specify reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3840932
    Productivity
    Beskrivning

    Productivity

    Alias
    UMLS CUI-1
    C0033269
    Were you scheduled to do paid work during this migraine attack?
    Beskrivning

    Were you scheduled to do paid work during this migraine attack?

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C3846711
    UMLS CUI [1,3]
    C1571999
    If you were scheduled to do paid work during this migraine attack, record the number of hours (to the nearest one-half hour) you were scheduled to do paid work during this migraine attack:
    Beskrivning

    Number of Hours Subject was Scheduled to Do Paid Work

    Datatyp

    float

    Måttenheter
    • Hours
    Alias
    UMLS CUI [1,1]
    C1265611
    UMLS CUI [1,2]
    C0043227
    UMLS CUI [1,3]
    C1571999
    Hours
    Productivity: Affect of Migraine Attack on work and non-work related activities
    Beskrivning

    Productivity: Affect of Migraine Attack on work and non-work related activities

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C0026516
    UMLS CUI-3
    C0441655
    Activity
    Beskrivning

    Activity

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0441655
    Number of hours missed from doing activity due to migraine symptoms
    Beskrivning

    Zero = 00.0

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0441655
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0149931
    Number of hours continued to do activity with migraine symptoms
    Beskrivning

    Number of hours continued to do activity with migraine symptoms

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0441655
    UMLS CUI [1,2]
    C1314677
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0149931
    Estimate how effective you were, compared to your usual performance, while you continued to do activity with migraine symptoms
    Beskrivning

    If number of hours doing activity is 00.0, DO NOT COMPLETE. 100% = effective as usual

    Datatyp

    integer

    Måttenheter
    • %
    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C1280519
    %
    PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
    Beskrivning

    PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C0030971
    UMLS CUI-3
    C0034394
    Date of completion
    Beskrivning

    Date of Completion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    Tillbaka till toppen

    Similar models

    Subject Diary

    1 Formulär
    1. StudyEvent: ODM
      1. Subject Diary
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Subject Diary Instructions
    C3890583 (UMLS CUI-1)
    C1442085 (UMLS CUI-2)
    Item Group
    Reminder to Site Personnel
    C1709896 (UMLS CUI-1)
    C2985654 (UMLS CUI-2)
    Item Group
    Migraine Symptoms
    C0149931 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    Date of migraine headache pain start
    Item
    Enter the date your migraine headache pain started
    date
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0332189 (UMLS CUI [1,3])
    C0808070 (UMLS CUI [1,4])
    Time of migraine headache pain start
    Item
    Enter the time your migraine headache pain started
    time
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0332189 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Item
    Did you wake up with your migraine headache pain?
    text
    C0442696 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0018681 (UMLS CUI [1,3])
    Did you wake up with your migraine headache pain?
    Code List
    Did you wake up with your migraine headache pain?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Aura
    text
    C0154723 (UMLS CUI [1])
    Aura during migraine
    Code List
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Aura
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Pain worsened by routine physical activity
    text
    C0018681 (UMLS CUI [1,1])
    C4054844 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    Migraine pain worsened by routine physical activity
    Code List
    From the time your migraine started until you took study drug, did you have any of the following symptoms? Pain worsened by routine physical activity
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Which best describes the quality of your migraine headache pain? Tick only one:
    integer
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1148406 (UMLS CUI [1,3])
    Quality of migraine headache pain
    Code List
    Which best describes the quality of your migraine headache pain? Tick only one:
    CL Item
    Pulsating, throbbing, or pounding headache pain (1)
    CL Item
    Pressure/tightening (2)
    Item
    Which best describes the location of your migraine headache pain? Tick only one:
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    C0450429 (UMLS CUI [1,4])
    Llocation of your migraine headache pain
    Code List
    Which best describes the location of your migraine headache pain? Tick only one:
    CL Item
    Only on one side of head (1)
    CL Item
    On both sides of head (2)
    Item Group
    Subject Reminder
    C0681850 (UMLS CUI-1)
    C1709896 (UMLS CUI-2)
    Item Group
    Date and Time Study Medication Taken
    C0011008 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C0040223 (UMLS CUI-3)
    C0013227 (UMLS CUI-4)
    Date study medication taken
    Item
    Date study medication taken
    date
    C0011008 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time study medication taken :
    Item
    Time study medication taken :
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item Group
    Details of Migraine Headache Pain and Symptoms
    C0149931 (UMLS CUI-1)
    C0018681 (UMLS CUI-2)
    C0030193 (UMLS CUI-3)
    C1457887 (UMLS CUI-4)
    Item
    Planned Timepoint
    text
    C0013227 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Planned Timepoint
    Code List
    Planned Timepoint
    CL Item
    At time of dosing (At time of dosing)
    CL Item
    30 minutes after dose (30 minutes after dose)
    CL Item
    1 hour after dose (1 hour after dose)
    CL Item
    2 hours after dose (2 hours after dose)
    CL Item
    4 hours after dose (4 hours after dose)
    Item
    How severe is your migraine headache pain? Tick one at each timepoint:
    integer
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0439793 (UMLS CUI [1,3])
    Severity of migraine headache pain
    Code List
    How severe is your migraine headache pain? Tick one at each timepoint:
    CL Item
    None (0)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Nausea
    text
    C0027497 (UMLS CUI [1])
    Nausea
    Code List
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Nausea
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Vomiting
    text
    C0042963 (UMLS CUI [1])
    Migraine Vomiting
    Code List
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Vomiting
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Light Sensitivity
    text
    C0149931 (UMLS CUI [1,1])
    C0085636 (UMLS CUI [1,2])
    Light Sensitivity during Migraine
    Code List
    Do you have any of the following symptoms? Tick Yes or No for each symptom at each timepoint: Light Sensitivity
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Do you have any of the following symptoms? Sound Sensitivity
    text
    C2938899 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    Sound Sensitivity during Migraine
    Code List
    Do you have any of the following symptoms? Sound Sensitivity
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Do you have any of the following symptoms? Neck Pain/Discomfort
    text
    C0863104 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0007859 (UMLS CUI [2,1])
    C0149931 (UMLS CUI [2,2])
    Neck Pain/ Discomfort during Migraine
    Code List
    Do you have any of the following symptoms? Neck Pain/Discomfort
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Do you have any of the following symptoms? Sinus (facial) Pain/Pressure
    text
    C0015468 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0522251 (UMLS CUI [2,1])
    C0149931 (UMLS CUI [2,2])
    Sinus (facial) Pain/Pressure during Migraine
    Code List
    Do you have any of the following symptoms? Sinus (facial) Pain/Pressure
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    ALLODYNIA QUESTIONNAIRE (Complete at time of dosing)
    C0034394 (UMLS CUI-1)
    C0458247 (UMLS CUI-2)
    C0149931 (UMLS CUI-3)
    C0439564 (UMLS CUI-4)
    C3469597 (UMLS CUI-5)
    Item Group
    Details of Work Ability
    C4274891 (UMLS CUI-1)
    Item
    Planned Relative Time
    text
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    At time of dosing (At time of dosing)
    CL Item
    2 hours after dose (2 hours after dose)
    CL Item
    4 hours after dose (4 hours after dose)
    Item
    How do you rate your ability to work or perform your normal/usual activities?
    integer
    C0441655 (UMLS CUI [1,1])
    C0085732 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    C4274891 (UMLS CUI [2,1])
    C0149931 (UMLS CUI [2,2])
    Ability to work or perform usual activities
    Code List
    How do you rate your ability to work or perform your normal/usual activities?
    CL Item
    Normal (0)
    CL Item
    Mildly Impaired (1)
    CL Item
    Moderately Impaired (2)
    CL Item
    Severely Impaired (3)
    CL Item
    Required Bedrest (4)
    Item Group
    ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing)
    C0034394 (UMLS CUI-1)
    C0458247 (UMLS CUI-2)
    C0149931 (UMLS CUI-3)
    C0439564 (UMLS CUI-4)
    C1548614 (UMLS CUI-5)
    C3469597 (UMLS CUI-6)
    Item Group
    Recurrence
    C0034897 (UMLS CUI-1)
    Item
    If your migraine headache pain was NONE at 2 hours, did any pain return between 2 and 24 hours after first treating?
    text
    C0030193 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C1882428 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    Return of Pain after Treatment
    Code List
    If your migraine headache pain was NONE at 2 hours, did any pain return between 2 and 24 hours after first treating?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of Migraine Headache Pain Recurrence
    Item
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: Date your pain first returned
    date
    C0807712 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    Time of Migraine Headache pain recurrence
    Item
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: Time your pain first returned
    time
    C0040223 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    Item
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: How severe was your migraine headache pain at the time your pain first returned?
    integer
    C0034897 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1507013 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    undefined item
    Code List
    If Yes was ticked (any pain returned after migraine headache pain had been none at 2 hours), complete the following: How severe was your migraine headache pain at the time your pain first returned?
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    If your migraine headache pain was MILD or NONE at 2 hours, did MODERATE or SEVERE pain return up to 24 hours after treating?
    text
    C2957106 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C1882428 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    C0278139 (UMLS CUI [2,1])
    C0018681 (UMLS CUI [2,2])
    C0034897 (UMLS CUI [2,3])
    C1882428 (UMLS CUI [2,4])
    C0149931 (UMLS CUI [2,5])
    Recurrence of Moderate or Severe Migraine Headache Pain
    Code List
    If your migraine headache pain was MILD or NONE at 2 hours, did MODERATE or SEVERE pain return up to 24 hours after treating?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of Moderate or Severe Migraine Headache Pain Recurrence
    Item
    If Yes was ticked (moderate or severe headache pain returned after the migraine headache pain had been none or mild 2 hours), complete the following: Date your pain became MODERATE or SEVERE
    date
    C0807712 (UMLS CUI [1,1])
    C2957106 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    C0807712 (UMLS CUI [2,1])
    C0278139 (UMLS CUI [2,2])
    C0018681 (UMLS CUI [2,3])
    C0149931 (UMLS CUI [2,4])
    Item
    If Yes was ticked (moderate or severe headache pain returned after the migraine headache pain had been none or mild 2 hours), complete the following: How severe was your migraine headache pain at the time it became moderate or severe?
    integer
    C0034897 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1507013 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    undefined item
    Code List
    If Yes was ticked (moderate or severe headache pain returned after the migraine headache pain had been none or mild 2 hours), complete the following: How severe was your migraine headache pain at the time it became moderate or severe?
    CL Item
    Moderate (1)
    CL Item
    Severe (2)
    Item Group
    Medications Taken
    C0013227 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Drug Name
    Item
    Drug Name Record one medication per row:
    text
    C2360065 (UMLS CUI [1])
    Date Medication Taken
    Item
    Date Taken
    date
    C0011008 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time Medication Taken
    Item
    Time Taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Primary Reason Medication Taken: Migraine Headache Pain
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1507013 (UMLS CUI [1,3])
    Migraine Headache Pain Severity
    Code List
    Primary Reason Medication Taken: Migraine Headache Pain
    CL Item
    Mild Migraine Headache Pain (1)
    CL Item
    Moderate Migraine Headache Pain (2)
    CL Item
    Severe Migraine Headache Pain (3)
    Other Reason for Medication
    Item
    Primary Reason Medication Taken: Other Reason
    text
    C0013227 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Productivity
    C0033269 (UMLS CUI-1)
    Item
    Were you scheduled to do paid work during this migraine attack?
    text
    C0149931 (UMLS CUI [1,1])
    C3846711 (UMLS CUI [1,2])
    C1571999 (UMLS CUI [1,3])
    Were you scheduled to do paid work during this migraine attack?
    Code List
    Were you scheduled to do paid work during this migraine attack?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Number of Hours Subject was Scheduled to Do Paid Work
    Item
    If you were scheduled to do paid work during this migraine attack, record the number of hours (to the nearest one-half hour) you were scheduled to do paid work during this migraine attack:
    float
    C1265611 (UMLS CUI [1,1])
    C0043227 (UMLS CUI [1,2])
    C1571999 (UMLS CUI [1,3])
    Item Group
    Productivity: Affect of Migraine Attack on work and non-work related activities
    C0149931 (UMLS CUI-1)
    C0026516 (UMLS CUI-2)
    C0441655 (UMLS CUI-3)
    Item
    Activity
    integer
    C0441655 (UMLS CUI [1])
    Activity
    Code List
    Activity
    CL Item
    Paid work activities. (Complete this row only if you were scheduled to do paid work during this attack.) (1.)
    CL Item
    Activities outside your paid work. (e.g., leisure activities, household chores/tasks, family/social activities, etc.) (2.)
    Number of hours missed from doing activity due to migraine symptoms
    Item
    Number of hours missed from doing activity due to migraine symptoms
    float
    C0441655 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    Number of hours continued to do activity with migraine symptoms
    Item
    Number of hours continued to do activity with migraine symptoms
    float
    C0441655 (UMLS CUI [1,1])
    C1314677 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0149931 (UMLS CUI [1,4])
    Estimation of Effectiveness with Migraine Symptoms
    Item
    Estimate how effective you were, compared to your usual performance, while you continued to do activity with migraine symptoms
    integer
    C0149931 (UMLS CUI [1,1])
    C1280519 (UMLS CUI [1,2])
    Item Group
    PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
    C0149931 (UMLS CUI-1)
    C0030971 (UMLS CUI-2)
    C0034394 (UMLS CUI-3)
    Date of Completion
    Item
    Date of completion
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
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