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ID

34173

Descrição

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 Subject Diary Instructions: Important Reminders: • All Pages: It is very important that you complete the diary information as accurately as possible and in a timely manner. Page 1: • Do NOT treat any headache with study medication until study personnel call you about your lab and ECG results. • Enter the date and time your migraine headache pain started and the date and time you took study medication. • Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD. • If you wake up with mild migraine headache pain, you should take the study medication as soon as possible after awakening. • If you wake up with moderate or severe headache pain, you should NOT take the study medication to treat the headache. You should not use the study medication to treat your migraine headache if you have used: • nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil or Motrin), naproxen (Aleve), aspirin (exception is aspirin not exceeding 325mg if taken for cardiovascular health) within 24 hours before taking study medication • an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide within 24 hours before taking study medication • a triptan (such as Imitrex, Zomig, Maxalt, Relpax, Amerge, Axert, or Frova) within 24 hours before taking study medication • medications for nausea or vomiting, narcotics, or other headache medications within 24 hours before taking study medication • any other pain medications (such as Tylenol or acetaminophen) within 6 hours before taking study medication Page 2: Complete this page at time of dosing with study medication and 30 minutes, 1 hour, 2 hours, and 4 hours after taking study medication. Page 3: Complete this page at time of dosing with study medication. Page 4: Complete this page at time of dosing with study medication and at 2 and 4 hours after dosing with study medication. Page 5: Complete this page at 2 hours after dosing with study medication. Page 6: Complete this page at 24 hours after taking study medication. Page 7: Complete this page. You should not use a medication for pain, nausea, or vomiting within 2 hours after taking study medication. If you have migraine pain from 2 to 24 hours after taking the study medication, you may take other headache medication that the study doctor has told you is acceptable to use. These include Tylenol (acetaminophen), drugs for nausea or vomiting, and narcotics. Pages 8, 9 - 12: Complete these pages 24 hours after taking study medication. • Contact the investigator if you feel any unusual symptoms after taking the study medication. • Ask the investigator if you are unsure of the above instructions. GENERAL INSTRUCTIONS FOR DIARY COMPLETION • Use black ink and print neatly and legibly. • If you make a mistake, draw a single line through the incorrect entry. • Do not 'write over' or erase an incorrect entry, or re-copy the original page. • Do not use correction materials (such as correction fluid or tape) on this diary card. DATE • Record dates in DD MMM YY format (for example: 15 JAN 04). • Use the first three letters of each month as the abbreviation for the months (e.g., JAN, FEB, MAR). TIME • Record time in 24-hour clock format unless specified otherwise, per conversion chart below. a.m. Midnight = 00:00 1:00 = 01:00 2:00 = 02:00 3:00 = 03:00 4:00 = 04:00 5:00 = 05:00 6:00 = 06:00 7:00 = 07:00 8:00 = 08:00 9:00 = 09:00 10:00 = 10:00 11:00 = 11:00 p.m. Noon = 12:00 1:00 = 13:00 2:00 = 14:00 3:00 = 15:00 4:00 = 16:00 5:00 = 17:00 6:00 = 18:00 7:00 = 19:00 8:00 = 20:00 9:00 = 21:00 10:00 = 22:00 11:00 = 23:00 Note: Midnight = 00:00 is the start of the new day, not the end of the previous day. Page 1: Migraine Symptoms - Date and Time Study Medication Taken Page 2: Details of Migraine Headache Pain and Symptoms Page 3: Allodynia Questionnaire (Complete at time of dosing) Page 4: Details of WOrk Ability Page 5: Allodynia Questionnaire (Complete 2 hours after dosing) Page 6: Recurrence Page 7: Medications Taken Page 8: Productivity Page 9: PPMQ-R Reminder to Site Personnel: Upon return of the completed diary, review the diary with the subject and address discrepancies while the subject is in the clinic. Subject Reminder: Take the study medication ONLY within one hour of the start of migraine head pain and ONLY if your headache pain is still MILD.

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Versões (3)
  1. 11/11/2018 11/11/2018 -
  2. 14/11/2018 14/11/2018 -
  3. 15/01/2019 15/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

15 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™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    Inglês

    Subject Diary

    1 Formulários  
    1. StudyEvent: ODM
      1. Subject Diary
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Migraine Symptoms
    Descrição

    Migraine Symptoms

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

    Date and time of migraine headache pain start

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0332189
    UMLS CUI [1,4]
    C0808070
    UMLS CUI [2,1]
    C0149931
    UMLS CUI [2,2]
    C0018681
    UMLS CUI [2,3]
    C0332189
    UMLS CUI [2,4]
    C1301880
    Did you wake up with your migraine headache pain?
    Descrição

    Did you wake up with your migraine headache pain?

    Tipo de dados

    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
    Descrição

    Aura during migraine

    Tipo de dados

    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
    Descrição

    Migraine pain worsened by routine physical activity

    Tipo de dados

    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:
    Descrição

    Quality of migraine headache pain

    Tipo de dados

    text

    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:
    Descrição

    Llocation of your migraine headache pain

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0018681
    UMLS CUI [1,3]
    C0030193
    UMLS CUI [1,4]
    C0450429
    Date and Time Study Medication Taken
    Descrição

    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
    Descrição

    Date study medication taken

    Tipo de dados

    date

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

    Time study medication taken :

    Tipo de dados

    time

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

    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
    Descrição

    Planned Timepoint of Medication

    Tipo de dados

    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:
    Descrição

    Severity of migraine headache pain

    Tipo de dados

    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
    Descrição

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    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
    Descrição

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    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
    Descrição

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    text

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

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    text

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

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    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
    Descrição

    Tick Yes or No for each symptom at each timepoint:

    Tipo de dados

    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)
    Descrição

    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
    Allodynia questionnaire result
    Descrição

    Allodynia Questionnaire Result

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0458247
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C1274040
    Details of Work Ability
    Descrição

    Details of Work Ability

    Alias
    UMLS CUI-1
    C4274891
    Planned Relative Time
    Descrição

    Planned Relative Time

    Tipo de dados

    text

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

    Tick one appropriate response at each timepoint:

    Tipo de dados

    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)
    Descrição

    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
    Allodynia questionnaire result
    Descrição

    Allodynia Questionnaire Result

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0458247
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C1274040
    Recurrence
    Descrição

    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?
    Descrição

    Return of Pain after Treatment

    Tipo de dados

    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 and time your pain first returned
    Descrição

    Date and Time of Migraine Headache Pain Recurrence

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C0807712
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C0149931
    UMLS CUI [2,1]
    C0034897
    UMLS CUI [2,2]
    C0040223
    UMLS CUI [2,3]
    C0030193
    UMLS CUI [2,4]
    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?
    Descrição

    Tick one:

    Tipo de dados

    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?
    Descrição

    Recurrence of Moderate or Severe Migraine Headache Pain

    Tipo de dados

    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
    Descrição

    Date of Moderate or Severe Migraine Headache Pain Recurrence

    Tipo de dados

    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?
    Descrição

    Tick one:

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0034897
    UMLS CUI [1,2]
    C1507013
    UMLS CUI [1,3]
    C0149931
    Medications Taken
    Descrição

    Medications Taken

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

    Drug Name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2360065
    Date Taken
    Descrição

    Date Medication Taken

    Tipo de dados

    date

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

    (24 hour clock)

    Tipo de dados

    time

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

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

    Tipo de dados

    text

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

    specify reason

    Tipo de dados

    text

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

    Productivity

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

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

    Tipo de dados

    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:
    Descrição

    Number of Hours Subject was Scheduled to Do Paid Work

    Tipo de dados

    float

    Unidades de medida
    • 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
    Descrição

    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
    Descrição

    Activity

    Tipo de dados

    text

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

    Zero = 00.0

    Tipo de dados

    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
    Descrição

    Number of hours continued to do activity with migraine symptoms

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    integer

    Unidades de medida
    • %
    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C1280519
    %
    PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
    Descrição

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

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

    Date of Completion

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    PPMQ-R result
    Descrição

    PPMQ-R Result

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030971
    UMLS CUI [1,3]
    C0034394
    UMLS CUI [1,4]
    C1274040
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    Subject Diary

    1 Formulários
    1. StudyEvent: ODM
      1. Subject Diary
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Migraine Symptoms
    C0149931 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    Date and time of migraine headache pain start
    Item
    Enter the date and time your migraine headache pain started
    datetime
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0332189 (UMLS CUI [1,3])
    C0808070 (UMLS CUI [1,4])
    C0149931 (UMLS CUI [2,1])
    C0018681 (UMLS CUI [2,2])
    C0332189 (UMLS CUI [2,3])
    C1301880 (UMLS CUI [2,4])
    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:
    text
    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
    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)
    Allodynia Questionnaire Result
    Item
    Allodynia questionnaire result
    text
    C0458247 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    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)
    Allodynia Questionnaire Result
    Item
    Allodynia questionnaire result
    text
    C0458247 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    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 and 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: Date and time your pain first returned
    datetime
    C0807712 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    C0034897 (UMLS CUI [2,1])
    C0040223 (UMLS CUI [2,2])
    C0030193 (UMLS CUI [2,3])
    C0149931 (UMLS CUI [2,4])
    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])
    C1507013 (UMLS CUI [1,2])
    C0149931 (UMLS CUI [1,3])
    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
    text
    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])
    PPMQ-R Result
    Item
    PPMQ-R result
    text
    C0149931 (UMLS CUI [1,1])
    C0030971 (UMLS CUI [1,2])
    C0034394 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
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