ID

34173

Description

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.

Keywords

Versions (3)
  1. 11/11/18 11/11/18 -
  2. 11/14/18 11/14/18 -
  3. 1/15/19 1/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 15, 2019

DOI

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License

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

English

Subject Diary

1 forms  
  1. StudyEvent: ODM
    1. Subject Diary
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Migraine Symptoms
Description

Migraine Symptoms

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

Date and time of migraine headache pain start

Data type

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?
Description

Did you wake up with your migraine headache pain?

Data type

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
Description

Aura during migraine

Data type

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
Description

Migraine pain worsened by routine physical activity

Data type

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:
Description

Quality of migraine headache pain

Data type

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:
Description

Llocation of your migraine headache pain

Data type

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
Description

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
Description

Date study medication taken

Data type

date

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

Time study medication taken :

Data type

time

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

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
Description

Planned Timepoint of Medication

Data type

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:
Description

Severity of migraine headache pain

Data type

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
Description

Tick Yes or No for each symptom at each timepoint:

Data type

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
Description

Tick Yes or No for each symptom at each timepoint:

Data type

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
Description

Tick Yes or No for each symptom at each timepoint:

Data type

text

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

Tick Yes or No for each symptom at each timepoint:

Data type

text

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

Tick Yes or No for each symptom at each timepoint:

Data type

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
Description

Tick Yes or No for each symptom at each timepoint:

Data type

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)
Description

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
Description

Allodynia Questionnaire Result

Data type

text

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

Details of Work Ability

Alias
UMLS CUI-1
C4274891
Planned Relative Time
Description

Planned Relative Time

Data type

text

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

Tick one appropriate response at each timepoint:

Data type

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)
Description

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
Description

Allodynia Questionnaire Result

Data type

text

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

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?
Description

Return of Pain after Treatment

Data type

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
Description

Date and Time of Migraine Headache Pain Recurrence

Data type

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?
Description

Tick one:

Data type

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?
Description

Recurrence of Moderate or Severe Migraine Headache Pain

Data type

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
Description

Date of Moderate or Severe Migraine Headache Pain Recurrence

Data type

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?
Description

Tick one:

Data type

integer

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

Medications Taken

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

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Date Taken
Description

Date Medication Taken

Data type

date

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

(24 hour clock)

Data type

time

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

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

Data type

text

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

specify reason

Data type

text

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

Productivity

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

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

Data type

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:
Description

Number of Hours Subject was Scheduled to Do Paid Work

Data type

float

Measurement units
  • 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
Description

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
Description

Activity

Data type

text

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

Zero = 00.0

Data type

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
Description

Number of hours continued to do activity with migraine symptoms

Data type

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
Description

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

Data type

integer

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

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

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

Date of Completion

Data type

date

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

PPMQ-R Result

Data type

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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Similar models

Subject Diary

1 forms
  1. StudyEvent: ODM
    1. Subject Diary
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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