ID

44579

Description

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

Keywords

Versions (3)
  1. 6/18/18 6/18/18 -
  2. 6/19/18 6/19/18 -
  3. 9/27/21 9/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2021

DOI

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License

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

English

Screening

1 forms  
  1. StudyEvent: ODM
    1. Screening
Date of Visit/Assessment
Description

Date of Visit/Assessment

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

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
For female: record Childbearing potential
Description

Childbearing potential

Data type

text

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Demography - Geographic Ancestry
Description

Demography - Geographic Ancestry

Alias
UMLS CUI-1
C3841890
Geographic Ancestry
Description

Geographic Ancestry

Data type

text

Alias
UMLS CUI [1]
C0034510
Contraceptive Methods
Description

Contraceptive Methods

Alias
UMLS CUI-1
C0700589
Contraceptive method
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1]
C0700589
Other
Description

Specify

Data type

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205394
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below.
Description

Entry criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-3
C0680251
Inclusion / Exclusion Criteria
Description

Inclusion / Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
Inclusion/Exclusion criteria applies
Description

Inclusion/Exclusion criteria applies

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
UMLS CUI [3]
C1552663
Screen Failure
Description

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Description

A subject who is assigned a subject number, but is not randomised has failed screening.

Data type

text

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Description

Screen Failure Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710476
If screen failure, what was the primary reason?
Description

If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
If Investigator discretion or Consent Withdrawal for screen failure, specify:
Description

Specify Reason for Screen Failure

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
Investigator signature
Description

Investigator signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Description

Is this casebook ready to sign?

Data type

boolean

Alias
UMLS CUI [1]
C2346576
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
Description

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.

Data type

boolean

Alias
UMLS CUI [1]
C1706256
Previous Clinical Trial Participation
Description

Previous Clinical Trial Participation

Alias
UMLS CUI-1
C2348568
Did the subject participate in the Treximet Migraine Adolescent Safety study, TXA107977?
Description

Previous study

Data type

boolean

Alias
UMLS CUI [1]
C2242969
Previous subject number/identifer if YES, complete the following:
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C1709561
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of Measurements
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Body height
Description

Height

Data type

text

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Weight

Data type

text

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

BMI

Data type

text

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
PGx-Pharmacogenetic Research Consent
Description

PGx-Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic Research?
Description

informed consent

Data type

text

Alias
UMLS CUI [1]
C0021430
Date informed consent obtained for PGx-Pharmacogenetic Research:
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Has blood sample been collected for PGx-Pharmacogenetic Research?
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes

Data type

text

Alias
UMLS CUI [1]
C0005834
Record date sample taken
Description

Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
No, provide reason below
Description

Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
reason informed consent was not obtained
Description

If other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
Sample type
Description

hidden

Data type

text

Alias
UMLS CUI [1]
C2347029
Medical conditions
Description

Medical conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Current Disease?
Description

Disease

Data type

integer

Alias
UMLS CUI [1]
C0012634
IHS Headache Classification
Description

IHS Headache Classification

Alias
UMLS CUI-1
C0018681
UMLS CUI-3
C3846158
Migraine without aura
Description

Migraine Without Aura

Data type

boolean

Alias
UMLS CUI [1]
C1389175
Typical aura with migraine headache
Description

Migraine with aura

Data type

boolean

Alias
UMLS CUI [1]
C0154723
Migraine history
Description

Migraine history

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C0262926
What is the average number of migraine attacks the subject typically experienced per 30 day calendar month during the past year?
Description

Number of migraine attacks

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1304680
UMLS CUI [1,3]
C0332177
What is the average duration of a typical untreated or unsuccessfully treated migraine attack?
Description

Duration of migraine attack

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0449238
Onset age of migraine attacks?
Description

(... years old)

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0206132
Does migraine headache pain usually recur within 24 hours of treatment?
Description

Migraine recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0034897
Specify nr of hrs for pain recurrence
Description

Migraine recurrence delay

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C2985752
Average number of days with any kind of headache per 30 day calendar month during past year?
Description

Nr of headache episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C4086638
Average number of days without any kind of headache per 30 day calendar month during past year?
Description

Nr of no headache episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C4086638
UMLS CUI [1,3]
C1298908
Previous treatment for migraine
Description

Previous treatment for migraine

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C0087111
Treatment for migraine
Description

Treatment for migraine

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0087111
Previous use of medication for the acute treatment of migraine
Description

medication for migraine treatment

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0013227
Other previous treatment for migraine
Description

Other previous treatment for migraine

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C1514463
Other medication, specify
Description

other migraine treatment

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205394
Previous use of medication for the acute treatment of migraine
Description

previous use of medication for migraine treatment

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0087111
Satisfied with the way medication worked
Description

satisfaction with medication

Data type

text

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C0013216
Prior treatment medication satisfaction questions
Description

Prior treatment medication satisfaction questions

Alias
UMLS CUI-1
C3476649
Date of completion of this form
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
How effective the medication is overall
Description

medication effectiveness

Data type

text

Alias
UMLS CUI [1]
C0087113
Side effects of the medication
Description

medication side effects

Data type

text

Alias
UMLS CUI [1]
C2984047
Overall satisfaction with the medication
Description

medication satisfaction

Data type

text

Alias
UMLS CUI [1]
C3476649
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Similar models

Screening

1 forms
  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (FEMALE)
CL Item
Male (MALE)
Item
For female: record Childbearing potential
text
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
For female: record Childbearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
text
C0034510 (UMLS CUI [1])
Race
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Demography - Geographic Ancestry
C3841890 (UMLS CUI-1)
Item
Geographic Ancestry
text
C0034510 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Contraceptive Methods
C0700589 (UMLS CUI-1)
Item
Contraceptive method
integer
C0700589 (UMLS CUI [1])
Contraceptive method
Code List
Contraceptive method
CL Item
Oral contraceptive (1)
C0009905 (UMLS CUI-1)
(Comment:en)
CL Item
Intrauterine contraceptive device (2)
C0021900 (UMLS CUI-1)
(Comment:en)
CL Item
Depot contraceptive (implants, injectables) (3)
C0700589 (UMLS CUI-1)
C2585377 (UMLS CUI-2)
(Comment:en)
CL Item
Double barrier (condom, diaphragm) (4)
C0042241 (UMLS CUI-1)
C3873750 (UMLS CUI-2)
(Comment:en)
CL Item
Sterilisation of male partner (5)
C0024559 (UMLS CUI-1)
(Comment:en)
CL Item
Abstinence (6)
C3843422 (UMLS CUI-1)
(Comment:en)
CL Item
Spermicide plus physical barrier (7)
C0037862 (UMLS CUI-1)
C0004764 (UMLS CUI-2)
(Comment:en)
Other contraceptive method
Item
Other
text
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Entry criteria
Item
Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below.
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion/Exclusion Criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-3)
Item
Inclusion / Exclusion Criteria
text
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Inclusion / Exclusion Criteria
Code List
Inclusion / Exclusion Criteria
CL Item
Inclusion Criteria 1 (1)
CL Item
Inclusion Criteria 2 (2)
CL Item
Inclusion Criteria 3 (3)
CL Item
Inclusion Criteria 4 (4)
CL Item
Inclusion Criteria 5 (5)
CL Item
Inclusion Criteria 6 (6)
CL Item
Inclusion Criteria 7 (7)
CL Item
Inclusion Criteria 8 (8)
CL Item
Inclusion Criteria 9 (9)
CL Item
Exclusion Criteria 1 (10)
CL Item
Exclusion Criteria 2 (11)
CL Item
Exclusion Criteria 3 (12)
CL Item
Exclusion Criteria 4 (13)
CL Item
Exclusion Criteria 5 (14)
CL Item
Exclusion Criteria 6 (15)
CL Item
Exclusion Criteria 7 (16)
CL Item
Exclusion Criteria 8 (17)
CL Item
Exclusion Criteria 9 (18)
CL Item
Exclusion Criteria 10 (19)
CL Item
Exclusion Criteria 11 (20)
CL Item
Exclusion Criteria 12 (21)
CL Item
Exclusion Criteria 13 (22)
CL Item
Exclusion Criteria 14 (23)
CL Item
Exclusion Criteria 15 (24)
CL Item
Exclusion Criteria 16 (25)
CL Item
Exclusion Criteria 17 (26)
Inclusion/Exclusion criteria applies
Item
Inclusion/Exclusion criteria applies
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C1552663 (UMLS CUI [3])
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Item
Was this subject a screen failure?
text
C1710476 (UMLS CUI [1])
Screen failure
Code List
Was this subject a screen failure?
CL Item
Yes (Y)
CL Item
No (N)
Screen Failure Date
Item
Screen Failure Date
date
C0011008 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
Item
If screen failure, what was the primary reason?
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for screen failure
Code List
If screen failure, what was the primary reason?
CL Item
Did not meet inclusion/exclusion criteria (1)
CL Item
Adverse Event (unspecified) (2)
CL Item
Study closed/terminated (unspecified) (3)
CL Item
Lost to follow up (unspecified) (4)
CL Item
Withdrew consent (specify!) (6)
CL Item
Investigator discretion (specify!) (5)
Specify Reason for Screen Failure
Item
If Investigator discretion or Consent Withdrawal for screen failure, specify:
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Is this casebook ready to sign?
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
re-sign case book
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
boolean
C1706256 (UMLS CUI [1])
Item Group
Previous Clinical Trial Participation
C2348568 (UMLS CUI-1)
Previous study
Item
Did the subject participate in the Treximet Migraine Adolescent Safety study, TXA107977?
boolean
C2242969 (UMLS CUI [1])
Subject number
Item
Previous subject number/identifer if YES, complete the following:
text
C1709561 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date of Measurements
date
C2985720 (UMLS CUI [1])
Height
Item
Body height
text
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
text
C0005910 (UMLS CUI [1])
BMI
Item
Body Mass Index
text
C1305855 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic Research Consent
C0008976 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
informed consent
Code List
Has informed consent been obtained for PGx-Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
date of informed consent
Item
Date informed consent obtained for PGx-Pharmacogenetic Research:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
Has blood sample been collected for PGx-Pharmacogenetic Research?
text
C0005834 (UMLS CUI [1])
undefined item
Code List
Has blood sample been collected for PGx-Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
date sample taken
Item
Record date sample taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
No, provide reason below
integer
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason informed consent was not obtained
Code List
No, provide reason below
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
reason informed consent was not obtained
Item
reason informed consent was not obtained
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Sample type
Item
Sample type
text
C2347029 (UMLS CUI [1])
Item Group
Medical conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Blood and lymphatic system disorders (Blood and lymphatic system disorders)
CL Item
Cardiac disorders (Cardiac disorders)
CL Item
Ear and labyrinth disorders (Ear and labyrinth disorders)
CL Item
Endocrine disorders (Endocrine disorders)
CL Item
Eye disorders (Eye disorders)
CL Item
Gastrointestinal disordem (Gastrointestinal disordem)
CL Item
Hepalobiliary disorders (Hepalobiliary disorders)
CL Item
Immune system disorders (Immune system disorders)
CL Item
Metabolism and nutrition disorders (Metabolism and nutrition disorders)
CL Item
Musculoskeletal and connective tissue disorders (Musculoskeletal and connective tissue disorders)
CL Item
Nervous system disorders (Nervous system disorders)
CL Item
Psychiatric disorders (Psychiatric disorders)
CL Item
Renal and urinary disorders (Renal and urinary disorders)
CL Item
Reproductive system and breast disorders (Reproductive system and breast disorders)
CL Item
Respiratory, thoracic and mediastinal disorders (Respiratory, thoracic and mediastinal disorders)
CL Item
Skin and subcutaneous tissue disorders (Skin and subcutaneous tissue disorders)
CL Item
Vascular disorders (Vascular disorders)
Item
Current Disease?
integer
C0012634 (UMLS CUI [1])
Disease
Code List
Current Disease?
CL Item
Current (1)
CL Item
Not Assessed (2)
CL Item
No Medical Condition (3)
Item Group
IHS Headache Classification
C0018681 (UMLS CUI-1)
C3846158 (UMLS CUI-3)
Migraine Without Aura
Item
Migraine without aura
boolean
C1389175 (UMLS CUI [1])
Migraine with aura
Item
Typical aura with migraine headache
boolean
C0154723 (UMLS CUI [1])
Item Group
Migraine history
C0149931 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Number of migraine attacks
Item
What is the average number of migraine attacks the subject typically experienced per 30 day calendar month during the past year?
integer
C0149931 (UMLS CUI [1,1])
C1304680 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
Item
What is the average duration of a typical untreated or unsuccessfully treated migraine attack?
text
C0149931 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of migraine attack
Code List
What is the average duration of a typical untreated or unsuccessfully treated migraine attack?
CL Item
less than 3 hours (1)
CL Item
3-24 hours (2)
CL Item
24-48 hours (3)
CL Item
48-72 hours (4)
CL Item
more than 72 hours (5)
Onset age of migraine attacks
Item
Onset age of migraine attacks?
integer
C0149931 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
Migraine recurrence
Item
Does migraine headache pain usually recur within 24 hours of treatment?
boolean
C0149931 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Migraine recurrence delay
Item
Specify nr of hrs for pain recurrence
integer
C0149931 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C2985752 (UMLS CUI [1,3])
Nr of headache episodes
Item
Average number of days with any kind of headache per 30 day calendar month during past year?
integer
C0018681 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Nr of no headache episodes
Item
Average number of days without any kind of headache per 30 day calendar month during past year?
integer
C0018681 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
Item Group
Previous treatment for migraine
C0149931 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Treatment for migraine
text
C0149931 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment for migraine
Code List
Treatment for migraine
CL Item
Triptans (1)
CL Item
Non-narcotic analgesics (2)
CL Item
Ergotamines (3)
CL Item
Prescription narcotics (4)
CL Item
Combination analgesics (5)
CL Item
OTC analgesics (6)
CL Item
NSAIDS (7)
CL Item
Prescription NSAIDS (8)
CL Item
Butalbital combinations (9)
CL Item
Cox-2 inhibitors (10)
Item
Previous use of medication for the acute treatment of migraine
text
C0149931 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
medication for migraine treatment
Code List
Previous use of medication for the acute treatment of migraine
CL Item
Currently using (1)
CL Item
Used at any time in the past (2)
CL Item
Never used (3)
Item Group
Other previous treatment for migraine
C0149931 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
other migraine treatment
Item
Other medication, specify
text
C0149931 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Previous use of medication for the acute treatment of migraine
text
C0149931 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
previous use of medication for migraine treatment
Code List
Previous use of medication for the acute treatment of migraine
CL Item
Currently using (1)
CL Item
Used at any time in past (2)
Item
Satisfied with the way medication worked
text
C0242428 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
satisfaction with medication
Code List
Satisfied with the way medication worked
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
Prior treatment medication satisfaction questions
C3476649 (UMLS CUI-1)
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Item
How effective the medication is overall
text
C0087113 (UMLS CUI [1])
medication effectiveness
Code List
How effective the medication is overall
CL Item
Very satisfied (1)
CL Item
Satisfied (2)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Dissatisfied (4)
CL Item
Very dissatisfied (5)
Item
Side effects of the medication
text
C2984047 (UMLS CUI [1])
medication effectiveness
Code List
Side effects of the medication
CL Item
Very satisfied (1)
CL Item
Satisfied (2)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Dissatisfied (4)
CL Item
Very dissatisfied (5)
Item
Overall satisfaction with the medication
text
C3476649 (UMLS CUI [1])
medication effectiveness
Code List
Overall satisfaction with the medication
CL Item
Very satisfied (1)
CL Item
Satisfied (2)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Dissatisfied (4)
CL Item
Very dissatisfied (5)
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