ID

44579

Descripción

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

Palabras clave

Versiones (3)
  1. 18/6/18 18/6/18 -
  2. 19/6/18 19/6/18 -
  3. 27/9/21 27/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

27 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Screening

1 formularios  
  1. StudyEvent: ODM
    1. Screening
Date of Visit/Assessment
Descripción

Date of Visit/Assessment

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

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Identification
Descripción

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

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

Childbearing potential

Tipo de datos

text

Alias
UMLS CUI [1]
C3831118
Ethnicity
Descripción

Race

Tipo de datos

text

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

Demography - Geographic Ancestry

Alias
UMLS CUI-1
C3841890
Geographic Ancestry
Descripción

Geographic Ancestry

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Contraceptive Methods
Descripción

Contraceptive Methods

Alias
UMLS CUI-1
C0700589
Contraceptive method
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C0700589
Other
Descripción

Specify

Tipo de datos

text

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

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.
Descripción

Entry criteria

Tipo de datos

boolean

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

Inclusion/Exclusion Criteria

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

Inclusion / Exclusion Criteria

Tipo de datos

text

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

Inclusion/Exclusion criteria applies

Tipo de datos

boolean

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

Screen Failure

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

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Descripción

Screen Failure Date

Tipo de datos

date

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

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

Tipo de datos

text

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

Specify Reason for Screen Failure

Tipo de datos

text

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

Investigator signature

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

Is this casebook ready to sign?

Tipo de datos

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
Descripción

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.

Tipo de datos

boolean

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

Previous Clinical Trial Participation

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

Previous study

Tipo de datos

boolean

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

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C1709561
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of Measurements
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Body height
Descripción

Height

Tipo de datos

text

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Descripción

Weight

Tipo de datos

text

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Descripción

BMI

Tipo de datos

text

Unidades de medida
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
PGx-Pharmacogenetic Research Consent
Descripción

PGx-Pharmacogenetic Research Consent

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

informed consent

Tipo de datos

text

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

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

Tipo de datos

date

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

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

Tipo de datos

text

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

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

Tipo de datos

date

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

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

Tipo de datos

integer

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

If other, please specify

Tipo de datos

text

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

hidden

Tipo de datos

text

Alias
UMLS CUI [1]
C2347029
Medical conditions
Descripción

Medical conditions

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

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

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
Current Disease?
Descripción

Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0012634
IHS Headache Classification
Descripción

IHS Headache Classification

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

Migraine Without Aura

Tipo de datos

boolean

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

Migraine with aura

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0154723
Migraine history
Descripción

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?
Descripción

Number of migraine attacks

Tipo de datos

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?
Descripción

Duration of migraine attack

Tipo de datos

text

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

(... years old)

Tipo de datos

integer

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

Migraine recurrence

Tipo de datos

boolean

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

Migraine recurrence delay

Tipo de datos

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?
Descripción

Nr of headache episodes

Tipo de datos

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?
Descripción

Nr of no headache episodes

Tipo de datos

integer

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

Previous treatment for migraine

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

Treatment for migraine

Tipo de datos

text

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

medication for migraine treatment

Tipo de datos

text

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

Other previous treatment for migraine

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

other migraine treatment

Tipo de datos

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
Descripción

previous use of medication for migraine treatment

Tipo de datos

text

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

satisfaction with medication

Tipo de datos

text

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

Prior treatment medication satisfaction questions

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

Date of completion

Tipo de datos

date

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

medication effectiveness

Tipo de datos

text

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

medication side effects

Tipo de datos

text

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

medication satisfaction

Tipo de datos

text

Alias
UMLS CUI [1]
C3476649
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Similar models

Screening

1 formularios
  1. StudyEvent: ODM
    1. Screening
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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