Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Item
For female: record Childbearing potential
text
C3831118 (UMLS CUI [1])
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])
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Contraceptive method
integer
C0700589 (UMLS CUI [1])
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])
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
Inclusion / Exclusion Criteria
text
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
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
Was this subject a screen failure?
text
C1710476 (UMLS CUI [1])
Code List
Was this subject a screen failure?
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])
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])
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])
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
Has informed consent been obtained for PGx-Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
Code List
Has informed consent been obtained for PGx-Pharmacogenetic Research?
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])
Code List
Has blood sample been collected for PGx-Pharmacogenetic Research?
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])
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])
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])
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])
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
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
Treatment for migraine
text
C0149931 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Treatment for migraine
CL Item
Non-narcotic analgesics (2)
CL Item
Prescription narcotics (4)
CL Item
Combination analgesics (5)
CL Item
OTC analgesics (6)
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])
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)
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])
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])
Code List
Satisfied with the way medication worked
CL Item
Not applicable (3)
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])
Code List
How effective the medication is overall
CL Item
Very satisfied (1)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Very dissatisfied (5)
Item
Side effects of the medication
text
C2984047 (UMLS CUI [1])
Code List
Side effects of the medication
CL Item
Very satisfied (1)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Very dissatisfied (5)
Item
Overall satisfaction with the medication
text
C3476649 (UMLS CUI [1])
Code List
Overall satisfaction with the medication
CL Item
Very satisfied (1)
CL Item
Neither satisfied nor dissatisfied (3)
CL Item
Very dissatisfied (5)