Baseline

1 forms
  1. StudyEvent: ODM
    1. Baseline
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Status T-SMBP
C2348568 (UMLS CUI-1)
Study Subject Participation Status
Item
Did the subject obtain the 3 days of Baseline T-SMBP measures?
boolean
C2348568 (UMLS CUI [1])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Inclusion Criteria
text
C1512693 (UMLS CUI [1])
Inclusion
Code List
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Inclusion Criteria
CL Item
Male or female between the ages of 18 and 64 years inclusive. (1)
CL Item
Male subjects, if female partner not using an acceptable method of contraception, must agree to use one of the contraception methods listed in Section 8.1.2. This criterion must be followed from the time of the first dose of study medication until one month post-last dose. (3)
CL Item
BMI within the range 18.8 – 35.0 kg/m2 (inclusive). (4)
CL Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. (5)
CL Item
Subject currently meets the diagnosis for MDD (without psychotic features), single episode or recurrent, as defined in the DSM-IV-TR, diagnosed with SCID-CT (Structural Clinical Interview for DSM-IV Axis I disorders – Clinical Trials Version) as assessed* by a physician with adequate training in psychiatry. (6)
CL Item
Subject must, in the investigator’s opinion based on clinical history, have met DSM IV-TR criteria for their current major depressive episode for at least 4 weeks but for no greater than 24 months. (7)
CL Item
Subject has an independent rater HAMD17 total score ≥24, that is within 10% of the computerised HAMD17 total score, at the baseline assessment. If scores are not within 10% the independent rater or principal investigator, physician from CRS and GSK medical monitor must agree that subject is suitable for inclusion in the study. (8)
CL Item
Non-smoker or smokers (< 20 cigarettes per day). (9)
CL Item
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]; Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until one month post-last dose = 2. A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]; Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until one month post-last dose (2)
CL Item
Subject must read and write at a level sufficient to complete study-related assessments. (10)
Item
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Exclusion Criteria
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Code List
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Exclusion Criteria
CL Item
Subjects has: Symptoms of the presenting illness which are better accounted for by another diagnosis*; or A current DSM-IV-TR Axis I diagnosis of Dementia; or Antisocial or Borderline Personality Disorder or other current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non- compliance with the protocol; or A current (or within six months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder. (1)
CL Item
Subjects who, in the investigator’s judgement, pose a homicidal or serious suicidal risk, have made a suicide attempt within 6 months preceding screening or who have ever been homicidal. (2)
CL Item
Subject has initiated psychotherapy within one month prior to the Screening visit, or plans to initiate psychotherapy during the trial. Subjects who present with their current MDD diagnosis despite longer term psychotherapy (i.e., greater than three months prior to the Screening visit) and who agree to maintain the same therapy schedule during the trial may be included. (3)
CL Item
Subject has received vagus nerve stimulation, electroconvulsive therapy, or transcranial magnetic stimulation within the six months prior to the Screening visit. (4)
CL Item
Subject has previously failed an adequate therapeutic course of pharmacotherapy for MDD (e.g., for ≥ 4 weeks) from two different classes of antidepressants. (5)
CL Item
Subject has an unstable medical disorder or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK163090 or may pose a safety concern, or interfere with the accurate assessment of safety or efficacy. (6)
CL Item
The subject has a past history of drug abuse or dependence according to DSM-IV TR criteria within the past 12 months or has tested positive for urine drugs of abuse at pre-study screening except as detailed in Section 9.1.1. (7)
CL Item
Abuse of alcohol. To determine if a subject is abusing alcohol investigator will consider: average weekly intake of alcohol, score achieved on Alcohol Use Disorders Identification Test (AUDIT –C, Appendix 8 ) and results from laboratory assessments (in particular any abnormalities to AST: ALT ratio, GGT and MCV). (8)
CL Item
The subject has a past history of serotonin syndrome or in the investigator’s judgement, a history of clinical significant intolerance of SSRIs. (9)
CL Item
Subjects with a history of migraine headaches that respond to treatment with triptan medication. (10)
CL Item
The subject has a history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure). (11)
CL Item
A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. (12)
CL Item
The subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to the current illness, or six months for studies related to MDD. (13)
CL Item
The subject has a screening ECG with a QTc value of >450msec and or a PR interval outside the range 110 to 220msec or an ECG that is not suitable for QT measurements (e.g poorly defined termination of the T-wave). (14)
CL Item
Any cardiac condition or ECG evidence that the investigator feels may predispose the subject to ischemia or arrhythmia or any ECG abnormality that, in the investigator’s judgment, may pose a potential safety concern. (15)
CL Item
The subject has a systolic blood pressure (SBP) ≥160mmHg or a diastolic blood pressure (DBP) ≥ 100 mmHg verified by repeated measurement at the Screening or Randomization visit. (16)
CL Item
The subject has any liver function enzyme (ALT, AST, ALP or GGT) elevated > 2 times, or total or direct bilirubin>1.5 times (unless consistent with presumed or diagnosed Gilbert’s disease), above the reference range at pre-study screening that remains elevated with a repeat LFT. (17)
CL Item
Subjects who are not euthyroid based on lab results at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least six months prior to the screen visit. (18)
CL Item
Subject has any laboratory abnormality that in the investigator’s judgement is considered to be clinically significant and could potentially affect subject safety or study outcome. (19)
CL Item
Subject is female and has a positive Human Chorionic Gonadotropin (HCG) pregnancy test at screen visit, a positive urine dipstick test at randomization, or who is lactating or planning to become pregnant within 4 weeks following the last dose of study medication. (20)
CL Item
Subject has received depot antipsychotics within the 12 weeks before screening. (21)
CL Item
Subject has taken a regular course of other psychoactive drugs within the two weeks (22)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription, dietary, or herbal products that are potent or moderate inducers and/or inhibitors of the cytochrome P450 3A4 pathway for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization visit. (23)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription, dietary, or herbal products metabolized via the cytochrome P450 3A4 pathway with a narrow therapeutic index within 2 weeks (or 5 half-lives, whichever is longer) prior to the Randomization visit. (24)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription that are inhibitors of the P-glycoprotein for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization visit. (25)
CL Item
Use of monoamine oxidase inhibitors (MAOI) and linezolid (antibiotic) for 1 month prior to first dose of study medication. (26)
CL Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. (27)
CL Item
prior to the Screening Visit (except as discussed and permitted in section 9.1.1): All antidepressants including SSRIs (with the exception of fluoxetine, which requires 5 weeks), Long acting benzodiazepines, other psychoactive medications (including psychoactive herbal treatments, e.g., St. John’s Wort, SAM-E), Lithium, other mood stabilizers (including anticonvulsants) and oral antipsychotics, Opiates (including tramadol), hypnotics, and all other sedatives (including sedating antihistamines if they are used for their sedating and/or hypnotic properties) (prior to the Screening Visit (except as discussed and permitted in section 9.1.1): All antidepressants including SSRIs (with the exception of fluoxetine, which requires 5 weeks), Long acting benzodiazepines, other psychoactive medications (including psychoactive herbal treatments, e.g., St. John’s Wort, SAM-E), Lithium, other mood stabilizers (including anticonvulsants) and oral antipsychotics, Opiates (including tramadol), hypnotics, and all other sedatives (including sedating antihistamines if they are used for their sedating and/or hypnotic properties))
Item Group
Baseline Failure
C1710476 (UMLS CUI-1)
Trial Screen Failure, Baseline
Item
Was this subject a Baseline failure?
boolean
C1710476 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Trial Screen Failure, Baseline, Date in time
Item
Baseline failure date
date
C1710476 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Select primary reason
text
C1710476 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Trial Screen Failure, Baseline, Reason and justification
Code List
Select primary reason
CL Item
Adverse Event Protocol deviation (1)
CL Item
Prohibited medication use - Study procedure could not be performed  (2)
CL Item
Prohibited medication use - Study closed/terminated (3)
CL Item
Lost to follow-up (4)
CL Item
Investigator discretion, specify (5)
CL Item
Did not meet continuation criteria  (6)
CL Item
Withdrew consent, Specify (7)
Item
Specify
text
C1710476 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Gender
Code List
Specify
Trial Screen Failure, Baseline, Clinical Study Case, Investigator Signature
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re- sign the case book
boolean
C1710476 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction, Request
Item
Has a request been made for blood sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx  (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Item
Specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Code List
Specify
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Clinical Study Case, Investigator Signature
Item
Is this casebook ready to sign?
boolean
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Clinical Study Case, Investigator Signature
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 [1,1])
C2346576 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Systolic Pressure
Item
Blood pressure(1st Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(1st Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(2nd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(2nd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(3rd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(3rd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Diastolic blood pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Systolic Pressure, Screening procedure, Low, Average
Item
Average of the lowest two blood pressure readings at Screening visit - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1510992 (UMLS CUI [1,4])
Diastolic blood pressure, Screening procedure, Low, Average
Item
Average of the lowest two blood pressure readings at Screening visit - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1510992 (UMLS CUI [1,4])
Item Group
IHS Headache Classification
C0018681 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
Headache, Classification, aura; migraine without aura
Item
Migraine without aura?
boolean
C0018681 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C1389175 (UMLS CUI [1,3])
Headache, Classification, Migraine with Aura
Item
Typical aura with migraine headache?
boolean
C0018681 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0154723 (UMLS CUI [1,3])
Item Group
Migraine History
C0149931 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Migraine Disorders, Frequencies
Item
What is the average number of migraine attacks the subject typically experienced per 30 day calendar month during the last six months?
integer
C0149931 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
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])
Migraine Disorders, Duration
Code List
What is the average duration of a typical untreated or unsuccessfully treated migraine attack?
CL Item
< 4 hours (1)
CL Item
4 - 24 hours  (2)
CL Item
24 - 48 hours  (3)
CL Item
48 - 72 hours  (4)
CL Item
> 72 hours (5)
Item
Onset age of migraine attacks?
integer
C0149931 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
Trial Screen Failure, Reason and justification
Code List
Onset age of migraine attacks?
Migraine Disorders, 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 Disorders, Headache, Frequencies
Item
Average number of days with any kind of headache per 30 day calendar month for past 6 months?
integer
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Migraine Disorders, Headache, Frequencies
Item
Average number of days without any kind of headache per 30 day calendar month for past 6 months?
integer
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Item
Blood and lymphatic system disorders
text
C0851353 (UMLS CUI [1])
Blood and lymphatic system disorders
Code List
Blood and lymphatic system disorders
CL Item
Current  (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cardiac disorders
text
C0018799 (UMLS CUI [1])
Heart Diseases
Code List
Cardiac disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Ear and labyrinth disorders
text
C0851354 (UMLS CUI [1])
Ear and labyrinth disorders
Code List
Ear and labyrinth disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Endocrine disorders
text
C0014130 (UMLS CUI [1])
Endocrine System Diseases
Code List
Endocrine disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Eye disorders
text
C0015397 (UMLS CUI [1])
Disorder of eye
Code List
Eye disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gastrointestinal disorders
text
C0017178 (UMLS CUI [1])
Gastrointestinal Diseases
Code List
Gastrointestinal disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatobiliary disorders
text
C0267792 (UMLS CUI [1])
Hepatobiliary disease
Code List
Hepatobiliary disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Immune system disorders
text
C1334156 (UMLS CUI [1])
Immune System and Related Disorders
Code List
Immune system disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Metabolism and nutrition disorders
text
C0851358 (UMLS CUI [1])
Metabolism and nutrition disorders
Code List
Metabolism and nutrition disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Musculoskeletal and connective tissue disorders
text
C0263660 (UMLS CUI [1])
Musculoskeletal and connective tissue disorders
Code List
Musculoskeletal and connective tissue disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Neoplasms benign, malignant and unspecified (including cysts and polyps)
text
C1882062 (UMLS CUI [1])
Neoplastic disease
Code List
Neoplasms benign, malignant and unspecified (including cysts and polyps)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Nervous system disorders
text
C0027765 (UMLS CUI [1])
Nervous system disorder
Code List
Nervous system disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psychiatric disorders
text
C0004936 (UMLS CUI [1])
Mental disorders
Code List
Psychiatric disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Renal and urinary disorders
text
C0042075 (UMLS CUI [1])
Urologic Diseases
Code List
Renal and urinary disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Reproductive system and breast disorders
text
C0851366 (UMLS CUI [1])
Reproductive System and Breast Disorder Class
Code List
Reproductive system and breast disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Respiratory, thoracic and mediastinal disorders
text
C0851355 (UMLS CUI [1])
Respiratory, thoracic and mediastinal disorders
Code List
Respiratory, thoracic and mediastinal disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Skin and subcutaneous tissue disorders
text
C0037274 (UMLS CUI [1])
Dermatologic disorders
Code List
Skin and subcutaneous tissue disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vascular disorders
text
C0042373 (UMLS CUI [1])
Vascular Diseases
Code List
Vascular disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Infections and infestations
text
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
Communicable Diseases, Infestation
Code List
Infections and infestations
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Congenital, familial and genetic disorders
text
C0851352 (UMLS CUI [1])
Congenital, familial and genetic disorders
Code List
Congenital, familial and genetic disorders
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Cardiac Conditions
C0018799 (UMLS CUI-1)
Heart Diseases, Sequence Number
Item
Sequence Number
integer
C0018799 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Heart Diseases
Item
Specific Condition
text
C0018799 (UMLS CUI [1])
Heart Diseases, Reported Term
Item
Modified Term
text
C0018799 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
Heart Diseases, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA Synonym
text
C0018799 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Heart Diseases, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C0018799 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Heart Diseases, Code, Failed
Item
Failed coding
text
C0018799 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Item Group
Endocrine Disorders
C0014130 (UMLS CUI-1)
Item
Thyroid hyperfunction disorder
text
C0020550 (UMLS CUI [1])
Hyperthyroidism
Code List
Thyroid hyperfunction disorder
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid hypofunction disorder
text
C0020676 (UMLS CUI [1])
Hypothyroidism
Code List
Thyroid hypofunction disorder
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other [insert study specific classification] Conditions
C2359476 (UMLS CUI-1)
Other diseases or conditions, Sequence Number
Item
Sequence Number
integer
C2359476 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Other diseases or conditions
Item
Specific Condition
text
C2359476 (UMLS CUI [1])
Other diseases or conditions, Reported Term
Item
Modified Term
text
C2359476 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
Other diseases or conditions, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym
Item
MedDRA Synonym
text
C2359476 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Other diseases or conditions, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C2359476 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Other diseases or conditions, Code, Failed
Item
Failed coding
text
C2359476 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Item
Status
text
C2359476 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Other diseases or conditions, Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Baseline Risk Factors for CV Events
C0850624 (UMLS CUI-1)
Item
Does the subject have hyperlipidemia? (by history)?
text
C0020473 (UMLS CUI [1])
Hyperlipidemia
Code List
Does the subject have hyperlipidemia? (by history)?
CL Item
No  (1)
CL Item
Unknown  (2)
CL Item
Yes (3)
Diabetes Mellitus
Item
Does the subject have diabetes mellitus? (by history)?
boolean
C0011849 (UMLS CUI [1])
Premature coronary artery disease
Item
Does the subject have family history of premature coronary disease?
boolean
C1867743 (UMLS CUI [1])
Tobacco use
Item
Does the subject use tobacco?
boolean
C0543414 (UMLS CUI [1])
Obesity
Item
Is the subject obese? (Defined as BMI > or = to 30kg/m2)
boolean
C0028754 (UMLS CUI [1])
Physical Inactivity
Item
Does the subject have history of inactivity (< 30 min/day)?
boolean
C3890554 (UMLS CUI [1])
Chronic disease; inflammatory
Item
Does the subject have any chronic inflammatory condition?
boolean
C0008679 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
Item
Does the subject have elevated C - reactive protein (by history)?
text
C4023452 (UMLS CUI [1])
Elevated C-reactive protein level
Code List
Does the subject have elevated C - reactive protein (by history)?
CL Item
No (1)
CL Item
Yes  (2)
CL Item
Unknown (3)
Item Group
Previous Treatment for Migraine
C0149931 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Item
Previous use of medication for the acute treatment of migraine - Triptans
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1567966 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Triptans
Code List
Previous use of medication for the acute treatment of migraine - Triptans
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - NSAIDS
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Anti-Inflammatory Agents, Non-Steroidal
Code List
Previous use of medication for the acute treatment of migraine - NSAIDS
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Ergotamines
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0014711 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Ergotamines
Code List
Previous use of medication for the acute treatment of migraine - Ergotamines
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Prescription narcotics
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0027415 (UMLS CUI [1,3])
C1521941 (UMLS CUI [1,4])
Migraine Disorders, Prior Therapy, Narcotics, Prescription document
Code List
Previous use of medication for the acute treatment of migraine - Prescription narcotics
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Combination analgesics
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Analgesics
Code List
Previous use of medication for the acute treatment of migraine - Combination analgesics
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - OTC analgesics
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C2709201 (UMLS CUI [1,4])
Migraine Disorders, Prior Therapy, Analgesics, OTC
Code List
Previous use of medication for the acute treatment of migraine - OTC analgesics
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Butalbital combinations
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0717441 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Aspirin / butalbital
Code List
Previous use of medication for the acute treatment of migraine - Butalbital combinations
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - TCAs
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0003290 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Tricyclic Antidepressive Agents
Code List
Previous use of medication for the acute treatment of migraine - TCAs
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Anti-convulsants
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0003286 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Anticonvulsants
Code List
Previous use of medication for the acute treatment of migraine - Anti-convulsants
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - SSRIs
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0360105 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Selective Serotonin Reuptake Inhibitors
Code List
Previous use of medication for the acute treatment of migraine - SSRIs
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Beta-blockers
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0001645 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Adrenergic beta-Antagonists
Code List
Previous use of medication for the acute treatment of migraine - Beta-blockers
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Calcium channel-blockers
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0006684 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Calcium Channel Blockers
Code List
Previous use of medication for the acute treatment of migraine - Calcium channel-blockers
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - Prophylactics
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0355642 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Drugs used in migraine prophylaxis
Code List
Previous use of medication for the acute treatment of migraine - Prophylactics
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Item
Previous use of medication for the acute treatment of migraine - SNRIs
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1579361 (UMLS CUI [1,3])
Migraine Disorders, Prior Therapy, Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
Code List
Previous use of medication for the acute treatment of migraine - SNRIs
CL Item
Currently using (during the past 3 months)  (1)
CL Item
Used at any time in past (but not within the past 3 months)  (2)
CL Item
Never used (3)
Migraine Disorders, Prior Therapy, Categories, Other
Item
Are there other categories to be entered?
boolean
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0014711 (UMLS CUI [1,3])
C0683312 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Migraine Disorders, Prior Therapy, Other
Item
Other medication, specify
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Previous use of medication(s) for the acute treatment of migraine
text
C0149931 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Migraine Disorders, Prior Therapy
Code List
Previous use of medication(s) for the acute treatment of migraine
CL Item
Currently using (during the past 3 months) (1)
CL Item
Used at any time in past (but not within the past 3 months) (2)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization, Date in time
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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