Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Health Status; Age; Gender
Item
Is the subject a healthy adult male or female between 18 and 55 years of age, inclusive?
boolean
C0018759 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Gender; Childbearing Potential; Contraceptive methods
Item
Is the subject male, or an eligible female?
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Gender; Childbearing Potential; Contraceptive methods
Item
Is the subject male, a female of non-childbearing potential, or a female taking oral contraceptives or HRT and has been on a stable regimen for at least 2 months prior to screening?
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Body mass index
Item
Is the subject's BMI 20-30 kg/m2, inclusive?
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
Has a signed and dated written informed consent been obtained from the subject?
boolean
C0021430 (UMLS CUI [1])
Abnormality, Clinically Significant Indicator
Item
Does the subject have any clinically relevant abnormality identified on the screening history and physical or laboratory examination?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Liver Dysfunction, Medical History; Renal Insufficiency, Medical History
Item
Does the subject have a history of impaired hepatic or renal function?
boolean
C0086565 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Migraine Disorders
Item
Does the subject suffer from migraine attacks?
text
C0149931 (UMLS CUI [1])
Myocardial Ischemia; Angina pectoris
Item
Does the subject have confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above?
boolean
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Cardiac Arrhythmia; Electrocardiography, Abnormality, Relevance, Clinical
Item
Does the subject have cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study?
boolean
C0003811 (UMLS CUI [1])
C1623258 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
Congenital heart disease, Medical History
Item
Does the subject have a history of congenital heart disease?
boolean
C0152021 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Cerebrovascular Disorders, Medical History
Item
Does the subject have a history of cerebrovascular pathology including stroke?
boolean
C0007820 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Cardiovascular Diseases; Cerebrovascular Disorders
Item
Is the subject, in the investigator’s opinion, likely to have unrecognized cardiovascular or cerebrovascular disease?
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Ischemic, Abdomen; Peripheral Vascular Disease; Raynaud Syndrome
Item
Does the subject have evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud Syndrome?
boolean
C0022116 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C0034734 (UMLS CUI [3])
Uncontrolled hypertension
Item
Does the subject have uncontrolled hypertension at screening (sitting systolic pressure >140mm/Hg, diastolic pressure >90mm/Hg)?
boolean
C1868885 (UMLS CUI [1])
Experimental drug, Previous
Item
Has the subject had treatment with an investigational drug within 30 days preceding the first dose of study medication?
boolean
C0304229 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pharmaceutical Preparations; Vitamins, Herbal supplements; Dietary Supplements
Item
Has the subject used other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication? NOTE: Excluded from this list are: acetaminophen at doses of <2 grams/day and contraceptives as detailed in Section 8.1 of the protocol).
boolean
C0013227 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
Pregnancy test positive
Item
Does the subject have a positive serum beta-human chorionic gonadotropin (β-hCG) test (females) at screening or check-in?
boolean
C0240802 (UMLS CUI [1])
Pregnancy; Breast Feeding
Item
Is the subject a pregnant or nursing female?
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Drug Abuse; Alcohol Abuse
Item
Does the subject have a history of drug or alcohol abuse?
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Alcohol consumption, Regular
Item
Does the subject have a history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening?
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Urine drug screen positive
Item
Does the subject have a positive urine drug screen (UDS) including alcohol at screening or check-in?
boolean
C0743300 (UMLS CUI [1])
Blood Donation
Item
Has the subject donated blood in excess of 500 mL within 56 days prior to first dose of study medication?
boolean
C0005794 (UMLS CUI [1])
Sumatriptan, Hypersensitivity
Item
Does the subject have a history of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to sumatriptan or drugs of a similar type, including sulphonamides?
boolean
C0075632 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Tobacco use
Item
Does the subject smoke more than 10 cigarettes per day?
boolean
C0543414 (UMLS CUI [1])
Heparin, Hypersensitivity; Heparin-induced Thrombocytopenia; Experimental drug, Hypersensitivity
Item
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
text
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
Demography, Assessment date
Item
Date of assessment
date
C0011298 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
American Hispanic (4)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005890 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item
Organ
text
C0262926 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
CL Item
Ear, Nose and Throat (1)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (5)
CL Item
Hepatobiliary and pancreas (6)
CL Item
Blood and lymphatic (10)
CL Item
Endocrine and metabolic (11)
CL Item
Muskuloskeletal (12)
Mediacal History, Disease
Item
Medical Condition
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Mediacal History, Description
Item
Description
text
C0262926 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Organ
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0678852 (UMLS CUI [1,3])
CL Item
Ear, Nose and Throat (1)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (5)
CL Item
Hepatobiliary and pancreas (6)
CL Item
Blood and lymphatic (10)
CL Item
Endocrine and metabolic (11)
CL Item
Muskuloskeletal (12)
Disease, Current
Item
Medical Condition?
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Disease, Current, Description
Item
Description
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History
Item
Were any medications taken by the subject within 30 days prior to screening?
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pharmaceutical Preparations, Medical History, Medication name
Item
Drug (Trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Start Date
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Start Date, Pre-study
Item
Check if started Pre-study
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, End Date
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmaceutical Preparations, Medical History, Continuous
Item
if continued Post-study
boolean
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Physical Examination Date
Item
Date of assessment
date
C2826643 (UMLS CUI [1])
Item
Organ
text
C0031809 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
CL Item
Hair and Skin (1)
CL Item
Ears, Nose and Throat (4)
CL Item
Cardiovascular (7)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental Status (14)
Physical Examination, Not Done
Item
Not Done
boolean
C0031809 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Normal or abnormal?
text
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Normal or abnormal?
Physical Examination, Description
Item
Description
text
C0031809 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Electrocardiogram Date
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Electrocardiogram, Time
Item
Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Electrocardiography, Heart rate
Item
Ventricular rate/heart rate
integer
C1623258 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Electrocardiogram: P-R interval
Item
PR interval
integer
C0429087 (UMLS CUI [1])
Electrocardiography, QRS complex duration
Item
QRS duration
integer
C1623258 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Electrocardiography, QT interval - finding
Item
QT interval
integer
C1623258 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Electrocardiography, QTc interval
Item
QTc interval
integer
C1623258 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
Item
Abnormalities?
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
CL Item
Abnormalities present (2)
Electrocardiography, Abnormality, Clinical Significance
Item
Were any of the abnormalities clinically significant?
boolean
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item
Rhythm
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (1)
CL Item
Sinus tachycardia (2)
CL Item
Ectopic supraventricular beats (4)
CL Item
Junctional rhythm (≤100/min) (5)
CL Item
Supraventricular tachycardia (>100/min) (6)
CL Item
Atrial flutter (7)
CL Item
Atrial fibrillation (8)
CL Item
Ectopic ventricular beats (9)
CL Item
Ventricular rhythm, comment below (10)
Item
P-Wave Morphology
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
Code List
P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
Item
Conduction
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval >0.20sec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
Third degree AV block (4)
CL Item
Left axis deviation (QRS axis more negative than - 30 degrees) (5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (6)
CL Item
Incomplete right bundle branch block (7)
CL Item
Right bundle branch block (8)
CL Item
Left bundle branch block (9)
CL Item
Nonspecific intraventricular conduction delay (QRS ≥0.12sec) (10)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (12)
CL Item
QT/QTc prolongation (13)
Item
Depolarization/Repolarization (QRS-T)
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C3279217 (UMLS CUI [1,4])
Code List
Depolarization/Repolarization (QRS-T)
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, other (2)
CL Item
Non-specific ST-T changes (3)
CL Item
Low QRS voltage (4)
Electrocardiography, Abnormality, Other
Item
Other
boolean
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Electrocardiography, Abnormality, Comment
Item
Comment
text
C1623258 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date hematology sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance
Item
Were there any clinically significant hematology abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date clinical chemistry sample taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Laboratory, Code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory Procedures, Urinalysis , Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis , Sampling, Time
Item
Time of sample
time
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Drug screen, Sampling, Date in time
Item
Date sample taken
date
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Drug
text
C0373483 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
CL Item
Benzoylecgonine (cocaine metabolite) (2)
CL Item
Benzodiazepines (5)
Item
Result
text
C0373483 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Serologic tests, HIV Screen, Sampling, Date in time
Item
Date sample taken
date
C0036743 (UMLS CUI [1,1])
C0459958 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Hepatitis B surface antigen
text
C0036743 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
Code List
Hepatitis B surface antigen
Item
Hepatitis C antibody
text
C0036743 (UMLS CUI [1,1])
C0201487 (UMLS CUI [1,2])
Code List
Hepatitis C antibody
Item
HIV antibody
text
C0459958 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
Item
Check the appropriate box to indicate the study cohort to which the subject is assigned:
text
C0087111 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
Code List
Check the appropriate box to indicate the study cohort to which the subject is assigned: