Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Pregnancy Tests, Applicable
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Pregnancy Tests, Diagnostic procedures performed
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1,1])
C3259360 (UMLS CUI [1,2])
Pregnancy Tests, Sampling, Date in time
Item
Date pregnancy sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If YES, pregnancy test result, check one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
If YES, pregnancy test result, check one
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])