Concomitant Medication - Sequence number
Item
Concomitant Medication - Sequence number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medicatin - Modified reported term
Item
Concomitant Medication - Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Medication - Failed coding
Item
Concomitant Medication - Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Medication Unit Dose
Item
Concomitant Medication Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Concomitant Medication Units
integer
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Code List
Concomitant Medication Units
CL Item
Area under curve (4)
CL Item
Cubic centimeter (7)
CL Item
Gamma per kilogram per minute (9)
CL Item
100 International units/ml (12)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per millilitre (17)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (MBq) MBQ (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/kilogram (25)
CL Item
Microgram/kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per millitre (28)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 (31)
CL Item
Milligram per day (33)
CL Item
Milligram per hour (34)
CL Item
Milligram/kilogram (35)
CL Item
Milligram/kilogram per hour (36)
CL Item
Milligram/kilogram per minute (37)
CL Item
Milligram/metre squared (38)
CL Item
Milligram/millilitre (39)
CL Item
Milligrams percent (40)
CL Item
Million international units (41)
CL Item
Millilitre per hour (43)
CL Item
Millilitre per minute (44)
CL Item
Megaunits (million units) (46)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram per minute (60)
CL Item
Units per minute (61)
Item
Concomitant Medication Frequency
integer
C2826654 (UMLS CUI [1])
Code List
Concomitant Medication Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (16)
CL Item
Every 3 months (18)
CL Item
Every 3 weeks (19)
CL Item
Once a month (27)
CL Item
Every other day (28)
Item
Concomitant Medication Route
integer
C2826730 (UMLS CUI [1])
Code List
Concomitant Medication Route
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial (3)
CL Item
Intra-articular (4)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intraperitoneal (14)
CL Item
Intrauterine (16)
CL Item
Subcutaneous (28)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date and Time
Item
Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Medication taken Prior to Study?
Item
Medication taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing?
Item
Concomitant medication ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time of concomitant medication
Item
End date and time of concomitant medication
datetime
C2826744 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR lnterval
Item
PR lnterval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT lnterval
Item
Uncorrected QT lnterval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Abnormal - Not clinically significan (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically rignificant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
A. Rhythm
text
C0232187 (UMLS CUI [1])
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 3(}-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus tachycardia (heart rate> 100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (wandering attial pacemaker w/rate > 100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate> 100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=I00 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
ldioventricular rhythm (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic venlricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial Pacemaker (A16)
CL Item
Other abnormal rhythm, enter comment (A99)
A. If other abnormal rhythm, enter comment
Item
A. If other abnormal rhythm, enter comment
text
C0232187 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
B. P-Wave Morphology
text
C2216025 (UMLS CUI [1])
Code List
B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
B. If other morphology, enter comment
Item
B. If other morphology, enter comment
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
CL Item
First degree AV block (PR interval > 200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
C. If other conduction, enter comment
Item
C. If other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
D. Myocardial Infarction
text
C0027051 (UMLS CUI [1])
Code List
D. Myocardial Infarction
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
D. If other myocardial infarction, enter comment
Item
D. If other myocardial infarction, enter comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
Code List
E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattering/ inversion (D17)
CL Item
Other depolarisation/ repolarisation, enter comment (D99)
E. If other depolarisation/ repolarisation, enter comment
Item
E. If other depolarisation/ repolarisation, enter comment
text
C1395184 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
If other abnormalities, enter comment
Item
If other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
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