Vital Signs - Date (Pre-Dose)
Item
Vital Signs - Date (Pre-Dose)
date
C2826644 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
Item
Vital Signs - Planned Relative Time (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
Code List
Vital Signs - Planned Relative Time (Pre-Dose)
Vital Signs - Actual Time (Pre-Dose)
Item
Vital Signs - Actual Time (Pre-Dose)
time
C2826762 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
Vital Signs - Systolic Blood Pressure (Pre-Dose)
Item
Vital Signs - Systolic Blood Pressure (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Vital Signs - Diastolic Blood Pressure (Pre-Dose)
Item
Vital Signs - Diastolic Blood Pressure (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Vital Signs - Heart Rate (Pre-Dose)
Item
Vital Signs - Heart Rate (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Start Date of ECG (Pre-Dose)
Item
Start Date of ECG (Pre-Dose)
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Item
12-Lead ECG - Planned Relative Time (Pre-Dose)
integer
C0430456 (UMLS CUI [1])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
Code List
12-Lead ECG - Planned Relative Time (Pre-Dose)
Start Time of ECG (Pre-Dose)
Item
Start Time of ECG (Pre-Dose)
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - Ventricular Rate (Pre-Dose)
Item
12-Lead ECG - Ventricular Rate (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - PR Interval (Pre-Dose)
Item
12-Lead ECG - PR Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - QRS Duration (Pre-Dose)
Item
12-Lead ECG - QRS Duration (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - Uncorrected QT Interval (Pre-Dose)
Item
12-Lead ECG - Uncorrected QT Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - QTc Interval (Pre-Dose)
Item
12-Lead ECG - QTc Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Item
12-Lead ECG - Result (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Code List
12-Lead ECG - Result (Pre-Dose)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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 30 - 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 tachycardia (Wandering atrial pacemaker with heart 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 <=100 beats/min) (A5)
CL Item
Junctional rhythm (A26)
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
Idioventricular rhythm (heart rate <100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsade 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 (A99)
Other abnormal rhythm - Comment
Item
Other abnormal rhythm - Comment
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
Code List
B. P-Wave and QRS 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 (B99)
Other P-Wave and QRS Morphology - Comment
Item
Other P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
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
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (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 >= 120msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 ms (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Other Conduction - Comment
Item
Other Conduction - Comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
D. Myocaridal Infarction
text
C0027051 (UMLS CUI [1])
Code List
D. Myocaridal Infarction
CL Item
Myocaridal 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 (D98)
Other Myocardial Infarction - Comment
Item
Other Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
E. Depolarisation/ Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
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 flattening/inversion (D17)
CL Item
Other depolarisatoin/repolarisation (D99)
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Item
Other Depolarisation/ Repolarisation (QRS-T) - Comment
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other abnormalities
CL Item
Other abnormalities (E99)
Other abnormalities - Comment
Item
Other abnormalities - Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Pulmonary Function Tests - Date (Pre-Dose)
Item
Pulmonary Function Tests - Date (Pre-Dose)
date
C0024119 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item
Pulmonary Function Test (Pre-Dose)
integer
C0024119 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
Code List
Pulmonary Function Test (Pre-Dose)
Item
Pulmonary Function Tests - Units (Pre-Dose)
integer
C0024119 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Code List
Pulmonary Function Tests - Units (Pre-Dose)
Item
Pulmonary Function Tests - Planned Relative Time (Pre-Dose)
integer
C0439564 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Code List
Pulmonary Function Tests - Planned Relative Time (Pre-Dose)
Pulmonary Function Tests - Actual Time of First Reading (Pre-Dose)
Item
Pulmonary Function Tests - Actual Time of First Reading (Pre-Dose)
time
C0024119 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 1 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 1 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 2 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 2 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 3 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 3 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pharmacodynamics - Planned Relative Time (Pre-Dose)
Item
Pharmacodynamics - Planned Relative Time (Pre-Dose)
text
C0851347 (UMLS CUI [1])
C0439564 (UMLS CUI [2])
C1301732 (UMLS CUI [3])
C0439565 (UMLS CUI [4])
Pharmacodynamics - Date sample taken (Pre-Dose)
Item
Pharmacodynamics - Date sample taken (Pre-Dose)
date
C0851347 (UMLS CUI [1])
C1302413 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pharmacodynamics - Actual Time (Pre-Dose)
Item
Pharmacodynamics - Actual Time (Pre-Dose)
time
C0851347 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item
Pharmacodynamics - Sample Number (Pre-Dose)
integer
C0851347 (UMLS CUI [1])
C1299222 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Code List
Pharmacodynamics - Sample Number (Pre-Dose)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0008000 (UMLS CUI [1])
C0200345 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
Item
Clinical Chemistry Test
text
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test
CL Item
Total Bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
Aspartate Transferase (AST) (14)
CL Item
Alanine Transferase (ALT) (15)
CL Item
Total Protein (16)
Clinical Chemistry Test Result
Item
Clinical Chemistry Test Result
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0018941 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Haematology Test
CL Item
Red blood Cells (2)
CL Item
White Blood Cells (7)
Haematologic Test Result
Item
Haematologic Test Result
text
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0042014 (UMLS CUI [1])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
CL Item
Positive (If positive, record results of individual tests) (POS)
Item
Urinalysis Test
integer
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Urinalysis Test
CL Item
Leucocyte Esterase (1)
CL Item
Specific Gravity (7)
Item
Urinalysis Test Result
text
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Urinalysis Test Result
CL Item
non or negative (NEG)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item
Urinalysis Microscopy Test
integer
C0430397 (UMLS CUI [1])
Code List
Urinalysis Microscopy Test
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Urinalysis Microscopy Test Result
Item
Urinalysis Microscopy Test Result
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Record randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])