undefined item
Item
Record 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])
C0011008 (UMLS CUI [1,2])
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of the ECG
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Electrocardiogram; Telemetry; Start Date
Item
Start Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; Start Time
Item
Start Time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Date
Item
End Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Time
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Result of the ECG
text
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of the ECG
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Date in time
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
Capillary Blood Glucose measurement; Date in time
Item
Date
date
C0457578 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; relative time
Item
Planned relative time (e.g. prior to breakfast)
text
C0457578 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Time
Item
Time
time
C0457578 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Result
Item
Result
float
C0457578 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Unit
text
C0457578 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Code List
Planned Relative Time
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Experimental Drug; Timepoint, Planned
Item
Planned Timepoint (e.g. Day 1)
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Date of Injection
date
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Time of Injection
time
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental Drug; Medication dose
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
No (give reasons) (No (give reasons))