Subject's randomisation
Item
Was the subject able to be randomised?
boolean
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Randomisation number
Item
In case the subject was able to be randomised, provide: Randomisation number
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Date of randomisation
Item
In case the subject was able to be randomised, provide: Date of randomisation
date
C0034656 (UMLS CUI [1])
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Receivement of the correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Reason(s) in case the subject did not receive the correct treatment
Item
In case the subject did not receive the correct treatment: record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Planend relative time
text
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Code List
Planend relative time
CL Item
Pre-dose (Pre-dose)
CL Item
0.5 hours (0.5 hours)
CL Item
0.75 hours (0.75 hours)
CL Item
1.5 hours (1.5 hours)
CL Item
2 hours (2 hours)
CL Item
2.17 hours (2.17 hours)
CL Item
2.25 hours (2.25 hours)
CL Item
2.5 hours (2.5 hours)
CL Item
2.75 hours (2.75 hours)
CL Item
3 hours (3 hours)
CL Item
4 hours (4 hours)
CL Item
6 hours (6 hours)
CL Item
8 hours (8 hours)
CL Item
10 hours (10 hours)
CL Item
12 hours (12 hours)
CL Item
14 hours (14 hours)
CL Item
24 hours (24 hours)
CL Item
48 hours (48 hours)
CL Item
72 hours (72 hours)
Actual time of blood sample collection for pharmacokinetics analysis
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Actual date/time of blood sample collection for pharmacokinetics analysis
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])