Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Infusion Start Date
Item
Infusion Start Date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start Time
Item
Infusion Start Time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop Date
Item
Infusion Stop Date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop Time
Item
Infusion Stop Time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Fasting
Item
Did the subject fast per protocol?
boolean
C0015663 (UMLS CUI [1])
Specification of quantities and time of food consumption
Item
If NO, specify time and quantities that were consumed:
text
C2983605 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Therapeutic Procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Reason and justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])