Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1])
Code List
Was the subject able to be randomised?
Randomisation Number
Item
If subject was able to be randomised, please provide the randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Code List
Investigational product container number
Item
Container Label
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Code List
Container Label
Item
Day
integer
C0439228 (UMLS CUI [1])
Date of dose, Experimental Drug
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of dose, Experimental Drug
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
No correct treatment, reason
Item
If subject did not receive the correct treatment, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])
Item
Day (between study visits)
integer
C0439228 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
Code List
Day (between study visits)
Start Date of dose, Experimental Drug
Item
Start Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Start Time of dose, Experimental Drug
Item
Start Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
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])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
No correct treatment, reason
Item
If subject did not receive the correct treatment, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])