Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
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
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Start Date
Item
Start Date of investigational Product
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Time
Item
Start Time of investigational Product
time
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date of investigational Product
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Time
Item
Stop Time of investigational Product
time
C1522314 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product container number
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Was dose interrupted?
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Code List
Was dose interrupted?
Item
Reason for dose interruption
integer
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
Reason for dose interruption
CL Item
Adverse event (1)
CL Item
Subject non-compliance (3)
CL Item
Mechanical problem (4)
Other reason for dose interruption, specification
Item
If other reason for dose interruption, please specify
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Total volume of infusion
Item
Total volume of infusion
float
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])