date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Cycle 1 week 1 (1)
CL Item
Cycle 1 week 2 (2)
CL Item
Cycle 1 week 3 (3)
CL Item
Cycle 1 week 4 (4)
CL Item
Cycle 2 week 1 (5)
CL Item
Cycle 2 week 2 (6)
CL Item
Cycle 2 week 3 (7)
CL Item
Cycle 2 week 4 (8)
Premedication, sequence number
Item
Sequence number
text
C0033045 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C0033045 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Premedication, modified reported term
Item
Modified reported term
text
C0033045 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
GSK drug synonym
Item
GSK drug synonym
text
C0033045 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK drug collection code
Item
GSK drug collection code
text
C0033045 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Premedication, Failed coding
Item
Failed coding
text
C0033045 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Premedication, Total daily dose
Item
Total daily dose
integer
C0033045 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0033045 (UMLS CUI [1,2])
Premedication, Start date
Item
Start date
partialDate
C0033045 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Premedication ongoing
Item
Ongoing?
boolean
C0033045 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Premedication, end date
Item
If no, please specify end date.
partialDate
C0033045 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product Infusion
Item
Did the subject receive Investigatonal Product?
boolean
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Investigational Product, infusion start date and time
Item
If yes, please state start date and time
partialDatetime
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C3897500 (UMLS CUI [1,3])
Investigational product, infusion end date and time
Item
If yes, please state end date and time
partialDatetime
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C3899266 (UMLS CUI [1,3])
Actual dose of Ofatumumab
Item
If yes, please state actual dose of Ofatumumab
integer
C1832027 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Investigational Product, total volume infused
Item
If yes, please state total volume infused
integer
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
Item
If yes, was the infusion interrupted or stopped?
text
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
Code List
If yes, was the infusion interrupted or stopped?
CL Item
Yes, due to an AE (1)
CL Item
Yes, due to a reason other than AE (OT)
Item
If the subject did not receive the investigational product, please specify the reason.
integer
C0304229 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If the subject did not receive the investigational product, please specify the reason.
CL Item
subject refused (2)
CL Item
adverse event (3)
Investigational product, other reason for not receiving
Item
If other, please specify
text
C0304229 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Start time of Infusion vitals
Item
Start time
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Item
Rate of infusion
text
C2964135 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Code List
Rate of infusion
Rate of infusion
Item
If there was a change, please specify:
integer
C2964135 (UMLS CUI [1])
Item
Blood pressure
text
C0005823 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Systolic blood pressure
Item
If assessed, please specify
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
If assessed, please specify
integer
C0428883 (UMLS CUI [1])
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Heart rate
Item
If assessed, please specify
integer
C0018810 (UMLS CUI [1])
Correct treatment
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])
C2349182 (UMLS CUI [1,2])
Treatment wrong
Item
If no, please record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])