Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Additional form
Item
Check if (additional) supplemental instance of this form was used.
boolean
C1706499 (UMLS CUI [1])
CRF Sequential Number
Item
Instance Number
integer
C1516308 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Did the patient experience any AEs?
text
C0877248 (UMLS CUI [1])
Code List
Did the patient experience any AEs?
Sequence number
Item
Line #
integer
C2348184 (UMLS CUI [1])
Adverse event
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
Start Date
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Adverse event start time
Item
Start Time
time
C0877248 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Adverse event stop date
Item
Stop Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Adverse event stop time
Item
Stop Time
time
C0877248 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Action taken with study treatment because of adverse event - none
Item
Action Taken: 0 = None
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
Action taken with study treatment because of adverse event - drug discontinued
Item
Action Taken: 1 = Drug discontinued
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0558681 (UMLS CUI [2])
Action taken with study treatment because of adverse event - drug dose adjusted
Item
Action Taken: 2 = Drug dose adjusted
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C2826232 (UMLS CUI [2])
Action taken with study treatment because of adverse event - drug interrupted
Item
Action Taken: 3 = Drug interrupted
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
Action taken with study treatment because of adverse event - Therapy required
Item
Action Taken: 4 = Therapy required
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Resolved with sequelae (2)
CL Item
Death / fatal (4)
Item
Relationship to Study Drug
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Relationship to Study Drug
Item
Severity
integer
C1710066 (UMLS CUI [1])
Item
Was Event Serious?
text
C1710056 (UMLS CUI [1])
Code List
Was Event Serious?