Patient ID
Item
Patient ID
integer
C1269815 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event
Item
Serial number of the Adverse Event
integer
C0877248 (UMLS CUI [1])
Adverse Event
Item
Please describe the Adverse Event, using CTCAE designations
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Item
CTCAE Grade
text
C1516728 (UMLS CUI [1])
Serious adverse event
Item
Was the Adverse Event serious (SAE)?
boolean
C1519255 (UMLS CUI [1])
Item
Criteria for serious adverse events, please specify
text
C1519255 (UMLS CUI [1])
Code List
Criteria for serious adverse events, please specify
CL Item
life threatening (2)
CL Item
hospitalization/prolonged stay at hospital (3)
CL Item
permanent or severe disability (4)
CL Item
congenital abberation/birth defect (5)
Serious adverse event start date
Item
Please give the date, the adverse event turned out to be serious
date
C1519255 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
resolved with sequelae (4)
CL Item
increased symptoms (5)
Item
Causality with trial substance
text
C1547657 (UMLS CUI [1])
Code List
Causality with trial substance
Adverse event treatment
Item
Adverse event treatment
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Adverse event treatment
Item
Please specify treatment given for this adverse event
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])