Number
Item
Consecutive number of adverse event
integer
C0750480 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
CTC classification
Item
CTC classification?
boolean
C1516728 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Version CTC
Item
Version CTC
integer
C0808391 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
CTCAE category
Item
CTCAE category
text
C1879645 (UMLS CUI [1])
Category ID
Item
Category ID
integer
C0683312 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Adverse event CTC term
Item
Adverse event CTC term (superordinate)
text
C0877248 (UMLS CUI [1,1])
C1705313 (UMLS CUI [1,2])
Adverse event CTC subordinate term
Item
Adverse event CTC subordinate term
text
C0877248 (UMLS CUI [1,1])
C2983704 (UMLS CUI [1,2])
C1705313 (UMLS CUI [1,3])
Meddra Low Level Term
Item
Meddra Low Level Term
text
C2347090 (UMLS CUI [1])
MedDRA Low Level Term Code
Item
MedDRA Low Level Term Code
text
C3898442 (UMLS CUI [1])
MedDRA Low Level Term ID
Item
MedDRA Low Level Term ID
integer
C2347090 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
CTC Adverse Event Grade
Item
Common Toxicity Criteria Adverse Event Grade
integer
C2985911 (UMLS CUI [1])
Adverse Event
Item
Please describe the AE
text
C0877248 (UMLS CUI [1])
Item
Adverse event severity
text
C1710066 (UMLS CUI [1])
Code List
Adverse event severity
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse event start time
Item
Adverse event start time
time
C2697889 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse event end time
Item
Adverse event end time
time
C2826658 (UMLS CUI [1])
Ongoing
Item
Adverse event ongoing?
boolean
C2826663 (UMLS CUI [1])
Serious Adverse Event
Item
Was the AE serious?
boolean
C1519255 (UMLS CUI [1])
Item
Causality with trial substance
text
C1547657 (UMLS CUI [1])
Code List
Causality with trial substance
CL Item
cannot be assessed (6)
Item
Actions taken with study medication
integer
C1704758 (UMLS CUI [1])
Code List
Actions taken with study medication
CL Item
dose increased (1)
CL Item
dose unchanged (2)
CL Item
dose decreased (3)
CL Item
medication paused (4)
CL Item
medication discontinued (5)
CL Item
not applicable (6)
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
Alive With Sequelae (3)
Item
Adverse event treatment
text
C2981656 (UMLS CUI [1])
Code List
Adverse event treatment
CL Item
with medication (1)
CL Item
other(please specify) (4)
Adverse event treatment
Item
Please specify treatment given for this adverse event
text
C2981656 (UMLS CUI [1])