Adverse Experiences
Item
None?
boolean
C0877248 (UMLS CUI [1])
AE#
Item
AE#
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience (one experience per Line)
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Grade per CTC
Item
Grade per CTC
text
C2985911 (UMLS CUI [1])
A Serious?
Item
A Serious?
boolean
C1519255 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Stop Date
Item
Stop Date or 'C' if continuing.
date
C2697886 (UMLS CUI [1])
Item
B Frequency
integer
C3476109 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Therapeutic Measures - Drug
integer
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Therapeutic Measures - Drug
CL Item
2 Infusion rate slowed (2)
CL Item
3 Infusion slopped permanently (3)
Item
Therapeutic Measures - Other
integer
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Therapeutic Measures - Other
CL Item
Procedure or physical therapy (3)
CL Item
Blood or blood products (4)
CL Item
Withdrawn from study (5)
CL Item
Prescription drug therapy (6)
CL Item
Non-prescriptlon drug therapy (7)
CL Item
Hospitalizatlon (8)
CL Item
Other (specify above) (10)
Therapeutic Measures - Other
Item
Therapeutic Measures - If Other specify here:
text
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
E Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Complete recovery (1)
CL Item
Unknown/lost to follow-up (3)
CL Item
AE persisting (4)
Item
Relationship AE - Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship AE - Drug
Item
Relationship AE - Disease
integer
C0439849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Code List
Relationship AE - Disease
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])