reference date
Item
Reference date
date
C1719096 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
eCRF
Item
electronic case report form
text
C1516308 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item
Are there any adverse events to report?
integer
C0877248 (UMLS CUI [1])
Code List
Are there any adverse events to report?
Description of Event
Item
Description of Event
text
C0678257 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Item
Seriousness of Adverse Event
integer
C1710056 (UMLS CUI [1])
Code List
Seriousness of Adverse Event
CL Item
Yes, complete Serious Adverse Event Form (1)
Item
Severity of adverse event
integer
C1710066 (UMLS CUI [1])
Code List
Severity of adverse event
Item
Relationship to study drug
integer
C0013227 (UMLS CUI [1])
Code List
Relationship to study drug
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Resolved with Sequelae (2)
Item
Action taken (other than with study drug)
integer
C0441472 (UMLS CUI [1])
Code List
Action taken (other than with study drug)
CL Item
Conmed, Complete Concomitant Medications Form (2)
CL Item
Non-Drug Therapy (3)
Item
Action taken with study drug
integer
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Action taken with study drug
CL Item
Interrupted and later re-started (2)
CL Item
Stopped permanently (4)