Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
number of episodes
Item
No. of Episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Code List
Intensity (maximum)
CL Item
Moderate (Moderate)
Item
Relationship to study procedures performed prior to randomisation
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Suspected)
CL Item
Probable (Probable)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1])
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])