baseline Event
Item
If no baseline events experienced, please mark box and sign form below.
boolean
C0037088 (UMLS CUI [1])
Diagnosis
Item
Baseline Sign/Symptom GSK Use
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2985916 (UMLS CUI [1])
Item
Outcome *If subject died, please inform GSK within 24 hours and complete Form D
integer
C1705586 (UMLS CUI [1])
Code List
Outcome *If subject died, please inform GSK within 24 hours and complete Form D
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Episode
Item
If intermittent, give No. of episodes
float
C0877248 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Item
Relationship to study procedures performed prior to randomisation
integer
C0008976 (UMLS CUI [1,1])
C2700391 (UMLS CUI [1,2])
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Suspected (reasonable possibility) (3)
Corrective Therapy
Item
Corrective Therapy If ´Yes`, Please record on Prior Medication form.
boolean
C0087111 (UMLS CUI [1])
Withdrawal
Item
Was subject withdrawn due to this event?
boolean
C2349954 (UMLS CUI [1])