Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Code List
Was the subject able to be randomised?
CL Item
Yes, provide randomisation number (Y)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Was this subject a run-in failure?
text
C1710476 (UMLS CUI [1])
Code List
Was this subject a run-in failure?
CL Item
Yes, complete run-in failure date and reason (Y)
Run-in failure date
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Select primary reason
integer
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Select primary reason
CL Item
Adverse Event, check if exacerbation of medical condition is under investigation (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent (8)
Primary reason for run-in failure: Adverse Event, COPD exacerbation under investigation
Item
If primary reason for run-in failure: Adverse Event, exacerbation of medical condition under investigation?
boolean
C1710476 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1261322 (UMLS CUI [2,1])
C0740304 (UMLS CUI [2,2])
Primary reason for run-in failure: Investigator discretion
Item
If primary reason for run-in failure: Investigator discretion, specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])