Randomisation criteria
Item
Did the subject meet all of the Randomisation criteria?
boolean
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
run-in failure
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, complete run-in failure reason
integer
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Yes, complete run-in failure reason
CL Item
Did not meet continuation criteria (1)
CL Item
Adverse Event (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion, specify (5)
CL Item
Withdrew consent, specify (6)
Run-in failure date
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
culture swab taken
Item
Was a swab taken?
boolean
C0563454 (UMLS CUI [1,1])
C0006849 (UMLS CUI [1,2])
Item
Yes, result of culture swab
integer
C0563454 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0006849 (UMLS CUI [1,3])
Code List
Yes, result of culture swab
CL Item
Not available (4)
liver chemistry results
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
smoking status
Item
Has the smoking status changed since the last time it was assessed?
boolean
C1519386 (UMLS CUI [1])
Item
If yes: Specify smoking status
integer
C1519386 (UMLS CUI [1])
Code List
If yes: Specify smoking status
CL Item
Subject started smoking (1)
CL Item
Subject stopped smoking (2)
date smoking status was changed
Item
Date a change was made
date
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
withdraw
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])