Visit 2 - Run-In Failure; Randomisation Number; Electronically Transferred Lab Data; Liver Assessment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Run-In Failure
C1710476 (UMLS CUI-1)
Was this subject a run-in failure?
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1])
Run-in failure date
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Run-in failure primary reason
integer
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Run-in failure primary reason
Code List
Run-in failure primary reason
CL Item
Adverse event  (1)
CL Item
Protocol deviation  (3)
CL Item
Study closed/terminated  (5)
CL Item
Withdrew consent, specify (8)
CL Item
Did not meet continuation criteria  (9)
CL Item
Did not meet joint counts criteria (096)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Randomisation number
Item
Randomisation number
text
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 Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date sample taken
Item
Haematology Date sample taken
date
C0018941 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Haematology sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample taken - Not Done
Code List
Haematology sample taken - Not Done
CL Item
Not Done (ND)
Biochemistry Date sample taken
Item
Biochemistry Date sample taken
date
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Biochemistry sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Biochemistry sample taken - Not Done
Code List
Biochemistry sample taken - Not Done
CL Item
Not Done (ND)
Urinalysis Date sample taken
Item
Urinalysis Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
Urinalysis sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sample taken - Not Done
Code List
Urinalysis sample taken - Not Done
CL Item
Not Done (ND)
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Liver Event Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
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])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
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