Engelsk

End of Study DM-ASP1941-1941-CL-0004 NCT01071850

1 Formulär  
End of Treatment / Premature Discontinuation
Beskrivning

End of Treatment / Premature Discontinuation

Alias
UMLS CUI-1
C0580352
UMLS CUI-3
C0457454
Date of Last Treatment Evaluation Through Visit 9
Beskrivning

Date of Collection

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Did subject complete Study Drug Treatment?
Beskrivning

Complete Study Drug Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
End of Treatment Reason
Beskrivning

End of Treatment Reason

Datatyp

integer

Alias
UMLS CUI [1]
C0457454
If reason is "Withdrawal by Subject" please speficy follow-up allowance
Beskrivning

Withdrawal by subject

Datatyp

integer

Alias
UMLS CUI [1]
C0589120
Date of Withdrawal
Beskrivning

Date of Withdrawal

Datatyp

date

Måttenheter
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
Did AE result in death?
Beskrivning

AE Result in death

Datatyp

integer

Alias
UMLS CUI [1]
C0011065
If protocol violation, specify
Beskrivning

Protocol Violation

Datatyp

text

Alias
UMLS CUI [1]
C1709750
If Other, specify
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
End of Study
Beskrivning

End of Study

Alias
UMLS CUI-1
C0444496
Date of Last Evaluation
Beskrivning

Date of collection

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
End of Study Assessment
Beskrivning

End of Study Assessment

Datatyp

integer

Alias
UMLS CUI [1]
C0220825
Details of Withdrawal
Beskrivning

Details of Withdrawal

Datatyp

text

Alias
UMLS CUI [1]
C2349954
If Other specify
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C2349954
UMLS CUI [2]
C0205394
Mortality Report
Beskrivning

Mortality Report

Alias
UMLS CUI-1
C0011065
Date of Death
Beskrivning

Date of Death

Datatyp

date

Alias
UMLS CUI [1]
C0011065
Cause of Death
Beskrivning

Cause of Death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Relationship of Study Drug to Subject's Death?
Beskrivning

Relationship to Study Drug

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
Was autopsy performed?
Beskrivning

Autopsy

Datatyp

integer

Alias
UMLS CUI [1]
C0004398
Breaking the Blind
Beskrivning

Breaking the Blind

Alias
UMLS CUI-1
C2347038
Was Blind Broken During the Study?
Beskrivning

Blind Broken

Datatyp

boolean

Alias
UMLS CUI [1]
C2347038
Date blind broken
Beskrivning

Date blind broken

Datatyp

date

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C2347038
Time Blind Broken
Beskrivning

Time Blind Broken

Datatyp

time

Alias
UMLS CUI [1]
C2347038
UMLS CUI [2]
C0040223
Person who requested blind to be broken
Beskrivning

Person Blind Broken

Datatyp

text

Alias
UMLS CUI [1]
C2347038
Person who broke the blind
Beskrivning

Person who broke the blind

Datatyp

text

Alias
UMLS CUI [1]
C2347038
Person contacted at Astellas
Beskrivning

Person contacted at Astellas

Datatyp

text

Alias
UMLS CUI [1]
C2347038
Reason for breaking the blind
Beskrivning

Reason for breaking the blind

Datatyp

text

Alias
UMLS CUI [1]
C2347038
UMLS CUI [2]
C0566251
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Similar models

End of Study DM-ASP1941-1941-CL-0004 NCT01071850

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
End of Treatment / Premature Discontinuation
C0580352 (UMLS CUI-1)
C0457454 (UMLS CUI-3)
Date of Collection
Item
Date of Last Treatment Evaluation Through Visit 9
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Complete Study Drug Treatment
Item
Did subject complete Study Drug Treatment?
boolean
C0013216 (UMLS CUI [1])
Item
End of Treatment Reason
integer
C0457454 (UMLS CUI [1])
End of Treatment Reason
Code List
End of Treatment Reason
CL Item
Not fulfill inclusion or exclusion criteria (1)
CL Item
adverse event (2)
CL Item
lack of efficacy (3)
CL Item
withdrawal by subject (4)
CL Item
subject lost to follow up (5)
CL Item
protocol violation (6)
CL Item
randomized/registered but never received/dispensed study drug (7)
CL Item
other (8)
Item
If reason is "Withdrawal by Subject" please speficy follow-up allowance
integer
C0589120 (UMLS CUI [1])
Withdrawal by subject
Code List
If reason is "Withdrawal by Subject" please speficy follow-up allowance
CL Item
allows follow-up after withdrawal (1)
CL Item
does not allow follow-up after withdrawal (2)
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did AE result in death?
integer
C0011065 (UMLS CUI [1])
AE Result in death
Code List
Did AE result in death?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Protocol Violation
Item
If protocol violation, specify
text
C1709750 (UMLS CUI [1])
Other
Item
If Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
End of Study
C0444496 (UMLS CUI-1)
Date of collection
Item
Date of Last Evaluation
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
End of Study Assessment
integer
C0220825 (UMLS CUI [1])
End of Study Assessment
Code List
End of Study Assessment
CL Item
Completed (1)
CL Item
Death (2)
CL Item
Lost to Follow-up (3)
CL Item
Withdrawal by Subject (4)
CL Item
Not Applicable (5)
CL Item
Other (6)
Details of Withdrawal
Item
Details of Withdrawal
text
C2349954 (UMLS CUI [1])
Other
Item
If Other specify
text
C2349954 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
Item Group
Mortality Report
C0011065 (UMLS CUI-1)
Date of Death
Item
Date of Death
date
C0011065 (UMLS CUI [1])
Cause of Death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Item
Relationship of Study Drug to Subject's Death?
integer
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Relationship to Study Drug
Code List
Relationship of Study Drug to Subject's Death?
CL Item
Not related (1)
CL Item
Possible (2)
CL Item
Probable (3)
Item
Was autopsy performed?
integer
C0004398 (UMLS CUI [1])
Autopsy
Code List
Was autopsy performed?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item Group
Breaking the Blind
C2347038 (UMLS CUI-1)
Blind Broken
Item
Was Blind Broken During the Study?
boolean
C2347038 (UMLS CUI [1])
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1])
C2347038 (UMLS CUI [2])
Time Blind Broken
Item
Time Blind Broken
time
C2347038 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
Person Blind Broken
Item
Person who requested blind to be broken
text
C2347038 (UMLS CUI [1])
Person who broke the blind
Item
Person who broke the blind
text
C2347038 (UMLS CUI [1])
Person contacted at Astellas
Item
Person contacted at Astellas
text
C2347038 (UMLS CUI [1])
Reason for breaking the blind
Item
Reason for breaking the blind
text
C2347038 (UMLS CUI [1])
C0566251 (UMLS CUI [2])
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