ID

20062

Beschreibung

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Stichworte

Versionen (2)
  1. 31.12.16 31.12.16 -
  2. 04.02.17 04.02.17 -
Hochgeladen am

4. Februar 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Screen Failure Log: Adverse Events [AE_1] NCT01117584

Englisch

Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulare  
General Information
Beschreibung

General Information

Was any adverse event reported or observed?
Beschreibung

Any Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Event
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Onset Date
Beschreibung

Onset Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0574845
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Course of Event
Beschreibung

Course of Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Severity
Beschreibung

Severity

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Serious AE?
Beschreibung

If Seriousness is "yes", tick all that apply.

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious AE Number
Beschreibung

Serious AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Death
Beschreibung

Death

Datentyp

boolean

Alias
UMLS CUI [1]
C1705232
Requires or prolongs hospitalization
Beschreibung

Requires or prolongs hospitalization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0019993
Congenital anomaly
Beschreibung

Congenital anomaly

Datentyp

boolean

Alias
UMLS CUI [1]
C2826727
Life-threatening
Beschreibung

Life-threatening

Datentyp

boolean

Alias
UMLS CUI [1]
C1517874
Persistent or significant disability/incapacity
Beschreibung

Disability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0231170
Other medical importance
Beschreibung

Medical Importance

Datentyp

boolean

Action Taken for Study Drug
Beschreibung

Action Taken for Study Drug

Datentyp

text

Alias
UMLS CUI [1]
C2826626
Was there any treatment required?
Beschreibung

If Yes, please select all that apply.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Medication Therapy
Beschreibung

Medication Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
Non-Medication Therapy
Beschreibung

Non-Medication Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relationship to Study Drug
Beschreibung

Relationship to Study Drug

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
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Ähnliche Modelle

Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0877248 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved  (3)
CL Item
Recovered/Resolved with Sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
Item
Course of Event
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Course of Event
Code List
Course of Event
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continous (3)
Item
Severity
text
C1710066 (UMLS CUI [1])
Severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Serious AE
Item
Serious AE?
boolean
C1519255 (UMLS CUI [1])
Serious AE Number
Item
Serious AE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Death
Item
Death
boolean
C1705232 (UMLS CUI [1])
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
C0877248 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Life-threatening
Item
Life-threatening
boolean
C1517874 (UMLS CUI [1])
Disability
Item
Persistent or significant disability/incapacity
boolean
C0877248 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Medical Importance
Item
Other medical importance
boolean
Item
Action Taken for Study Drug
text
C2826626 (UMLS CUI [1])
Action Taken for Study Drug
Code List
Action Taken for Study Drug
CL Item
Dose Not Changed (1)
CL Item
Drug Interrupted (2)
CL Item
Drug Withdrawn  (3)
CL Item
Not Applicable (4)
CL Item
Unknown (5)
Treatment
Item
Was there any treatment required?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication Therapy
Item
Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relationship to Study Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Relationship to Study Drug
Code List
Relationship to Study Drug
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)
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