ID

20062

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 31-12-16 31-12-16 -
  2. 04-02-17 04-02-17 -
Geüploaded op

4 februari 2017

DOI

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Licentie

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

Engels

Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulieren  
General Information
Beschrijving

General Information

Was any adverse event reported or observed?
Beschrijving

Any Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Event
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Onset Date
Beschrijving

Onset Date

Datatype

date

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

End Date

Datatype

date

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

Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586
Course of Event
Beschrijving

Course of Event

Datatype

text

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

Severity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Serious AE?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Serious AE Number
Beschrijving

Serious AE Number

Datatype

integer

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

Death

Datatype

boolean

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

Requires or prolongs hospitalization

Datatype

boolean

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

Congenital anomaly

Datatype

boolean

Alias
UMLS CUI [1]
C2826727
Life-threatening
Beschrijving

Life-threatening

Datatype

boolean

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

Disability

Datatype

boolean

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

Medical Importance

Datatype

boolean

Action Taken for Study Drug
Beschrijving

Action Taken for Study Drug

Datatype

text

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

If Yes, please select all that apply.

Datatype

boolean

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

Medication Therapy

Datatype

boolean

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

Non-Medication Therapy

Datatype

boolean

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

Relationship to Study Drug

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
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Similar models

Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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