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ID
19427
Description
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.
Keywords
Versions (2)
- 12/31/16 12/31/16 -
- 2/4/17 2/4/17 -
Uploaded on
December 31, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Screen Failure Log: Adverse Events [AE_1] NCT01117584
Screen Failure Log: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Similar models
Screen Failure Log: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
Adverse Event
Item
Adverse Event
text
Onset Date
Item
Onset Date
date
End Date
Item
End Date
date
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)
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continous (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Serious AE
Item
Serious AE?
boolean
Serious AE Number
Item
Serious AE Number
integer
Death
Item
Death
boolean
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
Congenital anomaly
Item
Congenital anomaly
boolean
Life-threatening
Item
Life-threatening
boolean
Disability
Item
Persistent or significant disability/incapacity
boolean
Medical Importance
Item
Other medical importance
boolean
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Drug Withdrawn (3)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
Medication Therapy
Item
Medication Therapy
boolean
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)