Informatie:
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ID
19424
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 (1)
- 31-12-16 31-12-16 -
Geüploaded op
31 december 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Throughout: Adverse Events [AE_1] NCT01117584
Throughout: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Similar models
Throughout: Adverse Events [AE_1] NCT01117584
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Item
If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one.
text
Code List
If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one.
CL Item
Onset before first dose of study drug (1)
CL Item
Onset after first dose of study drug (2)
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Drug Withdrawn (3)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)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CL Item
Severe Hypoglycemia (1)
CL Item
Documented symptomatic Hypoglycemia (2)
CL Item
Asymptomatic Hypoglycemia (3)
CL Item
Probable symptomatic Hypoglycemia (4)
CL Item
Relative Hypoglycemia (5)
Glucometer Reading
Item
Was a glucometer reading taken prior to treating the hypoglycemic event?
boolean
Hours since last meal
Item
Number of hours since the last meal or snack
float
Hours since Study Drug
Item
Number of hours since the last dose of study medication
float
Hours since Metformin
Item
Number of hours since the last dose of Metformin
float
Adjudication Reference ID
Item
Adjudication Reference ID
text
LLT Code
Item
LLT Code
text
LLT Term
Item
LLT Term
text
PT Code
Item
PT Code
text
PT Term
Item
PT Term
text
HLT Code
Item
HLT Code
text
HLT Term
Item
HLT Term
text
HLGT Code
Item
HLGT Code
text
HLGT Term
Item
HLGT Term
text
SOC Code
Item
SOC Code
text
SOC Term
Item
SOC Term
text