ID

19424

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 (1)
  1. 12/31/16 12/31/16 -
Uploaded on

December 31, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Throughout: Adverse Events [AE_1] NCT01117584

English

Throughout: Adverse Events [AE_1] NCT01117584

1 forms  
General Information
Description

General Information

Was any adverse event reported or observed?
Description

Any Adverse Event

Data type

boolean

Adverse Event
Description

Adverse Event

Data type

text

Onset Date
Description

Onset Date

Data type

date

If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one.
Description

Start Relative to Reference Period

Data type

text

End Date
Description

End Date

Data type

date

Outcome
Description

Outcome

Data type

text

Course of Event
Description

Course of Event

Data type

text

Severity
Description

Severity

Data type

text

Serious AE?
Description

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

Data type

boolean

Serious AE Number
Description

Serious AE Number

Data type

integer

Death
Description

Death

Data type

boolean

Requires or prolongs hospitalization
Description

Requires or prolongs hospitalization

Data type

boolean

Congenital anomaly
Description

Congenital anomaly

Data type

boolean

Life-threatening
Description

Life-threatening

Data type

boolean

Persistent or significant disability/incapacity
Description

Disability

Data type

boolean

Other medical importance
Description

Medical Importance

Data type

boolean

Action Taken for Study Drug
Description

Action Taken for Study Drug

Data type

text

Was there any treatment required?
Description

If Yes, please select all that apply.

Data type

boolean

Medication Therapy
Description

Medication Therapy

Data type

boolean

Non-Medication Therapy
Description

Non-Medication Therapy

Data type

boolean

Relationship to Study Drug
Description

Relationship to Study Drug

Data type

text

Genital Infection
Description

Genital Infection

Was the infection symptomatic?
Description

Symptomatic Infection

Data type

text

Was the infection confirmed by a laboratory?
Description

Confirmation by lab

Data type

text

Hypoglycemia Event
Description

Hypoglycemia Event

Hypoglycemic Event Classification
Description

Hypoglycemic Event Classification

Data type

integer

Was a glucometer reading taken prior to treating the hypoglycemic event?
Description

Glucometer Reading

Data type

boolean

Number of hours since the last meal or snack
Description

Hours since last meal

Data type

float

Number of hours since the last dose of study medication
Description

Hours since Study Drug

Data type

float

Number of hours since the last dose of Metformin
Description

Hours since Metformin

Data type

float

Adjudication Reference ID
Description

Adjudication Reference ID

Data type

text

LLT Code
Description

LLT Code

Data type

text

LLT Term
Description

LLT Term

Data type

text

PT Code
Description

PT Code

Data type

text

PT Term
Description

PT Term

Data type

text

HLT Code
Description

HLT Code

Data type

text

HLT Term
Description

HLT Term

Data type

text

HLGT Code
Description

HLGT Code

Data type

text

HLGT Term
Description

HLGT Term

Data type

text

SOC Code
Description

SOC Code

Data type

text

SOC Term
Description

SOC Term

Data type

text

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Similar models

Throughout: Adverse Events [AE_1] NCT01117584

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
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
Start Relative to Reference Period
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
Item
Outcome
text
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
Course of Event
Code List
Course of Event
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continous (3)
Item
Severity
text
Severity
Code List
Severity
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
Item
Action Taken for Study Drug
text
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
Medication Therapy
Item
Medication Therapy
boolean
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
Item
Relationship to Study Drug
text
Relationship to Study Drug
Code List
Relationship to Study Drug
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)
Item Group
Genital Infection
Item
Was the infection symptomatic?
text
Symptomatic Infection
Code List
Was the infection symptomatic?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Was the infection confirmed by a laboratory?
text
Confirmation by lab
Code List
Was the infection confirmed by a laboratory?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item Group
Hypoglycemia Event
Item
Hypoglycemic Event Classification
integer
Hypoglycemic Event Classification
Code List
Hypoglycemic Event Classification
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
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