ID

20061

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)
  1. 12/31/16 12/31/16 -
  2. 2/4/17 2/4/17 -
Uploaded on

February 4, 2017

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

Alias
UMLS CUI [1]
C0877248
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Onset Date
Description

Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0574845
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

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0013227
End Date
Description

End Date

Data type

date

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

Outcome

Data type

text

Course of Event
Description

Course of Event

Data type

text

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

Severity

Data type

text

Alias
UMLS CUI [1]
C1710066
Serious AE?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Serious AE Number
Description

Serious AE Number

Data type

integer

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

Death

Data type

boolean

Requires or prolongs hospitalization
Description

Requires or prolongs hospitalization

Data type

boolean

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

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
Life-threatening
Description

Life-threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2826244
Persistent or significant disability/incapacity
Description

Disability

Data type

boolean

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

Medical Importance

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C1705104
Action Taken for Study Drug
Description

Action Taken for Study Drug

Data type

text

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

If Yes, please select all that apply.

Data type

boolean

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

Medication Therapy

Data type

boolean

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

Non-Medication Therapy

Data type

boolean

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

Relationship to Study Drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Genital Infection
Description

Genital Infection

Alias
UMLS CUI-1
C0729552
Was the infection symptomatic?
Description

Symptomatic Infection

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0231220
Was the infection confirmed by a laboratory?
Description

Confirmation by lab

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0521091
Hypoglycemia Event
Description

Hypoglycemia Event

Alias
UMLS CUI-1
C0020615
Hypoglycemic Event Classification
Description

Hypoglycemic Event Classification

Data type

integer

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0008902
Was a glucometer reading taken prior to treating the hypoglycemic event?
Description

Glucometer Reading

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0020615
UMLS CUI [1,3]
C0472226
UMLS CUI [1,4]
C0005802
Number of hours since the last meal or snack
Description

Hours since last meal

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0578574
Number of hours since the last dose of study medication
Description

Hours since Study Drug

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0946444
UMLS CUI [1,5]
C0013227
Number of hours since the last dose of Metformin
Description

Hours since Metformin

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0946444
UMLS CUI [1,5]
C0025598
Adjudication Reference ID
Description

Adjudication Reference ID

Data type

text

Alias
UMLS CUI [1]
C0680730
LLT Code
Description

LLT Code

Data type

text

Alias
UMLS CUI [1]
C2347090
LLT Term
Description

LLT Term

Data type

text

Alias
UMLS CUI [1]
C2347090
PT Code
Description

PT Code

Data type

text

Alias
UMLS CUI [1]
C2347664
PT Term
Description

PT Term

Data type

text

Alias
UMLS CUI [1]
C2347664
HLT Code
Description

HLT Code

Data type

text

Alias
UMLS CUI [1]
C2348972
HLT Term
Description

HLT Term

Data type

text

Alias
UMLS CUI [1]
C2348972
HLGT Code
Description

HLGT Code

Data type

text

Alias
UMLS CUI [1]
C2347089
HLGT Term
Description

HLGT Term

Data type

text

Alias
UMLS CUI [1]
C2347089
SOC Code
Description

SOC Code

Data type

text

Alias
UMLS CUI [1]
C2347091
SOC Term
Description

SOC Term

Data type

text

Alias
UMLS CUI [1]
C2347091
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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
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])
Item
If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one.
text
C0877248 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
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
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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
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
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
C0877248 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1705104 (UMLS CUI [1,3])
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)
Item Group
Genital Infection
C0729552 (UMLS CUI-1)
Item
Was the infection symptomatic?
text
C0729552 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
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
C0729552 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,3])
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
C0020615 (UMLS CUI-1)
Item
Hypoglycemic Event Classification
integer
C0020615 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0020615 (UMLS CUI [1,2])
C0472226 (UMLS CUI [1,3])
C0005802 (UMLS CUI [1,4])
Hours since last meal
Item
Number of hours since the last meal or snack
float
C0877248 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0578574 (UMLS CUI [1,4])
Hours since Study Drug
Item
Number of hours since the last dose of study medication
float
C0877248 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,5])
Hours since Metformin
Item
Number of hours since the last dose of Metformin
float
C0877248 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
C0025598 (UMLS CUI [1,5])
Adjudication Reference ID
Item
Adjudication Reference ID
text
C0680730 (UMLS CUI [1])
LLT Code
Item
LLT Code
text
C2347090 (UMLS CUI [1])
LLT Term
Item
LLT Term
text
C2347090 (UMLS CUI [1])
PT Code
Item
PT Code
text
C2347664 (UMLS CUI [1])
PT Term
Item
PT Term
text
C2347664 (UMLS CUI [1])
HLT Code
Item
HLT Code
text
C2348972 (UMLS CUI [1])
HLT Term
Item
HLT Term
text
C2348972 (UMLS CUI [1])
HLGT Code
Item
HLGT Code
text
C2347089 (UMLS CUI [1])
HLGT Term
Item
HLGT Term
text
C2347089 (UMLS CUI [1])
SOC Code
Item
SOC Code
text
C2347091 (UMLS CUI [1])
SOC Term
Item
SOC Term
text
C2347091 (UMLS CUI [1])
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