ID

17680

Descripción

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes Mellitus Cumulative

Palabras clave

Versiones (2)
  1. 22/8/16 22/8/16 -
  2. 28/9/16 28/9/16 -
Subido en

28 de septiembre de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

Inglés

Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 formularios  
Targeted Medical History
Descripción

Targeted Medical History

Mecial Condition
Descripción

Medical Condition

Tipo de datos

text

Alias
UMLS CUI [1]
C0012634
History
Descripción

Medical History Occurrence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Onset Date
Descripción

Onset Date Medical History

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0262926
Is Medical Condition ongoing?
Descripción

Medical Condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
Currently treated with medication?
Descripción

Medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
Medical History
Descripción

Medical History

Alias
UMLS CUI-1
C0262926
Is there any past or present Medical Condition?
Descripción

medical Condition, past or present

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332119
Medical Condition, specify:
Descripción

Medical Condition

Tipo de datos

text

Alias
UMLS CUI [1]
C0012634
Onset date Medical Condition
Descripción

Onset Date Medical Condition

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
Is Medical Condition ongoing? If no, please provide Recovered Date.
Descripción

Medical Condition Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
Recovered Date
Descripción

Recovery

Tipo de datos

date

Alias
UMLS CUI [1]
C2004454
Currently treated with medication?
Descripción

Medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
Concomitant Medication
Descripción

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Is there any previous medication and/or concomitant medication to record?
Descripción

Concomitant Medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Medication
Descripción

Medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0013227
Route of administration
Descripción

Route of administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
UMLS CUI [2]
C2347852
Start date
Descripción

Start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

StopDate

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0011008
Ongoing
Descripción

Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C2347852
Dose
Descripción

Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C2347852
Dose Units
Descripción

Dose Units

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C2347852
Frequency
Descripción

Frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C3476109
UMLS CUI [2]
C2347852
Indication
Descripción

Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C3146298
UMLS CUI [2]
C2347852
Reason for Use
Descripción

Reason

Tipo de datos

integer

Alias
UMLS CUI [1]
C0392360
UMLS CUI [2]
C2347852
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Was any adverse event reported or observed?
Descripción

Adverse Events

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Events
Descripción

Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Onset Date
Descripción

Adverse Event Onset Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985916
If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one:
Descripción

Adverse Event Onset Date

Tipo de datos

integer

Alias
UMLS CUI [1]
C2985916
Adverse Event End Date
Descripción

Adverse Event End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2697886
Adverse Event Outcome
Descripción

Adverse Event Outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event Course
Descripción

Adverse Event Course

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
Adverse Event Severity
Descripción

Adverse Event Severity

Tipo de datos

integer

Alias
UMLS CUI [1]
C1710066
Serious AE? If seriousness is "yes", tick all that apply
Descripción

Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Serious AE Number
Descripción

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Death?
Descripción

AE Death

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0011065
Requires or prolongs hospitalization?
Descripción

AE Hospital

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0019993
Congenital Anomaly
Descripción

AE Congenital

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C2826727
Life Threatening?
Descripción

AE Life threatening

Tipo de datos

integer

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

AE persistent

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0231170
Other medical importance?
Descripción

AE Other

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0205394
Action taken with study treatment
Descripción

Study treatment

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0949266
Treatment required?
Descripción

Treatment required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1521801
Drug Treatment required?
Descripción

Drug Treatment required

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0013216
Non Medication Therapy
Descripción

Non Medication Therapy

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
Relationship to Study Drug
Descripción

AE Relation to study drug

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0304229
Was the infection symptomatic? (Only UTI/Genital Infection)
Descripción

AE UTI/Genital

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0729552
UMLS CUI [3]
C0042029
Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
Descripción

AE UTI/Genital

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0729552
UMLS CUI [3]
C0042029
UMLS CUI [4]
C3244125
Hypoglycemic Event Classification
Descripción

AE hypoglycemia

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
Was a glucometer reading taken prior to treating the Hypoglycemic Event?
Descripción

AE hypoglycemia glucometer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
UMLS CUI [3]
C0472226
glucometer reading
Descripción

AE hypoglycemia glucometer

Tipo de datos

text

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
UMLS CUI [3]
C0472226
UMLS CUI [4]
C0005802
mmol/L
Number of hours since the last meal/ snack?
Descripción

AE hypoglycemia last meal

Tipo de datos

text

Unidades de medida
  • hours
Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
hours
Number of hours since the last dose of ASP1941 study medication.
Descripción

AE hypoglycemia last meal

Tipo de datos

text

Unidades de medida
  • hours
Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
UMLS CUI [3]
C0013216
hours
Number of hours since the last dose of Metformin study medication.
Descripción

AE hypoglycemia last meal

Tipo de datos

text

Unidades de medida
  • hours
Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0020615
UMLS CUI [3]
C0013216
hours
Serious Adverse Event reconciled?
Descripción

Serious Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
Adjudication Reference ID
Descripción

Adjudication Reference ID

Tipo de datos

text

Alias
UMLS CUI [1]
C0680730
Hospitalization Records
Descripción

Hospitalization Records

Alias
UMLS CUI-1
C0019993
Was the subject hospitalized from the time of First Dose of Randomized Study Drug through Visit 11?
Descripción

Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
Date of admission:
Descripción

Date of admission

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0019993
Ongoing?
Descripción

Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0019993
Date of discharge:
Descripción

Date of Discharge

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C0019993
Type of Hospitalization
Descripción

Type of Hospitalization

Tipo de datos

integer

Alias
UMLS CUI [1]
C0019993
Reason for Hospitalization
Descripción

Reason for Hospitalization

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0019993
If Other, specify
Descripción

Reason for Hospitalization, Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0205394
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Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Targeted Medical History
Medical Condition
Item
Mecial Condition
text
C0012634 (UMLS CUI [1])
Medical History Occurrence
Item
History
boolean
C0262926 (UMLS CUI [1])
Onset Date Medical History
Item
Onset Date
date
C0574845 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Medical Condition
Item
Is Medical Condition ongoing?
boolean
C0012634 (UMLS CUI [1])
Medication
Item
Currently treated with medication?
boolean
C0013227 (UMLS CUI [1])
Item Group
Medical History
C0262926 (UMLS CUI-1)
medical Condition, past or present
Item
Is there any past or present Medical Condition?
boolean
C0012634 (UMLS CUI [1,1])
C0332119 (UMLS CUI [1,2])
Medical Condition
Item
Medical Condition, specify:
text
C0012634 (UMLS CUI [1])
Onset Date Medical Condition
Item
Onset date Medical Condition
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Medical Condition Ongoing
Item
Is Medical Condition ongoing? If no, please provide Recovered Date.
boolean
C0012634 (UMLS CUI [1])
Recovery
Item
Recovered Date
date
C2004454 (UMLS CUI [1])
Medication
Item
Currently treated with medication?
boolean
C0013227 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Is there any previous medication and/or concomitant medication to record?
boolean
C2347852 (UMLS CUI [1])
Medication
Item
Medication
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
Item
Route of administration
integer
C0013153 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Route of administration
Code List
Route of administration
CL Item
oral (1)
CL Item
intravenous (2)
CL Item
topical (3)
CL Item
nasogastric (4)
CL Item
subcutaneous (5)
CL Item
intramuscular (6)
CL Item
ear/auricular (7)
CL Item
ophthalmic (8)
CL Item
sublingual (9)
CL Item
inhaled (10)
CL Item
continuous inhalation (11)
CL Item
swish & spit/swallow (12)
CL Item
intranasal (13)
CL Item
transdermal (14)
CL Item
vaginal (15)
CL Item
rectal (16)
CL Item
epidural (17)
CL Item
intrathecal (18)
CL Item
peri-articular (19)
CL Item
intraperitoneal (20)
CL Item
intradermal (21)
CL Item
intra-arterial (22)
CL Item
intra-urethral (23)
CL Item
unknown (24)
CL Item
other (25)
Start date
Item
Start date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
StopDate
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Ongoing
Item
Ongoing
boolean
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Dose Units
Item
Dose Units
text
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Item
Reason for Use
integer
C0392360 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Reason
Code List
Reason for Use
CL Item
Primary Diagnosis (1)
CL Item
For Medical History (2)
CL Item
For AE (3)
CL Item
Prophylaxis (4)
CL Item
Other (5)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Events
Item
Was any adverse event reported or observed?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Adverse Event Onset Date
Item
Onset Date
date
C2985916 (UMLS CUI [1])
Item
If the AE onset date is the same day as the First Date of Randomized Study Drug, please select one:
integer
C2985916 (UMLS CUI [1])
Adverse Event Onset Date
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)
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event 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
Adverse Event Course
integer
C0877248 (UMLS CUI [1])
Adverse Event Course
Code List
Adverse Event Course
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continuous (3)
Item
Adverse Event Severity
integer
C1710066 (UMLS CUI [1])
Adverse Event Severity
Code List
Adverse Event Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Serious Adverse Event
Item
Serious AE? If seriousness is "yes", tick all that apply
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Serious AE Number
text
C1519255 (UMLS CUI [1])
Item
Death?
integer
C1519255 (UMLS CUI [1])
C0011065 (UMLS CUI [2])
AE Death
Code List
Death?
CL Item
Yes (1)
Item
Requires or prolongs hospitalization?
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
AE Hospital
Code List
Requires or prolongs hospitalization?
CL Item
Yes (1)
Item
Congenital Anomaly
integer
C1519255 (UMLS CUI [1])
C2826727 (UMLS CUI [2])
AE Congenital
Code List
Congenital Anomaly
CL Item
Yes (1)
Item
Life Threatening?
integer
C1517874 (UMLS CUI [1])
AE Life threatening
Code List
Life Threatening?
CL Item
Yes (1)
Item
Persistent or significant disability / incapacity
integer
C1519255 (UMLS CUI [1])
C0231170 (UMLS CUI [2])
AE persistent
Code List
Persistent or significant disability / incapacity
CL Item
Yes (1)
Item
Other medical importance?
integer
C1519255 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
AE Other
Code List
Other medical importance?
CL Item
Yes (1)
Item
Action taken with study treatment
integer
C1519255 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Study treatment
Code List
Action taken with study treatment
CL Item
Dose not changed (1)
CL Item
drup interrupted (2)
CL Item
drug withdrawn (3)
CL Item
Not Applicable (4)
CL Item
Unknown (5)
Treatment required
Item
Treatment required?
boolean
C0332307 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1521801 (UMLS CUI [1,4])
Item
Drug Treatment required?
integer
C1519255 (UMLS CUI [1])
C0013216 (UMLS CUI [2])
Drug Treatment required?
Code List
Drug Treatment required?
CL Item
Yes (1)
Item
Non Medication Therapy
integer
C1519255 (UMLS CUI [1])
Non Medication Therapy
Code List
Non Medication Therapy
CL Item
Yes (1)
Item
Relationship to Study Drug
integer
C1519255 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
AE Relation to study drug
Code List
Relationship to Study Drug
CL Item
Not related (1)
CL Item
possible (2)
CL Item
probable (3)
Item
Was the infection symptomatic? (Only UTI/Genital Infection)
integer
C0877248 (UMLS CUI [1])
C0729552 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
AE UTI/Genital
Code List
Was the infection symptomatic? (Only UTI/Genital Infection)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
integer
C0877248 (UMLS CUI [1])
C0729552 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
C3244125 (UMLS CUI [4])
AE UTI/Genital
Code List
Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Hypoglycemic Event Classification
integer
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
hypoglycemia
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)
AE hypoglycemia glucometer
Item
Was a glucometer reading taken prior to treating the Hypoglycemic Event?
boolean
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
C0472226 (UMLS CUI [3])
AE hypoglycemia glucometer
Item
glucometer reading
text
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
C0472226 (UMLS CUI [3])
C0005802 (UMLS CUI [4])
AE hypoglycemia last meal
Item
Number of hours since the last meal/ snack?
text
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
AE hypoglycemia last meal
Item
Number of hours since the last dose of ASP1941 study medication.
text
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
AE hypoglycemia last meal
Item
Number of hours since the last dose of Metformin study medication.
text
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
Item
Serious Adverse Event reconciled?
integer
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Serious Adverse Event reconciled?
CL Item
Yes (1)
CL Item
Reviewed (2)
Adjudication Reference ID
Item
Adjudication Reference ID
text
C0680730 (UMLS CUI [1])
Item Group
Hospitalization Records
C0019993 (UMLS CUI-1)
Hospitalization
Item
Was the subject hospitalized from the time of First Dose of Randomized Study Drug through Visit 11?
boolean
C0019993 (UMLS CUI [1])
Date of admission
Item
Date of admission:
date
C0011008 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Ongoing
Item
Ongoing?
boolean
C0549178 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Date of Discharge
Item
Date of discharge:
date
C2361123 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item
Type of Hospitalization
integer
C0019993 (UMLS CUI [1])
Type of Hospitalization
Code List
Type of Hospitalization
CL Item
Non ICU (1)
CL Item
ICU (2)
Item
Reason for Hospitalization
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Type of Hospitalization
Code List
Reason for Hospitalization
CL Item
Adverse Event (1)
CL Item
Other (2)
Reason for Hospitalization, Other
Item
If Other, specify
text
C0019993 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
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