Informações:
Falhas:
ID
17680
Descrição
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
Palavras-chave
Versões (2)
- 22/08/2016 22/08/2016 -
- 28/09/2016 28/09/2016 -
Transferido a
28 de setembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Similar models
Cumulative Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
C0013227 (UMLS CUI [2])
Item
Route of administration
integer
C0013153 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
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])
C0808070 (UMLS CUI [1,2])
StopDate
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Ongoing
Item
Ongoing
boolean
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Dose Units
Item
Dose Units
text
C3174092 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
CL Item
Primary Diagnosis (1)
CL Item
For Medical History (2)
CL Item
For AE (3)
CL Item
Prophylaxis (4)
CL Item
Other (5)
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])
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])
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
Continuous (3)
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])
CL Item
Yes (1)
Item
Requires or prolongs hospitalization?
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0019993 (UMLS CUI [2])
CL Item
Yes (1)
CL Item
Yes (1)
CL Item
Yes (1)
Item
Persistent or significant disability / incapacity
integer
C1519255 (UMLS CUI [1])
C0231170 (UMLS CUI [2])
C0231170 (UMLS CUI [2])
CL Item
Yes (1)
CL Item
Yes (1)
Item
Action taken with study treatment
integer
C1519255 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0949266 (UMLS CUI [2])
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])
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])
C0013216 (UMLS CUI [2])
CL Item
Yes (1)
CL Item
Yes (1)
Item
Relationship to Study Drug
integer
C1519255 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
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])
C0729552 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
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])
C0729552 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
C3244125 (UMLS CUI [4])
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])
C0020615 (UMLS CUI [2])
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])
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])
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])
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])
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])
C0020615 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
CL Item
Yes (1)
CL Item
Reviewed (2)
Adjudication Reference ID
Item
Adjudication Reference ID
text
C0680730 (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])
C0019993 (UMLS CUI [1,2])
Ongoing
Item
Ongoing?
boolean
C0549178 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
Date of Discharge
Item
Date of discharge:
date
C2361123 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
CL Item
Non ICU (1)
CL Item
ICU (2)
Item
Reason for Hospitalization
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0019993 (UMLS CUI [2])
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])
C0205394 (UMLS CUI [2])