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])
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])
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])
Code List
Route of administration
CL Item
intramuscular (6)
CL Item
ear/auricular (7)
CL Item
continuous inhalation (11)
CL Item
swish & spit/swallow (12)
CL Item
peri-articular (19)
CL Item
intraperitoneal (20)
CL Item
intra-arterial (22)
CL Item
intra-urethral (23)
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])
CL Item
Primary Diagnosis (1)
CL Item
For Medical History (2)
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])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
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)
Item
Adverse Event Course
integer
C0877248 (UMLS CUI [1])
Code List
Adverse Event Course
CL Item
Single Episode (1)
Item
Adverse Event Severity
integer
C1710066 (UMLS CUI [1])
Code List
Adverse Event Severity
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])
Item
Requires or prolongs hospitalization?
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Code List
Requires or prolongs hospitalization?
Item
Congenital Anomaly
integer
C1519255 (UMLS CUI [1])
C2826727 (UMLS CUI [2])
Code List
Congenital Anomaly
Item
Life Threatening?
integer
C1517874 (UMLS CUI [1])
Code List
Life Threatening?
Item
Persistent or significant disability / incapacity
integer
C1519255 (UMLS CUI [1])
C0231170 (UMLS CUI [2])
Code List
Persistent or significant disability / incapacity
Item
Other medical importance?
integer
C1519255 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
Code List
Other medical importance?
Item
Action taken with study treatment
integer
C1519255 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
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)
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])
Code List
Drug Treatment required?
Item
Non Medication Therapy
integer
C1519255 (UMLS CUI [1])
Code List
Non Medication Therapy
Item
Relationship to Study Drug
integer
C1519255 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Code List
Relationship to Study Drug
Item
Was the infection symptomatic? (Only UTI/Genital Infection)
integer
C0877248 (UMLS CUI [1])
C0729552 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
Code List
Was the infection symptomatic? (Only UTI/Genital Infection)
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])
Code List
Was the infection confirmed by a laboratory? (Only UTI/Genital Infection)
Item
Hypoglycemic Event Classification
integer
C0877248 (UMLS CUI [1])
C0020615 (UMLS CUI [2])
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])
Code List
Serious Adverse Event reconciled?
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])
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])
Code List
Type of Hospitalization
Item
Reason for Hospitalization
integer
C1519255 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Code List
Reason for Hospitalization
CL Item
Adverse Event (1)
Reason for Hospitalization, Other
Item
If Other, specify
text
C0019993 (UMLS CUI [1])
C0205394 (UMLS CUI [2])