ID

41629

Descripción

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Palabras clave

Versiones (2)
  1. 16/11/20 16/11/20 -
  2. 29/11/20 29/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de noviembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Inglés

Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Site
Descripción

Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Subject
Descripción

Subject

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Status
Descripción

Status

Tipo de datos

text

Alias
UMLS CUI [1]
C0449438
Doc#
Descripción

Doc#

Tipo de datos

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Descripción

Is Page Blank?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Study Completion
Descripción

Study Completion

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Date of final contact
Descripción

Date of final contact

Tipo de datos

date

Alias
UMLS CUI [1]
C0805839
Date of last dose
Descripción

Date of last dose

Tipo de datos

date

Alias
UMLS CUI [1]
C1762893
Did subject complete the study?
Descripción

Did subject complete the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348577
Date of discontinuation
Descripción

Date of discontinuation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
If subject did not complete the study, mark ONE reason
Descripción

If subject did not complete the study, mark ONE reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3827242
UMLS CUI [1,2]
C0566251
Specify AE No (Liver chemistry stopping criteria)
Descripción

Specify AE No (Liver chemistry stopping criteria)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0008000
UMLS CUI [3,1]
C2746065
UMLS CUI [3,2]
C0243161
Specify AE No (Adverse event)
Descripción

Specify AE No (Adverse event)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Specify AE No (Severe or repeated occurences of hypoglycaemia)
Descripción

Specify AE No (Severe or repeated occurences of hypoglycaemia)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C0342316
Specify AE No (Occurence of Pancreatitis)
Descripción

Specify AE No (Occurence of Pancreatitis)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C0030305
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Vital Signs (Unscheduled)
Descripción

Vital Signs (Unscheduled)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C3854240
Vital Signs - Repeat or Unscheduled?
Descripción

Vital Signs - Repeat or Unscheduled?

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0205341
UMLS CUI [3]
C3854240
Vital Signs - If Repeat, please specify original period/day
Descripción

Vital Signs - If Repeat, please specify original period/day

Tipo de datos

text

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0205341
UMLS CUI [3]
C2347804
UMLS CUI [4]
C0439228
Vital Signs - Date
Descripción

Vital Signs - Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826644
Vital Signs - Time
Descripción

Vital Signs - Time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Respirations
Descripción

Respirations

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0035203
breaths/min
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs - Body Position
Descripción

Vital Signs - Body Position

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Vital Signs - Comment
Descripción

Vital Signs - Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0947611
Physical Examination (Unscheduled Visit)
Descripción

Physical Examination (Unscheduled Visit)

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C3854240
Date of Physical Exam
Descripción

Date of Physical Exam

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Assessment
Descripción

Assessment

Tipo de datos

integer

Alias
UMLS CUI [1]
C2911685
Electrocardiogram (Unscheduled)
Descripción

Electrocardiogram (Unscheduled)

Alias
UMLS CUI-1
C0013798
UMLS CUI-2
C3854240
Electrocardiogram - Repeat or Unscheduled?
Descripción

Electrocardiogram - Repeat or Unscheduled?

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013798
UMLS CUI [2]
C0205341
UMLS CUI [3]
C3854240
Electrocardiogram - If Repeat, please specify original Period/Day
Descripción

Electrocardiogram - If Repeat, please specify original Period/Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0013798
UMLS CUI [2]
C0205341
UMLS CUI [3]
C2347804
UMLS CUI [4]
C0439228
Electrocardiogram - Date
Descripción

Electrocardiogram - Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
Electrocardiogram - Time
Descripción

Electrocardiogram - Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Electrocardiogram - Heart Rate
Descripción

Electrocardiogram - Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0013798
UMLS CUI [2]
C0018810
bpm
Electrocardiogram - PR Interval
Descripción

Electrocardiogram - PR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
Electrocardiogram - QRS Duration
Descripción

Electrocardiogram - QRS Duration

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0013798
UMLS CUI [2]
C0429025
ms
Electrocardiogram - QT Interval
Descripción

Electrocardiogram - QT Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1287082
ms
Electrocardiogram - Q-TcB Interval
Descripción

Electrocardiogram - Q-TcB Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C1882512
ms
Electrocardiogram - Q-TcF Interval
Descripción

Electrocardiogram - Q-TcF Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C1882513
ms
Electrocardiogram - RR Interval
Descripción

Electrocardiogram - RR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0489636
ms
Electrocardiogram - Normal Sinus Rhythm?
Descripción

Electrocardiogram - Normal Sinus Rhythm?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960147
Overall Interpretation of ECG
Descripción

Overall Interpretation of ECG

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0459471
Electrocardiogram - If abnormal, please specify
Descripción

Electrocardiogram - If abnormal, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2348235
Central Laboratory Blood (Unscheduled)
Descripción

Central Laboratory Blood (Unscheduled)

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C3854240
UMLS CUI-3
C0005767
Central Laboratory Blood
Descripción

Central Laboratory Blood

Tipo de datos

integer

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0005767
Central Laboratory Blood - Repeat or Unscheduled?
Descripción

Central Laboratory Blood - Repeat or Unscheduled?

Tipo de datos

integer

Alias
UMLS CUI [1]
C0205341
UMLS CUI [2]
C0005767
UMLS CUI [3]
C3854240
Central Laboratory Blood - If Repeat, please specify original period/day:
Descripción

Central Laboratory Blood - If Repeat, please specify original period/day:

Tipo de datos

text

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0005767
UMLS CUI [3]
C0205341
UMLS CUI [4]
C2347804
UMLS CUI [5]
C0439228
UMLS CUI [6]
C2348235
Central Laboratory Blood - Sample Date
Descripción

Central Laboratory Blood - Sample Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0005767
UMLS CUI [3]
C1302413
Central Laboratory Blood - Sample Time
Descripción

Central Laboratory Blood - Sample Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0005767
UMLS CUI [3,1]
C0040223
UMLS CUI [3,2]
C0200345
Central Laboratory Blood - Comment
Descripción

Central Laboratory Blood - Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0005767
UMLS CUI [3]
C0947611
Central Laboratory Urine (Unscheduled)
Descripción

Central Laboratory Urine (Unscheduled)

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C3854240
UMLS CUI-3
C0042036
Central Laboratory Urine
Descripción

Central Laboratory Urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0042036
Central Laboratory Urine - Repeat or Unscheduled?
Descripción

Central Laboratory Urine - Repeat or Unscheduled?

Tipo de datos

text

Alias
UMLS CUI [1]
C0205341
UMLS CUI [2]
C0042036
UMLS CUI [3]
C3854240
Central Laboratory Urine - If Repeat, please specify original period/day:
Descripción

Central Laboratory Urine - If Repeat, please specify original period/day:

Tipo de datos

text

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0042036
UMLS CUI [3]
C0205341
UMLS CUI [4]
C2347804
UMLS CUI [5]
C0439228
UMLS CUI [6]
C2348235
Central Laboratory Urine - Sample Date
Descripción

Central Laboratory Urine - Sample Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0042036
UMLS CUI [3]
C1302413
Central Laboratory Urine - Sample Time
Descripción

Central Laboratory Urine - Sample Time

Tipo de datos

time

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0042036
UMLS CUI [3,1]
C0040223
UMLS CUI [3,2]
C0200345
Central Laboratory Urine - Comment
Descripción

Central Laboratory Urine - Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C1880016
UMLS CUI [2]
C0042036
UMLS CUI [3]
C0947611
Hypoglycaemia
Descripción

Hypoglycaemia

Alias
UMLS CUI-1
C0020615
Has the subject experienced any protocol defined hypoglycaemic events?
Descripción

Has the subject experienced any protocol defined hypoglycaemic events?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0745153
UMLS CUI [2]
C2348563
AE/SAE Reference Event Number
Descripción

AE/SAE Reference Event Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0237753
Start date of Event
Descripción

Start date of Event

Tipo de datos

date

Alias
UMLS CUI [1]
C2697888
Start time of Event
Descripción

Start time of Event

Tipo de datos

time

Alias
UMLS CUI [1]
C2697889
End date of Event
Descripción

End date of Event

Tipo de datos

date

Alias
UMLS CUI [1]
C2697886
End time of Event
Descripción

End time of Event

Tipo de datos

time

Alias
UMLS CUI [1]
C2826658
Blood Glucose Test Result at Time of Event (mg/dL)
Descripción

Blood Glucose Test Result at Time of Event (mg/dL)

Tipo de datos

integer

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1]
C0457578
UMLS CUI [2]
C0040223
UMLS CUI [3]
C2697889
mg/dL
Blood Glucose Test Result at Time of Event (mmol/L)
Descripción

Blood Glucose Test Result at Time of Event (mmol/L)

Tipo de datos

integer

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0457578
UMLS CUI [2]
C0040223
UMLS CUI [3]
C2697889
mmol/L
Frequency
Descripción

Frequency

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439603
Severity of hypoglycaemic event: (per ADA working group guidelines)
Descripción

Severity of hypoglycaemic event: (per ADA working group guidelines)

Tipo de datos

integer

Alias
UMLS CUI [1]
C1710066
UMLS CUI [2]
C0745153
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
Descripción

If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:

Tipo de datos

integer

Alias
UMLS CUI [1]
C0205082
Required days of hospitalization
Descripción

Please follow serious adverse event instructions.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C0439228
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
Descripción

Intervention (enter the most severe, enter details on concomitant medication page if applicable)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184661
Action Taken with Background or Anti-Hyperglycemic Medication?
Descripción

Action Taken with Background or Anti-Hyperglycemic Medication?

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826626
Injection Site Reaction
Descripción

Injection Site Reaction

Alias
UMLS CUI-1
C0151735
AE/SAE Number
Descripción

AE/SAE Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0237753
Date of injection
Descripción

Date of injection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021485
Date of Reaction
Descripción

Date of Reaction

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0443286
UMLS CUI [1,2]
C0011008
Size of skin reaction 1. diameter
Descripción

(maximum)

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0221743
UMLS CUI [1,2]
C0456389
UMLS CUI [2]
C1301886
mm
Size of skin reaction 2. diameter
Descripción

(maximum)

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0221743
UMLS CUI [1,2]
C0456389
UMLS CUI [2]
C1301886
mm
Location of injection
Descripción

Location of injection

Tipo de datos

integer

Alias
UMLS CUI [1]
C2700396
Specify other location of injection
Descripción

Specify other location of injection

Tipo de datos

text

Alias
UMLS CUI [1]
C2700396
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Was this local reaction within 24 hrs of dose?
Descripción

Was this local reaction within 24 hrs of dose?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853813
UMLS CUI [2]
C0178602
Check all that apply regarding local reaction symptoms:
Descripción

Check all that apply regarding local reaction symptoms:

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853813
Specify other symptoms
Descripción

Specify other symptoms

Tipo de datos

text

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Was treatment given for this local reaction?
Descripción

If Yes, please record all treatments on the Concomitant Medications/Non-drug Therapies eCRF

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853813
UMLS CUI [2]
C0087111
Serum sample obtained?
Descripción

Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1-mL serum samples obtained for immunogenicity testing.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0229671
UMLS CUI [2]
C0200345
Provide date sample obtained
Descripción

Provide date sample obtained

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
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Similar models

Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Completion
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of final contact
Item
Date of final contact
date
C0805839 (UMLS CUI [1])
Date of last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Did subject complete the study?
Item
Did subject complete the study?
boolean
C2348577 (UMLS CUI [1])
Date of discontinuation
Item
Date of discontinuation
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If subject did not complete the study, mark ONE reason
integer
C3827242 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
If subject did not complete the study, mark ONE reason
Code List
If subject did not complete the study, mark ONE reason
CL Item
Liver chemistry stopping criteria (specify AE No) (1)
CL Item
Adverse event (specify AE No) (2)
CL Item
Severe or repeated occurences of hypoglycaemia (specify AE No) (3)
CL Item
Occurence of Pancreatitits (AE No) (4)
CL Item
Consent withdrawn (5)
CL Item
Lost to Follow-Up (6)
CL Item
Protocol violation (7)
CL Item
Noncompliance with study visit schedule (8)
CL Item
Termination of study by sponsor (9)
CL Item
Pregnancy (10)
CL Item
Other (specify in comments) (11)
Specify AE No (Liver chemistry stopping criteria)
Item
Specify AE No (Liver chemistry stopping criteria)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0023884 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Specify AE No (Adverse event)
Item
Specify AE No (Adverse event)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE No (Severe or repeated occurences of hypoglycaemia)
Item
Specify AE No (Severe or repeated occurences of hypoglycaemia)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0342316 (UMLS CUI [2])
Specify AE No (Occurence of Pancreatitis)
Item
Specify AE No (Occurence of Pancreatitis)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vital Signs (Unscheduled)
C0518766 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Vital Signs - Repeat or Unscheduled?
integer
C0518766 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
Repeat or Unscheduled?
Code List
Vital Signs - Repeat or Unscheduled?
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Vital Signs - If Repeat, please specify original period/day
Item
Vital Signs - If Repeat, please specify original period/day
text
C0518766 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
Vital Signs - Date
Item
Vital Signs - Date
date
C2826644 (UMLS CUI [1])
Vital Signs - Time
Item
Vital Signs - Time
time
C2826762 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Respirations
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Vital Signs - Body Position
integer
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Body Position
Code List
Vital Signs - Body Position
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Vital Signs - Comment
Item
Vital Signs - Comment
text
C0518766 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Item Group
Physical Examination (Unscheduled Visit)
C0031809 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Date of Physical Exam
Item
Date of Physical Exam
date
C2826643 (UMLS CUI [1])
Item
Assessment
integer
C2911685 (UMLS CUI [1])
Assessment
Code List
Assessment
CL Item
Skin including Injection Site (1)
CL Item
Head, Eyes, Ears, Nose, Throat (2)
CL Item
Thyroid (3)
CL Item
Central Nervous System (4)
CL Item
Respiratory System (5)
CL Item
Cardiovascular System (6)
CL Item
Abdomen (Liver and Spleen) (7)
CL Item
Lymph Nodes (8)
CL Item
Extremities (9)
CL Item
Other (10)
Item Group
Electrocardiogram (Unscheduled)
C0013798 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Electrocardiogram - Repeat or Unscheduled?
integer
C0013798 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
Electrocardiogram - Repeat or Unscheduled?
Code List
Electrocardiogram - Repeat or Unscheduled?
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Electrocardiogram - If Repeat, please specify original Period/Day
Item
Electrocardiogram - If Repeat, please specify original Period/Day
text
C0013798 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
Electrocardiogram - Date
Item
Electrocardiogram - Date
date
C2826640 (UMLS CUI [1])
Electrocardiogram - Time
Item
Electrocardiogram - Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Electrocardiogram - Heart Rate
Item
Electrocardiogram - Heart Rate
integer
C0013798 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Electrocardiogram - PR Interval
Item
Electrocardiogram - PR Interval
integer
C0429087 (UMLS CUI [1])
Electrocardiogram - QRS Duration
Item
Electrocardiogram - QRS Duration
integer
C0013798 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
Electrocardiogram - QT Interval
Item
Electrocardiogram - QT Interval
integer
C0013798 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Electrocardiogram - Q-TcB Interval
Item
Electrocardiogram - Q-TcB Interval
integer
C0429087 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])
Electrocardiogram - Q-TcF Interval
Item
Electrocardiogram - Q-TcF Interval
integer
C0429087 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Electrocardiogram - RR Interval
Item
Electrocardiogram - RR Interval
integer
C0013798 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])
Electrocardiogram - Normal Sinus Rhythm?
Item
Electrocardiogram - Normal Sinus Rhythm?
boolean
C1960147 (UMLS CUI [1])
Item
Overall Interpretation of ECG
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
Overall Interpretation of ECG
Code List
Overall Interpretation of ECG
CL Item
Normal (1)
CL Item
Abnormal; Not Clinically Significant (2)
CL Item
Abnormal; Clinically Significant (3)
Electrocardiogram - If abnormal, please specify
Item
Electrocardiogram - If abnormal, please specify
text
C0522055 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Central Laboratory Blood (Unscheduled)
C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
Item
Central Laboratory Blood
integer
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
Central Laboratory
Code List
Central Laboratory Blood
CL Item
Haematology (1)
CL Item
Chemistry (2)
CL Item
Serology (3)
CL Item
Serum HCG (4)
CL Item
SP Chem (5)
Item
Central Laboratory Blood - Repeat or Unscheduled?
integer
C0205341 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
Repeat or Unscheduled?
Code List
Central Laboratory Blood - Repeat or Unscheduled?
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Central Laboratory Blood - If Repeat, please specify original period/day:
Item
Central Laboratory Blood - If Repeat, please specify original period/day:
text
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
Central Laboratory Blood - Sample Date
Item
Central Laboratory Blood - Sample Date
date
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
Central Laboratory Blood - Sample Time
Item
Central Laboratory Blood - Sample Time
time
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Central Laboratory Blood - Comment
Item
Central Laboratory Blood - Comment
text
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item Group
Central Laboratory Urine (Unscheduled)
C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
Item
Central Laboratory Urine
integer
C1880016 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Central Laboratory Urine
Code List
Central Laboratory Urine
CL Item
UA (1)
CL Item
UDS (2)
CL Item
Urine HCG (3)
CL Item
Urine Chem (4)
Central Laboratory Urine - Repeat or Unscheduled?
Item
Central Laboratory Urine - Repeat or Unscheduled?
text
C0205341 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
Central Laboratory Urine - If Repeat, please specify original period/day:
Item
Central Laboratory Urine - If Repeat, please specify original period/day:
text
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
Central Laboratory Urine - Sample Date
Item
Central Laboratory Urine - Sample Date
date
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
Central Laboratory Urine - Sample Time
Item
Central Laboratory Urine - Sample Time
time
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Central Laboratory Urine - Comment
Item
Central Laboratory Urine - Comment
text
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item Group
Hypoglycaemia
C0020615 (UMLS CUI-1)
Has the subject experienced any protocol defined hypoglycaemic events?
Item
Has the subject experienced any protocol defined hypoglycaemic events?
boolean
C0745153 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
AE/SAE Reference Event Number
Item
AE/SAE Reference Event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Start date of Event
Item
Start date of Event
date
C2697888 (UMLS CUI [1])
Start time of Event
Item
Start time of Event
time
C2697889 (UMLS CUI [1])
End date of Event
Item
End date of Event
date
C2697886 (UMLS CUI [1])
End time of Event
Item
End time of Event
time
C2826658 (UMLS CUI [1])
Blood Glucose Test Result at Time of Event (mg/dL)
Item
Blood Glucose Test Result at Time of Event (mg/dL)
integer
C0457578 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
Blood Glucose Test Result at Time of Event (mmol/L)
Item
Blood Glucose Test Result at Time of Event (mmol/L)
integer
C0457578 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
Item
Frequency
integer
C0439603 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Severity of hypoglycaemic event: (per ADA working group guidelines)
integer
C1710066 (UMLS CUI [1])
C0745153 (UMLS CUI [2])
Severity of hypoglycaemic event: (per ADA working group guidelines)
Code List
Severity of hypoglycaemic event: (per ADA working group guidelines)
CL Item
Severe (1)
CL Item
Documented Symptomatic (2)
CL Item
Asymptomatic (3)
CL Item
Probable Symptomatic (4)
CL Item
Relative (5)
CL Item
Not Applicable (6)
Item
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
integer
C0205082 (UMLS CUI [1])
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
Code List
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
CL Item
Assistance provided to the subject by a non-healthcare professional (e.g., relative, or non-relative) at the location of the hypoglycemic event. (1)
CL Item
Assistance provided to the subject by a healthcare professional (i.e., a nurse, physician, or emergency medical service was contacted and responded) at the location of the hypoglycemic event. (2)
CL Item
Event required an unscheduled visit to the investigator (but did not require hospitalization). (3)
CL Item
Event required a visit to another healthcare professional (but did not require hospitalization). (4)
CL Item
The event required a visit to the emergency room. (5)
CL Item
The subject required hospitalization (6)
Required days of hospitalization
Item
Required days of hospitalization
integer
C0019993 (UMLS CUI [1])
C0439228 (UMLS CUI [2])
Item
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
integer
C0184661 (UMLS CUI [1])
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
Code List
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
CL Item
None (1)
CL Item
Minor; Adminstered sugary drinks or sweets (2)
CL Item
Immediate; glucose drinks or suppliments (3)
CL Item
Extensive; glucose injection/ infusion/ glucagon (4)
Item
Action Taken with Background or Anti-Hyperglycemic Medication?
integer
C2826626 (UMLS CUI [1])
Action Taken with Background or Anti-Hyperglycemic Medication?
Code List
Action Taken with Background or Anti-Hyperglycemic Medication?
CL Item
Yes (If yes, please update Anti-Hyperglycemic Medications page) (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item Group
Injection Site Reaction
C0151735 (UMLS CUI-1)
AE/SAE Number
Item
AE/SAE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Date of injection
Item
Date of injection
date
C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
Date of Reaction
Item
Date of Reaction
date
C0443286 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Size of skin reaction 1. diameter
Item
Size of skin reaction 1. diameter
integer
C0221743 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
Size of skin reaction 2. diameter
Item
Size of skin reaction 2. diameter
integer
C0221743 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
Item
Location of injection
integer
C2700396 (UMLS CUI [1])
Location of injection
Code List
Location of injection
CL Item
Left abdomen (1)
CL Item
Right abdomen (2)
CL Item
Other, specify (3)
Specify other location of injection
Item
Specify other location of injection
text
C2700396 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Was this local reaction within 24 hrs of dose?
Item
Was this local reaction within 24 hrs of dose?
boolean
C0853813 (UMLS CUI [1])
C0178602 (UMLS CUI [2])
Item
Check all that apply regarding local reaction symptoms:
integer
C1457887 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])
Check all that apply regarding local reaction symptoms:
Code List
Check all that apply regarding local reaction symptoms:
CL Item
Redness/ Erythema Mild (1)
CL Item
Redness/ Erythema Moderate (2)
CL Item
Redness/ Erythema Severe (3)
CL Item
Itching/ Prutitus Mild (4)
CL Item
Itching/ Prutitus Moderate (5)
CL Item
Itching/ Prutitus Severe (6)
CL Item
Raised Mild (7)
CL Item
Raised Moderate (8)
CL Item
Raised Severe (9)
CL Item
Warmth Mild (10)
CL Item
Warmth Moderate (11)
CL Item
Warmth Severe (12)
CL Item
Other symptoms Mild (13)
CL Item
Other symptoms Moderate (14)
CL Item
Other symptoms Severe (15)
Specify other symptoms
Item
Specify other symptoms
text
C1457887 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Was treatment given for this local reaction?
Item
Was treatment given for this local reaction?
boolean
C0853813 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Serum sample obtained?
Item
Serum sample obtained?
boolean
C0229671 (UMLS CUI [1])
C0200345 (UMLS CUI [2])
Provide date sample obtained
Item
Provide date sample obtained
date
C1302413 (UMLS CUI [1])
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