ID

32511

Descripción

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Palabras clave

Versiones (2)
  1. 8/10/18 8/10/18 -
  2. 6/11/18 6/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Inglés

Day 2

1 formularios  
  1. StudyEvent: ODM
    1. Day 2
12-Lead ECG
Descripción

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Descripción

12 lead ECG; Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Ventricular Rate
Descripción

12 lead ECG; Ventricular Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Descripción

12 lead ECG; PR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Descripción

12 lead ECG; QRS complex Duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Descripción

12 lead ECG; QT interval finding

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Descripción

12 lead ECG; QTc Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Descripción

12 lead ECG; result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Descripción

Date in time

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Blood Pressure (sitting) - Systolic
Descripción

Systolic Pressuure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Descripción

Heart rate

Tipo de datos

text

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Electronically transferred laboratory data - Clinical Chemistry
Descripción

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date Sample Taken
Descripción

Clinical Chemistry; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Clinical Chemistry; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Haematology
Descripción

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0474523
Date Sample Taken
Descripción

Hematology finding; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Hematology finding; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Urinalysis
Descripción

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Descripción

Urinalysis; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Urinalysis; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Capillary Blood Glucose
Descripción

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Descripción

Capillary Blood Glucose measurement; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0011008
Planned relative time (e.g. prior to breakfast)
Descripción

Capillary Blood Glucose measurement; relative time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0439564
Time
Descripción

Capillary Blood Glucose measurement; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0040223
Result
Descripción

Capillary Blood Glucose measurement; Result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1274040
Unit
Descripción

Capillary Blood Glucose measurement; Unit of measure

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1519795
Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]
Descripción

Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005767
UMLS CUI-3
C0017725
UMLS CUI-4
C0017687
UMLS CUI-5
C0021641
UMLS CUI-6
C0006558
Planned Relative Time
Descripción

Pharmacodynamics; relative time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0439564
Date Sample Taken
Descripción

Pharmacokinetic aspects; Blood; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Pharmacokinetic aspects; Blood; Sampling; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Sample Number
Descripción

Pharmacokinetic aspects; Blood; Sample identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C1299222
Pharmacodynamics - Blood [GLP-1 Total]
Descripción

Pharmacodynamics - Blood [GLP-1 Total]

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005767
UMLS CUI-3
C0061355
Planned Relative Time
Descripción

Pharmacodynamics; relative time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0439564
Date Sample Taken
Descripción

Pharmacokinetic aspects; Blood; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Pharmacokinetic aspects; Blood; Sampling; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Sample Number
Descripción

Pharmacokinetic aspects; Blood; Sample identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0851347
UMLS CUI [1,2]
C1299222
Bioactivity Sampling; Blood
Descripción

Bioactivity Sampling; Blood

Alias
UMLS CUI-1
C0599112
UMLS CUI-2
C0005834
Planned Relative Time
Descripción

drug biological activity; Collection of blood specimen for laboratory procedure; relative time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0439564
Date Sample Taken
Descripción

drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0040223
Sample Number
Descripción

drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C1299222
Pharmacokinetic aspects; Blood (GLP-1 total)
Descripción

Pharmacokinetic aspects; Blood (GLP-1 total)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031328
UMLS CUI-3
C0061355
Planned Relative Time
Descripción

Pharmacokinetic aspects; Blood; relative time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Descripción

Pharmacokinetic aspects; Blood; Sampling; Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Descripción

Pharmacokinetic aspects; Blood; Sampling; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Descripción

Pharmacokinetic aspects; Blood; Sample identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Anti-Diabetic Agent Tolerability Scale (ADATS)
Descripción

Anti-Diabetic Agent Tolerability Scale (ADATS)

Alias
UMLS CUI-1
C0935929
UMLS CUI-2
C3274448
Current Date
Descripción

Antidiabetics; Tolerability Study;Date in Time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C3274448
UMLS CUI [1,3]
C0011008
Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
Descripción

Adverse event; Serious Adverse Event; Hypoglycaemic episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0745153
How many AEs has the subject reported during the past two days?
Descripción

Adverse event; Quantity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1265611
Adverse events
Descripción

Adverse events

Alias
UMLS CUI-1
C0877248
Adverse Event
Descripción

Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
AE page number
Descripción

Adverse event; Page, Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C0237753
AE row number
Descripción

Adverse event; row (table), number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1552840
UMLS CUI [1,3]
C0237753
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
Descripción

Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet

Alias
UMLS CUI-1
C0935929
UMLS CUI-2
C3274448
UMLS CUI-3
C2349155
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
Descripción

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
Descripción

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
Descripción

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
Descripción

Experimental drug; Adverse reaction to drug; Impaired

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0221099
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Similar models

Day 2

1 formularios
  1. StudyEvent: ODM
    1. Day 2
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Pressuure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
Item Group
Electronically transferred laboratory data - Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry; Sampling; Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Chemistry; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Haematology
C0474523 (UMLS CUI-1)
Hematology finding; Sampling; Date in time
Item
Date Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology finding; Time
Item
Actual Time
time
C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis; Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Capillary Blood Glucose
C0457578 (UMLS CUI-1)
Capillary Blood Glucose measurement; Date in time
Item
Date
date
C0457578 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; relative time
Item
Planned relative time (e.g. prior to breakfast)
text
C0457578 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Time
Item
Time
time
C0457578 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Result
Item
Result
float
C0457578 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Unit
text
C0457578 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Unit of measure
Code List
Unit
CL Item
mmol/L (mmol/L)
CL Item
mg/dL (mg/dL)
Item Group
Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]
C0851347 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
C0017687 (UMLS CUI-4)
C0021641 (UMLS CUI-5)
C0006558 (UMLS CUI-6)
Item
Planned Relative Time
text
C0851347 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Pharmacodynamics; relative time
Code List
Planned Relative Time
CL Item
Predose (Predose)
CL Item
0.5hr (Pre-meal) (0.5hr (Pre-meal))
CL Item
0.75 hr (0.75 hr)
CL Item
1 hr (1 hr)
CL Item
1.5 hr (1.5 hr)
CL Item
2 hr (2 hr)
CL Item
2.5 hr (2.5 hr)
CL Item
3.5 hr (3.5 hr)
CL Item
4.5 hr (Pre-meal) (4.5 hr (Pre-meal))
CL Item
4.75 hr (4.75 hr)
CL Item
5 hr (5 hr)
CL Item
5.5 hr (5.5 hr)
CL Item
6 hr (6 hr)
CL Item
6.5 hr (6.5 hr)
CL Item
7.5 hr (7.5 hr)
CL Item
8.5 hr (8.5 hr)
CL Item
10 hr (10 hr)
CL Item
10.5 hr (Pre-meal) (10.5 hr (Pre-meal))
CL Item
10.75 hr (10.75 hr)
CL Item
11 hr (11 hr)
CL Item
11.5 hr (11.5 hr)
CL Item
12 hr (12 hr)
CL Item
12.5 hr (12.5 hr)
CL Item
13.5 hr (13.5 hr)
CL Item
14.5 hr (14.5 hr)
CL Item
18.5 hr (18.5 hr)
CL Item
24 hr (24 hr)
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0851347 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
301 (1)
CL Item
302 (2)
CL Item
303 (3)
CL Item
304  (4)
CL Item
305 (5)
CL Item
306 (6)
CL Item
307 (7)
CL Item
308 (8)
CL Item
309 (9)
CL Item
310 (10)
CL Item
311 (11)
CL Item
312 (12)
CL Item
313 (13)
CL Item
314 (14)
CL Item
315 (15)
CL Item
316 (16)
CL Item
317 (17)
CL Item
318 (18)
CL Item
319 (19)
CL Item
320 (20)
CL Item
321 (21)
CL Item
322 (22)
CL Item
323 (23)
CL Item
324 (24)
CL Item
325 (25)
CL Item
326 (26)
CL Item
327 (27)
Item Group
Pharmacodynamics - Blood [GLP-1 Total]
C0851347 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0061355 (UMLS CUI-3)
Item
Planned Relative Time
text
C0851347 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Pharmacodynamics; relative time
Code List
Planned Relative Time
CL Item
Predose (Predose)
CL Item
0.75 hr (0.75 hr)
CL Item
1 hr (1 hr)
CL Item
1.5 hr (1.5 hr)
CL Item
2 hr (2 hr)
CL Item
4.5 hr (Pre-meal) (4.5 hr (Pre-meal))
CL Item
4.75 hr (4.75 hr)
CL Item
5.5 hr (5.5 hr)
CL Item
6.5 hr (6.5 hr)
CL Item
10.5 hr (Pre-meal) (10.5 hr (Pre-meal))
CL Item
10.75 hr (10.75 hr)
CL Item
11 hr (11 hr)
CL Item
11.5 hr (11.5 hr)
CL Item
12 hr (12 hr)
CL Item
12.5 hr (12.5 hr)
CL Item
0.5 hr (Pre-meal) (0.5 hr (Pre-meal))
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0851347 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
328 (1)
CL Item
329 (2)
CL Item
330 (3)
CL Item
331 (4)
CL Item
332 (5)
CL Item
333 (6)
CL Item
334 (7)
CL Item
335 (8)
CL Item
336 (9)
CL Item
337 (10)
CL Item
338 (11)
CL Item
339 (12)
CL Item
340 (13)
CL Item
341 (14)
CL Item
342 (15)
CL Item
343 (16)
Item Group
Bioactivity Sampling; Blood
C0599112 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Item
Planned Relative Time
text
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; relative time
Code List
Planned Relative Time
CL Item
Day 9 (Day 9)
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
Item
Date Sample Taken
date
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
Item
Actual Time
time
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
Code List
Sample Number
CL Item
604 (1)
Item Group
Pharmacokinetic aspects; Blood (GLP-1 total)
C0005834 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0061355 (UMLS CUI-3)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; relative time
Code List
Planned Relative Time
CL Item
Predose (Predose)
CL Item
12 hr (12 hr)
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
105 (1)
CL Item
106 (2)
Item Group
Anti-Diabetic Agent Tolerability Scale (ADATS)
C0935929 (UMLS CUI-1)
C3274448 (UMLS CUI-2)
Antidiabetics; Tolerability Study;Date in Time
Item
Current Date
date
C0935929 (UMLS CUI [1,1])
C3274448 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Adverse event; Serious Adverse Event; Hypoglycaemic episode
Item
Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
boolean
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0745153 (UMLS CUI [3])
Adverse event; Quantity
Item
How many AEs has the subject reported during the past two days?
integer
C0877248 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
Adverse events
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse event; Page, Number
Item
AE page number
integer
C0877248 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Adverse event; row (table), number
Item
AE row number
integer
C0877248 (UMLS CUI [1,1])
C1552840 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
C0935929 (UMLS CUI-1)
C3274448 (UMLS CUI-2)
C2349155 (UMLS CUI-3)
Item
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
text
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
undefined item
Code List
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
CL Item
Not at all bothersome (0)
CL Item
A little bothered  (1)
CL Item
Moderately bothered  (2)
CL Item
Quite bothered  (3)
CL Item
Extremely bothered (4)
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