ID

31926

Description

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

Keywords

Versions (1)
  1. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 2018

DOI

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License

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

English

Day 9

1 forms  
  1. StudyEvent: ODM
    1. Day 9
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

12 lead ECG; Start Date

Data type

date

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

12 lead ECG; Ventricular Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Description

12 lead ECG; PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG; QRS complex Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG; QT interval finding

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG; QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

12 lead ECG; result

Data type

integer

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date in time

Data type

date

Alias
UMLS CUI [1]
C0011008
Blood Pressure (sitting)
Description

Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate (sitting)
Description

Heart rate

Data type

text

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Electronically transferred laboratory data - Clinical Chemistry
Description

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date Sample Taken
Description

Clinical Chemistry; Sampling; Date in time

Data type

date

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

Clinical Chemistry; Time

Data type

time

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

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0474523
Date Sample Taken
Description

Hematology finding; Sampling; Date in time

Data type

date

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

Hematology finding; Time

Data type

time

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

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Description

Urinalysis; Sampling; Date in time

Data type

date

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

Urinalysis; Time

Data type

time

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

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Description

Capillary Blood Glucose measurement; Date in time

Data type

date

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

Capillary Blood Glucose measurement; relative time

Data type

text

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

Capillary Blood Glucose measurement; Time

Data type

time

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

Capillary Blood Glucose measurement; Result

Data type

float

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

Capillary Blood Glucose measurement; Unit of measure

Data type

text

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

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
Description

Pharmacodynamics; relative time

Data type

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Data type

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Data type

time

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

Pharmacokinetic aspects; Blood; Sample identification number

Data type

integer

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

Pharmacodynamics - Blood [GLP-1 Total]

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

Pharmacodynamics; relative time

Data type

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Data type

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Data type

time

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

Pharmacokinetic aspects; Blood; Sample identification number

Data type

integer

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

Bioactivity Sampling; Blood

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

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

Data type

text

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

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

Data type

date

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

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

Data type

time

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

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

Data type

integer

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

Pharmacokinetic aspects; Blood (GLP-1 total)

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

Pharmacokinetic aspects; Blood; relative time

Data type

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Data type

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Data type

time

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

Pharmacokinetic aspects; Blood; Sample identification number

Data type

integer

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

Anti-Diabetic Agent Tolerability Scale (ADATS)

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

Antidiabetics; Tolerability Study;Date in Time

Data type

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?
Description

Adverse event; Serious Adverse Event; Hypoglycaemic episode

Data type

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?
Description

Adverse event; Quantity

Data type

integer

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

Adverse events

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
AE page number
Description

Adverse event; Page, Number

Data type

integer

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

Adverse event; row (table), number

Data type

integer

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

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?
Description

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

Data type

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?
Description

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

Data type

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?
Description

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

Data type

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?
Description

Experimental drug; Adverse reaction to drug; Impaired

Data type

text

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

Day 9

1 forms
  1. StudyEvent: ODM
    1. Day 9
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Blood Pressure
Item
Blood Pressure (sitting)
integer
C0005823 (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
201 (1)
CL Item
202 (2)
CL Item
203 (3)
CL Item
204  (4)
CL Item
205 (5)
CL Item
206 (6)
CL Item
207 (7)
CL Item
208 (8)
CL Item
209 (9)
CL Item
210 (10)
CL Item
211 (11)
CL Item
212 (12)
CL Item
213 (13)
CL Item
214 (14)
CL Item
215 (15)
CL Item
216 (16)
CL Item
217 (17)
CL Item
218 (18)
CL Item
219 (19)
CL Item
220 (20)
CL Item
221 (21)
CL Item
222 (22)
CL Item
223 (23)
CL Item
224 (24)
CL Item
225 (25)
CL Item
226 (26)
CL Item
227 (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
0.5hr (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
201 (1)
CL Item
202 (2)
CL Item
203 (3)
CL Item
204  (4)
CL Item
205 (5)
CL Item
206 (6)
CL Item
207 (7)
CL Item
208 (8)
CL Item
209 (9)
CL Item
210 (10)
CL Item
211 (11)
CL Item
212 (12)
CL Item
213 (13)
CL Item
214 (14)
CL Item
215 (15)
CL Item
216 (16)
CL Item
217 (17)
CL Item
218 (18)
CL Item
219 (19)
CL Item
220 (20)
CL Item
221 (21)
CL Item
222 (22)
CL Item
223 (23)
CL Item
224 (24)
CL Item
225 (25)
CL Item
226 (26)
CL Item
227 (27)
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
0.5 hr (Pre-meal) (0.5 hr (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
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)
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
428 (1)
CL Item
429 (2)
CL Item
430 (3)
CL Item
431 (4)
CL Item
432 (5)
CL Item
433 (6)
CL Item
434 (7)
CL Item
435 (8)
CL Item
436 (9)
CL Item
437 (10)
CL Item
438 (11)
CL Item
439 (12)
CL Item
440 (13)
CL Item
441 (14)
CL Item
442 (15)
CL Item
443 (16)
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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